Venlafaxine 75 Mg Tablets
Package leaflet: Information for the user_
Venlafaxine 37.5 mg Tablets
_Venlafaxine 75 mg Tablets_
Important things you need to know about Venlafaxine
Please read all of this leaflet before you start to take your medicine as it contains
important information about Venlafaxine
• Venlafaxine is used to treat depression
• Venlafaxine should not be given to anyone under 18 years of age-see in section 2 '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, and that you have been prescribed this medication; it might be useful to show them this leaflet.
• Venlafaxine may not work straight away. After you start treatment, you may feel worse before you feel 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 feel better
• Some people who are depressed may think of harming or killing themselves.
If you have these thoughts at any time, tell 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 have taken too many tablets 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 your tablets or change the amount you take without checking with your doctor first. Keep taking them even if you feel better. If you stop taking Venlafaxine suddenly you may get withdrawal reactions-see in section 3 'If you stop taking Venlafaxine tablets'
• Taking some other medicines with Venlafaxine may cause problems. Tell your doctor if you are taking or have recently taken any other medicines- see in 'Other medicines and Venlafaxine Tablets'
• Tell your doctor straight away if you feel restless and can't keep still, feel 'high' or over-excited or have jerky muscle movements which you can't control- see section 4 'Possible side effects'
• If you have problems with your heart problems such as fast or irregular heart rate or have high blood pressure, talk to your doctor before taking Venlafaxine-see in section 2 'What you need to know before you take Venlafaxine Tablets'
• If you are pregnant, planning to become pregnant, or are breast-feeding, talk to your doctor before taking Venlafaxine- see section 2 'Pregnancy and breast feeding' There is more information on all of these points in the rest of this leaflet.
Read all of this leaflet carefully before you start taking 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 or pharmacist. This includes any possible side effects not listed in this leaflet, See section 4.
What is in this leaflet:
1. What Venlafaxine Tablets are and what they are used for
2. What you need to know before you take Venlafaxine Tablets
3. How to take Venlafaxine Tablets
4. Possible side effects
5. How to store Venlafaxine Tablets
6. Contents of the pack and other information
1. What Venlafaxine Tablets are and what they are used for
Venlafaxine Tablets contains Venlafaxine Hydrochloride as the active ingredient. Venlafaxine 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.
People who are depressed may have lower levels than usual of substances called "serotonin" and “noradrenaline" in their brain. While it is not fully understood how anti-depressants work, Venlafaxine may help by increasing the levels of these substances in your brain.
Venlafaxine is a treatment for adults with depression. Treating depression 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 Venlafaxine Tablets Do not take Venlafaxine tablets if
• you are allergic to venlafaxine or any of the other ingredients of this medicine (listed in section 6)
• you are also taking, or have taken 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 Venlafaxine can cause serious or even life- threatening side effects. Also you must wait at least one week after you stop taking Venlafaxine tablets before you can take an MAOI.
Warnings and precautions
Talk to your doctor or pharmacist before taking Venlafaxine if you:
• use other medicines that taken together with Venlafaxine could increase the risk of developing serotonin syndrome (see the section "Other medicines and Venlafaxine tablets").
• have eye problems, such as certain kinds of glaucoma (increased pressure in the eye).
• have a history of high blood pressure.
• have a history of heart problems.
• have been told you have an abnormal heart rhythm.
• have a history of fits (seizures).
• have a history of low sodium levels in your blood (hyponatraemia).
• 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).
• have a history of, or if someone in your family has had, mania or bipolar disorder (feeling over-excited or euphoric).
• have a history of aggressive behaviour.
Venlafaxine 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. 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 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 1 in 10 patients treated with Venlafaxine. This may increase the risk of tooth decay (dental caries). Therefore, you should take special care with your dental hygiene.
Diabetes
Your blood glucose levels may be altered due to Venlafaxine. Therefore, the dosage of your diabetes medicines may need to be adjusted.
Children and adolescents
Venlafaxine 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 Venlafaxine for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed Venlafaxine 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 Venlafaxine. Also, the long-term safety concerning growth, maturation and cognitive and behavioural development of the brain in this age group have not yet been demonstrated.
Other medicines and Venlafaxine Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Your doctor should decide whether you can take Venlafaxine 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 Venlafaxine. Tell your doctor if you have taken these medicines within the last 14 days. (MAOIs: see section 2).
• Serotonin syndrome:
A potentially life-threatening condition or Neuroleptic Malignant Syndrome (NMS)-like reactions (see the section "Possible Side Effects"), may occur with venlafaxine treatment, particularly when taken with other medicines.
