Venlalic Xl 75mg Prolonged-Release Tablets
Axyantapid XL 75 mg prolonged-release tablets
(venlafaxine hydrochloride)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions please ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
• The name of your medicine is Axyantapid XL 75 mg prolonged-release tablets but will be referred to as Axyantapid XL throughout the remainder of this leaflet.
• Axyantapid XL is also available in other strengths.
What is in this leaflet:
1) What Axyantapid XL is and what it is used for
2) What you need to know before you take Axyantapid XL
3) How to take Axyantapid XL
4) Possible side effects
5) How to store Axyantapid XL
6) Contents of the pack and other information
1) WHAT AXYANTAPID XL IS AND WHAT IT IS USED FOR
Axyantapid XL is an antidepressant that belongs to a group of medicines called serotonin and norepinephrine reuptake inhibitors (SNRIs). This group of medicines is used to treat depression and other conditions such as anxiety disorders. It is thought that people who are depressed and/or anxious have lower levels of serotonin and noradrenaline in the brain. It is not fully understood how antidepressants work, but they may help by increasing the levels of serotonin and noradrenaline in the brain.
Axyantapid XL is a treatment for adults with depression and panic disorder (panic attacks). Treating depression or anxiety disorders properly is important to help you get better. If it is not treated, your condition may not go away and may become more serious and more difficult to treat.
2) WHAT YOU NEED TO KNOW BEFORE YOU TAKE AXYANTAPID XL
Do not take Axyantapid XL
• If you are allergic to venlafaxine or any of the other ingredients of this medicine (listed in section 6).
• If you are also taking or have taken any time within the last 14 days any medicines known as irreversible monoamine oxidase inhibitors (MAOIs), used to treat depression or Parkinson's disease. Taking an irreversible MAOI together with Axyantapid XL, can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop taking Axyantapid XL before you take any MAOI (see also the sections entitled “Taking other medicines” and the information in that section about “Serotonin syndrome”).
Warnings and precautions
Talk to your doctor before taking Axyantapid XL
• If you use other medicines that taken concomitantly with Axyantapid XL could increase the risk of developing serotonin syndrome (see the section “Taking other medicines”).
• If you have a swallowing, stomach or intestinal disorder that reduces your ability to swallow or pass foods by normal bowel movements.
• If you have eye problems, such as certain kinds of glaucoma (increased pressure in the eye).
• If you have a history of high blood pressure.
• If you have a history of heart problems.
• If you have a history of fits (seizures).
• If you have a history of low sodium levels in your blood (hyponatraemia).
• If you have a tendency to develop bruises or a tendency to bleed easily (history of bleeding disorders), or if you are taking other medicines that may increase the risk of bleeding e.g. warfarin (used to prevent blood clots).
• If your cholesterol levels get higher.
• If you have a history of, or if someone in your family has had, mania or bipolar disorder (feeling over-excited or euphoric).
• If you have a history of aggressive behaviour.
Axyantapid XL may cause a sensation of restlessness or an inability to sit or stand still during the first few weeks of treatment. You should tell your doctor if this happens to you.
If any of these conditions apply to you, please talk with your doctor before taking Axyantapid XL.
Thoughts of suicide and worsening of your depression or feelings of anxiety
If you are depressed and/or have anxiety disorders, you can sometimes have thoughts of harming or killing yourself. These may be increased when you first start taking antidepressants, since these medicines all take time to work, usually about two weeks, but sometimes longer.
You may be more likely to think like this:
• If you have previously had thoughts about killing yourself or harming yourself.
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in young adults (less than 25 years old) with psychiatric conditions who were treated with an antidepressant.
If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.
Dry mouth
Dry mouth is reported in 10 % of patients treated with venlafaxine. This may increase the risk of caries. Therefore, you should take special care in your dental hygiene.
Diabetes
Your blood glucose levels may be altered due to Axyantapid XL. Therefore, the dosages of your diabetes medicines may need to be adjusted.
Use in children and adolescents under 18 years of age
Axyantapid XL should normally not be used for children and adolescents under 18 years. Also, you should know that patients under 18 have an increased risk of side effects, such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. Despite this, your doctor may prescribe this medicine for patients under 18 because he/she decides that this is in their best interests.
If your doctor has prescribed Axyantapid XL for a patient under 18, and you want to discuss this, please go back to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking Axyantapid XL. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of Axyantapid XL in this age group has not yet been demonstrated.
Other medicines and Axyantapid XL
Tell your doctor or pharmacist if you are taking, or have recently taken any other medicines.
Your doctor should decide whether you can take Axyantapid XL with other medicines.
Do not start or stop taking any medicines, including those bought without a prescription, natural and herbal remedies, before checking with your doctor or pharmacist.
• Monoamine oxidase inhibitors which are used to treat depression or Parkinson's disease must not be taken with Axyantapid XL. Tell your doctor if you have taken these medicines within the last 14 days. (MAOIs: see the section “Before you take Axyantapid XL”).
• Serotonin syndrome:
Serotonin syndrome, a potentially life-threatening condition (see the section “Possible Side Effects”), may occur with venlafaxine treatment, particularly when taken with other medicines.
Examples of these medicines include:
• Triptans (used for migraine)
• Medicines to treat depression, for instance SNRI, SSRIs, tricyclics, or medicines containing lithium
• Medicines containing linezolid, an antibiotic (used to treat infections)
• Medicines containing moclobemide, a reversible MAOI (used to treat depression)
• Medicines containing sibutramine (used for weight loss)
• Medicines containing tramadol (a pain-killer)
• Medicines containing methylene blue (used to treat high levels of methaemoglobin in the blood)
• Products containing St. John's Wort (also called Hypericum perforatum, a natural or herbal remedy used to treat mild depression)
• Products containing tryptophan (used for problems such as sleep and depression)
• Antipsychotics (used to treat a disease with symptoms such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, unclear reasoning and becoming withdrawn)
Signs and symptoms of serotonin syndrome may include a combination of the following:
restlessness, hallucinations, loss of coordination, fast heart beat, increased body temperature, fast changes in blood pressure, overactive reflexes, diarrhoea, coma, nausea, vomiting.
In its most severe form, serotonin syndrome can resemble Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, fast heart beat, sweating, severe muscle stiffness, confusion, increased muscle enzymes (determined by a blood test).
Tell your doctor immediately, or go to the casualty department at your nearest hospital if you think serotonin syndrome is happening to you
The following medicines may also interact with Axyantapid XL and should be used with caution. It is especially important to mention to your doctor or pharmacist if you are taking medicines containing:
• Ketoconazole, Itraconazole, Voriconazole, Posaconazole (antifungal medicines)
• Clarithromycin, telithromycin (antibiotics used to treat infections)
• Atazanavir, indinavir, nelfinavir, ritonavir, saquinavir (used to treat HIV infection)
• Haloperidol or risperidone (to treat psychiatric conditions)
• Metoprolol (a beta blocker to treat high blood pressure and heart problems)
Axyantapid XL with food, drink and alcohol
Axyantapid XL should be taken with food (see section 3 “How to take Axyantapid XL”).
You should avoid alcohol while you are taking Axyantapid XL.
Pregnancy, breast-feeding and fertility
Tell your doctor if you become pregnant, or you are trying to become pregnant. You should use Axyantapid XL only after discussing the potential benefits and the potential risks to your unborn child with your doctor.
Make sure your midwife and/or doctor knows you are on Axyantapid XL. When taken during pregnancy, similar drugs (SSRIs) may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and appear bluish. These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your baby you should contact your midwife and/or doctor immediately.
If you are taking Axyantapid XL during pregnancy, let your midwife and/or doctor know, as your baby might have some symptoms when it is born. These symptoms usually begin during the first 24 hours after the baby is born. They include irritability, tremor, hypotonia, constant crying, sleeping difficulties and, not feeding properly. If your baby has these symptoms when it is born and you are concerned, contact your doctor and/or midwife who will be able to advise you.
Venlafaxine passes into breast milk. There is a risk of an effect on the baby, which may cause symptoms such as crying, irritabilty and abnormal sleep patterns. Symptoms consistent with venlafaxine drug discontinuation can also occur after stopping breast-feeding. Therefore, you should discuss the matter with your doctor, and he/she will decide whether you should stop breast-feeding or stop the therapy with Axyantapid XL.
Driving and using machines
Do not drive or use any tools or machines until you know how Axyantapid XL affects you.
Important information about some of the ingredients of Axyantapid XL
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
POM
3) HOW TO TAKE AXYANTAPID XL
Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual recommended starting dose for treatment of depression and social anxiety disorder is 75 mg per day. The dose can be raised by your doctor gradually, and if needed, even up to a maximum dose of 375 mg daily for depression. The maximum dose for social anxiety disorder is 225 mg/day.
Take Axyantapid XL at approximately the same time each day, either in the morning or in the evening. Tablets must be swallowed whole with fluid and not opened, crushed, chewed or dissolved.
Axyantapid XL should be taken with food.
If you have liver or kidney problems, talk to your doctor, since your dose of Axyantapid XL may need to be different.
Do not stop taking Axyantapid XL without talking to your doctor (see the section “If you stop taking Axyantapid XL”).
If you take more Axyantapid XL than you should
Call your doctor or pharmacist immediately if you take more than the amount of Axyantapid XL prescribed by your doctor.
The symptoms of a possible overdose may include a rapid heart beat, changes in level of alertness (ranging from sleepiness to coma), blurred vision, seizures or fits, and vomiting.
If you forget to take Axyantapid XL
If you miss a dose, take it as soon as you remember. However, if it is time for your next dose, skip the missed dose and take only a single dose as usual. Do not take more than the daily amount of Axyantapid XL that has been prescribed for you in one day.
If you stop taking Axyantapid XL
Do not stop taking your treatment or reduce the dose without the advice of your doctor even if you feel better. If your doctor thinks that you no longer need Axyantapid XL, he/she may ask you to reduce your dose slowly before stopping treatment altogether. Side effects are known to occur when people stop using Axyantapid XL, especially when Axyantapid XL is stopped suddenly or the dose is reduced too quickly. Some patients may experience symptoms such as tiredness, dizziness, light-headedness, headache, sleeplessness, sensation that everything around you is spinning or moving (vertigo), nightmares, dry mouth, loss of appetite, nausea, diarrhoea, nervousness, agitation, confusion, ringing in the ears, tingling or rarely electric shock sensations, weakness, sweating, seizures, or flu-like symptoms.
Your doctor will advise you on how you should gradually discontinue Axyantapid XL treatment. If you experience any of these or other symptoms that are troublesome, ask your doctor for further advice.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4) POSSIBLE SIDE EFFECTS
Like all medicines, Axyantapid XL can cause side effects, although not everybody gets them.
Do not be concerned if you see a tablet in your stools after taking Axyantapid XL. As the tablet travels the length of your gastrointestinal tract, venlafaxine is slowly released. The shape of the tablet remains undissolved and is eliminated in your stools. Therefore, even though you may see a tablet in your stools, your dose of venlafaxine has been absorbed.
Allergic reactions
If any of the following happen, do not take more Axyantapid XL. Tell your doctor immediately, or go to the casualty department at your nearest hospital:
• Chest tightness, wheezing, trouble swallowing or breathing
• Swelling of the face, throat, hands, or feet
• Feeling nervous or anxious, dizziness, throbbing sensations, sudden reddening of the skin and/or a warm feeling
• Severe rash, itching, or hives (elevated patches of red or pale skin that often itch)
• Signs and symptoms of serotonin syndrome which may include restlessness, hallucinations, loss of coordination, fast heart beat, increased body temperature, fast changes in blood pressure, overactive reflexes, diarrhoea, coma, nausea, vomiting.
In its most severe form, serotonin syndrome can resemble Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, fast heart beat, sweating, severe muscle stiffness, confusion, increased muscle enzymes (determined by a blood test).
