PACKAGE LEAFLET: INFORMATION FOR THE USER

Teva Fluvoxamine 50 mg & 100 mg Tablets

fluvoxamine maleate

Read all of this leaflet carefully before you start taking this medicine because it containes 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 illnes 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 Teva Fluvoxamine 50 mg & 100 mg Tablet is and what it is used for

2.    What you need to know before you take Teva Fluvoxamine 50 mg & 100 mg Tablet

3.    How to take Teva Fluvoxamine 50 mg & 100 mg Tablet

4.    Possible side effects

5.    How to store Teva Fluvoxamine 50 mg & 100 mg Tablet

6.    Contents of the pack and other information

1.    WHAT TEVA FLUVOXAMINE 50 mg & 100 mg Tablet IS AND WHAT IT IS USED FOR

Fluvoxamine belongs to a group of drugs called selective serotonin re-uptake inhibitors (SSRIs).

Serotonin is a chemical that, in the brain, passes nerve impulses (‘messages’) between nerve cells and

may help to control mood. Fluvoxamine increases the availability of serotonin.

Fluvoxamine tablets are used to treat the symptoms of depression or obsessive-compulsive disorder.

Ask your doctor or pharmacist if you need additional information.

2.    WHAT YOU NEED TO KNOW BEFORE YOU TAKE TEVA FLUVOXAMINE 50 mg & 100 mg Tablet

Do not take Teva Fluvoxamine 50 mg & 100 mg Tablet

-    if you are allergic to fluvoxamine maleate or any of the other ingredients of this medicine (listed in section 6).

-    if you breast-feeding

-    if you are taking, or have taken in the past two weeks, any monoamine oxidase inhibitors (used to treat depression) such as phenelzine, moclobemide or linezolid (an antibiotic which is also an MAOI). Treatment with fluvoxamine should only be started at least 2 weeks after discontinuation of an irreversible MAOI. However treatment with fluvoxamine after discontinuation of certain reversible MAOIs can be started the following day. In exceptional cases linezolid (an antibiotic MAOI) may be used with fluvoxamine provided the doctor can monitor you closely. Your doctor will advise you how you should begin taking Teva Fluvoxamine 50 mg & 100 mg Tablet once you have stopped taking the MAOI.

-    if you are taking tizanidine, a medicine often used as a muscle relaxant Warnings and precautions

Talk to your doctor or pharmacist before taking Teva Fluvoxamine 50 mg & 100 mg Tablet:

-    if you recently suffered from a heart attack

-    if you are pregnant or could be pregnant

-    if you have a history of fits or you are taking carbamazepine or phenytoin (used to treat epilepsy)

-    if you have any liver or kidney problems

-    if you are taking aspirin or any non-steroidal anti-inflammatory drugs (usually taken to relieve pain, inflammation and/or stiffness) such as naproxen or ibuprofen

-    If you are taking tramadol (a painkiller) or methadone (used to treat severe pain or in the management of drug dependency)

-    if you have a history of bleeding disorders or if you are taking any anticoagulants (used to prevent blood clots) such as warfarin or acenocoumarol

-    if you are being treated with electroconvulsive therapy (ECT)

-    if you ever had mania (a feeling of elation or over-excitement)

-    if you are diabetic

-    if you have high pressure in your eyes (glaucoma)

-    you are less than 18 years old (See also section 3 ‘How to take Teva Fluvoxamine 50 mg & 100 mg Tablet)

Occasionally, thoughts of restlessness, for example, you cannot sit or stand still (akathisia) may occur or may increase during the first few weeks of treatment with Teva Fluvoxamine, until the antidepressant effect has worked.

Tell your doctor immediately if you experience these symptoms. Then a dosage adjustment may be helpful.

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 themselves. 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.

Don’t stop taking Teva Fluvoxamine 50 mg & 100 mg Tablet without talking to your doctor. If

you stop taking Teva Fluvoxamine 50 mg & 100 mg Tablet suddenly or miss a dose, you may get withdrawal effects. See Section 3, How to take Teva Fluvoxamine 50 mg & 100 mg Tablet.

Other medicines and Teva Fluvoxamine 50 mg & 100 mg Tablet

Tell your doctor or pharmacist if you are taking have recently taken or might take any other medicines:

-    aspirin (acetylsalicylic acid) or aspirin-like medicines, used to treat pain and inflammation (arthritis)

-    clozapine, olanzapine or thioridazine (used to treat schizophrenia)

-    theophylline (used to treat asthma and bronchitis)

-    propranolol or mexiletine (used to treat high blood pressure and heart problems)

-    ciclosporin (an immunosuppressant) used after organ transplant

-    terfenadine or astemizole to treat allergies

-    any medicine used to treat migraines e.g. sumatriptan or rizatriptan

-    ropinirole (used to treat Parkinson’s disease)

-    tacrine (used to treat Alzheimer’s disease)

-    any benzodiazepines (used to treat anxiety and insomnia) such as midazolam, diazepam or alprazolam

-    any antipsychotic drugs (used to treat mental illnesses) such as risperidone, chlorpromazine or haloperidol

