Foraven Xl 150mg Modified Release Capsules
PACKAGE LEAFLET
FORAVEN XL
75mg and 150mg
MODIFIED RELEASE CAPSULES VENLAFAXINE
The name of your medicine is FORAVEN XL 75mg or 150mg modified release capsules, referred to as FORAVEN XL Capsules or venlafaxine throughout this leaflet.
Please read this leaflet carefully before you start to take this medicine.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What FORAVEN XL Capsules are and what they are
used for
2. Before you take FORAVEN XL Capsules
3. How to take FORAVEN XL Capsules
4. Possible side effects
5. How to store FORAVEN XL Capsules
6. Further information
1. WHAT FORAVEN XL CAPSULES ARE AND WHAT THEY ARE USED FOR
The active ingredient in the capsules is venlafaxine which is an antidepressant. The capsules are a modified release capsule which means you only need to take your medicine once a day.
Venlafaxine belongs to a group of antidepressant medicines called serotonin norepinephrine reuptake inhibitors (SNRIs). It is thought that people who are depressed may have lower levels of serotonin and norepinephrine in their brain. Venlafaxine may help to relieve the symptoms of depression by increasing the levels of these substances in the brain.
You have been given FORAVEN XL Capsules because you are suffering from the symptoms of depressive illness which may or may not be accompanied by anxiety. FORAVEN XL Capsules are a treatment which can relieve these symptoms and help you get better.
Your doctor may continue to give you FORAVEN XL Capsules when you are feeling better to prevent your symptoms from returning or prevent you from becoming depressed in the future.
You may find it helpful to tell a friend or relative that you are depressed or suffering from symptoms of anxiety, and ask them to read this leaflet. You might ask them to tell you if they think your depression is getting worse, or if they are worried about any other changes in your behaviour.
2. BEFORE YOU TAKE FORAVEN XL CAPSULES
Do not take FORAVEN XL Capsules if you:
• Are allergic to any of the ingredients in FORAVEN XL Capsules.
• Are taking or have taken within the last 14 days any medicines known as irreversible monoamine oxidase inhibitors (also known as MAOIs), used to treat depression or Parkinson's disease. If you are prescribed a MAOI you must discontinue FORAVEN XL and must not start taking the MAOI for at least 7 days after stopping. Examples of MAOIs are rasagiline, selegiline, phenelzine, tranylcypromine and isocarboxazid.
Tell your doctor before taking FORAVEN XL Capsules if you think any of the above applies to you.
Take special care with FORAVEN XL Capsules and tell your doctor or pharmacist if you:
• Are taking any other medicines that could increase the risk if developing serotonin syndrome (see the section “Taking other medicines”).
• Have liver or kidney disease. Your dose of venlafaxine capsules may be lowered.
• Have heart problems, such as a previous heart disease (ask your doctor if you are not sure).
• Have ever had high blood pressure.
• Have had 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 (such as warfarin to prevent blood clots).
• Have had epilepsy or fits (seizures). Your doctor will supervise you carefully while you are taking venlafaxine capsules.
• Are having electroconvulsive therapy (ECT) for
depression.
• Have ever suffered from, or have a family history of, mania or bipolar disorder (feeling elated or over-excited).
• Have eye problems or suffer from, or have a history of, glaucoma.
• Have a history of aggressive behaviour.
• Have diabetes.
• Have high cholesterol levels.
• Are being treated for weight-loss.
FORAVEN XL may cause a sensation of restlessness or an inability to sit or stand still (usually within the first few weeks). You should tell your doctor if this happens to you at any time during treatment.
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 venlafaxine. This may increase the risk of caries. Therefore, you should take special care in your dental hygiene.
Use in children and adolescents under 18
FORAVEN XL Capsules should normally not be used for children and adolescents under 18 years because it has not been proven to be an effective medicine in this age-group. Also you should know that patients under 18 years have an increased risk of side effects such as suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. Despite this, your doctor may prescribe FORAVEN XL Capsules for patients under 18 because he/she decides that this is in their best interest. If your doctor has prescribed FORAVEN XL Capsules for a patient under 18 (you or your child) 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 a patient under 18 is taking FORAVEN XL Capsules.