Other side effects that you should tell your doctor about include:
• Coughing, wheezing, shortness of breath and a high temperature
• Black (tarry) stools or blood in stools
• Yellow skin or eyes, itchiness or dark urine, which may be symptoms of inflammation of the liver (hepatitis)
• Heart problems, such as fast or irregular heart rate, increased blood pressure
• Eye problems, such as blurred vision, dilated pupils
• Nerve problems, such as dizziness, pins and needles, movement disorder, seizures or fits
• Psychiatric problems, such as hyperactivity and euphoria (feeling unusually overexcited)
• Withdrawal effects (see the section “How to take Axyantapid XL, if you stop taking Axyantapid XL”)
• Prolonged bleeding - if you cut or injure yourself, it may take slightly longer than usual for bleeding to stop
Complete side effect listing
Very common (may affect more than 1 in 10 people)
• Dizziness; headache
• Nausea; dry mouth
• Sweating (including night sweats)
Common (may affect up to 1 in 10 people)
• Appetite decreased
• Confusion; feeling separated (or detached) from yourself; lack of orgasm; decreased libido
• nervousness; insomnia; abnormal dreams
• Drowsiness; tremor; pins and needles; increased muscle tonus
• Visual disturbance including blurred vision; dilated pupils; inability of the eye to automatically change focus from distant to near objects
• Ringing in the ears (tinnitus)
• Palpitations
• Increase in blood pressure; flushing
• Yawning
• Vomiting; constipation; diarrhoea
• Increased frequency in urination; difficulties passing urine
• Menstrual irregularities such as increased bleeding or increased irregular bleeding; abnormal ejaculation/orgasm (males); erectile dysfunction (impotence)
• Weakness (asthenia); fatigue; chills
• Increased cholesterol
Uncommon (may affect up to 1 in 100 people)
• Hallucinations; feeling separated (or detached) from reality; agitation; abnormal orgasm (females); lack of feeling or emotion; feeling overexcited; grinding of the teeth
• A sensation of restlessness or an inability to sit or stand still; fainting; involuntary movements of the muscles; impaired coordination and balance; altered taste sensation
• Fast heartbeat; feeling dizzy (particularly when standing up too quickly)
• Vomiting blood, black tarry stools (faeces) or blood in stools; which can be a sign of internal bleeding
• General swelling of the skin especially the face, mouth, tongue, throat area or hands and feet and/or a raised itchy rash (hives) may be present; sensitivity to sunlight; bruising; rash; abnormal hair loss
• Inability to pass urine
• Weight gain; weight loss
Rare (may affect up to 1 in 1,000 people)
• Seizures or fits
• Inability to control urination
• Over activity, racing thoughts and decreased need for sleep (mania)
Not known (frequency cannot be estimated from the available data)
• Reduced number of platelets in your blood, leading to an increased risk of bruising or bleeding; blood disorders which may lead to an increased risk of infection
• Swollen face or tongue, shortness of breath or difficulty breathing, often with skin rashes (this may be a serious allergic reaction)
• Excessive water intake (known as SIADH)
• Decrease in blood sodium levels
• Suicidal ideation and suicidal behaviours; cases of suicidal ideation and suicidal behaviours have been reported during venlafaxine therapy or early after treatment discontinuation (see section 2, Before you take Axyantapid XL)
• Disorientation and confusion often accompanied by hallucination (delirium); aggression
• A high temperature with rigid muscles, confusion or agitation, and sweating, or if you experience jerky muscle movements which you can't control, these may be symptoms of serious conditions known as neuroleptic malignant syndrome; euphoric feelings, drowsiness, sustained rapid eye movement, clumsiness, restlessness, feeling of being drunk, sweating or rigid muscles, which are symptoms of serotonin syndrome; stiffness, spasms and involuntary movements of the muscles
• Severe eye pain and decreased or blurred vision
• Vertigo
• Decrease in blood pressure; abnormal, rapid or irregular heart beat, which could lead to fainting; unexpected bleeding, e.g. bleeding gums, blood in the urine or in vomit, or the appearance of unexpected bruises or broken blood vessels (broken veins)
• Coughing, wheezing, shortness of breath and a high temperature, which are symptoms of inflammation of the lungs associated with an increase in white blood cells (pulmonary eosinophilia)
• Severe abdominal or back pains (which could indicate a serious problem in the gut, liver or pancreas)
• Itchiness, yellow skin or eyes, dark urine, or flu-like symptoms, which are symptoms of inflammation of the liver (hepatitis); slight changes in blood levels of liver enzymes
• Skin rash, which may lead to severe blistering and peeling of the skin; itching; mild rash
• Unexplained muscle pain, tenderness or weakness (rhabdomyolysis)
• Abnormal breast milk production
Axyantapid XL sometimes causes unwanted effects that you may not be aware of, such as increases in blood pressure or abnormal heart beat; slight changes in blood levels or liver enzymes, sodium or cholesterol. More rarely, Axyantapid XL may reduce the function of platelets in your blood, leading to an increased risk of bruising or bleeding. Therefore, your doctor may wish to do blood tests occasionally, particularly if you have been taking Axyantapid XL for a long time.
If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.
5) HOW TO STORE AXYANTAPID XL
• Keep out of the sight and reach of children.
• Do not use Axyantapid XL after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
• Do not store above 30C.
• Store in the original package in order to protect from moisture.
• If the tablets become discoloured or show any sign of deterioration return them to your pharmacist.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6) CONTENTS OF THE PACK AND OTHER INFORMATION
What Axyantapid XL contains
Each prolonged-release tablet contains 75 mg venlafaxine (as hydrochloride).
The other ingredients are:
Core: Mannitol, Povidone K-90, Macrogol 400, Microcrystalline cellulose, Colloidal anhydrous silica, Magnesium stearate.
Coating: Cellulose acetate, Cellulose acetate 320s, Cellulose acetate 398-10, Macrogol 400, Opadry Y 30 18037 (hypromellose, lactose monohydrate, titanium dioxide (E171) and triacetin)
What Axyantapid XL looks like and contents of the pack
Axyantapid XL 75 mg prolonged-release tablets are white, round, biconvex tablets with a laser hole on one side.
Axyantapid XL 75 mg prolonged-release tablets are available in packs of 28 tablets.
Manufacturer
Laboratorios LICONSA, S.A., Avda. Miralcampo, No 7, Pollgono Industrial Miralcampo, 19200 Azuqueca de Henares, Spain
Procured from within the EU by Product Licence holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall WS9 8ER
Repackaged by XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX PL 33532/0466
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions please ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
• The name of your medicine is Axydepitab XL 75 mg prolonged-release tablets but will be referred to as Axydepitab XL throughout the remainder of this leaflet.
• Axydepitab XL is also available in other strengths.
What is in this leaflet:
1) What Axydepitab XL is and what it is used for
2) What you need to know before you take Axydepitab XL
3) How to take Axydepitab XL
4) Possible side effects
5) How to store Axydepitab XL
6) Contents of the pack and other information
1) WHAT AXYDEPITAB XL IS AND WHAT IT IS USED FOR
Axydepitab XL is an antidepressant that belongs to a group of medicines called serotonin and norepinephrine reuptake inhibitors (SNRIs). This group of medicines is used to treat depression and other conditions such as anxiety disorders. It is thought that people who are depressed and/or anxious have lower levels of serotonin and noradrenaline in the brain. It is not fully understood how antidepressants work, but they may help by increasing the levels of serotonin and noradrenaline in the brain.
Axydepitab XL is a treatment for adults with depression and panic disorder (panic attacks). Treating depression or anxiety disorders properly is important to help you get better. If it is not treated, your condition may not go away and may become more serious and more difficult to treat.
2) WHAT YOU NEED TO KNOW BEFORE YOU TAKE AXYDEPITAB XL
Do not take Axydepitab XL
• If you are allergic to venlafaxine or any of the other ingredients of this medicine (listed in section 6).
• If you are also taking or have taken any time within the last 14 days any medicines known as irreversible monoamine oxidase inhibitors (MAOIs), used to treat depression or Parkinson's disease. Taking an irreversible MAOI together with Axydepitab XL, can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop taking Axydepitab XL before you take any MAOI (see also the sections entitled “Taking other medicines” and the information in that section about “Serotonin syndrome”).
Warnings and precautions
Talk to your doctor before taking Axydepitab XL
• If you use other medicines that taken concomitantly with Axydepitab XL could increase the risk of developing serotonin syndrome (see the section “Taking other medicines”).
• If you have a swallowing, stomach or intestinal disorder that reduces your ability to swallow or pass foods by normal bowel movements.
• If you have eye problems, such as certain kinds of glaucoma (increased pressure in the eye).
• If you have a history of high blood pressure.
• If you have a history of heart problems.
• If you have a history of fits (seizures).
• If you have a history of low sodium levels in your blood (hyponatraemia).
• If you have a tendency to develop bruises or a tendency to bleed easily (history of bleeding disorders), or if you are taking other medicines that may increase the risk of bleeding e.g. warfarin (used to prevent blood clots).
• If your cholesterol levels get higher.
• If you have a history of, or if someone in your family has had, mania or bipolar disorder (feeling over-excited or euphoric).
• If you have a history of aggressive behaviour.
Axydepitab XL may cause a sensation of restlessness or an inability to sit or stand still during the first few weeks of treatment. You should tell your doctor if this happens to you.
If any of these conditions apply to you, please talk with your doctor before taking Axydepitab XL.
Thoughts of suicide and worsening of your depression or feelings of anxiety
If you are depressed and/or have anxiety disorders, you can sometimes have thoughts of harming or killing yourself. These may be increased when you first start taking antidepressants, since these medicines all take time to work, usually about two weeks, but sometimes longer.
You may be more likely to think like this:
• If you have previously had thoughts about killing yourself or harming yourself.
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in young adults (less than 25 years old) with psychiatric conditions who were treated with an antidepressant.
If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.
Dry mouth
Dry mouth is reported in 10 % of patients treated with venlafaxine. This may increase the risk of caries. Therefore, you should take special care in your dental hygiene.
Diabetes
Your blood glucose levels may be altered due to Axydepitab XL. Therefore, the dosages of your diabetes medicines may need to be adjusted.
Use in children and adolescents under 18 years of age
Axydepitab XL should normally not be used for children and adolescents under 18 years. Also, you should know that patients under 18 have an increased risk of side effects, such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. Despite this, your doctor may prescribe this medicine for patients under 18 because he/she decides that this is in their best interests.
If your doctor has prescribed Axydepitab XL for a patient under 18, and you want to discuss this, please go back to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking Axydepitab XL. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of Axydepitab XL in this age group has not yet been demonstrated.
Other medicines and Axydepitab XL
Tell your doctor or pharmacist if you are taking, or have recently taken any other medicines.
Your doctor should decide whether you can take Axydepitab XL with other medicines.
Do not start or stop taking any medicines, including those bought without a prescription, natural and herbal remedies, before checking with your doctor or pharmacist.
• Monoamine oxidase inhibitors which are used to treat depression or Parkinson's disease must not be taken with Axydepitab XL. Tell your doctor if you have taken these medicines within the last 14 days. (MAOIs: see the section “Before you take Axydepitab XL”).
• Serotonin syndrome:
Serotonin syndrome, a potentially life-threatening condition (see the section “Possible Side Effects”), may occur with venlafaxine treatment, particularly when taken with other medicines.
Examples of these medicines include:
• Triptans (used for migraine)
• Medicines to treat depression, for instance SNRI, SSRIs, tricyclics, or medicines containing lithium
• Medicines containing linezolid, an antibiotic (used to treat infections)
• Medicines containing moclobemide, a reversible MAOI (used to treat depression)
• Medicines containing sibutramine (used for weight loss)
• Medicines containing tramadol (a pain-killer)
• Medicines containing methylene blue (used to treat high levels of methaemoglobin in the blood)
• Products containing St. John's Wort (also called Hypericum perforatum, a natural or herbal remedy used to treat mild depression)
• Products containing tryptophan (used for problems such as sleep and depression)
• Antipsychotics (used to treat a disease with symptoms such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, unclear reasoning and becoming withdrawn)
Signs and symptoms of serotonin syndrome may include a combination of the following:
restlessness, hallucinations, loss of coordination, fast heart beat, increased body temperature, fast changes in blood pressure, overactive reflexes, diarrhoea, coma, nausea, vomiting.
In its most severe form, serotonin syndrome can resemble Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, fast heart beat, sweating, severe muscle stiffness, confusion, increased muscle enzymes (determined by a blood test).
Tell your doctor immediately, or go to the casualty department at your nearest hospital if you think serotonin syndrome is happening to you
The following medicines may also interact with Axydepitab XL and should be used with caution. It is especially important to mention to your doctor or pharmacist if you are taking medicines containing:
• Ketoconazole, Itraconazole, Voriconazole, Posaconazole (antifungal medicines)
• Clarithromycin, telithromycin (antibiotics used to treat infections)
• Atazanavir, indinavir, nelfinavir, ritonavir, saquinavir (used to treat HIV infection)
• Haloperidol or risperidone (to treat psychiatric conditions)
• Metoprolol (a beta blocker to treat high blood pressure and heart problems)
Axydepitab XL with food, drink and alcohol
Axydepitab XL should be taken with food (see section 3 “How to take Axydepitab XL”).
You should avoid alcohol while you are taking Axydepitab XL.
Pregnancy, breast-feeding and fertility
Tell your doctor if you become pregnant, or you are trying to become pregnant. You should use Axydepitab XL only after discussing the potential benefits and the potential risks to your unborn child with your doctor.
Make sure your midwife and/or doctor knows you are on Axydepitab XL. When taken during pregnancy, similar drugs (SSRIs) may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and appear bluish. These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your baby you should contact your midwife and/or doctor immediately.
If you are taking Axydepitab XL during pregnancy, let your midwife and/or doctor know, as your baby might have some symptoms when it is born. These symptoms usually begin during the first 24 hours after the baby is born. They include irritability, tremor, hypotonia, constant crying, sleeping difficulties and, not feeding properly. If your baby has these symptoms when it is born and you are concerned, contact your doctor and/or midwife who will be able to advise you.
Venlafaxine passes into breast milk. There is a risk of an effect on the baby, which may cause symptoms such as crying, irritabilty and abnormal sleep patterns. Symptoms consistent with venlafaxine drug discontinuation can also occur after stopping breast-feeding. Therefore, you should discuss the matter with your doctor, and he/she will decide whether you should stop breast-feeding or stop the therapy with Axydepitab XL.
Driving and using machines
Do not drive or use any tools or machines until you know how Axydepitab XL affects you.
Important information about some of the ingredients of Axydepitab XL
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
POM
3) HOW TO TAKE AXYDEPITAB XL
Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual recommended starting dose for treatment of depression and social anxiety disorder is 75 mg per day. The dose can be raised by your doctor gradually, and if needed, even up to a maximum dose of 375 mg daily for depression. The maximum dose for social anxiety disorder is 225 mg/day.
Take Axydepitab XL at approximately the same time each day, either in the morning or in the evening. Tablets must be swallowed whole with fluid and not opened, crushed, chewed or dissolved.
Axydepitab XL should be taken with food.
If you have liver or kidney problems, talk to your doctor, since your dose of Axydepitab XL may need to be different.
