tevaUK Ref: 231-30-68935-ZC LEA VENLAFAXINE A/S TAB TUK    Version: 3    8 July 2016

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•    Increased frequency in urination; difficulties passing urine

•    Menstrual irregularities such as increased bleeding or increased irregular bleeding; abnormal

•    ejaculation/orgasm (males); erectile dysfunction (impotence)

•    Weakness (asthenia); fatigue; chills

•    Increased cholesterol

Uncommon (may affect up to 1 in 100 people)

•    Hallucinations; feeling separated (or detached) from reality; agitation; abnormal orgasm (females); lack of feeling or emotion; feeling over-excited; grinding of the teeth

•    A sensation of restlessness or an inability to sit or stand still; fainting; involuntary movements of the muscles; impaired coordination and balance; altered taste sensation

•    Fast heartbeat; feeling dizzy (particularly when standing up too quickly)

•    Shortness of breath

•    Vomiting blood, black tarry stools (faeces) or blood in stools; which can be a sign of internal bleeding

•    Sensitivity to sunlight; bruising; rash; abnormal hair loss

•    Inability to pass urine;

•    Weight gain; weight loss

Rare (may affect up to 1 in 1,000 people)

•    Seizures or fits

•    Inability to control urination

•    Over activity, racing thoughts and decreased need for sleep (mania)

Frequency not known (cannot be estimated from the available data)

•    Prolonged bleeding, which may be a sign of reduced number of platelets in your blood, leading to an increased risk of bruising or bleeding

•    Excessive water intake (known as SIADH)

•    Decrease in blood sodium levels

•    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, What you need to know before you take Venlafaxine)

•    Disorientation and confusion often accompanied by hallucination (delirium); aggression

•    Stiffness, spasms and involuntary movements of the muscles

•    Severe eye pain and decreased or blurred vision

•    Vertigo

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

•    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)

•    Itchiness, yellow skin or eyes, dark urine, or flu-like symptoms, which are symptoms of inflammation of the liver (hepatitis); slight changes in blood levels of liver enzymes

•    Itching; mild rash

•    Abnormal breast milk production 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 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

Keep out of the sight and reach of children.

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

Contents of the pack and other 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, BN22 9AG.

This leaflet was last revised in June 2016

PL 00289/0711-0714

68935-ZC

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

PACKAGE LEAFLET: INFORMATION FOR THE 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 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.

isin

1.    What Venlafaxine is and what it is used for

2.    What you need to know before you take Venlafaxine

3.    How to take Venlafaxine

4.    Possible side effects

5.    How to store Venlafaxine

6.    Contents of the pack and other information

OWhat 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

What

this leaflet

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.

©What you need to know before you take Venlafaxine

DO NOT take Venlafaxine

• If you are allergic to Venlafaxine or any of the other ingredients of 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 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 "Other medicines and venlafaxine"). 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")

• 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 e.g., warfarin (used to prevent blood clots)

• 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.

If any of these conditions apply to you, please talk with your doctor before taking Venlafaxine.

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 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

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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 Venlafaxine.

Driving and using machines

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

Venlafaxine 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.

How to take Venlafaxine

Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The recommended dose is 75 mg per day in divided doses, two or three times a 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.

Take Venlafaxine at approximately the same time each day, in the morning and in the evening.

Venlafaxine should be taken with food.

If you have liver or kidney problems, talk to your doctor, since your dose of Venlafaxine may need to be different.

Do not stop taking Venlafaxine without talking to your doctor (see the section "If you stop taking Venlafaxine").

If you take more Venlafaxine than you should

Call your doctor or pharmacist immediately if you take more than the amount of Venlafaxine prescribed by your doctor.

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 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 Venlafaxine that has been prescribed for you in one day.

If you stop taking Venlafaxine

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 Venlafaxine, he/she may ask you to reduce your dose slowly, before stopping treatment altogether. Side effects are known to occur when people stop using Venlafaxine, especially when Venlafaxine 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 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

Frequency not known (cannot be estimated from the available data)

•    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, shortness of breath and 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

•    Nausea; dry mouth

•    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;

•    nervousness; insomnia; abnormal dreams

•    Drowsiness; tremor; pins and needles; 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)

•    Palpitations

•    Increase in blood pressure; flushing

•    Yawning

•    Vomiting; constipation; diarrhoea

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