Xenalven Xl 150 Mg Prolonged Release Capsule
PACKAGE LEAFLET: INFORMATION FOR THE USER
Xenalven XL 37.5 mg, 75 mg and 150 mg Prolonged release capsules
venlafaxine
IMPORTANT THINGS YOU SHOULD KNOW ABOUT Xenalven XL
Please read all of this leaflet before you start to take your medicine as it contains important information about Xenalven XL
• Xenalven XL is used to treat depression, severe and persistent anxiety known as generalised anxiety disorder (GAD), social anxiety disorder (also known as social phobia) and panic disorder (panic attacks)
• Xenalven XL is not for use in children and adolescents - see in section 2 ‘Use in children and adolescents’
• If you have any concerns about how you feel, or about this medication, it is important that you talk to your doctor - even if you feel anxious or worried about doing so. You may find it helpful to tell a friend or relative that you are depressed or suffering from an anxiety disorder, and that you have been prescribed this medication; it might be useful to show them this leaflet.
• Xenalven XL may not start to work immediately.
Some people taking antidepressants may feel worse before feeling better. Your doctor may ask to see you again a couple of weeks after you start treatment and then regularly until you start to feel well again. Tell your doctor if you do not start to feel better.
• Some people who are depressed may think of harming or killing themself. If this happens you should see your doctor or go to a hospital straight away - see in section 2 ‘Thoughts of suicide and worsening of your depression or anxiety disorder’
• If you take too many capsules it is important to seek immediate medical attention, even if you feel well, because of the risk of serious side effects
• Do not stop taking Xenalven XL or change your dose without the advice of your doctor even if you feel better. If you stop taking Xenalven XL abruptly you may get withdrawal reactions - see in section 3 ‘If you stop taking Xenalven XL’
• If you have heart problems such as fast or irregular heart rate or high blood pressure you should talk to your doctor before taking Xenalven XL - see in
section 2 ‘Before you take Xenalven XL’
• Taking certain other medicines with Xenalven XL may cause problems. You should tell your doctor if you are taking any other medicines - see in section 2 ‘Before you take Xenalven XL’
• See your doctor without delay if you feel restless and feel like you can’t keep still, feel ‘high’ or very overexcited, have jerky muscle movements which you can’t control. See section 4 - ‘Possible side effects’ for other important information
• If you are pregnant, or intend to become pregnant, or breast-feeding, you should talk to your doctor - see in section 2 ‘Pregnancy, breast-feeding and Xenalven XL’
More information on all of these points is provided in the rest of this leaflet.
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Xenalven XL Capsules are and what are they used for
2. What you need to know before you take Xenalven XL Capsules.
3. How to take Xenalven XL Capsules
4. Possible side effects
5. How to store Xenalven XL Capsules
6. Contents of the pack and other information
1. WHAT XENALVEN XL CAPSULES ARE AND WHAT ARE THEY USED FOR
Xenalven XL is an antidepressant and one of a group of medicines called serotonin noradrenaline reuptake inhibitors (SNRIs). This group of medicines is used to treat depression. It is thought that people who are depressed may have lower levels of serotonin and noradrenaline in their brain. Whilst it is not fully understood how antidepressants work, Xenalven XL prolonged release capsules may help to relieve the symptoms of depression by increasing the levels of these substances in the brain.
Xenalven XL capsules is a treatment for adults with depression. Xenalven XL capsules is also a treatment for adults with the following anxiety disorders: generalised anxiety disorder, social anxiety disorder (fear or avoidance of social situations) 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 XENALVEN XL CAPSULES.
Do not take Xenalven XL
• if you are allergic to venlafaxine or any 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 other medicines, including venla-faxine can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop taking Xenalven XL before you take any MAOI (see also the section "Taking other medicines" and the information in that section about "Serotonin Syndrome")
Warnings and precautions
Take special care with Xenalven XL
• if you use other medicines that taken at the same time as Xenalven XL could increase the risk of developing serotonin syndrome (see the section “Taking other medicines”)
• 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 eg.warfarin (used to prevent blood clot)
• if your cholesterol levels get higher
• if you have been told you have an abnormal heart rhythm.
• 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.
Xenalven XL may cause a sensation of restlessness or an inability to sit or stand still. 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 Xenalven XL capsules.
Thoughts of suicide and worsening of your depression or anxiety disorder
If you are depressed and/or have anxiety disorders, you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting 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 or harming yourself
• if you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults (aged less than 25 years) 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 Xenalven XL. This may increase the risk of tooth decay. Therefore, you should take special care in your dental hygiene
Diabetes
Your blood glucose levels may be altered due to Xenalven XL. Therefore, the dosage of your diabetes medicines may need to be adjusted.
Children and adolescents
Xenalven 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 Xenalven XL for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed Xenalven 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 Xenalven XL. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of Xenalven XL in this age group has not yet been demonstrated.
Other medicines and Xenalven XL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including medicines obtained without a prescription.
Your doctor should decide whether you can take Xenalven 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 Xenalven XL capsules. Tell your doctor if you have taken these medicines within the last 14 days. (MAOIs: see the section “What you need to know before you take Xenalven XL Capsules”).