Do not stop taking Axydepitab XL without talking to your doctor (see the section “If you stop taking Axydepitab XL”).
If you take more Axydepitab XL than you should
Call your doctor or pharmacist immediately if you take more than the amount of Axydepitab XL prescribed by your doctor.
The symptoms of a possible overdose may include a rapid heart beat, changes in level of alertness (ranging from sleepiness to coma), blurred vision, seizures or fits, and vomiting.
If you forget to take Axydepitab XL
If you miss a dose, take it as soon as you remember. However, if it is time for your next dose, skip the missed dose and take only a single dose as usual. Do not take more than the daily amount of Axydepitab XL that has been prescribed for you in one day.
If you stop taking Axydepitab XL
Do not stop taking your treatment or reduce the dose without the advice of your doctor even if you feel better. If your doctor thinks that you no longer need Axydepitab XL, he/she may ask you to reduce your dose slowly before stopping treatment altogether. Side effects are known to occur when people stop using Axydepitab XL, especially when Axydepitab XL is stopped suddenly or the dose is reduced too quickly. Some patients may experience symptoms such as tiredness, dizziness, light-headedness, headache, sleeplessness, sensation that everything around you is spinning or moving (vertigo), nightmares, dry mouth, loss of appetite, nausea, diarrhoea, nervousness, agitation, confusion, ringing in the ears, tingling or rarely electric shock sensations, weakness, sweating, seizures, or flu-like symptoms.
Your doctor will advise you on how you should gradually discontinue Axydepitab XL treatment. If you experience any of these or other symptoms that are troublesome, ask your doctor for further advice.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4) POSSIBLE SIDE EFFECTS
Like all medicines, Axydepitab XL can cause side effects, although not everybody gets them.
Do not be concerned if you see a tablet in your stools after taking Axydepitab XL. As the tablet travels the length of your gastrointestinal tract, venlafaxine is slowly released. The shape of the tablet remains undissolved and is eliminated in your stools. Therefore, even though you may see a tablet in your stools, your dose of venlafaxine has been absorbed.
Allergic reactions
If any of the following happen, do not take more Axydepitab XL. Tell your doctor immediately, or go to the casualty department at your nearest hospital:
• Chest tightness, wheezing, trouble swallowing or breathing
• Swelling of the face, throat, hands, or feet
• Feeling nervous or anxious, dizziness, throbbing sensations, sudden reddening of the skin and/or a warm feeling
• Severe rash, itching, or hives (elevated patches of red or pale skin that often itch)
• Signs and symptoms of serotonin syndrome which may include restlessness, hallucinations, loss of coordination, fast heart beat, increased body temperature, fast changes in blood pressure, overactive reflexes, diarrhoea, coma, nausea, vomiting.
In its most severe form, serotonin syndrome can resemble Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, fast heart beat, sweating, severe muscle stiffness, confusion, increased muscle enzymes (determined by a blood test).
Other side effects that you should tell your doctor about include:
• Coughing, wheezing, shortness of breath and a high temperature
• Black (tarry) stools or blood in stools
• Yellow skin or eyes, itchiness or dark urine, which may be symptoms of inflammation of the liver (hepatitis)
• Heart problems, such as fast or irregular heart rate, increased blood pressure
• Eye problems, such as blurred vision, dilated pupils
• Nerve problems, such as dizziness, pins and needles, movement disorder, seizures or fits
• Psychiatric problems, such as hyperactivity and euphoria (feeling unusually overexcited)
• Withdrawal effects (see the section “How to take Axydepitab XL, if you stop taking Axydepitab XL”)
• Prolonged bleeding - if you cut or injure yourself, it may take slightly longer than usual for bleeding to stop
Complete side effect listing
Very common (may affect more than 1 in 10 people)
• Dizziness; headache
• Nausea; dry mouth
• Sweating (including night sweats)
Common (may affect up to 1 in 10 people)
• Appetite decreased
• Confusion; feeling separated (or detached) from yourself; lack of orgasm; decreased libido
• nervousness; insomnia; abnormal dreams
• Drowsiness; tremor; pins and needles; increased muscle tonus
• Visual disturbance including blurred vision; dilated pupils; inability of the eye to automatically change focus from distant to near objects
• Ringing in the ears (tinnitus)
• Palpitations
• Increase in blood pressure; flushing
• Yawning
• Vomiting; constipation; diarrhoea
• Increased frequency in urination; difficulties passing urine
• Menstrual irregularities such as increased bleeding or increased irregular bleeding; abnormal ejaculation/orgasm (males); erectile dysfunction (impotence)
• Weakness (asthenia); fatigue; chills
• Increased cholesterol
Uncommon (may affect up to 1 in 100 people)
• Hallucinations; feeling separated (or detached) from reality; agitation; abnormal orgasm (females); lack of feeling or emotion; feeling overexcited; grinding of the teeth
• A sensation of restlessness or an inability to sit or stand still; fainting; involuntary movements of the muscles; impaired coordination and balance; altered taste sensation
• Fast heartbeat; feeling dizzy (particularly when standing up too quickly)
• Vomiting blood, black tarry stools (faeces) or blood in stools; which can be a sign of internal bleeding
• General swelling of the skin especially the face, mouth, tongue, throat area or hands and feet and/or a raised itchy rash (hives) may be present; sensitivity to sunlight; bruising; rash; abnormal hair loss
• Inability to pass urine
• Weight gain; weight loss
Rare (may affect up to 1 in 1,000 people)
• Seizures or fits
• Inability to control urination
• Over activity, racing thoughts and decreased need for sleep (mania)
Not known (frequency cannot be estimated from the available data)
• Reduced number of platelets in your blood, leading to an increased risk of bruising or bleeding; blood disorders which may lead to an increased risk of infection
• Swollen face or tongue, shortness of breath or difficulty breathing, often with skin rashes (this may be a serious allergic reaction)
• Excessive water intake (known as SIADH)
• Decrease in blood sodium levels
• Suicidal ideation and suicidal behaviours; cases of suicidal ideation and suicidal behaviours have been reported during venlafaxine therapy or early after treatment discontinuation (see section 2, Before you take Axydepitab XL)
• Disorientation and confusion often accompanied by hallucination (delirium); aggression
• A high temperature with rigid muscles, confusion or agitation, and sweating, or if you experience jerky muscle movements which you can't control, these may be symptoms of serious conditions known as neuroleptic malignant syndrome; euphoric feelings, drowsiness, sustained rapid eye movement, clumsiness, restlessness, feeling of being drunk, sweating or rigid muscles, which are symptoms of serotonin syndrome; stiffness, spasms and involuntary movements of the muscles
• Severe eye pain and decreased or blurred vision
• Vertigo
• Decrease in blood pressure; abnormal, rapid or irregular heart beat, which could lead to fainting; unexpected bleeding, e.g. bleeding gums, blood in the urine or in vomit, or the appearance of unexpected bruises or broken blood vessels (broken veins)
• Coughing, wheezing, shortness of breath and a high temperature, which are symptoms of inflammation of the lungs associated with an increase in white blood cells (pulmonary eosinophilia)
• Severe abdominal or back pains (which could indicate a serious problem in the gut, liver or pancreas)
• Itchiness, yellow skin or eyes, dark urine, or flu-like symptoms, which are symptoms of inflammation of the liver (hepatitis); slight changes in blood levels of liver enzymes
• Skin rash, which may lead to severe blistering and peeling of the skin; itching; mild rash
• Unexplained muscle pain, tenderness or weakness (rhabdomyolysis)
• Abnormal breast milk production
Axydepitab XL sometimes causes unwanted effects that you may not be aware of, such as increases in blood pressure or abnormal heart beat; slight changes in blood levels or liver enzymes, sodium or cholesterol. More rarely, Axydepitab XL may reduce the function of platelets in your blood, leading to an increased risk of bruising or bleeding. Therefore, your doctor may wish to do blood tests occasionally, particularly if you have been taking Axydepitab XL for a long time.
If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.
5) HOW TO STORE AXYDEPITAB XL
• Keep out of the sight and reach of children.
• Do not use Axydepitab XL after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
• Do not store above 30C.
• Store in the original package in order to protect from moisture.
• If the tablets become discoloured or show any sign of deterioration return them to your pharmacist.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6) CONTENTS OF THE PACK AND OTHER INFORMATION
What Axydepitab XL contains
Each prolonged-release tablet contains 75 mg venlafaxine (as hydrochloride).
The other ingredients are:
Core: Mannitol, Povidone K-90, Macrogol 400, Microcrystalline cellulose, Colloidal anhydrous silica, Magnesium stearate.
Coating: Cellulose acetate, Cellulose acetate 320s, Cellulose acetate 398-10, Macrogol 400, Opadry Y 30 18037 (hypromellose, lactose monohydrate, titanium dioxide (E171) and triacetin)
What Axydepitab XL looks like and contents of the pack
Axydepitab XL 75 mg prolonged-release tablets are white, round, biconvex tablets with a laser hole on one side.
Axydepitab XL 75 mg prolonged-release tablets are available in packs of 28 tablets.
Manufacturer
Laboratorios LICONSA, S.A., Avda. Miralcampo, No 7, Pollgono Industrial Miralcampo, 19200 Azuqueca de Henares, Spain
Procured from within the EU by Product Licence holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall WS9 8ER
Repackaged by XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX PL 33532/0466
Axyven® 75 mg prolonged-release tablets (venlafaxine hydrochloride)
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions please ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
• The name of your medicine is Axyven 75 mg prolonged-release tablets but will be referred to as Axyven throughout the remainder of this leaflet.
• Axyven is also available in other strengths.
What is in this leaflet:
1) What Axyven is and what it is used for
2) What you need to know before you take Axyven
3) How to take Axyven
4) Possible side effects
5) How to store Axyven
6) Contents of the pack and other information
1) WHAT AXYVEN IS AND WHAT IT IS USED FOR
Axyven is an antidepressant that belongs to a group of medicines called serotonin and norepinephrine reuptake inhibitors (SNRIs). This group of medicines is used to treat depression and other conditions such as anxiety disorders. It is thought that people who are depressed and/or anxious have lower levels of serotonin and noradrenaline in the brain. It is not fully understood how antidepressants work, but they may help by increasing the levels of serotonin and noradrenaline in the brain.
Axyven is a treatment for adults with depression and panic disorder (panic attacks). Treating depression or anxiety disorders properly is important to help you get better. If it is not treated, your condition may not go away and may become more serious and more difficult to treat.
2) WHAT YOU NEED TO KNOW BEFORE YOU TAKE AXYVEN Do not take Axyven
• If you are allergic to venlafaxine or any of the other ingredients of this medicine (listed in section 6).
• If you are also taking or have taken any time within the last 14 days any medicines known as irreversible monoamine oxidase inhibitors (MAOIs), used to treat depression or Parkinson's disease. Taking an irreversible MAOI together with Axyven, can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop taking Axyven before you take any MAOI (see also the sections entitled “Taking other medicines” and the information in that section about “Serotonin syndrome”).
Warnings and precautions
Talk to your doctor before taking Axyven
• If you use other medicines that taken concomitantly with Axyven could increase the risk of developing serotonin syndrome (see the section “Taking other medicines”).
• If you have a swallowing, stomach or intestinal disorder that reduces your ability to swallow or pass foods by normal bowel movements.
• If you have eye problems, such as certain kinds of glaucoma (increased pressure in the eye).
• If you have a history of high blood pressure.
• If you have a history of heart problems.
• If you have a history of fits (seizures).
• If you have a history of low sodium levels in your blood (hyponatraemia).
• If you have a tendency to develop bruises or a tendency to bleed easily (history of bleeding disorders), or if you are taking other medicines that may increase the risk of bleeding e.g. warfarin (used to prevent blood clots).
• If your cholesterol levels get higher.
• If you have a history of, or if someone in your family has had, mania or bipolar disorder (feeling over-excited or euphoric).
• If you have a history of aggressive behaviour.
Axyven may cause a sensation of restlessness or an inability to sit or stand still during the first few weeks of treatment. You should tell your doctor if this happens to you.
If any of these conditions apply to you, please talk with your doctor before taking Axyven.
Thoughts of suicide and worsening of your depression or feelings of anxiety
If you are depressed and/or have anxiety disorders, you can sometimes have thoughts of harming or killing yourself. These may be increased when you first start taking antidepressants, since these medicines all take time to work, usually about two weeks, but sometimes longer.
You may be more likely to think like this:
• If you have previously had thoughts about killing yourself or harming yourself.
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in young adults (less than 25 years old) with psychiatric conditions who were treated with an antidepressant.
If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.
Dry mouth
Dry mouth is reported in 10 % of patients treated with venlafaxine. This may increase the risk of caries. Therefore, you should take special care in your dental hygiene.
Diabetes
Your blood glucose levels may be altered due to Axyven. Therefore, the dosages of your diabetes medicines may need to be adjusted.
Use in children and adolescents under 18 years of age
Axyven should normally not be used for children and adolescents under 18 years. Also, you should know that patients under 18 have an increased risk of side effects, such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. Despite this, your doctor may prescribe this medicine for patients under 18 because he/she decides that this is in their best interests.
If your doctor has prescribed Axyven for a patient under 18, and you want to discuss this, please go back to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking Axyven. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of Axyven in this age group has not yet been demonstrated.
Other medicines and Axyven
Tell your doctor or pharmacist if you are taking, or have recently taken any other medicines.
Your doctor should decide whether you can take Axyven with other medicines.
Do not start or stop taking any medicines, including those bought without a prescription, natural and herbal remedies, before checking with your doctor or pharmacist.