Also the long-term safety effects of venlafaxine concerning growth, maturation and cognitive and behavioural development in this age group have not yet been demonstrated.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription or if you are taking herbal remedies.
• Monoamine oxidase inhibitors (MAOIs). Irreversible MAOIs must not be taken with FORAVEN XL (see the top of this section “Before you take FORAVEN XL”). There is a risk of serotonin syndrome (see below) when venlafaxine is used with medicines containing reversible MAOIs which include;
- Linezolid, an antibiotic (used to treat infections)
- Moclobemide, a reversible MAOI (used to treat depression)
• Serotonin syndrome is a potentially life-threatening condition (see the section “Possible side-effects”), and 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 for weight loss such as sibutramine and phentermine
- Medicines containing tramadol (a pain-killer)
- 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)
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. If you develop any of these signs or symptoms, tell your doctor immediately or go quickly to the casualty department of the nearest hospital.
The following medicines may also interact with FORAVEN XL and so it is important to mention to your doctor or pharmacist if you:
• Are taking cimetidine (to treat stomach problems) and are elderly or have liver problems, since cimetidine might increase the effect of venlafaxine.
• Are taking any ketoconazole (for treatment of fungal infection); since it can effect the way venlafaxine passes through your body.
• Are taking warfarin (blood thinner).
• Are taking haloperidol, risperidone, clozapine or other drugs for schizophrenia.
• Are taking metoprolol (a beta blocker) to treat high blood pressure and heart problems.
• Are taking medication for AIDS or HIV e.g. indinavir.
Similarly, tell your doctor or pharmacist that you are taking venlafaxine before taking any other drugs or if you enter hospital for treatment.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant; intend to become pregnant or currently breast-feeding.
If you are a woman of child-bearing age, you are recommended to use contraception whilst taking venlafaxine capsules. If, however, you are pregnant or intend to become pregnant whilst taking venlafaxine you should talk to your doctor.
If you are already taking venlafaxine and have just found out you are pregnant, you should talk to your doctor immediately.
For some women it would be better to gradually stop taking venlafaxine, but in some circumstances a woman may agree with her doctor that she should continue to take venlafaxine.
Make sure your midwife and/or doctor know you are on Foraven XL Capsules. 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 venlafaxine in the last three months of pregnancy you should let your midwife know as your baby might have some symptoms. These could appear within the first 24 hours after being born. Possible effects might include crying a lot, not feeding or sleeping properly, vomiting, blue-ish skin or they feel too hot or too cold, difficulty breathing, rigid or floppy muscles, listlessness and the shakes or fits. If your baby has any of these symptoms or you are concerned, you should contact your midwife or doctor.
If you are breast-feeding, venlafaxine may get into breast milk in very small amounts, and you should discuss with your doctor whether to continue treatment or gradually stop.
Driving and using machines
Possible side effects of venlafaxine include confusion, dizziness and blurred vision. If you get these side effects do not drive or use machinery.
Important information about some of the ingredients
The capsule shells of 150mg FORAVEN XL Capsules contain sunset yellow (E110) and allura red (E129) colorants which may sometimes cause allergic reactions. For the complete list of colorants please refer to section “What your medicine contains”.
3. HOW TO TAKE FORAVEN XL CAPSULES
Method of administration
Do not break open, crush or chew the capsules, or put them in water before swallowing.
The capsules should be swallowed whole with a drink of water after food at approximately the same time each day, either in the morning or in the evening.
You should avoid alcohol while you are taking FORAVEN XL Capsules.
Dosage
Your doctor will tell you how much you should take and how often. Always follow you doctor's instructions exactly and those printed on the pharmacy label.
For depression the usual starting dose is one 75mg capsule a day. However, your doctor may decide a different dose is better for you. If you are elderly or have liver or kidney problems your doctor may start with a lower dose. Do not take more than advised by your doctor.
Also the label on your medicine will tell you how many capsules to take and how often. If it does not, or you are not sure, ask your doctor or pharmacist.
Your doctor may have changed your treatment from Venlafaxine Tablets (which, unlike your capsules, are not of modified release formulation) to FORAVEN XL Capsules. If so, your doctor will have decided which dose of FORAVEN XL Capsules is closest to your total daily dose of Venlafaxine Tablets. This dose of FORAVEN XL Capsules should only be taken once daily.