-    any other antidepressants such as amitriptyline, clomipramine, imipramine, lithium, tryptophan, monoamine oxidase inhibitors (MAOI) such as moclobemide or selective serotonin reuptake inhibitors (SSRI) such as citalopram

-    St. John’s Wort (Hypericum perforatum), a herbal remedy used for depression

-    methadone, used to treat pain and withdrawal symptoms

-    phenytoin or carbamazepine, used to treat epilepsy

-    tramadol, a pain-killer

-    warfarin or any other drug used to prevent blood clots

-    sildenafil, used to treat erectile dysfunction

Teva Fluvoxamine 50 mg & 100 mg Tablet with drink and alcohol

Fluvoxamine may increase the effects of alcohol, and you should therefore avoid alcohol while taking these tablets.

Fluvoxamine may increase the effects of caffeine, and you should therefore keep your intake of drinks that contain caffeine (e.g. coffee, tea and cola) to a minimum whilst taking these tablets.

Pregnancy, breast-feeding and fertility

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.

Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

Make sure your midwife and/or doctor know you are on Teva Fluvoxamine 50 mg & 100 mg Tablet. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Teva Fluvoxamine 50 mg & 100 mg Tablet 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.

You should not discontinue treatment with fluvoxamine abruptly. If you are taking fluvoxamine in the last 3 months of pregnancy, your baby might have some other symptoms when it is born in addition to having trouble breathing or bluish skin, such as not being able to sleep or feed properly, being too hot or cold, being sick, crying a lot, stiff or floppy muscles, lethargy, drowsiness, tremors, j itters or fits. If your baby has any of these symptoms when it is born contact your doctor immediately.

Breast-feeding

Fluvoxamine 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 fluvoxamine.

Fertility

Fluvoxamine has been shown to reduce the quality of sperm in animal studies. Theoretically, this could affect fertility, but impact on human fertility has not been observed as yet.

Driving and using machines

Your tablets may make you feel sleepy. If affected do not drive or operate machinery until you are used to these tablets.

3. HOW TO TAKE TEVA FLUVOXAMINE 50 mg & 100 mg Tablet

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor has decided the dose which is suited to you.

The tablets should be swallowed with a drink of water.

The score line is only there to help break the tablet if you have difficulty swallowing it whole.

The usual dosage instructions are given below:

Depression:

Adults (including the Elderly):

The recommended starting dose is 50 mg or 100 mg taken once daily in the evening. This may be increased gradually until a dose is found that is suitable for you. The maximum daily dose is 300 mg. If you are taking more than 150 mg in one day, your medicine should be taken in divided doses.

Use in children and adolescents

Not recommended.

Fluvoxamine should normally not be used for children and adolescents under 18 years except for patients with obsessive-compulsive disorder. 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 fluvoxamine for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed fluvoxamine 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 fluvoxamine. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of fluvoxamine in this age group have not yet been demonstrated.

Obsessive-Compulsive Disorder:

Adults (including the Elderly):

The recommended starting dose is 50 mg taken once daily in the evening. If you don’t start to feel better after a couple of weeks, talk to your doctor, who will advise you. He or she may decide to increase the dose gradually. until a dose is found that is suitable for you. The maximum daily dose is 300 mg. If you are taking more than 150 mg in one day, your medicine should be taken in divided doses.

Use in children

Children (over 8 years old) :

The recommended starting dose is 25 mg daily. The dose can be increased by 25 mg every 4 to 7 days until a suitable dose has been found. The maximum daily dose is 200 mg.

Children (under 8 years old):

Not recommended.

If you have kidney or liver problems, your doctor may start your treatment with a lower dose of fluvoxamine, and then monitor your progress.

If you take more Teva Fluvoxamine 50 mg & 100 mg Tablet than you should

If you or someone else swallows a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately.

An overdose can cause nausea, vomiting, diarrhoea, sleepiness, dizziness/light-headedness, changes in heart rhythm and can lead to fits or coma.

If you forget to take Teva Fluvoxamine 50 mg & 100 mg Tablet

If you forget to take a tablet, take one as soon as you remember, unless it is within 12 hours of taking the next one. Never take two doses together. Take the remaining doses at the correct time.

If you stop taking Teva Fluvoxamine 50 mg & 100 mg Tablet

Sometimes fluvoxamine takes a little time to start working and it may be 2-3 weeks before you start to feel better. Do not stop taking your tablets suddenly. If you do, you may suffer from withdrawal symptoms such as headache, nausea and/or vomiting, dizziness, pins-and-needles, visual disturbances, sweating, tremors, palpitations (faster heartbeat), confusion, diarrhoea, difficulty sleeping, emotionala instability, irritability, agitation and anxiety. Most people find that any symptoms on stopping Teva Fluvoxamine 50 mg & 100 mg Tablet are mild and go away on their own within two weeks. For some people, these symptoms may be more severe, or go on for longer. If your doctor decides to stop your tablets, he/she will reduce the dose gradually.