• Monoamine oxidase inhibitors which are used to treat depression or Parkinson's disease must not be taken with Axyven. Tell your doctor if you have taken these medicines within the last 14 days. (MAOIs: see the section “Before you take Axyven”).
• Serotonin syndrome:
Serotonin syndrome, a potentially life-threatening condition (see the section “Possible Side Effects”), may occur with venlafaxine treatment, particularly when taken with other medicines.
Examples of these medicines include:
• Triptans (used for migraine)
• Medicines to treat depression, for instance SNRI, SSRIs, tricyclics, or medicines containing lithium
• Medicines containing linezolid, an antibiotic (used to treat infections)
• Medicines containing moclobemide, a reversible MAOI (used to treat depression)
• Medicines containing sibutramine (used for weight loss)
• Medicines containing tramadol (a pain-killer)
• Medicines containing methylene blue (used to treat high levels of methaemoglobin in the blood)
• Products containing St. John's Wort (also called Hypericum perforatum, a natural or herbal remedy used to treat mild depression)
• Products containing tryptophan (used for problems such as sleep and depression)
• Antipsychotics (used to treat a disease with symptoms such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, unclear reasoning and becoming withdrawn)
Signs and symptoms of serotonin syndrome may include a combination of the following:
restlessness, hallucinations, loss of coordination, fast heart beat, increased body temperature, fast changes in blood pressure, overactive reflexes, diarrhoea, coma, nausea, vomiting.
In its most severe form, serotonin syndrome can resemble Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, fast heart beat, sweating, severe muscle stiffness, confusion, increased muscle enzymes (determined by a blood test).
Tell your doctor immediately, or go to the casualty department at your nearest hospital if you think serotonin syndrome is happening to you
The following medicines may also interact with Axyven and should be used with caution. It is especially important to mention to your doctor or pharmacist if you are taking medicines containing:
• Ketoconazole, Itraconazole, Voriconazole, Posaconazole (antifungal medicines)
• Clarithromycin, telithromycin (antibiotics used to treat infections)
• Atazanavir, indinavir, nelfinavir, ritonavir, saquinavir (used to treat HIV infection)
• Haloperidol or risperidone (to treat psychiatric conditions)
• Metoprolol (a beta blocker to treat high blood pressure and heart problems)
Axyven with food, drink and alcohol
Axyven should be taken with food (see section 3 “How to take Axyven”). You should avoid alcohol while you are taking Axyven.
Pregnancy, breast-feeding and fertility
Tell your doctor if you become pregnant, or you are trying to become pregnant. You should use Axyven only after discussing the potential benefits and the potential risks to your unborn child with your doctor.
Make sure your midwife and/or doctor knows you are on Axyven. When taken during pregnancy, similar drugs (SSRIs) may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and appear bluish. These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your baby you should contact your midwife and/or doctor immediately.
If you are taking Axyven during pregnancy, let your midwife and/or doctor know, as your baby might have some symptoms when it is born. These symptoms usually begin during the first 24 hours after the baby is born. They include irritability, tremor, hypotonia, constant crying, sleeping difficulties and, not feeding properly. If your baby has these symptoms when it is born and you are concerned, contact your doctor and/or midwife who will be able to advise you.
Venlafaxine passes into breast milk. There is a risk of an effect on the baby, which may cause symptoms such as crying, irritabilty and abnormal sleep patterns. Symptoms consistent with venlafaxine drug discontinuation can also occur after stopping breast-feeding. Therefore, you should discuss the matter with your doctor, and he/she will decide whether you should stop breast-feeding or stop the therapy with Axyven.
Driving and using machines
Do not drive or use any tools or machines until you know how Axyven affects you.
Important information about some of the ingredients of Axyven
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
POM
3) HOW TO TAKE AXYVEN
Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual recommended starting dose for treatment of depression and social anxiety disorder is 75 mg per day. The dose can be raised by your doctor gradually, and if needed, even up to a maximum dose of 375 mg daily for depression. The maximum dose for social anxiety disorder is 225 mg/day.
Take Axyven at approximately the same time each day, either in the morning or in the evening. Tablets must be swallowed whole with fluid and not opened, crushed, chewed or dissolved.
Axyven should be taken with food.
If you have liver or kidney problems, talk to your doctor, since your dose of Axyven may need to be different.
Do not stop taking Axyven without talking to your doctor (see the section “If you stop taking Axyven”).
If you take more Axyven than you should
Call your doctor or pharmacist immediately if you take more than the amount of Axyven prescribed by your doctor.
The symptoms of a possible overdose may include a rapid heart beat, changes in level of alertness (ranging from sleepiness to coma), blurred vision, seizures or fits, and vomiting.
If you forget to take Axyven
If you miss a dose, take it as soon as you remember. However, if it is time for your next dose, skip the missed dose and take only a single dose as usual. Do not take more than the daily amount of Axyven that has been prescribed for you in one day.
If you stop taking Axyven
Do not stop taking your treatment or reduce the dose without the advice of your doctor even if you feel better. If your doctor thinks that you no longer need Axyven, he/she may ask you to reduce your dose slowly before stopping treatment altogether. Side effects are known to occur when people stop using Axyven, especially when Axyven is stopped suddenly or the dose is reduced too quickly. Some patients may experience symptoms such as tiredness, dizziness, light-headedness, headache, sleeplessness, sensation that everything around you is spinning or moving (vertigo), nightmares, dry mouth, loss of appetite, nausea, diarrhoea, nervousness, agitation, confusion, ringing in the ears, tingling or rarely electric shock sensations, weakness, sweating, seizures, or flu-like symptoms.
Your doctor will advise you on how you should gradually discontinue Axyven treatment. If you experience any of these or other symptoms that are troublesome, ask your doctor for further advice.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4) POSSIBLE SIDE EFFECTS
Like all medicines, Axyven can cause side effects, although not everybody gets them.
Do not be concerned if you see a tablet in your stools after taking Axyven. As the tablet travels the length of your gastrointestinal tract, venlafaxine is slowly released. The shape of the tablet remains undissolved and is eliminated in your stools. Therefore, even though you may see a tablet in your stools, your dose of venlafaxine has been absorbed.
Allergic reactions
If any of the following happen, do not take more Axyven. Tell your doctor immediately, or go to the casualty department at your nearest hospital:
• Chest tightness, wheezing, trouble swallowing or breathing
• Swelling of the face, throat, hands, or feet
• Feeling nervous or anxious, dizziness, throbbing sensations, sudden reddening of the skin and/or a warm feeling
• Severe rash, itching, or hives (elevated patches of red or pale skin that often itch)
• Signs and symptoms of serotonin syndrome which may include restlessness, hallucinations, loss of coordination, fast heart beat, increased body temperature, fast changes in blood pressure, overactive reflexes, diarrhoea, coma, nausea, vomiting.
In its most severe form, serotonin syndrome can resemble Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, fast heart beat, sweating, severe muscle stiffness, confusion, increased muscle enzymes (determined by a blood test).
Other side effects that you should tell your doctor about include:
• Coughing, wheezing, shortness of breath and a high temperature
• Black (tarry) stools or blood in stools
• Yellow skin or eyes, itchiness or dark urine, which may be symptoms of inflammation of the liver (hepatitis)
• Heart problems, such as fast or irregular heart rate, increased blood pressure
• Eye problems, such as blurred vision, dilated pupils
• Nerve problems, such as dizziness, pins and needles, movement disorder, seizures or fits
• Psychiatric problems, such as hyperactivity and euphoria (feeling unusually overexcited)
• Withdrawal effects (see the section “How to take Axyven, if you stop taking Axyven”)
• Prolonged bleeding - if you cut or injure yourself, it may take slightly longer than usual for bleeding to stop
Complete side effect listing
Very common (may affect more than 1 in 10 people)
• Dizziness; headache
• Nausea; dry mouth
• Sweating (including night sweats)
Common (may affect up to 1 in 10 people)
• Appetite decreased
• Confusion; feeling separated (or detached) from yourself; lack of orgasm; decreased libido
• nervousness; insomnia; abnormal dreams
• Drowsiness; tremor; pins and needles; increased muscle tonus
• Visual disturbance including blurred vision; dilated pupils; inability of the eye to automatically change focus from distant to near objects
• Ringing in the ears (tinnitus)
• Palpitations
• Increase in blood pressure; flushing
• Yawning
• Vomiting; constipation; diarrhoea
• Increased frequency in urination; difficulties passing urine
• Menstrual irregularities such as increased bleeding or increased irregular bleeding; abnormal ejaculation/orgasm (males); erectile dysfunction (impotence)
• Weakness (asthenia); fatigue; chills
• Increased cholesterol
Uncommon (may affect up to 1 in 100 people)
• Hallucinations; feeling separated (or detached) from reality; agitation; abnormal orgasm (females); lack of feeling or emotion; feeling overexcited; grinding of the teeth
• A sensation of restlessness or an inability to sit or stand still; fainting; involuntary movements of the muscles; impaired coordination and balance; altered taste sensation
• Fast heartbeat; feeling dizzy (particularly when standing up too quickly)
• Vomiting blood, black tarry stools (faeces) or blood in stools; which can be a sign of internal bleeding
• General swelling of the skin especially the face, mouth, tongue, throat area or hands and feet and/or a raised itchy rash (hives) may be present; sensitivity to sunlight; bruising; rash; abnormal hair loss
• Inability to pass urine
• Weight gain; weight loss
Rare (may affect up to 1 in 1,000 people)
• Seizures or fits
• Inability to control urination
• Over activity, racing thoughts and decreased need for sleep (mania)
Not known (frequency cannot be estimated from the available data)
• Reduced number of platelets in your blood, leading to an increased risk of bruising or bleeding; blood disorders which may lead to an increased risk of infection
• Swollen face or tongue, shortness of breath or difficulty breathing, often with skin rashes (this may be a serious allergic reaction)
• Excessive water intake (known as SIADH)
• Decrease in blood sodium levels
• Suicidal ideation and suicidal behaviours; cases of suicidal ideation and suicidal behaviours have been reported during venlafaxine therapy or early after treatment discontinuation (see section 2, Before you take Axyven)
• Disorientation and confusion often accompanied by hallucination (delirium); aggression
• A high temperature with rigid muscles, confusion or agitation, and sweating, or if you experience jerky muscle movements which you can't control, these may be symptoms of serious conditions known as neuroleptic malignant syndrome; euphoric feelings, drowsiness, sustained rapid eye movement, clumsiness, restlessness, feeling of being drunk, sweating or rigid muscles, which are symptoms of serotonin syndrome; stiffness, spasms and involuntary movements of the muscles
• Severe eye pain and decreased or blurred vision
• Vertigo
• Decrease in blood pressure; abnormal, rapid or irregular heart beat, which could lead to fainting; unexpected bleeding, e.g. bleeding gums, blood in the urine or in vomit, or the appearance of unexpected bruises or broken blood vessels (broken veins)
• Coughing, wheezing, shortness of breath and a high temperature, which are symptoms of inflammation of the lungs associated with an increase in white blood cells (pulmonary eosinophilia)
• Severe abdominal or back pains (which could indicate a serious problem in the gut, liver or pancreas)
• Itchiness, yellow skin or eyes, dark urine, or flu-like symptoms, which are symptoms of inflammation of the liver (hepatitis); slight changes in blood levels of liver enzymes
• Skin rash, which may lead to severe blistering and peeling of the skin; itching; mild rash
• Unexplained muscle pain, tenderness or weakness (rhabdomyolysis)
• Abnormal breast milk production
Axyven sometimes causes unwanted effects that you may not be aware of, such as increases in blood pressure or abnormal heart beat; slight changes in blood levels or liver enzymes, sodium or cholesterol. More rarely, Axyven may reduce the function of platelets in your blood, leading to an increased risk of bruising or bleeding. Therefore, your doctor may wish to do blood tests occasionally, particularly if you have been taking Axyven for a long time.
If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.
5) HOW TO STORE AXYVEN
• Keep out of the sight and reach of children.
• Do not use Axyven after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
• Do not store above 30C.
• Store in the original package in order to protect from moisture.
• If the tablets become discoloured or show any sign of deterioration return them to your pharmacist.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6) CONTENTS OF THE PACK AND OTHER INFORMATION
What Axyven contains
Each prolonged-release tablet contains 75 mg venlafaxine (as hydrochloride).
The other ingredients are:
Core: Mannitol, Povidone K-90, Macrogol 400, Microcrystalline cellulose, Colloidal anhydrous silica, Magnesium stearate.
Coating: Cellulose acetate, Cellulose acetate 320s, Cellulose acetate 398-10, Macrogol 400, Opadry Y 30 18037 (hypromellose, lactose monohydrate, titanium dioxide (E171) and triacetin)
What Axyven looks like and contents of the pack
Axyven 75 mg prolonged-release tablets are white, round, biconvex tablets with a laser hole on one side.
Axyven 75 mg prolonged-release tablets are available in packs of 28 tablets.
Manufacturer
Laboratorios LICONSA, S.A., Avda. Miralcampo, No 7, Pollgono Industrial Miralcampo, 19200 Azuqueca de Henares, Spain
Procured from within the EU by Product Licence holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall WS9 8ER
Repackaged by XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX PL 33532/0466
Leaflet date: 23 June 2014 Leaflet code: XXXXXXXXXX
Axyven® is a registered trademark of Axxon Sp. z o. o.
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions please ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
• The name of your medicine is Venantapid XL 75 mg prolonged-release tablets but will be referred to as Venantapid XL throughout the remainder of this leaflet.