Examples of these medicines include:
• Medicines for migraine such as sumatriptan (triptans)
• Medicines for depression such as fluoxetine (SSRI), duloxetine (SNRI), imipramine (tricyclics), or medicines containing lithium
• Antibiotics, such as linezolid, used to treat infections
• Medicines used to treat depression such as moclobemide (called reversible MAOIs)
• Medicines to help with weight loss such as sibutramine
• Medicines containing dextromethorphan (used to treat coughing)
• Medicines containing methadone (used to treat opioid drug addiction or severe pain)
• Medicines containing methylene blue (used to treat high levels of methaemoglobin in the blood)
• Medicines containing tramadol, fentanyl, tapentadol, pethidine, or pentazocine (used to treat severe pain)
• 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, nausea, coma, 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 Venlafaxine and should be used with caution. It is especially important to mention to your doctor or pharmacist if you are taking medicines containing:
• Ketoconazole (to treat fungal infections)
• Haloperidol or risperidone (to treat psychiatric conditions)
• Metoprolol (a beta blocker to treat high blood pressure and heart problems) Venlafaxine Tablets with food, drink and alcohol
• Venlafaxine should be taken with food (see section 3)
• You should avoid alcohol while you are taking Venlafaxine Tablets.
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 Venlafaxine only after discussing the potential benefits and the potential risks to your unborn child with your doctor.
If you are taking this medicine and you find out that you are pregnant, make sure your midwife and/or doctor know you are on Venlafaxine Tablets. When taken during pregnancy, similar drugs (SSRIs) may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the new born (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 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
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VENLAFAXINE HYDROCHLORIDE SAME SIZE ARTWORK 480 mm x 140 mm
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. 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 this medicine.
Driving and using machines
Do not drive or use any tools or machines until you know how this medicine affects you. Venlafaxine Tablets contain Lactose
If you have been told by your doctor that you have intolerance to some sugars, contact
your doctor before taking these tablets._
| 3. How to take Venlafaxine Tablets |
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The usual recommended starting dose is 75mg per day. If needed, your doctor may increase the dose gradually up to a maximum of 375mg daily.
If you have liver or kidney problems, talk to your doctor, as your dose may need to be different.
Take Venlafaxine tablets at approximately the same time each day, in the morning and in the evening, with food. Tablets must be swallowed whole with fluid and not opened, crushed, chewed or dissolved.
Do not stop taking Venlafaxine tablets without talking to your doctor (see section 'If you stop taking Venlafaxine Tablets').
If you take more Venlafaxine Tablets than you should
If you take too many tablets you must seek immediate medical attention, even if you feel well, because of the risk of serious side effects. Remember to take the packet with you, even if it is empty.
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 Venlafaxine Tablets
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 a double dose to makeup for a forgotten dose. Do not take more than the daily amount of Venlafaxine that has been prescribed for you in one day.
If you stop taking Venlafaxine Tablets
Do not stop taking your tablets or change the dose without the advice of your doctor even if you feel better. If your doctor thinks thatyou no longer need Venlafaxine Tablets he/she will ask you to reduce your dose slowly before stopping treatment altogether. If Venlafaxine Tablets are 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, feeling or being sick, diarrhoea, nervousness, agitation, confusion, tinnitus (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 Venlafaxine 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, this medicine can cause side effects, although not everybody gets them.
If any of the following happen, do not take more Venlafaxine. Tell your doctor immediately, or go to the casualty department at your nearest hospital: Uncommon (may affect up to 1 in 100 people)
• Swelling of the face, mouth, tongue, throat hands, or feet, and/or a raised itchy rash (hives), trouble swallowing or breathing
Rare (may affect up to 1 in 1,000 people)
• Chest tightness, wheezing, trouble swallowing or breathing
• Severe skin 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).
• Signs of infection, such as high temperature, chills, shivering, headaches, sweating, flu-like symptoms. This may be the result of a blood disorder which leads to an increased risk of infection.
• Severe rash, which may lead to severe blistering and peeling of the skin.
• Unexplained muscle pain, tenderness or weakness. This may be a sign of rhabdomyolysis.
Other side effects that you should tell your doctor about include (The frequency of these side effects are included in the list "Other side effects that may occur" below):
• Coughing, wheezing and shortness of breath which may be accompanied by a high temperature
• Black (tarry) stools or blood in stools
• Itchiness, yellow skin or eyes, 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 (muscle spasms or stiffness), seizures or fits
• Psychiatric problems, such as hyperactivity and feeling unusually overexcited
• Withdrawal effects (see the section "How to take Venlafaxine, if you stop taking Venlafaxine").
