Venlafaxine 37.5mg, 50mg & 75mg Tablets

VENLAFAXINE 37.5MG, 50MG AND 75MG TABLETS

Important things you need to know about venlafaxine

• Venlafaxine is for depression


• Venlafaxine should not be given to anyone under 18 years of age– see Section 3 ‘Children and teenagers under 18 years old’


• Venlafaxine may not work straight away. After you start treatment, you may feel worse before you feel better. It may take between two and four weeks before you start to feel better Tell your doctor if you do not start to feel better - see Section 2 ‘You may feel worse before you 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 Section 2 ‘Thoughts of suicide and worsening of your depression or anxiety disorder’


• If you have taken too many tablets tell your doctor or go to a hospital straight away. Do this even if you feel well. This is because taking too much of this medicine can be dangerous


• 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 Section 3 ‘When and how to stop taking venlafaxine’


• Taking some other medicines with venlafaxine may cause problems. Tell your doctor if you are taking or have recently taken any other medicines – see Section 2 ‘Taking venlafaxine with other medicines’


• 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 or have high blood pressure, talk to your doctor before taking venlafaxine – see Section 2 ‘Do not take venlafaxine' and 'Take special care’


• 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.

• 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 personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• Your doctor may have given you this medicine before from another company and it may have looked slightly different. However, either brand will have the same effect.


• 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 venlafaxine is and what it is used for


• 2. Before you take venlafaxine


• 3. How to take venlafaxine


• 4. Possible side effects


• 5. How to store venlafaxine


• 6. Further information

What Venlafaxine Is And What It Is Used For

The name of this medicine is Venlafaxine 37.5mg, 50mg or 75mg Tablets (referred to as venlafaxine throughout this leaflet).This belongs to a group of medicines called “Serotonin Noradrenaline Reuptake Inhibitors” or SNRIs.

Venlafaxine is used to relieve the symptoms of depression. Your doctor may continue to give you venlafaxine even when you are feeling better. This will help prevent your symptoms from returning. It may also prevent you from becoming depressed in the future.

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.

Before You Take Venlafaxine

Do not take venlafaxine and tell your doctor if:

• You have ever had an allergic (hypersensitive) reaction to venlafaxine or any of the other ingredients in these tablets (listed in Section 6: Further information).
  
  Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of the face, lips, tongue or throat
  


• You are under 18 years old


• You have ever had serious problems with your heart rhythm


• You have moderate or severe heart failure


• You have high blood pressure which is not properly controlled


• You are taking, or have recently been taking medicines called “MonoAmine Oxidase Inhibitors” or MAOIs. These medicines include phenelzine, isocarboxazid or selegiline. See “Taking venlafaxine with other medicines”.

Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking venlafaxine.

Take special care and check with your doctor or pharmacist before taking venlafaxine if:

• You have ever thought about suicide or tried to kill yourself


• You have ever had a mental health problem called “mania”. This is where you see or hear things that aren’t there (hallucinations), feel great excitement and have difficulty concentrating or staying still


• You are currently having electroconvulsive therapy (ECT)


• You have any other mental health problems


• You have ever had fits (seizures)


• You have ever had heart problems (for example a recent heart attack) or high blood pressure


• You have kidney or liver disease. You may be asked to take a lower dose of this medicine


• You have bleeding problems such as bruising easily, bleeding from your gums or nosebleeds


• You are elderly. You may be more sensitive to some of the side effects of this medicine


• You have ever had an eye problem called narrow angle glaucoma


• You have any other eye problems


• You have a history of drug abuse

If any of the above apply to you (or you are not sure) talk to your doctor or pharmacist before taking this medicine.

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.

You may feel worse before you feel better

Venlafaxine may not work straight away. After you start treatment, you may feel worse before you feel better. It may take between two and four weeks before you start to feel better Your doctor may ask to see you again in a couple of weeks and then regularly until you start to feel well again. Tell your doctor if you do not start to feel better.