• Venantapid XL is also available in other strengths.
What is in this leaflet:
1) What Venantapid XL is and what it is used for
2) What you need to know before you take Venantapid XL
3) How to take Venantapid XL
4) Possible side effects
5) How to store Venantapid XL
6) Contents of the pack and other information
1) WHAT VENANTAPID XL IS AND WHAT IT IS USED FOR
Venantapid XL is an antidepressant that belongs to a group of medicines called serotonin and norepinephrine reuptake inhibitors (SNRIs). This group of medicines is used to treat depression and other conditions such as anxiety disorders. It is thought that people who are depressed and/or anxious have lower levels of serotonin and noradrenaline in the brain. It is not fully understood how antidepressants work, but they may help by increasing the levels of serotonin and noradrenaline in the brain.
Venantapid XL is a treatment for adults with depression and panic disorder (panic attacks). Treating depression or anxiety disorders properly is important to help you get better. If it is not treated, your condition may not go away and may become more serious and more difficult to treat.
2) WHAT YOU NEED TO KNOW BEFORE YOU TAKE VENANTAPID XL
Do not take Venantapid XL
• If you are allergic to venlafaxine or any of the other ingredients of this medicine (listed in section 6).
• If you are also taking or have taken any time within the last 14 days any medicines known as irreversible monoamine oxidase inhibitors (MAOIs), used to treat depression or Parkinson's disease. Taking an irreversible MAOI together with Venantapid XL, can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop taking Venantapid XL before you take any MAOI (see also the sections entitled “Taking other medicines” and the information in that section about “Serotonin syndrome”).
Warnings and precautions
Talk to your doctor before taking Venantapid XL
• If you use other medicines that taken concomitantly with Venantapid XL could increase the risk of developing serotonin syndrome (see the section “Taking other medicines”).
• If you have a swallowing, stomach or intestinal disorder that reduces your ability to swallow or pass foods by normal bowel movements.
• If you have eye problems, such as certain kinds of glaucoma (increased pressure in the eye).
• If you have a history of high blood pressure.
• If you have a history of heart problems.
• If you have a history of fits (seizures).
• If you have a history of low sodium levels in your blood (hyponatraemia).
• If you have a tendency to develop bruises or a tendency to bleed easily (history of bleeding disorders), or if you are taking other medicines that may increase the risk of bleeding e.g. warfarin (used to prevent blood clots).
• If your cholesterol levels get higher.
• If you have a history of, or if someone in your family has had, mania or bipolar disorder (feeling over-excited or euphoric).
• If you have a history of aggressive behaviour.
Venantapid XL may cause a sensation of restlessness or an inability to sit or stand still during the first few weeks of treatment. You should tell your doctor if this happens to you.
If any of these conditions apply to you, please talk with your doctor before taking Venantapid XL.
Thoughts of suicide and worsening of your depression or feelings of anxiety
If you are depressed and/or have anxiety disorders, you can sometimes have thoughts of harming or killing yourself. These may be increased when you first start taking antidepressants, since these medicines all take time to work, usually about two weeks, but sometimes longer.
You may be more likely to think like this:
• If you have previously had thoughts about killing yourself or harming yourself.
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in young adults (less than 25 years old) with psychiatric conditions who were treated with an antidepressant.
If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.
Dry mouth
Dry mouth is reported in 10 % of patients treated with venlafaxine. This may increase the risk of caries. Therefore, you should take special care in your dental hygiene.
Diabetes
Your blood glucose levels may be altered due to Venantapid XL. Therefore, the dosages of your diabetes medicines may need to be adjusted.
Use in children and adolescents under 18 years of age
Venantapid XL should normally not be used for children and adolescents under 18 years. Also, you should know that patients under 18 have an increased risk of side effects, such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. Despite this, your doctor may prescribe this medicine for patients under 18 because he/she decides that this is in their best interests.
If your doctor has prescribed Venantapid XL for a patient under 18, and you want to discuss this, please go back to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking Venantapid XL. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of Venantapid XL in this age group has not yet been demonstrated.
Other medicines and Venantapid XL
Tell your doctor or pharmacist if you are taking, or have recently taken any other medicines.
Your doctor should decide whether you can take Venantapid XL with other medicines.
Do not start or stop taking any medicines, including those bought without a prescription, natural and herbal remedies, before checking with your doctor or pharmacist.
• Monoamine oxidase inhibitors which are used to treat depression or Parkinson's disease must not be taken with Venantapid XL. Tell your doctor if you have taken these medicines within the last 14 days. (MAOIs: see the section “Before you take Venantapid XL”).
• Serotonin syndrome:
Serotonin syndrome, a potentially life-threatening condition (see the section “Possible Side Effects”), may occur with venlafaxine treatment, particularly when taken with other medicines.
Examples of these medicines include:
• Triptans (used for migraine)
• Medicines to treat depression, for instance SNRI, SSRIs, tricyclics, or medicines containing lithium
• Medicines containing linezolid, an antibiotic (used to treat infections)
• Medicines containing moclobemide, a reversible MAOI (used to treat depression)
• Medicines containing sibutramine (used for weight loss)
• Medicines containing tramadol (a pain-killer)
• Medicines containing methylene blue (used to treat high levels of methaemoglobin in the blood)
• Products containing St. John's Wort (also called Hypericum perforatum, a natural or herbal remedy used to treat mild depression)
• Products containing tryptophan (used for problems such as sleep and depression)
• Antipsychotics (used to treat a disease with symptoms such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, unclear reasoning and becoming withdrawn)
Signs and symptoms of serotonin syndrome may include a combination of the following:
restlessness, hallucinations, loss of coordination, fast heart beat, increased body temperature, fast changes in blood pressure, overactive reflexes, diarrhoea, coma, nausea, vomiting.
In its most severe form, serotonin syndrome can resemble Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, fast heart beat, sweating, severe muscle stiffness, confusion, increased muscle enzymes (determined by a blood test).
Tell your doctor immediately, or go to the casualty department at your nearest hospital if you think serotonin syndrome is happening to you
The following medicines may also interact with Venantapid XL and should be used with caution. It is especially important to mention to your doctor or pharmacist if you are taking medicines containing:
• Ketoconazole, Itraconazole, Voriconazole, Posaconazole (antifungal medicines)
• Clarithromycin, telithromycin (antibiotics used to treat infections)
• Atazanavir, indinavir, nelfinavir, ritonavir, saquinavir (used to treat HIV infection)
• Haloperidol or risperidone (to treat psychiatric conditions)
• Metoprolol (a beta blocker to treat high blood pressure and heart problems)
Venantapid XL with food, drink and alcohol
Venantapid XL should be taken with food (see section 3 “How to take Venantapid XL”).
You should avoid alcohol while you are taking Venantapid XL.
Pregnancy, breast-feeding and fertility
Tell your doctor if you become pregnant, or you are trying to become pregnant. You should use Venantapid XL only after discussing the potential benefits and the potential risks to your unborn child with your doctor.
Make sure your midwife and/or doctor knows you are on Venantapid XL. When taken during pregnancy, similar drugs (SSRIs) may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and appear bluish. These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your baby you should contact your midwife and/or doctor immediately.
If you are taking Venantapid XL during pregnancy, let your midwife and/or doctor know, as your baby might have some symptoms when it is born. These symptoms usually begin during the first 24 hours after the baby is born. They include irritability, tremor, hypotonia, constant crying, sleeping difficulties and, not feeding properly. If your baby has these symptoms when it is born and you are concerned, contact your doctor and/or midwife who will be able to advise you.
Venlafaxine passes into breast milk. There is a risk of an effect on the baby, which may cause symptoms such as crying, irritabilty and abnormal sleep patterns. Symptoms consistent with venlafaxine drug discontinuation can also occur after stopping breast-feeding. Therefore, you should discuss the matter with your doctor, and he/she will decide whether you should stop breast-feeding or stop the therapy with Venantapid XL.
Driving and using machines
Do not drive or use any tools or machines until you know how Venantapid XL affects you.
Important information about some of the ingredients of Venantapid XL
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
POM
3) HOW TO TAKE VENANTAPID XL
Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual recommended starting dose for treatment of depression and social anxiety disorder is 75 mg per day. The dose can be raised by your doctor gradually, and if needed, even up to a maximum dose of 375 mg daily for depression. The maximum dose for social anxiety disorder is 225 mg/day.
Take Venantapid XL at approximately the same time each day, either in the morning or in the evening. Tablets must be swallowed whole with fluid and not opened, crushed, chewed or dissolved.
Venantapid XL should be taken with food.
If you have liver or kidney problems, talk to your doctor, since your dose of Venantapid XL may need to be different.
Do not stop taking Venantapid XL without talking to your doctor (see the section “If you stop taking Venantapid XL”).
If you take more Venantapid XL than you should
Call your doctor or pharmacist immediately if you take more than the amount of Venantapid XL prescribed by your doctor.
The symptoms of a possible overdose may include a rapid heart beat, changes in level of alertness (ranging from sleepiness to coma), blurred vision, seizures or fits, and vomiting.
If you forget to take Venantapid XL
If you miss a dose, take it as soon as you remember. However, if it is time for your next dose, skip the missed dose and take only a single dose as usual. Do not take more than the daily amount of Venantapid XL that has been prescribed for you in one day.
If you stop taking Venantapid XL
Do not stop taking your treatment or reduce the dose without the advice of your doctor even if you feel better. If your doctor thinks that you no longer need Venantapid XL, he/she may ask you to reduce your dose slowly before stopping treatment altogether. Side effects are known to occur when people stop using Venantapid XL, especially when Venantapid XL is stopped suddenly or the dose is reduced too quickly. Some patients may experience symptoms such as tiredness, dizziness, light-headedness, headache, sleeplessness, sensation that everything around you is spinning or moving (vertigo), nightmares, dry mouth, loss of appetite, nausea, diarrhoea, nervousness, agitation, confusion, ringing in the ears, tingling or rarely electric shock sensations, weakness, sweating, seizures, or flu-like symptoms.
Your doctor will advise you on how you should gradually discontinue Venantapid XL treatment. If you experience any of these or other symptoms that are troublesome, ask your doctor for further advice.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4) POSSIBLE SIDE EFFECTS
Like all medicines, Venantapid XL can cause side effects, although not everybody gets them.
Do not be concerned if you see a tablet in your stools after taking Venantapid XL. As the tablet travels the length of your gastrointestinal tract, venlafaxine is slowly released. The shape of the tablet remains undissolved and is eliminated in your stools. Therefore, even though you may see a tablet in your stools, your dose of venlafaxine has been absorbed.
Allergic reactions
If any of the following happen, do not take more Venantapid XL. T ell your doctor immediately, or go to the casualty department at your nearest hospital:
• Chest tightness, wheezing, trouble swallowing or breathing
• Swelling of the face, throat, hands, or feet
• Feeling nervous or anxious, dizziness, throbbing sensations, sudden reddening of the skin and/or a warm feeling
• Severe rash, itching, or hives (elevated patches of red or pale skin that often itch)
• Signs and symptoms of serotonin syndrome which may include restlessness, hallucinations, loss of coordination, fast heart beat, increased body temperature, fast changes in blood pressure, overactive reflexes, diarrhoea, coma, nausea, vomiting.
In its most severe form, serotonin syndrome can resemble Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, fast heart beat, sweating, severe muscle stiffness, confusion, increased muscle enzymes (determined by a blood test).