If you experience any symptoms on stopping the treatment, contact your doctor.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Feeling sick and sometimes vomiting. This will almost always pass if you keep taking your tablets.

If bruising or purple patches appear on your skin, or you vomit blood or pass blood in your stool; or in rare cases an allergic reaction occurs (itchy, raised rash, stomach pain, wheezing, swelling of the tongue or throat) or you become oversensitive to light (rash or itchy skin following exposure to sunlight), tell your doctor.

Occasionally, thoughts of suicide or self harm may occur or increase in the first few weeks of treatment with fluvoxamine, until the antidepressant effect becomes apparent.

Tell your doctor immediately if you have any distressing thoughts or experiences.

If you have several symptoms at the same time you might have one of the following rare conditions:

•    Serotonin syndrome: if you have sweating, muscle stiffness or spasms, instability, confusion, irritability or extreme agitation.

•    Neuroleptic malignant syndrome: if you have stiff muscles, high temperature, confusion and other related symptoms.

•    SIADH: if you feel tired, weak or confused and have achy, stiff or uncontrolled muscles.

Stop taking Teva Fluvoxamine 50 mg & 100 mg Tablet and contact your doctor immediately.

Stopping of fluvoxamine (particularly when abrupt) commonly leads to withdrawal symptoms.

Common side effects (affects 1 to 10 users in 100):

•    agitation

•    anxiety

•    constipation

•    diarrhoea

•    difficulty sleeping

•    dizziness

•    dry mouth

•    faster heart beat

•    feeling drowsy (lethargy)

•    feeling unwell (malaise)

•    headache

•    indigestion

•    loss of appetite

•    nervousness

•    stomach pain

•    sweating

•    shakiness

•    muscle weakness (asthenia)

•    vomiting

Uncommon side effects (affects 1 to 10 users in 1,000):

•    allergic skin reactions (including swelling of face, lip or tongue, rash or itching)

•    confusion

•    delayed ejaculation

•    dizziness when standing up too quickly

•    hallucinations

•    lack of co-ordination

•    muscle or joint pain

Rare side effects (affects 1 to 10 users in 10,000):

•    convulsions

•    liver complaints

•    mania (a feeling of elation or over-excitement)

•    sensitivity to sunlight

•    unexpected milk flow

Other side effects reported (frequency cannot be estimated from the available data):

•    akathisia (restlessness)

•    abnormal taste

•    anorgasmy (failure to achieve orgasm)

•    for female patients: disorders with menstruation (monthly bleeding)

•    micturition disorders (such as the need to urinate frequently during the day and/or the night, the sudden lack of control over urinating during the day nad/or the night, or the lack of ability to urinate)

•    paraesthesia (tingling or numbness)

•    weight gain or loss

•    low sodium levels in your blood

•    glaucoma (eye disease)

•    dilated pupils

•    withdrawal syndrome (see section 3 How to take Teva Fluvoxamine 50 mg & 100 mg Tablet)

•    increase in the hormon prolactin (a hormone that supports milk production in a nursing mother)

An increased risk of bone factures has been observed in patients taking this type of medicines.

Side effects related to the treatment for obsessive-compulsive disorder, in children and adolescents:

•    Mania (a feeling of elation and over excitement)

•    Agitation

•    Convulsions

•    Difficulty sleeping (insomnia)

•    Lack of energy (asthenia)

•    Hyperactivity (hyperkinesia)

•    Drowsy (somnolence)

•    Indigestion

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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 TEVA FLUVOXAMINE 50 mg & 100 mg Tablet

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date shown on the outside of the packaging. Do not store above 25 °C. Store in the original package. Do not transfer them to another container. This medicine is for you ONLY, do not give it to anyone else. Unless your doctor tells you to, do not keep these tablets for longer than you need.

Do not throw away any medicines via wastewater 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 Teva Fluvoxamine 50 mg & 100 mg Tablet contains

-    The active substance is 50 mg or 100 mg fluvoxamine maleate

-    The other ingredients are mannitol, starch, hydroxypropylcellulose, colloidal silica and sodium stearyl fumarate. The coating contains hypromellose, macrogol, polysorbate, and the colourings titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172) and black iron oxide (E172).

What Teva Fluvoxamine 50 mg & 100 mg Tablet looks like and contents of the pack

50 mg - yellow, film-coated capsule shaped tablet, scored and debossed with “93” on one side (“9” and “3” on either side of the score-line) and “56” on the other side.

100 mg - pink to light brick, film coated capsule shaped tablet, scored and debossed with “93” on one side (“9” and “3” on either side of the score-line) and “57” on the other side.

The 50 mg tablet is available in pack sizes of 20, 30, 50, 60, 100 and 250 tablets, and the 100 mg tablet is available in pack sizes of 15, 20, 30, 50, 60, 90, 100 and 250 tablets. See outer packaging or the pharmacy label for contents i.e. the number of tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Teva pharma B.V. Swensweg 5, 2031 GA Haarlem, The Netherlands.

Manufacturer: Teva UK Ltd, Eastbourne, BN22 9AG

This leaflet was last revised in October 2015

PL 14776/0051 PL 14776/0052