• Serotonin syndrome: A potentially life-threatening condition or Neuroleptic Malignant Syndrome (NMS)-like reactions (see the section "Possible Side Effects"), may occur with Xenalven XL 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, fentanyl, tapentadol, pethidine, or pentazocine (used to treat severe pain)
- Medicines containing methadone (used to treat opioid drug addiction or severe pain)
- Medicines containing dextromethorphan (used to treat coughing)
- 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.
You must tell your doctor if you are taking medicines that can affect your heart rhythm.
Examples of these medicines include:
• Antiarrhythmics such as quinidine, amiodarone, sotalol or dofetilide (used to treat abnormal heart rhythm)
• Antipsychotics such as thioridazine (See also Serotonin syndrome above)
• Antibiotics such as erythromycin or moxifloxacin (used to treat bacterial infections)
• Antihistamines (used to treat allergy)
The following medicines may also interact with Xenalven 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 (an antifungal medicine)
• haloperidol or risperidone (to treat psychiatric conditions)
• metoprolol (a beta blocker to treat high blood pressure and heart problems)
Xenalven XL with food and alcohol
Xenalven XL should be taken with food (see section “How to take Xenalven XL Capsules”).
You should avoid alcohol while you are taking Xenalven XL.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should use Xenalven XL only after discussing the potential benefits and the potential risks to your unborn child with your doctor.
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 you are taking this medicine during pregnancy, other symptoms your baby might have when it is born is not feeding properly, in addition to having trouble breathing. 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.
Xenalven XL passes into breast milk. There is a risk of an effect on the baby. 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 Xenalven XL.
Driving and using machines
Venlafaxine can cause impaired judgement, thinking, and movement and coordination as well as problems with vision. If you are affected by any of these you should not drive, operate machinery or take part in any activities where such effects could put you or others at risk.
Xenalven XL contains sunset yellow, ponceau 4R red and sucrose.
<N
• sunset yellow as a colouring agent - is contained in the 75 mg and 150 mg strength capsules. It may cause an allergic reaction.
• ponceau 4R red as a colouring agent - is contained in the 37.5 mg capsules. It may cause as allergic reaction.
• sucrose - is contained in all strengths capsules. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE XENALVEN XL CAPSULES
Always take Xenalven XL 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, generalised anxiety disorder 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. If you are being treated for panic disorder, your doctor will start with a lower dose (37.5 mg) and then increase the dose gradually. The maximum dose for generalised anxiety disorder, social anxiety disorder and panic disorder is 225 mg/day.
Take Xenalven XL at approximately the same time each day, either in the morning or in the evening. Capsules must be swallowed whole with fluid and not opened, crushed, chewed or dissolved.
Xenalven XL should be taken with food.
If you have liver or kidney problems, talk to your doctor, since your dose of Xenalven XL may need to be different. Do not stop taking Xenalven XL without talking to your doctor (see the section “If you stop taking Xenalven XL”).
If you take more Xenalven XL than you should Call your doctor or pharmacist immediately if you take more than the amount of Xenalven XL prescribed by your doctor.
The symptoms of a possible overdose may include a rapid heartbeat, changes in level of alertness (ranging from sleepiness to coma), blurred vision, seizures or fits, and vomiting.
If you forget to take Xenalven 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 Xenalven XL that has been prescribed for you in one day.
If you stop taking Xenalven 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 Xenalven 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 Xenalven XL, especially when Xenalven XL is stopped suddenly or the dose is reduced too quickly. Some patients may experience symptoms such as tiredness, dizziness, light-headedness, headache, sleeplessness, 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 Xenalven 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, Xenalven XL can cause side effects, although not everybody gets them.
Do not be concerned if you see small white granules or balls in your stools after taking Xenalven XL. Inside Xenalven XL capsules are spheroids or small white balls that contain the Xenalven XL active ingredient. These spheroids are released from the capsules into your gastrointestinal tract. As the spheroids travel the length of your gastrointestinal tract, Xenalven XL is slowly released. The spheroid “shell” remains undissolved and is eliminated in your stools. Therefore, even though you may see spheroids in your stools, your dose of Xenalven XL has been absorbed
Allergic reactions
If any of the following happen, do not take more Xenalven 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 ofcoordination, 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).
Serious side effects
If you notice any signs of the following, you may need urgent medical attention:
• 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 serotonergic syndrome
• Unexplained muscle pain, tenderness or weakness (rhabdomyolysis)
• 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
• treatment withdrawal (see the section “How to take Xenalven XL Capsules, if you stop taking Xenalven XL)
• Prolonged bleeding - if you cut or injure yourself, it may take slightly longer than usual for bleeding to stop.
