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Rare (affecting fewer than one person in 1000 but more than one person in 10,000):

•    restlessness or an inability to keep still

•    fits

•    feeling over-excited or euphoric

•    urinary incontinence.

Frequency not known

•    blood disorders leading to increased bruising or bleeding or risk of infection

•    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

•    severe abdominal or back pains (which could indicate a serious problem in the gut, liver or pancreas)

•    decrease in blood pressure; abnormal, rapid or irregular heart beat which could lead to fainting

•    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

•    unexplained muscle pain, tenderness or weakness (rhabdomyolysis)

•    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 a serious condition known as neuroleptic malignant syndrome

•    a feeling of euphoria, drowsiness, sustained rapid eye movement, clumsiness, restlessness, a feeling of being drunk, and sweating or rigid muscles; these may be symptoms of a condition known as serotonergic syndrome

•    stiffness, spasms and involuntary movements of the muscles

•    disorientation and confusion often accompanied by hallucinations, vertigo (a feeling of dizziness or "spinning"), aggression

•    thoughts of harming or killing yourself

•    skin rash which may lead to severe blistering and peeling of the skin, itching, mild rash

•    severe eye pain and decreased or blurred vision

•    swollen face or tongue, shortness of breath or difficulty breathing, often with skin rashes (this may be a serious allergic reaction).

Venlafaxine 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, 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.

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.

0 HOWTO STORE VENLAFAXINE

Keep out of the reach and sight of children.

Do not use Venlafaxine after the expiry date which is stated on the blister and carton

after EXRThe expiry date refers to the last day of the month.

This medicinal product does not require any special storage conditions.

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

•    The active substance is venlafaxine. Each tablet contains 25 mg, 37.5 mg,

50 mg, 75 mg of venlafaxine (as hydrochloride)

•    The other ingredients are lactose monohydrate, lactose spray-dried, sodium starch glycolate (type A), colloidal silica anhydrous, magnesium stearate, yellow iron oxide (E172) and red iron oxide (E172).

What Venlafaxine looks like and contents

of the pack

•    25 mg tablets: Mottled peach, round, flat beveled tablet, scored on one side and debossed “9" on one side of the score and "3" on the other side, debossed "199" on the opposite side of the tablet. The tablet can be divided into equal halves and is available in pack sizes of 30 and 60 tablets. A hospital pack size of 50 tablets is also available

•    37.5 mg tablets: Mottled peach, round, flat beveled tablet, scored on one side and debossed "9" on one side of the score and “3" on the other side, debossed “7380" on the opposite side of the tablet. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.The tablets are available in pack sizes of 10, 20, 28, 30, 50, 56, 60 and 100 tablets. A hospital pack size of 50 tablets is also available

•    50 mg tablets: Mottled peach, round, flat beveled tablet, scored on one side and debossed "9" on one side of the score and "3" on the other side, debossed with "7381" on the opposite side of the tablet. The tablet can be divided into equal halves and is available in pack sizes of 28, 30, 42, 56, 60 and 100 tablets. A hospital pack size of 50 tablets is also available

•    75 mg tablets: Mottled peach, round, flat beveled tablet, scored on one side and debossed "9" on one side of the score and "3" on the other side, debossed with "7382" on the opposite side of the tablet. The tablet can be divided into equal halves and is available in pack sizes of 20, 28, 30, 50, 56, 60 and 100 tablets. Hospital pack sizes of 50 and 500 tablets are also available

•    Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

TEVA UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN229AG.

This leaflet was last revised in December 2010

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VENLAFAXINE 25 mg, 37.5 mg, 50 mg AND 75 mg TABLETS Venlafaxine

PACKAGE LEAFLET: INFORMATION FORTHE USER

Important things you should know about

Venlafaxine

•    Venlafaxine is for depression

•    Venlafaxine should not be given to anyone under 18 years of age - see Section 2 'Use in children and adolescents under 18 years of age'

•    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

•    Some people who are depressed may think of harming or killing themselves. If this happens you should 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 as 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 'If you stop taking Venlafaxine'

•    Taking certain 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 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 Take special care with Venlafaxine'

•    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 any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their 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.

I NTH IS 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.    Howto store Venlafaxine

6.    Further Infomiation

o WHAT VENLAFAXINE IS AND WHAT IT IS USED FOR

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. It is thought that people who are depressed and/or anxious have lower levels of serotonin and noradrenaline in the brain. It is not fully understood how antidepressants work, but they may help by increasing the levels of serotonin and noradrenaline in the brain.

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.

Q BEFORE YOU TAKE VENLAFAXINE

DO NOT take Venlafaxine

•    If you are allergic to Venlafaxine or any of the other ingredients of Venlafaxine tablets

•    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 Venlafaxine, can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop taking Venlafaxine before you take any irreversible MAOI (see also the section Taking other medicines").

Take special care with Venlafaxine

•    If you use other medicines that taken concomitantly with Venlafaxine 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 are diabetic, as your insulin or oral antidiabetic dosage may need to be changed

•    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

•    If your cholesterol levels get higher

•    If you have a history of, or if someone in your family has had, mania or bipolar disorder (feeling over-excited or euphoric)

•    If you have a history of aggressive behaviour.

Venlafaxine 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 Venlafaxine.

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.

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These may be increased when you first start taking antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer. You may be more likely to think like this:

•    If you have previously had thoughts about killing or harming yourself

•    If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in young adults (less than 25 years old) with psychiatric conditions who were treated with an antidepressant.

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.

You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet.You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.

Dry mouth

Dry mouth is reported in 10% of patients treated with Venlafaxine.This may increase the risk of caries. Therefore, you should take special care in your dental hygiene.

Use In children and adolescents under 18 years of age

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 effects concerning growth, maturation and cognitive and behavioural development of Venlafaxine in this age group has not yet been demonstrated.

Taking other medicines

Please tell your doctor or pharmacist if you

are taking or have recently taken any other

medicines, including medicines obtained

without a prescription, and herbal

products.

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 (MAOIs: see the section “Before you take Venlafaxine')

•    Serotonin syndrome:

Serotonin syndrome, a potentially life-threatening condition (see the section "Possible Side Effects"), may occur with Venlafaxine treatment, particularly when taken with other medicines. Examples of these medicines include:

• Triptans (used for migraine)

•    Medicines to treat depression, for instance SNRI, SSRIs, tricyclics, or medicines containing lithium

•    Medicines containing linezolid, an antibiotic (used to treat infections)

•    Medicines containing moclobemide, a reversible MAOI (used to treat depression)

•    Medicines containing sibutramine (used for weight loss)

•    Medicines containing tramadol (a pain-killer)

•    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. Get medical care right away if you think serotonin syndrome is happening to you.

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 (an antifungal medicine)

•    Haloperidol or risperidone (to treat psychiatric conditions)

•    Metoprolol (a beta blocker to treat high blood pressure and heart problems).

Taking Venlafaxine with food and drink

•    Venlafaxine should be taken with food (see section 3 "How to take Venlafaxine")

•    You should avoid alcohol while you are taking Venlafaxine.

Pregnancy and breast-feeding

•    Tell your doctor if you become pregnant, or you are trying to become pregnant. You should use Venlafaxine only after discussing the potential benefits and the potential risks to your unborn child with your doctor

•    Make sure your midwife and/or doctor know you are on Venlafaxine. 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

•    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 Venlafaxine.

Driving and using machines

•    Do not drive or use any tools or machines until you know how Venlafaxine affects you.

Important Information about some of the ingredients of this medicine

•    This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.