Other side effects that you should tell your doctor about include:
• Coughing, wheezing, shortness of breath and a high temperature
• Black (tarry) stools or blood in stools
• Yellow skin or eyes, itchiness or dark urine, which may be symptoms of inflammation of the liver (hepatitis)
• Heart problems, such as fast or irregular heart rate, increased blood pressure
• Eye problems, such as blurred vision, dilated pupils
• Nerve problems, such as dizziness, pins and needles, movement disorder, seizures or fits
• Psychiatric problems, such as hyperactivity and euphoria (feeling unusually overexcited)
• Withdrawal effects (see the section “How to take Venantapid XL, if you stop taking Venantapid XL”)
• Prolonged bleeding - if you cut or injure yourself, it may take slightly longer than usual for bleeding to stop
Complete side effect listing
Very common (may affect more than 1 in 10 people)
• Dizziness; headache
• Nausea; dry mouth
• Sweating (including night sweats)
Common (may affect up to 1 in 10 people)
• Appetite decreased
• Confusion; feeling separated (or detached) from yourself; lack of orgasm; decreased libido
• nervousness; insomnia; abnormal dreams
• Drowsiness; tremor; pins and needles; increased muscle tonus
• Visual disturbance including blurred vision; dilated pupils; inability of the eye to automatically change focus from distant to near objects
• Ringing in the ears (tinnitus)
• Palpitations
• Increase in blood pressure; flushing
• Yawning
• Vomiting; constipation; diarrhoea
• Increased frequency in urination; difficulties passing urine
• Menstrual irregularities such as increased bleeding or increased irregular bleeding; abnormal ejaculation/orgasm (males); erectile dysfunction (impotence)
• Weakness (asthenia); fatigue; chills
• Increased cholesterol
Uncommon (may affect up to 1 in 100 people)
• Hallucinations; feeling separated (or detached) from reality; agitation; abnormal orgasm (females); lack of feeling or emotion; feeling overexcited; grinding of the teeth
• A sensation of restlessness or an inability to sit or stand still; fainting; involuntary movements of the muscles; impaired coordination and balance; altered taste sensation
• Fast heartbeat; feeling dizzy (particularly when standing up too quickly)
• Vomiting blood, black tarry stools (faeces) or blood in stools; which can be a sign of internal bleeding
• General swelling of the skin especially the face, mouth, tongue, throat area or hands and feet and/or a raised itchy rash (hives) may be present; sensitivity to sunlight; bruising; rash; abnormal hair loss
• Inability to pass urine
• Weight gain; weight loss
Rare (may affect up to 1 in 1,000 people)
• Seizures or fits
• Inability to control urination
• Over activity, racing thoughts and decreased need for sleep (mania)
Not known (frequency cannot be estimated from the available data)
• Reduced number of platelets in your blood, leading to an increased risk of bruising or bleeding; blood disorders which may lead to an increased risk of infection
• Swollen face or tongue, shortness of breath or difficulty breathing, often with skin rashes (this may be a serious allergic reaction)
• Excessive water intake (known as SIADH)
• Decrease in blood sodium levels
• Suicidal ideation and suicidal behaviours; cases of suicidal ideation and suicidal behaviours have been reported during venlafaxine therapy or early after treatment discontinuation (see section 2, Before you take Venantapid XL)
• Disorientation and confusion often accompanied by hallucination (delirium); aggression
• A high temperature with rigid muscles, confusion or agitation, and sweating, or if you experience jerky muscle movements which you can't control, these may be symptoms of serious conditions known as neuroleptic malignant syndrome; euphoric feelings, drowsiness, sustained rapid eye movement, clumsiness, restlessness, feeling of being drunk, sweating or rigid muscles, which are symptoms of serotonin syndrome; stiffness, spasms and involuntary movements of the muscles
• Severe eye pain and decreased or blurred vision
• Vertigo
• Decrease in blood pressure; abnormal, rapid or irregular heart beat, which could lead to fainting; unexpected bleeding, e.g. bleeding gums, blood in the urine or in vomit, or the appearance of unexpected bruises or broken blood vessels (broken veins)
• Coughing, wheezing, shortness of breath and a high temperature, which are symptoms of inflammation of the lungs associated with an increase in white blood cells (pulmonary eosinophilia)
• Severe abdominal or back pains (which could indicate a serious problem in the gut, liver or pancreas)
• Itchiness, yellow skin or eyes, dark urine, or flu-like symptoms, which are symptoms of inflammation of the liver (hepatitis); slight changes in blood levels of liver enzymes
• Skin rash, which may lead to severe blistering and peeling of the skin; itching; mild rash
• Unexplained muscle pain, tenderness or weakness (rhabdomyolysis)
• Abnormal breast milk production
Venantapid XL sometimes causes unwanted effects that you may not be aware of, such as increases in blood pressure or abnormal heart beat; slight changes in blood levels or liver enzymes, sodium or cholesterol. More rarely, Venantapid XL may reduce the function of platelets in your blood, leading to an increased risk of bruising or bleeding. Therefore, your doctor may wish to do blood tests occasionally, particularly if you have been taking Venantapid XL for a long time.
If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.
5) HOW TO STORE VENANTAPID XL
• Keep out of the sight and reach of children.
• Do not use Venantapid XL after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
• Do not store above 30C.
• Store in the original package in order to protect from moisture.
• If the tablets become discoloured or show any sign of deterioration return them to your pharmacist.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6) CONTENTS OF THE PACK AND OTHER INFORMATION
What Venantapid XL contains
Each prolonged-release tablet contains 75 mg venlafaxine (as hydrochloride).
The other ingredients are:
Core: Mannitol, Povidone K-90, Macrogol 400, Microcrystalline cellulose, Colloidal anhydrous silica, Magnesium stearate.
Coating: Cellulose acetate, Cellulose acetate 320s, Cellulose acetate 398-10, Macrogol 400, Opadry Y 30 18037 (hypromellose, lactose monohydrate, titanium dioxide (E171) and triacetin)
What Venantapid XL looks like and contents of the pack
Venantapid XL 75 mg prolonged-release tablets are white, round, biconvex tablets with a laser hole on one side.
Venantapid XL 75 mg prolonged-release tablets are available in packs of 28 tablets.
Manufacturer
Laboratorios LICONSA, S.A., Avda. Miralcampo, No 7, Pollgono Industrial Miralcampo, 19200 Azuqueca de Henares, Spain
Procured from within the EU by Product Licence holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall WS9 8ER
Repackaged by XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX PL 33532/0466
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions please ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
• The name of your medicine is Venantdepitab XL 75 mg prolonged-release tablets but will be referred to as Venantdepitab XL throughout the remainder of this leaflet.
• Venantdepitab XL is also available in other strengths.
What is in this leaflet:
1) What Venantdepitab XL is and what it is used for
2) What you need to know before you take Venantdepitab XL
3) How to take Venantdepitab XL
4) Possible side effects
5) How to store Venantdepitab XL
6) Contents of the pack and other information
1) WHAT VENANTDEPITAB XL IS AND WHAT IT IS USED FOR
Venantdepitab XL is an antidepressant that belongs to a group of medicines called serotonin and norepinephrine reuptake inhibitors (SNRIs). This group of medicines is used to treat depression and other conditions such as anxiety disorders. It is thought that people who are depressed and/or anxious have lower levels of serotonin and noradrenaline in the brain. It is not fully understood how antidepressants work, but they may help by increasing the levels of serotonin and noradrenaline in the brain.
Venantdepitab XL is a treatment for adults with depression and panic disorder (panic attacks). Treating depression or anxiety disorders properly is important to help you get better. If it is not treated, your condition may not go away and may become more serious and more difficult to treat.
2) WHAT YOU NEED TO KNOW BEFORE YOU TAKE VENANTDEPITAB XL
Do not take Venantdepitab XL
• If you are allergic to venlafaxine or any of the other ingredients of this medicine (listed in section 6).
• If you are also taking or have taken any time within the last 14 days any medicines known as irreversible monoamine oxidase inhibitors (MAOIs), used to treat depression or Parkinson's disease. Taking an irreversible MAOI together with Venantdepitab XL, can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop taking Venantdepitab XL before you take any MAOI (see also the sections entitled “Taking other medicines” and the information in that section about “Serotonin syndrome”).
Warnings and precautions
Talk to your doctor before taking Venantdepitab XL
• If you use other medicines that taken concomitantly with Venantdepitab XL could increase the risk of developing serotonin syndrome (see the section “Taking other medicines”).
• If you have a swallowing, stomach or intestinal disorder that reduces your ability to swallow or pass foods by normal bowel movements.
• If you have eye problems, such as certain kinds of glaucoma (increased pressure in the eye).
• If you have a history of high blood pressure.
• If you have a history of heart problems.
• If you have a history of fits (seizures).
• If you have a history of low sodium levels in your blood (hyponatraemia).
• If you have a tendency to develop bruises or a tendency to bleed easily (history of bleeding disorders), or if you are taking other medicines that may increase the risk of bleeding e.g. warfarin (used to prevent blood clots).
• If your cholesterol levels get higher.
• If you have a history of, or if someone in your family has had, mania or bipolar disorder (feeling over-excited or euphoric).
• If you have a history of aggressive behaviour.
Venantdepitab XL may cause a sensation of restlessness or an inability to sit or stand still during the first few weeks of treatment. You should tell your doctor if this happens to you.
If any of these conditions apply to you, please talk with your doctor before taking Venantdepitab XL.
Thoughts of suicide and worsening of your depression or feelings of anxiety
If you are depressed and/or have anxiety disorders, you can sometimes have thoughts of harming or killing yourself. These may be increased when you first start taking antidepressants, since these medicines all take time to work, usually about two weeks, but sometimes longer.
You may be more likely to think like this:
• If you have previously had thoughts about killing yourself or harming yourself.
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in young adults (less than 25 years old) with psychiatric conditions who were treated with an antidepressant.
If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.
Dry mouth
Dry mouth is reported in 10 % of patients treated with venlafaxine. This may increase the risk of caries. Therefore, you should take special care in your dental hygiene.
Diabetes
Your blood glucose levels may be altered due to Venantdepitab XL. Therefore, the dosages of your diabetes medicines may need to be adjusted.
Use in children and adolescents under 18 years of age
Venantdepitab XL should normally not be used for children and adolescents under 18 years. Also, you should know that patients under 18 have an increased risk of side effects, such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. Despite this, your doctor may prescribe this medicine for patients under 18 because he/she decides that this is in their best interests.
If your doctor has prescribed Venantdepitab XL for a patient under 18, and you want to discuss this, please go back to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking Venantdepitab XL. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of Venantdepitab XL in this age group has not yet been demonstrated.
Other medicines and Venantdepitab XL
Tell your doctor or pharmacist if you are taking, or have recently taken any other medicines.
Your doctor should decide whether you can take Venantdepitab XL with other medicines.
Do not start or stop taking any medicines, including those bought without a prescription, natural and herbal remedies, before checking with your doctor or pharmacist.
• Monoamine oxidase inhibitors which are used to treat depression or Parkinson's disease must not be taken with Venantdepitab XL. Tell your doctor if you have taken these medicines within the last 14 days. (MAOIs: see the section “Before you take Venantdepitab XL”).
• Serotonin syndrome:
Serotonin syndrome, a potentially life-threatening condition (see the section “Possible Side Effects”), may occur with venlafaxine treatment, particularly when taken with other medicines.
Examples of these medicines include:
• Triptans (used for migraine)
• Medicines to treat depression, for instance SNRI, SSRIs, tricyclics, or medicines containing lithium
• Medicines containing linezolid, an antibiotic (used to treat infections)
• Medicines containing moclobemide, a reversible MAOI (used to treat depression)
• Medicines containing sibutramine (used for weight loss)
• Medicines containing tramadol (a pain-killer)
• Medicines containing methylene blue (used to treat high levels of methaemoglobin in the blood)
• Products containing St. John's Wort (also called Hypericum perforatum, a natural or herbal remedy used to treat mild depression)
• Products containing tryptophan (used for problems such as sleep and depression)
• Antipsychotics (used to treat a disease with symptoms such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, unclear reasoning and becoming withdrawn)
Signs and symptoms of serotonin syndrome may include a combination of the following:
restlessness, hallucinations, loss of coordination, fast heart beat, increased body temperature, fast changes in blood pressure, overactive reflexes, diarrhoea, coma, nausea, vomiting.
In its most severe form, serotonin syndrome can resemble Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, fast heart beat, sweating, severe muscle stiffness, confusion, increased muscle enzymes (determined by a blood test).
Tell your doctor immediately, or go to the casualty department at your nearest hospital if you think serotonin syndrome is happening to you
The following medicines may also interact with Venantdepitab XL and should be used with caution. It is especially important to mention to your doctor or pharmacist if you are taking medicines containing:
• Ketoconazole, Itraconazole, Voriconazole, Posaconazole (antifungal medicines)
• Clarithromycin, telithromycin (antibiotics used to treat infections)
• Atazanavir, indinavir, nelfinavir, ritonavir, saquinavir (used to treat HIV infection)
• Haloperidol or risperidone (to treat psychiatric conditions)
• Metoprolol (a beta blocker to treat high blood pressure and heart problems)
Venantdepitab XL with food, drink and alcohol
Venantdepitab XL should be taken with food (see section 3 “How to take Venantdepitab XL”).
You should avoid alcohol while you are taking Venantdepitab XL. Pregnancy, breast-feeding and fertility
Tell your doctor if you become pregnant, or you are trying to become pregnant. You should use Venantdepitab XL only after discussing the potential benefits and the potential risks to your unborn child with your doctor.
Make sure your midwife and/or doctor knows you are on Venantdepitab XL. When taken during pregnancy, similar drugs (SSRIs) may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and appear bluish. These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your baby you should contact your midwife and/or doctor immediately.
If you are taking Venantdepitab XL during pregnancy, let your midwife and/or doctor know, as your baby might have some symptoms when it is born. These symptoms usually begin during the first 24 hours after the baby is born. They include irritability, tremor, hypotonia, constant crying, sleeping difficulties and, not feeding properly. If your baby has these symptoms when it is born and you are concerned, contact your doctor and/or midwife who will be able to advise you.
Venlafaxine passes into breast milk. There is a risk of an effect on the baby, which may cause symptoms such as crying, irritabilty and abnormal sleep patterns. Symptoms consistent with venlafaxine drug discontinuation can also occur after stopping breast-feeding. Therefore, you should discuss the matter with your doctor, and he/she will decide whether you should stop breast-feeding or stop the therapy with Venantdepitab XL.
Driving and using machines
Do not drive or use any tools or machines until you know how Venantdepitab XL affects you.
Important information about some of the ingredients of Venantdepitab XL
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
POM
3) HOW TO TAKE VENANTDEPITAB XL
Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual recommended starting dose for treatment of depression and social anxiety disorder is 75 mg per day. The dose can be raised by your doctor gradually, and if needed, even up to a maximum dose of 375 mg daily for depression. The maximum dose for social anxiety disorder is 225 mg/day.
Take Venantdepitab XL at approximately the same time each day, either in the morning or in the evening. Tablets must be swallowed whole with fluid and not opened, crushed, chewed or dissolved.
Venantdepitab XL should be taken with food.
If you have liver or kidney problems, talk to your doctor, since your dose of Venantdepitab XL may need to be different.
Do not stop taking Venantdepitab XL without talking to your doctor (see the section “If you stop taking Venantdepitab XL”).
If you take more Venantdepitab XL than you should
Call your doctor or pharmacist immediately if you take more than the amount of Venantdepitab XL prescribed by your doctor.
The symptoms of a possible overdose may include a rapid heart beat, changes in level of alertness (ranging from sleepiness to coma), blurred vision, seizures or fits, and vomiting.