Other reported side effects
Very common (may affect more than 1 in 10 people)
• Headache; dry mouth; sweating (including night sweats)
• Nausea
• Dizziness
Common (may affect up to 1 in 10 people)
• Appetite decreased; constipation; vomiting; increased cholesterol
• Feeling separated (or detached) from yourself and reality; nervousness; confusion; abnormal dreams; insomnia
• Drowsiness; tremor; pins and needles; increased muscle tonus
• Increase in blood pressure; flushing; palpitations
• Increased frequency in urination; difficulties passing urine
• Decreased libido; abnormal ejaculation/orgasm (males); lack of orgasm; erectile dysfunction (impotence)
• Menstrual irregularities such as increased bleeding or increased irregular bleeding
• Weakness (asthenia); fatigue, chills
• Visual disturbance including blurred vision; dilated pupils; inability of the eye to automatically change focus from distant to near objects
• Yawning
• Ringing in the ears (tinnitus)
• diarrhoea
Uncommon (may affect up to 1 in 100 people)
• Bruising; black tarry stools (faeces) or blood in stools, which can be a sign of internal bleeding
• Grinding of the teeth; involuntary movement of the muscles
• Hallucinations; feeling separated (or detached) from reality
• 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; abnormal hair loss; rash
• Impaired coordination and balance; feeling dizzy (particularly when standing up too quickly), fainting, fast heartbeat
• Weight gain; weight loss
• Lack of feeling or emotion; agitation feeling separated (or detached) from reality
• Inability to pass urine
• Abnormal orgasm (females)
• A sensation of restlessness or an inability to sit or stand still; seizures or fits; feeling over-excited or euphoric.
• Shortness of breath
Rare (may affect up to 1 in 1000 people)
• Seizures or fits
• Inability to control urination
• Over activity, racing thoughts and decreased need for sleep (mania)
Frequency not known
• Reduced number of platelets in your blood, leading to an increased risk of brushing or bleeding; blood disorders which may lead to an increased risk of infection; slight changes in blood levels of liver enzymes; decrease in blood sodium levels;
• Itchiness, yellow skin or eyes, dark urine, or flu-like symptoms, which are symptoms of inflammation of the liver (hepatitis)
• Excessive water intake (known as SIADH)
• Abnormal breast milk production
• Disorientation and confusion often accompanied by hallucination (delirium)
• Stiffness, spasms and involuntary movements of the muscles
• 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).
• Severe eye pain and decreased or blurred vision
• Decrease in blood pressure; abnormal, rapid or irregular heartbeat, which could lead to fainting
• 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)
• Skin rash, which may lead to severe blistering and peeling of the skin; itching; mild rash
• Swollen face or tongue, shortness of breath or difficulty breathing, often with skin rashes (this may be a serious allergic reaction)
• Confusion
• Vertigo
• Aggression
• Unexpected bleeding e.g. bleeding gums, blood in urine or vomit, or the appearance of unexpected bruises or broken blood vessels (broken veins).
• Unexplained muscle pain, tenderness or weakness (rhabdomyolysis)
Xenalven 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, Xenalven 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 Xenalven XL for a long time. 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 XENALVEN XL CAPSULES
Keep this medicine out of the sight and reach of children.
Do not use Xenalven XL after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.
Store below 30°C and store in the original container to protect from moisture.
Do not use Xenalven XL after 100 days of opening the bottle.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Xenalven XL contains
- The name of your medicine is Xenalven XL 37.5 mg or 75 mg or 150 mg Prolonged release capsules. It will be referred to as Xenalven XL Capsules throughout this leaflet. Each prolonges release capsules contains either 37.5 mg or 75 mg or 150 mg venlafaxine hydrochloride as an active substance.
- The other contents of the capsules are Sugar Spheres (contains sucrose), Ethyl cellulose (E462), Hydroxy propyl cellulose, Hypromellose (E464), Talc (E553b), Dibutyl sebacate, Oleic acid and Colloidal anhydrous silica.
- The capsules shell contains: Gelatin, Sodium Lauryl sulphate, Ponceau 4R (E124), Quinoline yellow (E104) and Titanium dioxide (E171) for 37.5 mg, Sunset yellow (E110), Quinoline yellow (E104) and Titanium dioxide (E171) for 75 mg, Sunset yellow (E110), Quinoline yellow (E104), Patent blue (E131) and Titanium dioxide (E171) for 150 mg.
Remember: This medicine is for you. Only a doctor can prescribe it for you. Never give it to someone else. It may harm them even if their symptoms are the same as yours. What Xenalven XL looks like and contents of the pack
Xenalven XL Prolonged release capsules is available in three strengths
- 37.5 mg: White to off-white pellets filled in hard gelatin capsules shells ‘size 3’ with orange cap and clear transparent body
- 75 mg: White to off-white pellets filled in hard gelatin capsules shells ‘size 1’ with yellow cap and clear transparent body
- 150 mg: White to off-white pellets filled in hard gelatin capsules shells ‘size 0’ with buff cap and clear transparent body.
Xenalven XL is available in a PVC/aluminium foil blister packs of 14, 28 or 30 capsules and in HDPE bottles of 100 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom.
Manufacturer:
Cipla (EU) Limited,
20 Balderton Street, London W1K 6TL, United Kingdom Cipla Europe NV,
Uitbreidingstraat 80, 2600 Antwerp, Belgium This leaflet was last revised in 09/2015.
21050042
Date: 09-09-15