• Prolonged bleeding - if you cut or injure yourself, it may take slightly longer than usual for bleeding to stop.
Other side effects that may occur
Very common (may affect more than 1 in 10 people)
• Dizziness: headache; drowsiness
• Insomnia
• Nausea; dry mouth; constipation
• 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; agitation; nervousness; abnormal dreams
• Tremor; a sensation of restlessness or an inability to sit or stand still; pins and needles; altered taste sensation; 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)
• Fast heartbeat; palpitations
• Increase in blood pressure; flushing
• Shortness of breath; yawning
• Vomiting; diarrhoea
• Mild rash; itching
• Increased frequency in urination; inability to pass urine; difficulties passing urine
• Menstrual irregularities such as increased bleeding or increased irregular bleeding; abnormal ejaculation/orgasm (males); erectile dysfunction (impotence)
• Weakness (asthenia); fatigue; chills
• Weight gain; weight loss
• Increased cholesterol
Uncommon (may affect up to 1 in 100 people)
• Over activity, racing thoughts and decreased need for sleep (mania)
• Hallucinations; feeling separated (or detached) from reality; abnormal orgasm; lack of feeling or emotion; feeling over-excited; grinding of the teeth
• Fainting; involuntary movements of the muscles; impaired coordination and balance
• Feeling dizzy (particularly when standing up too quickly); decrease in blood pressure
SAME SIZE ARTWORK 480 mmx140mm
• Vomiting blood, black tarry stools (faeces) or blood in stools; which can be a sign of internal bleeding
• Sensitivity to sunlight; bruising; abnormal hair loss
• Inability to control urination
• Stiffness, spasms and involuntary movements of the muscles
• Slight changes in blood levels of liver enzymes Rare (may affect up to 1 in 1,000 people)
• Seizures or fits
• Coughing, wheezing and shortness of breath which may be accompanied by a high temperature
• Disorientation and confusion often accompanied by hallucination (delirium)
• Excessive water intake (known as SIADH)
• Decrease in blood sodium levels
• Severe eye pain and decreased or blurred vision
• Abnormal, rapid or irregular heartbeat, which could lead to fainting
• 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)
Very rare (may affect up to 1 in 10,000 people)
• Prolonged bleeding, which may be a sign of reduced number of platelets in your blood, leading to an increased risk of bruising or bleeding
• Abnormal breast milk production
• 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)
Frequency not known (cannot be estimated from the available data)
• 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)
• Aggression
• Vertigo
Venlafaxine sometimes causes unwanted effects thatyou may not be aware of, such as increases in blood pressure or abnormal heart beat; slight changes in blood levels of liver enzymes, sodium or cholesterol. More rarely, Venlafaxine 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 Venlafaxine for a long time.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 Venlafaxine Tablets |
• Keep this medicine out of the sight and reach of children.
• Do not store above 25°C. Store in the original package.
• Do not use this medicine after the expiry date which is stated on the carton after 'EXP'. The expiry date refers to the last day of that month.
• Do not throw away any medicines via waste water 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 Venlafaxine Tablets contain
Each tablet contains Venlafaxine Hydrochloride Ph.Eur equivalent to Venlafaxine 37.5 mg or 75 mg as the active ingredient.
The other ingredients are lactose, microcrystalline cellulose, sodium starch glycollate, pregelatinised starch, magnesium stearate, yellow iron oxide (El 72) and red iron oxide (El 72).
What Venlafaxine Tablets look like and contents of the pack
Venlafaxine Tablets 75 mg are Peach colour, circular, flat bevelled edged uncoated tablets having embossed '75' on one side and 'BL' on other side.
Venlafaxine Tablets 37.5 mg are Peach colour, circular, flat bevelled edged uncoated tablets having embossed '37.5' on one side and 'BL' on other side.
Venlafaxine Tablets 75 mg and 37.5 mg are packed in blister pack of 28 and 56 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP41 EG, UK
Telephone: 0044 (0)1442 200922
Fax: 0044 (0)1442 873717
Email: info@bristol-labs.co.uk
Venlafaxine 37.5 mg Tablets: PL 17907/0250
Venlafaxine 75 mg Tablets: PL 17907/0251
This leaflet was last revised in October 2016
To request a copy of this leaflet in Braille, large print or audio format, contact the licence holder at the address (or telephone, fax, email) above.
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