During treatment
It may take a few weeks or more before you feel your medicine is having an effect and you may need to take venlafaxine for several months. If so, do not worry - this is not uncommon.
Your doctor may wish to monitor your blood pressure and heart rate particularly if you require treatment with high (greater than 200mg a day) doses of FORAVEN XL Capsules.
If your condition does not improve after some time your doctor may decide that the treatment with FORAVEN XL Capsules should be discontinued.
If you have taken more FORAVEN XL Capsules than you should
Always take your medicine as your doctor recommended. If you take too many capsules you must seek immediate medical attention, even if you feel well, because of the risk of serious side effects. Remember to take the pack with you, even if it is empty.
If you forget to take FORAVEN XL Capsules
Do not worry if you forget to take a capsule. You can take it up to 12 hours after you usually take it then take your next capsule at the usual time. If the period after the missed dose is more than 12 hours, you should miss the dose altogether and just take your next capsule at the usual time. Do not take a double dose to make up for a forgotten dose.
If you stop taking FORAVEN XL Capsules
Do not stop taking your capsules or change the dose without the advice of your doctor even if you feel better. If your doctor thinks that you no longer need venlafaxine he/she will ask you to reduce your dose slowly before stopping treatment altogether. This should help reduce the chance of withdrawal symptoms. If venlafaxine is stopped suddenly or the dose reduced too quickly, some patients may experience symptoms such as tiredness, dizziness, lightheadedness, headache, sleeplessness, nightmares, dry mouth, loss of appetite, feeling or being sick, diarrhoea, nervousness, agitation, confusion, ringing in the ears, tingling or rarely electric shock sensations, weakness, poor co-ordination, shaking, sweating, fits (seizures) or flu-like symptoms.
Around 3 in 10 patients may notice symptoms on stopping venlafaxine but these symptoms are generally mild and disappear within a few days. In rare cases they can be more severe, usually in the first few days of discontinuation, or can last longer.
Your doctor will advise you on how you should gradually discontinue venlafaxine treatment. If you experience any of these or other symptoms which are troublesome, return to your doctor for further advice. Your doctor may ask you to come off your treatment more slowly.
4. POSSIBLE SIDE EFFECTS
Like all medicines, FORAVEN XL Capsules can cause side effects, although not everybody gets them.
Very serious side effects
If any of the following happen, stop taking FORAVEN XL Capsules and tell your doctor immediately, or go to the casualty department at your nearest hospital.
An allergic reaction which may occur as
• Swollen face, tongue, hands or feet
• Shortness of breath, chest tightness, difficulty breathing or swallowing
• Severe skin rash, itching or hives (elevated patches of red or pale skin that often itch)
Signs and symptoms of serotonin syndrome (see the section “Taking other medicines”) which can include euphoric feelings (feeling 'high' or over-excited), drowsiness, sustained rapid eye movement, clumsiness, restlessness, feeling of being drunk, sweating or rigid muscles.
Serious side effects
Tell your doctor immediately or go to your local hospital emergency department as you may need medical attention if you experience any of the following:
• Rapid or irregular heart beat, flushing or fainting.
• Frequent or unusual bruising or bleeding, such as nose bleeds (this could indicate that venlafaxine has had an effect on your blood, and this may need to be tested).
• A condition called neuroleptic malignant syndrome (resembling serotonin syndrome) which can include high temperature with rigid muscles, confusion or agitation, sweating or experiencing jerky muscle movements which you cannot control.
• Black tarry stools, which can be a sign of internal bleeding.
• Fits.
• Severe muscle tenderness, stiffness or weakness, especially if accompanied by dark urine (this can be caused by abnormal muscle breakdown leading to kidney problems).
• Severe abdominal or back pains (which could indicate a serious problem in the gut, liver or pancreas).
Side effects on withdrawal
Some side effects can appear after you have stopped taking FORAVEN XL. Refer to the section “If you stop taking FORAVEN XL Capsules” above.
Complete list of side effects
You should tell your doctor as soon as possible if the effects are becoming troublesome or continue for more than a few days.