Taking venlafaxine with other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because venlafaxine can affect the way some other medicines work. Also, some other medicines can affect the way venlafaxine works.

In particular, do not take venlafaxine and tell your doctor if you are taking or have recently taken:

• Medicines called “MonoAmine Oxidase Inhibitors” or MAOIs. You may be using these medicines for depression or Parkinson’s Disease. This includes phenelzine, isocarboxazid and selegiline. You must not start taking venlafaxine tablets until two weeks after finishing your MAOI. Allow at least one week after stopping venlafaxine before starting an MAOI

Check with your doctor before taking venlafaxine if you are taking any of the following medicines. They may want to check you regularly

• Other medicines for depression called tricyclic antidepressants such as imipramine


• Other medicines for depression called Selective Serotonin Reuptake Inhibitors (SSRIs) such as citalopram or fluoxetine


• Lithium, haloperidol or clozapine – for serious mental health problems


• Medicines for migraine called triptans such as sumitriptan or almotriptan


• Medicines to thin the blood such as warfarin or high-dose aspirin


• Medicines to stop you feeling hungry and help with weight loss such as phentermine. The safety of these products when used with venlafaxine is not known


• Antibiotics such as erythromycin


• Medicines for fungal infections such as ketoconazole


• Cimetidine - for stomach problems


• Indinavir - for HIV

If any of the above apply to you (or you are not sure) talk to your doctor or pharmacist before taking venlafaxine. Your doctor may want to check you regularly.

Taking venlafaxine with food or alcohol

• Take venlafaxine with food


• Do not drink alcohol while taking venlafaxine

Pregnancy

If you are pregnant or planning to get pregnant, talk to your doctor before taking venlafaxine. It is not advisable to get pregnant while taking venlafaxine so you should use contraception. Please ask your doctor if you have any questions about the right contraception for you.

If you do become pregnant while taking venlafaxine talk to your doctor straight away. Depending on how well venlafaxine is working for you, they may decide it is better for you to:

• Gradually stop taking the medicine while you are pregnant


• Continue taking the medicine

Breast-feeding

Do not breast-feed if you are taking venlafaxine. This is because small amounts may pass into the mother’s milk.

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Driving and using machines

Venlafaxine may make you feel tired, dizzy or affect your judgment. If any of these things happen to you, do not drive or use any tools or machines.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist.

How To Take Venlafaxine

Always take venlafaxine exactly as your doctor has told you. The dose of venlafaxine will depend on your needs and the illness you are being treated for. The dose will have been decided by your doctor. The usual doses are listed below. Check with your doctor or pharmacist if you have any questions about your medicine and how to take it.

Taking your venlafaxine tablets

• Take one tablet in the morning and one tablet in the evening


• Take with food


• Swallow your tablets whole. Do not crush or chew them


• Try to take your medicine at the same times each day so that it becomes part of your daily routine

How much to take

Adults

• The starting dose is usually 75mg each day. Take 37.5mg in the morning and 37.5mg in the evening


• Your doctor may gradually increase your dose up to a maximum of 375mg a day

People with liver or kidney problems

If you have problems with your liver or kidneys your doctor may prescribe a lower dose. This depends on how serious your condition is.

Elderly people

Elderly people may be more sensitive to the effects of venlafaxine. This means your doctor may prescribe a lower dose.

Children and teenagers under 18 years old

Venlafaxine tablets must not be given to anyone under 18 years of age. This is because it has not been shown to work well in this age group. Also, patients under 18 years may be more likely to get side effects such as thoughts of killing or harming themselves. If your doctor has prescribed venlafaxine for you (or your child) and you want to discuss this, please go back to your doctor.

Tests

Your doctor may do regular checks on your blood pressure and heart rate. This is more likely to happen if you need to take high doses of venlafaxine (more than 200mg a day).

How long to take venlafaxine for?