If you forget to take Venantdepitab XL
If you miss a dose, take it as soon as you remember. However, if it is time for your next dose, skip the missed dose and take only a single dose as usual. Do not take more than the daily amount of Venantdepitab XL that has been prescribed for you in one day.
If you stop taking Venantdepitab XL
Do not stop taking your treatment or reduce the dose without the advice of your doctor even if you feel better. If your doctor thinks that you no longer need Venantdepitab XL, he/she may ask you to reduce your dose slowly before stopping treatment altogether. Side effects are known to occur when people stop using Venantdepitab XL, especially when Venantdepitab XL is stopped suddenly or the dose is reduced too quickly. Some patients may experience symptoms such as tiredness, dizziness, light-headedness, headache, sleeplessness, sensation that everything around you is spinning or moving (vertigo), nightmares, dry mouth, loss of appetite, nausea, diarrhoea, nervousness, agitation, confusion, ringing in the ears, tingling or rarely electric shock sensations, weakness, sweating, seizures, or flu-like symptoms.
Your doctor will advise you on how you should gradually discontinue Venantdepitab XL treatment. If you experience any of these or other symptoms that are troublesome, ask your doctor for further advice.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4) POSSIBLE SIDE EFFECTS
Like all medicines, Venantdepitab XL can cause side effects, although not everybody gets them.
Do not be concerned if you see a tablet in your stools after taking Venantdepitab XL. As the tablet travels the length of your gastrointestinal tract, venlafaxine is slowly released. The shape of the tablet remains undissolved and is eliminated in your stools. Therefore, even though you may see a tablet in your stools, your dose of venlafaxine has been absorbed.
Allergic reactions
If any of the following happen, do not take more Venantdepitab XL. Tell your doctor immediately, or go to the casualty department at your nearest hospital:
• Chest tightness, wheezing, trouble swallowing or breathing
• Swelling of the face, throat, hands, or feet
• Feeling nervous or anxious, dizziness, throbbing sensations, sudden reddening of the skin and/or a warm feeling
• Severe rash, itching, or hives (elevated patches of red or pale skin that often itch)
• Signs and symptoms of serotonin syndrome which may include restlessness, hallucinations, loss of coordination, fast heart beat, increased body temperature, fast changes in blood pressure, overactive reflexes, diarrhoea, coma, nausea, vomiting.
In its most severe form, serotonin syndrome can resemble Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, fast heart beat, sweating, severe muscle stiffness, confusion, increased muscle enzymes (determined by a blood test).
Other side effects that you should tell your doctor about include:
• Coughing, wheezing, shortness of breath and a high temperature
• Black (tarry) stools or blood in stools
• Yellow skin or eyes, itchiness or dark urine, which may be symptoms of inflammation of the liver (hepatitis)
• Heart problems, such as fast or irregular heart rate, increased blood pressure
• Eye problems, such as blurred vision, dilated pupils
• Nerve problems, such as dizziness, pins and needles, movement disorder, seizures or fits
• Psychiatric problems, such as hyperactivity and euphoria (feeling unusually overexcited)
• Withdrawal effects (see the section “How to take Venantdepitab XL, if you stop taking Venantdepitab XL”)
• Prolonged bleeding - if you cut or injure yourself, it may take slightly longer than usual for bleeding to stop
Complete side effect listing
Very common (may affect more than 1 in 10 people)
• Dizziness; headache
• Nausea; dry mouth
• Sweating (including night sweats)
Common (may affect up to 1 in 10 people)
• Appetite decreased
• Confusion; feeling separated (or detached) from yourself; lack of orgasm; decreased libido
• nervousness; insomnia; abnormal dreams
• Drowsiness; tremor; pins and needles; increased muscle tonus
• Visual disturbance including blurred vision; dilated pupils; inability of the eye to automatically change focus from distant to near objects
• Ringing in the ears (tinnitus)
• Palpitations
• Increase in blood pressure; flushing
• Yawning
• Vomiting; constipation; diarrhoea
• Increased frequency in urination; difficulties passing urine
• Menstrual irregularities such as increased bleeding or increased irregular bleeding; abnormal ejaculation/orgasm (males); erectile dysfunction (impotence)
• Weakness (asthenia); fatigue; chills
• Increased cholesterol
Uncommon (may affect up to 1 in 100 people)
• Hallucinations; feeling separated (or detached) from reality; agitation; abnormal orgasm (females); lack of feeling or emotion; feeling overexcited; grinding of the teeth
• A sensation of restlessness or an inability to sit or stand still; fainting; involuntary movements of the muscles; impaired coordination and balance; altered taste sensation
• Fast heartbeat; feeling dizzy (particularly when standing up too quickly)
• Vomiting blood, black tarry stools (faeces) or blood in stools; which can be a sign of internal bleeding
• General swelling of the skin especially the face, mouth, tongue, throat area or hands and feet and/or a raised itchy rash (hives) may be present; sensitivity to sunlight; bruising; rash; abnormal hair loss
• Inability to pass urine
• Weight gain; weight loss
Rare (may affect up to 1 in 1,000 people)
• Seizures or fits
• Inability to control urination
• Over activity, racing thoughts and decreased need for sleep (mania)
Not known (frequency cannot be estimated from the available data)
• Reduced number of platelets in your blood, leading to an increased risk of bruising or bleeding; blood disorders which may lead to an increased risk of infection
• Swollen face or tongue, shortness of breath or difficulty breathing, often with skin rashes (this may be a serious allergic reaction)
• Excessive water intake (known as SIADH)
• Decrease in blood sodium levels
• Suicidal ideation and suicidal behaviours; cases of suicidal ideation and suicidal behaviours have been reported during venlafaxine therapy or early after treatment discontinuation (see section 2, Before you take Venantdepitab XL)
• Disorientation and confusion often accompanied by hallucination (delirium); aggression
• A high temperature with rigid muscles, confusion or agitation, and sweating, or if you experience jerky muscle movements which you can't control, these may be symptoms of serious conditions known as neuroleptic malignant syndrome; euphoric feelings, drowsiness, sustained rapid eye movement, clumsiness, restlessness, feeling of being drunk, sweating or rigid muscles, which are symptoms of serotonin syndrome; stiffness, spasms and involuntary movements of the muscles
• Severe eye pain and decreased or blurred vision
• Vertigo
• Decrease in blood pressure; abnormal, rapid or irregular heart beat, which could lead to fainting; unexpected bleeding, e.g. bleeding gums, blood in the urine or in vomit, or the appearance of unexpected bruises or broken blood vessels (broken veins)
• Coughing, wheezing, shortness of breath and a high temperature, which are symptoms of inflammation of the lungs associated with an increase in white blood cells (pulmonary eosinophilia)
• Severe abdominal or back pains (which could indicate a serious problem in the gut, liver or pancreas)
• Itchiness, yellow skin or eyes, dark urine, or flu-like symptoms, which are symptoms of inflammation of the liver (hepatitis); slight changes in blood levels of liver enzymes
• Skin rash, which may lead to severe blistering and peeling of the skin; itching; mild rash
• Unexplained muscle pain, tenderness or weakness (rhabdomyolysis)
• Abnormal breast milk production
Venantdepitab XL sometimes causes unwanted effects that you may not be aware of, such as increases in blood pressure or abnormal heart beat; slight changes in blood levels or liver enzymes, sodium or cholesterol. More rarely, Venantdepitab XL may reduce the function of platelets in your blood, leading to an increased risk of bruising or bleeding. Therefore, your doctor may wish to do blood tests occasionally, particularly if you have been taking Venantdepitab XL for a long time.
If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.
5) HOW TO STORE VENANTDEPITAB XL
• Keep out of the sight and reach of children.
• Do not use Venantdepitab XL after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
• Do not store above 30C.
• Store in the original package in order to protect from moisture.
• If the tablets become discoloured or show any sign of deterioration return them to your pharmacist.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6) CONTENTS OF THE PACK AND OTHER INFORMATION
What Venantdepitab XL contains
Each prolonged-release tablet contains 75 mg venlafaxine (as hydrochloride).
The other ingredients are:
Core: Mannitol, Povidone K-90, Macrogol 400, Microcrystalline cellulose, Colloidal anhydrous silica, Magnesium stearate.
Coating: Cellulose acetate, Cellulose acetate 320s, Cellulose acetate 398-10, Macrogol 400, Opadry Y 30 18037 (hypromellose, lactose monohydrate, titanium dioxide (E171) and triacetin)
What Venantdepitab XL looks like and contents of the pack
Venantdepitab XL 75 mg prolonged-release tablets are white, round, biconvex tablets with a laser hole on one side.
Venantdepitab XL 75 mg prolonged-release tablets are available in packs of 28 tablets.
Manufacturer
Laboratorios LICONSA, S.A., Avda. Miralcampo, No 7, Pollgono Industrial Miralcampo, 19200 Azuqueca de Henares, Spain
Procured from within the EU by Product Licence holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall WS9 8ER
Repackaged by XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX PL 33532/0466
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions please ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
• The name of your medicine is Venlalic XL 75 mg prolonged-release tablets but will be referred to as Venlalic XL throughout the remainder of this leaflet.
• Venlalic XL is also available in other strengths.
What is in this leaflet:
1) What Venlalic XL is and what it is used for
2) What you need to know before you take Venlalic XL
3) How to take Venlalic XL
4) Possible side effects
5) How to store Venlalic XL
6) Contents of the pack and other information
1) WHAT VENLALIC XL IS AND WHAT IT IS USED FOR
Venlalic XL is an antidepressant that belongs to a group of medicines called serotonin and norepinephrine reuptake inhibitors (SNRIs). This group of medicines is used to treat depression and other conditions such as anxiety disorders. It is thought that people who are depressed and/or anxious have lower levels of serotonin and noradrenaline in the brain. It is not fully understood how antidepressants work, but they may help by increasing the levels of serotonin and noradrenaline in the brain.
Venlalic XL is a treatment for adults with depression and panic disorder (panic attacks). Treating depression or anxiety disorders properly is important to help you get better. If it is not treated, your condition may not go away and may become more serious and more difficult to treat.
2) WHAT YOU NEED TO KNOW BEFORE YOU TAKE VENLALIC XL Do not take Venlalic XL
• If you are allergic to venlafaxine or any of the other ingredients of this medicine (listed in section 6).
• If you are also taking or have taken any time within the last 14 days any medicines known as irreversible monoamine oxidase inhibitors (MAOIs), used to treat depression or Parkinson's disease. Taking an irreversible MAOI together with Venlalic XL, can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop taking Venlalic XL before you take any MAOI (see also the sections entitled “Taking other medicines” and the information in that section about “Serotonin syndrome”).
Warnings and precautions
Talk to your doctor before taking Venlalic XL
• If you use other medicines that taken concomitantly with Venlalic XL could increase the risk of developing serotonin syndrome (see the section “Taking other medicines”).
• If you have a swallowing, stomach or intestinal disorder that reduces your ability to swallow or pass foods by normal bowel movements.
• If you have eye problems, such as certain kinds of glaucoma (increased pressure in the eye).
• If you have a history of high blood pressure.
• If you have a history of heart problems.
• If you have a history of fits (seizures).
• If you have a history of low sodium levels in your blood (hyponatraemia).
• If you have a tendency to develop bruises or a tendency to bleed easily (history of bleeding disorders), or if you are taking other medicines that may increase the risk of bleeding e.g. warfarin (used to prevent blood clots).
• If your cholesterol levels get higher.
• If you have a history of, or if someone in your family has had, mania or bipolar disorder (feeling over-excited or euphoric).
• If you have a history of aggressive behaviour.
Venlalic XL may cause a sensation of restlessness or an inability to sit or stand still during the first few weeks of treatment. You should tell your doctor if this happens to you.
If any of these conditions apply to you, please talk with your doctor before taking Venlalic XL.
Thoughts of suicide and worsening of your depression or feelings of anxiety
If you are depressed and/or have anxiety disorders, you can sometimes have thoughts of harming or killing yourself. These may be increased when you first start taking antidepressants, since these medicines all take time to work, usually about two weeks, but sometimes longer.
You may be more likely to think like this:
• If you have previously had thoughts about killing yourself or harming yourself.
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in young adults (less than 25 years old) with psychiatric conditions who were treated with an antidepressant.
If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.
Dry mouth
Dry mouth is reported in 10 % of patients treated with venlafaxine. This may increase the risk of caries. Therefore, you should take special care in your dental hygiene.
Diabetes
Your blood glucose levels may be altered due to Venlalic XL. Therefore, the dosages of your diabetes medicines may need to be adjusted.
Use in children and adolescents under 18 years of age
Venlalic XL should normally not be used for children and adolescents under 18 years. Also, you should know that patients under 18 have an increased risk of side effects, such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. Despite this, your doctor may prescribe this medicine for patients under 18 because he/she decides that this is in their best interests.
If your doctor has prescribed Venlalic XL for a patient under 18, and you want to discuss this, please go back to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking Venlalic XL. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of Venlalic XL in this age group has not yet been demonstrated.
Other medicines and Venlalic XL
Tell your doctor or pharmacist if you are taking, or have recently taken any other medicines.
Your doctor should decide whether you can take Venlalic XL with other medicines.
Do not start or stop taking any medicines, including those bought without a prescription, natural and herbal remedies, before checking with your doctor or pharmacist.
• Monoamine oxidase inhibitors which are used to treat depression or Parkinson's disease must not be taken with Venlalic XL. Tell your doctor if you have taken these medicines within the last 14 days. (MAOIs: see the section “Before you take Venlalic XL”).