Very common (affects more than 1 person in 10 users):
• dry mouth; headache
• nausea
• sweating (including night sweats)
Common (affects less than 1 person in 10 users):
• weight loss; increased cholesterol
• abnormal dreams; decreased libido; dizziness; increased muscle tonus; insomnia; nervousness; pins and needles; sedation; tremor; confusion; feeling separated (or detached) from yourself and reality
• blurred vision
• increase in blood pressure; flushing; palpitations
• yawning
• decreased appetite; constipation; vomiting
• difficulties passing urine; increased frequency in urination
• abnormal ejaculation/orgasm (males); lack of orgasm; erectile dysfunction (impotence); menstrual irregularities such as increased bleeding or increased irregular bleeding
• weakness (asthenia); chills
Uncommon (affects less than 1 person in 100 users):
• bruising; black tarry stools (faeces) or blood in stools, which can be a sign of internal bleeding
• weight gain
• lack of feeling or emotion; hallucinations; involuntary movement of the muscles; agitation; impaired coordination and balance
• altered taste sensation; ringing in the ears (tinnitus)
• feeling dizzy (particularly when standing up too quickly), fainting, fast heartbeat
• grinding of the teeth; diarrhoea
• rash; abnormal hair loss
• inability to pass urine
• abnormal orgasm (females)
• sensitivity to sunlight
• swelling of tongue, lips, face or throat (angioedema)
Rare (affects less than 1 person in 1000 users):
• a sensation of restlessness or an inability to sit or stand still; seizures or fits; feeling overexcited or euphoric
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
• 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); confusion, excessive water intake (known as SIADH); abnormal breast milk production
• 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; disorientation and confusion often accompanied by hallucination (delirium); stiffness, spasms and involuntary movements of the muscles; thoughts of harming or killing yourself; a feeling of dizziness or “spinning” (vertigo); aggression
• severe eye pain and decreased or blurred vision
• decrease in blood pressure; abnormal, rapid or irregular heart beat, 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
• unexplained muscle pain, tenderness or weakness (rhabdomyolysis)
• swollen face or tongue, shortness of breath or difficulty breathing, often with skin rashes (this may be a serious allergic reaction).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Effects on laboratory tests
Venlafaxine sometimes causes unwanted effects which you 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 number 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.
5. HOW TO STORE FORAVEN XL CAPSULES
KEEP THIS MEDICINE IN A SAFE PLACE WHERE CHILDREN CANNOT REACH OR SEE IT. YOUR MEDICINE COULD HARM THEM.
You should not use this medicine after the expiry date shown on the packaging.
Store in the original package to protect from moisture. Do not store above 25°C.
If your doctor decides to stop treatment, return any leftover capsules to your pharmacist. Only keep them if your doctor tells you to.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer needed. These measures will help to protect the environment.
6. FURTHER INFORMATION
What your medicine contains
There are two strengths of FORAVEN XL Capsules. The 75mg strength contains 75mg of venlafaxine base (as active ingredient) in form of venlafaxine hydrochloride; the 150mg strength contains 150mg of venlafaxine base. In both strengths the active ingredient is in a modified release formulation which means you only need to take your medicine once a day.
Other ingredients in these capsules are: microcrystalline cellulose (E460), povidone (E1201), talc (E553b), colloidal anhydrous silica, magnesium stearate (E470b), ethyl cellulose (E462), copovidone, gelatine, titanium dioxide (E171), black and red iron oxides (E172; colorants in the 75mg strength only), brilliant blue/sunset yellow/ allura red colorants (E133, E110 and E129, respectively; colorants in the 150mg strength only) and printing inks.
What your medicine looks like and contents of the pack
The 75mg capsules are opaque peach coloured and have a thick and a thin radial circular band on the body and also on the cap of the capsules in red ink. The 150mg capsules are opaque dark orange coloured and have a thick and a thin radial circular band on the body and also on the cap of the capsules in white ink.
The 75mg and 150mg capsules come in packs of 28 capsules. Marketing authorisation holder and manufacturer Forum Products Ltd, Crown House, 2-8 Gloucester Road,
Redhill, RH1 1FH
Leaflet approval date: August 2014 UK005