It may take between two and four weeks before you start to feel better. This is normal for this type of medicine. Your doctor may want to monitor you closely during this time. Once you start to feel better, you may need to carry on taking venlafaxine for several months. Do not stop taking the tablets just because you feel better. If you stop them, you might feel worse again.

If you take more venlafaxine than you should

Taking too much of this medicine can be dangerous. Tell your doctor or go to a hospital straight away if you have taken too many tablets. Do this even if you feel well. Also do this if someone accidentally swallows some. Remember to take the pack and any remaining tablets with you. This is so that the doctor knows what you have taken.

The following effects may happen if you take too much:

• Feeling sleepy, shaky or agitated


• Feeling dizzy, feeling sick (nausea) or being sick (vomiting)


• Abnormal heartbeat

If you forget to take venlafaxine

Do not worry if you forget to take a tablet. Do not take extra tablets to make up for any you have missed, just take the next tablet as usual.

When and how to stop taking venlafaxine

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 your doctor thinks that you no longer need venlafaxine they will discuss with you how to lower your dose slowly before stopping treatment altogether. This should help reduce the chance of withdrawal symptoms.

If venlafaxine is stopped suddenly or the dose is reduced too quickly, the following effects may happen:

• Feeling tired, dizzy or light-headed, headache


• Fast or uneven heartbeat


• Sleep problems such as being unable to sleep or having nightmares


• Dry mouth, loss of appetite, feeling sick (nausea) or being sick (vomiting), diarrhoea


• Feeling nervous, agitated or confused, ringing in the ears (tinnitus)


• Tingling and numbness of the skin or ‘electric shock’ sensations in the arms or legs


• Feeling weak, poor co-ordination, shaking, sweating or fits (seizures)

Around 3 in 10 people may notice some symptoms when they stop taking venlafaxine. These are normally mild and disappear within a few days.

In rare cases they can be more severe. This is usually in the first few days after stopping treatment but sometimes the symptoms may last longer. Your doctor will advise you on how you should gradually stop taking venlafaxine. If you get any of the above or other symptoms which bother you, tell your doctor. Your doctor may then discuss with you how to come off your treatment more slowly.

Possible Side Effects

Like all medicines, venlafaxine can have side effects, although not everbody gets them.

Stop taking venlafaxine and see a doctor or go to a hospital straight away if:

• You have muscle weakness, tenderness or pain, feel unwell or have a high temperature. You may have a rare but serious illness that can be life-threatening, called "rhabdomyolysis"


• You get swelling of your hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria). You may be having an allergic reaction to venlafaxine


• You get blistering or peeling of the skin around your lips, eyes, mouth, nose and genitals, with flu-like symptoms and fever. These could be signs an illness called “Stevens-Johnson syndrome”

Tell your doctor straight away if:

• You notice yellowing of your skin or eyes and your urine becomes darker in colour. You may also have a high temperature, feel tired, lose your appetite, have stomach pain or feel sick. These could be signs of a liver problem, such as jaundice or hepatitis


• You feel agitated, confused, sweat more than usual, have diarrhoea, a high temperature, higher blood pressure than usual, sudden jerking of your muscles and an unusually fast heartbeat. These could be signs of an illness called “serotonin syndrome”


• You get severe stomach pain which may reach through to your back. This could be a sign of pancreatitis


• You have uncontrollable twitching, jerking or writhing movements


• You feel unwell, lose your appetite, have a fever lasting 2 to 3 days, have difficulty breathing, shortness of breath and a cough. This could be due to a lung problem


• You notice blood in your vomit or pass black tarry stools (motions). These may be signs of bleeding in your stomach or bowel


• You have fits (seizures) or, in patients with epilepsy, you notice an increase in the number of seizures


• You feel ‘high’ or over-excited, see or hear things which are not there (hallucinations) and have difficulty concentrating or staying still (mania or hypomania)

The side effects above are either rare (affect less than 1 in 1,000 people) or very rare (affect less than 1 in 10,000 people).

If any of the following side effects gets serious or lasts longer than a few days, tell your doctor or pharmacist.