• Serotonin syndrome:
Serotonin syndrome, a potentially life-threatening condition (see the section “Possible Side Effects”), may occur with venlafaxine treatment, particularly when taken with other medicines.
Examples of these medicines include:
• Triptans (used for migraine)
• Medicines to treat depression, for instance SNRI, SSRIs, tricyclics, or medicines containing lithium
• Medicines containing linezolid, an antibiotic (used to treat infections)
• Medicines containing moclobemide, a reversible MAOI (used to treat depression)
• Medicines containing sibutramine (used for weight loss)
• Medicines containing tramadol (a pain-killer)
• Medicines containing methylene blue (used to treat high levels of methaemoglobin in the blood)
• Products containing St. John's Wort (also called Hypericum perforatum, a natural or herbal remedy used to treat mild depression)
• Products containing tryptophan (used for problems such as sleep and depression)
• Antipsychotics (used to treat a disease with symptoms such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, unclear reasoning and becoming withdrawn)
Signs and symptoms of serotonin syndrome may include a combination of the following:
restlessness, hallucinations, loss of coordination, fast heart beat, increased body temperature, fast changes in blood pressure, overactive reflexes, diarrhoea, coma, nausea, vomiting.
In its most severe form, serotonin syndrome can resemble Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, fast heart beat, sweating, severe muscle stiffness, confusion, increased muscle enzymes (determined by a blood test).
Tell your doctor immediately, or go to the casualty department at your nearest hospital if you think serotonin syndrome is happening to you
The following medicines may also interact with Venlalic XL and should be used with caution. It is especially important to mention to your doctor or pharmacist if you are taking medicines containing:
• Ketoconazole, Itraconazole, Voriconazole, Posaconazole (antifungal medicines)
• Clarithromycin, telithromycin (antibiotics used to treat infections)
• Atazanavir, indinavir, nelfinavir, ritonavir, saquinavir (used to treat HIV infection)
• Haloperidol or risperidone (to treat psychiatric conditions)
• Metoprolol (a beta blocker to treat high blood pressure and heart problems)
Venlalic XL with food, drink and alcohol
Venlalic XL should be taken with food (see section 3 “How to take Venlalic XL”).
You should avoid alcohol while you are taking Venlalic XL.
Pregnancy, breast-feeding and fertility
Tell your doctor if you become pregnant, or you are trying to become pregnant. You should use Venlalic XL only after discussing the potential benefits and the potential risks to your unborn child with your doctor.
Make sure your midwife and/or doctor knows you are on Venlalic XL. When taken during pregnancy, similar drugs (SSRIs) may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and appear bluish. These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your baby you should contact your midwife and/or doctor immediately.
If you are taking Venlalic XL during pregnancy, let your midwife and/or doctor know, as your baby might have some symptoms when it is born. These symptoms usually begin during the first 24 hours after the baby is born. They include irritability, tremor, hypotonia, constant crying, sleeping difficulties and, not feeding properly. If your baby has these symptoms when it is born and you are concerned, contact your doctor and/or midwife who will be able to advise you.
Venlafaxine passes into breast milk. There is a risk of an effect on the baby, which may cause symptoms such as crying, irritabilty and abnormal sleep patterns. Symptoms consistent with venlafaxine drug discontinuation can also occur after stopping breast-feeding. Therefore, you should discuss the matter with your doctor, and he/she will decide whether you should stop breast-feeding or stop the therapy with Venlalic XL.
Driving and using machines
Do not drive or use any tools or machines until you know how Venlalic XL affects you.
Important information about some of the ingredients of Venlalic XL
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
POM
3) HOW TO TAKE VENLALIC XL
Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual recommended starting dose for treatment of depression and social anxiety disorder is 75 mg per day. The dose can be raised by your doctor gradually, and if needed, even up to a maximum dose of 375 mg daily for depression. The maximum dose for social anxiety disorder is 225 mg/day.
Take Venlalic XL at approximately the same time each day, either in the morning or in the evening. Tablets must be swallowed whole with fluid and not opened, crushed, chewed or dissolved.
Venlalic XL should be taken with food.
If you have liver or kidney problems, talk to your doctor, since your dose of Venlalic XL may need to be different.
Do not stop taking Venlalic XL without talking to your doctor (see the section “If you stop taking Venlalic XL”).
If you take more Venlalic XL than you should
Call your doctor or pharmacist immediately if you take more than the amount of Venlalic XL prescribed by your doctor.
The symptoms of a possible overdose may include a rapid heart beat, changes in level of alertness (ranging from sleepiness to coma), blurred vision, seizures or fits, and vomiting.
If you forget to take Venlalic XL
If you miss a dose, take it as soon as you remember. However, if it is time for your next dose, skip the missed dose and take only a single dose as usual. Do not take more than the daily amount of Venlalic XL that has been prescribed for you in one day.
If you stop taking Venlalic XL
Do not stop taking your treatment or reduce the dose without the advice of your doctor even if you feel better. If your doctor thinks that you no longer need Venlalic Xl, he/she may ask you to reduce your dose slowly before stopping treatment altogether. Side effects are known to occur when people stop using Venlalic XL, especially when Venlalic XL is stopped suddenly or the dose is reduced too quickly. Some patients may experience symptoms such as tiredness, dizziness, light-headedness, headache, sleeplessness, sensation that everything around you is spinning or moving (vertigo), nightmares, dry mouth, loss of appetite, nausea, diarrhoea, nervousness, agitation, confusion, ringing in the ears, tingling or rarely electric shock sensations, weakness, sweating, seizures, or flu-like symptoms.
Your doctor will advise you on how you should gradually discontinue Venlalic XL treatment. If you experience any of these or other symptoms that are troublesome, ask your doctor for further advice.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4) POSSIBLE SIDE EFFECTS
Like all medicines, Venlalic XL can cause side effects, although not everybody gets them.
Do not be concerned if you see a tablet in your stools after taking Venlalic XL. As the tablet travels the length of your gastrointestinal tract, venlafaxine is slowly released. The shape of the tablet remains undissolved and is eliminated in your stools. Therefore, even though you may see a tablet in your stools, your dose of venlafaxine has been absorbed.
Allergic reactions
If any of the following happen, do not take more Venlalic XL. Tell your doctor immediately, or go to the casualty department at your nearest hospital:
• Chest tightness, wheezing, trouble swallowing or breathing
• Swelling of the face, throat, hands, or feet
• Feeling nervous or anxious, dizziness, throbbing sensations, sudden reddening of the skin and/or a warm feeling
• Severe rash, itching, or hives (elevated patches of red or pale skin that often itch)
• Signs and symptoms of serotonin syndrome which may include restlessness, hallucinations, loss of coordination, fast heart beat, increased body temperature, fast changes in blood pressure, overactive reflexes, diarrhoea, coma, nausea, vomiting.
In its most severe form, serotonin syndrome can resemble Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, fast heart beat, sweating, severe muscle stiffness, confusion, increased muscle enzymes (determined by a blood test).
Other side effects that you should tell your doctor about include:
• Coughing, wheezing, shortness of breath and a high temperature
• Black (tarry) stools or blood in stools
• Yellow skin or eyes, itchiness or dark urine, which may be symptoms of inflammation of the liver (hepatitis)
• Heart problems, such as fast or irregular heart rate, increased blood pressure
• Eye problems, such as blurred vision, dilated pupils
• Nerve problems, such as dizziness, pins and needles, movement disorder, seizures or fits
• Psychiatric problems, such as hyperactivity and euphoria (feeling unusually overexcited)
• Withdrawal effects (see the section “How to take Venlalic XL, if you stop taking Venlalic XL”)
• Prolonged bleeding - if you cut or injure yourself, it may take slightly longer than usual for bleeding to stop
Complete side effect listing
Very common (may affect more than 1 in 10 people)
• Dizziness; headache
• Nausea; dry mouth
• Sweating (including night sweats)
Common (may affect up to 1 in 10 people)
• Appetite decreased
• Confusion; feeling separated (or detached) from yourself; lack of orgasm; decreased libido
• nervousness; insomnia; abnormal dreams
• Drowsiness; tremor; pins and needles; increased muscle tonus
• Visual disturbance including blurred vision; dilated pupils; inability of the eye to automatically change focus from distant to near objects
• Ringing in the ears (tinnitus)
• Palpitations
• Increase in blood pressure; flushing
• Yawning
• Vomiting; constipation; diarrhoea
• Increased frequency in urination; difficulties passing urine
• Menstrual irregularities such as increased bleeding or increased irregular bleeding; abnormal ejaculation/orgasm (males); erectile dysfunction (impotence)
• Weakness (asthenia); fatigue; chills
• Increased cholesterol
Uncommon (may affect up to 1 in 100 people)
• Hallucinations; feeling separated (or detached) from reality; agitation; abnormal orgasm (females); lack of feeling or emotion; feeling overexcited; grinding of the teeth
• A sensation of restlessness or an inability to sit or stand still; fainting; involuntary movements of the muscles; impaired coordination and balance; altered taste sensation
• Fast heartbeat; feeling dizzy (particularly when standing up too quickly)
• Vomiting blood, black tarry stools (faeces) or blood in stools; which can be a sign of internal bleeding
• General swelling of the skin especially the face, mouth, tongue, throat area or hands and feet and/or a raised itchy rash (hives) may be present; sensitivity to sunlight; bruising; rash; abnormal hair loss
• Inability to pass urine
• Weight gain; weight loss
Rare (may affect up to 1 in 1,000 people)
• Seizures or fits
• Inability to control urination
• Over activity, racing thoughts and decreased need for sleep (mania)
Not known (frequency cannot be estimated from the available data)
• Reduced number of platelets in your blood, leading to an increased risk of bruising or bleeding; blood disorders which may lead to an increased risk of infection
• Swollen face or tongue, shortness of breath or difficulty breathing, often with skin rashes (this may be a serious allergic reaction)
• Excessive water intake (known as SIADH)
• Decrease in blood sodium levels
• Suicidal ideation and suicidal behaviours; cases of suicidal ideation and suicidal behaviours have been reported during venlafaxine therapy or early after treatment discontinuation (see section 2, Before you take Venlalic XL)
• Disorientation and confusion often accompanied by hallucination (delirium); aggression
• A high temperature with rigid muscles, confusion or agitation, and sweating, or if you experience jerky muscle movements which you can't control, these may be symptoms of serious conditions known as neuroleptic malignant syndrome; euphoric feelings, drowsiness, sustained rapid eye movement, clumsiness, restlessness, feeling of being drunk, sweating or rigid muscles, which are symptoms of serotonin syndrome; stiffness, spasms and involuntary movements of the muscles
• Severe eye pain and decreased or blurred vision
• Vertigo
• Decrease in blood pressure; abnormal, rapid or irregular heart beat, which could lead to fainting; unexpected bleeding, e.g. bleeding gums, blood in the urine or in vomit, or the appearance of unexpected bruises or broken blood vessels (broken veins)
• Coughing, wheezing, shortness of breath and a high temperature, which are symptoms of inflammation of the lungs associated with an increase in white blood cells (pulmonary eosinophilia)
• Severe abdominal or back pains (which could indicate a serious problem in the gut, liver or pancreas)
• Itchiness, yellow skin or eyes, dark urine, or flu-like symptoms, which are symptoms of inflammation of the liver (hepatitis); slight changes in blood levels of liver enzymes
• Skin rash, which may lead to severe blistering and peeling of the skin; itching; mild rash
• Unexplained muscle pain, tenderness or weakness (rhabdomyolysis)
• Abnormal breast milk production
Venlalic XL sometimes causes unwanted effects that you may not be aware of, such as increases in blood pressure or abnormal heart beat; slight changes in blood levels or liver enzymes, sodium or cholesterol. More rarely, Venlalic XL may reduce the function of platelets in your blood, leading to an increased risk of bruising or bleeding. Therefore, your doctor may wish to do blood tests occasionally, particularly if you have been taking Venlalic XL for a long time.
If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.
5) HOW TO STORE VENLALIC XL
• Keep out of the sight and reach of children.
• Do not use Venlalic XL after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
• Do not store above 30C.
• Store in the original package in order to protect from moisture.
• If the tablets become discoloured or show any sign of deterioration return them to your pharmacist.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6) CONTENTS OF THE PACK AND OTHER INFORMATION
What Venlalic XL contains
Each prolonged-release tablet contains 75 mg venlafaxine (as hydrochloride).
The other ingredients are:
Core: Mannitol, Povidone K-90, Macrogol 400, Microcrystalline cellulose, Colloidal anhydrous silica, Magnesium stearate.
Coating: Cellulose acetate, Cellulose acetate 320s, Cellulose acetate 398-10, Macrogol 400, Opadry Y 30 18037 (hypromellose, lactose monohydrate, titanium dioxide (E171) and triacetin)
What Venlalic XL looks like and contents of the pack
Venlalic XL 75 mg prolonged-release tablets are white, round, biconvex tablets with a laser hole on one side.
Venlalic XL 75 mg prolonged-release tablets are available in packs of 28 tablets.
Manufacturer
Laboratorios LICONSA, S.A., Avda. Miralcampo, No 7, Pollgono Industrial Miralcampo, 19200 Azuqueca de Henares, Spain
Procured from within the EU by Product Licence holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall WS9 8ER
Repackaged by XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX PL 33532/0466
Leaflet date: 23 June 2014 Leaflet code: XXXXXXXXXX
Venlalic® is a registered trademark of Dallas Burston Ashbourne Holdings Ltd.