Very common (affects more than 1 in 10 people)

• Constipation, feeling sick (nausea)


• Feeling dizzy, feeling weak, dry mouth, headache


• Being unable to sleep (insomnia), feeling nervous, feeling sleepy or drowsy


• Difficulty having an orgasm (in both men and women), problems with getting or keeping an erection (impotence)


• Sweating more than usual

Common (affects less than 1 in 10 people)

• Heart problems including high blood pressure (hypertension), palpitations, flushing


• Weight gain or weight loss


• Loss of appetite (anorexia), diarrhoea, indigestion or heartburn, being sick (vomiting)


• Stomach pains, shivering, fever


• Sore joints or muscles, stiff or tense muscles


• Strange dreams, feeling restless, anxious or confused, shaking


• Numbness, tingling, pricking, burning, or a creeping feeling on the skin (paraesthesia)


• Passing urine more or less often than usual


• Reduced sex drive


• Menstrual cycle changes in women


• Difficulty breathing or shortness of breath, yawning


• Skin rash


• Problems with your eyesight, ringing in your ears (tinnitus).

Uncommon (affects less than 1 in 100 people)

• Feeling faint or light-headed when standing up quickly. These could be signs of low blood pressure


• Fainting


• Heart problems including an abnormal heartbeat, a faster or slower than usual heart rate


• Teeth grinding


• Muscle cramp (spasm), including twitching muscles


• Lack of emotion or interest in things (apathy), seeing or hearing things which are not there (hallucinations)


• Difficulty passing urine


• Heavy menstrual bleeding


• Being more sensitive to sunlight (or artificial UV light) than usual (photosensitivity)


• Hair loss


• Changes in the way things taste

Rare (affects less than 1 in 1000 people)

• Loss of balance and co-ordination, difficulty speaking or slurring your words


• Abnormal production of breast milk (in both men and women)


• Feeling aggressive or having aggressive thoughts - this is more likely at the start of, and after stopping, treatment

Very rare (affects less than 1 in 10,000 people)

• Serious chest pain and collapse


• Feeling very confused, unsettled and unable to think clearly


• Bruising more easily than usual, bleeding more or for longer than usual after an injury, unusual bleeding from the gums or elsewhere, a rash of purple dark red spots under the skin, getting infections more easily than usual. These could be signs of a blood problem

Blood tests

The following side effects also affect the blood. They are only found in blood test results:

• Increase in blood cholesterol levels


• Changes to some of the cells or other parts of your blood


• Changes in the way your liver is working


• Changes in the levels of sodium in your blood

Your doctor may wish to do blood tests occasionally, particularly if you have been taking venlafaxine for a long time.

If any of the side effects get serious, or if you notice any side effects not listed in the leaflet, please tell your doctor or pharmacist.

Storing Venlafaxine

• Keep your medicine in a safe place where children cannot see or reach it


• This medicine does not need any special storage conditions


• Do not use this medicine after the expiry date shown on the pack. The expiry date refers to the last day of that month


• 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.

Further Information

What venlafaxine contains

• Each tablet contains 37.5mg, 50mg, or 75mg of the active substance venlafaxine as venlafaxine hydrochloride


• The other ingredients are microcrystalline cellulose, sodium starch glycolate, magnesium stearate, yellow iron oxide (E172), red iron oxide (E172) and titanium dioxide (E171)

What venlafaxine looks like and contents of the pack

• The tablets are round and peach in colour


• They are supplied in blister packs of 28, 42, 56, 60 and 100 tablets. (Not all pack sizes may be marketed)

The Marketing Authorisation Holder is:

Winthrop Pharmaceuticals

PO Box 611

Guildford

Surrey

GU1 4YS

UK

The Manufacturer is:

Pharmathen S.A.

Dervenakion 6

Pallini 15351

Attikis

Greece

This leaflet was last revised in August 2008.

‘Winthrop’ is a registered trademark.

© 2008 Winthrop Pharmaceuticals.

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