Document: leaflet MAH GENERIC_PL 00289-0347 change

• leaflet MAH GENERIC_PL 00289-0347
• leaflet MAH GENERIC_PL 14776-0052

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PAGE 1: FRONT FACE (INSIDE OF REEL)

FLUVOXAMINE 50 mg & 100 mg Tablets

PACKAGE LEAFLET: INFORMATION FORTHE USER

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. 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.

IN THIS LEAFLET:

1.    What Fluvoxamine is and what it is used for

2.    What you need to know before you take Fluvoxamine

3.    How to take Fluvoxamine

4.    Possible side effects

5.    How to store Fluvoxamine

6.    Contents of the pack and other information

OWHAT FLUVOXAMINE 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 is used to treat depression or obsessive-compulsive disorders.

WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUVOXAMINE

DO NOT take Fluvoxamine if you:

•    are allergic (hypersensitive) to fluvoxamine or any of the other ingredients of this medicine (listed in section 6)

•    are taking any of the medicines listed in the section "DO NOT take Fluvoxamine in combination with:").

Warnings and precautions

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. Use in children and adolescents under 18 years of age Fluvoxamine is not normally prescribed for children and adolescents under the age of 18 years except for patients with obsessive compulsive disorder. Your doctor may decide that this treatment is appropriate for you or your child.

Treatment with Fluvoxamine in this age group carries an increased risk of the following side effects:

•    attempts at committing suicide

•    suicidal thoughts

•    aggression and anger

•    argumentative behaviour.

If you have any concerns regarding these side effects or worsening of behaviour whilst you or you child are taking Fluvoxamine please discuss this with your doctor. The long term safety effects on child or adolescent development (including their self-image, what they think, their behaviour and maturity) whilst taking Fluvoxamine in this age group has not been determined.

Talk to your doctor before you start to take this medicine if you:

•    have a history of suicidal events or suicide related events

•    have history of severe mood swings (hypomania/mania)

•    have a history of serotonin syndrome which is characterised by coldness, rigidity, muscle spasm, confusion, extreme agitation, irritability and coma

•    are under 18 years of age as Fluvoxamine is not recommended for treating depression in this age group

•    have unstable epilepsy (a history of fits)

•    are being treated with ECT (electro-convulsive therapy)

•    have any liver or kidney problems

•    have suffered from a heart attack

•    are diabetic

•    have a history of bleeding disorders or you regularly take medicines which increase the risk of bleeding, e.g. aspirin, ibuprofen.

Taking other medicines

DO NOT take Fluvoxamine in combination with:

•    antidepressants known as MAOIs (monoamine oxidase inhibitors) e.g. phenelzine, moclobemide.

You should not take Fluvoxamine until at least 14 days after you have stopped taking an MAOI.

If you stop treatment with Fluvoxamine, you should wait at least 1 week before starting any treatment with a MAOI.

•    terfenadine or astemizole to treat allergies such as hay fever

•    tizanidine (used as a muscle relaxant)

•    cisapride (used for stomach problems).

If you are taking any of these medicines, DO NOT take

Fluvoxamine, and return to your doctor to discuss your

treatment.

Talk to your doctor if you are taking any of the following:

•    any other antidepressants such as amitriptyline, clomipramine, imipramine, lithium or tryptophan

•    other SSRIs for depression or obsessive-compulsive disorders such as fluoxetine

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

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

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

•    antidiabetic agents

•    carbamazepine or phenytoin (used to treat epilepsy)

•    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

•    tramadol (a painkiller) or methadone (used to treat severe pain or in the management of drug dependency)

•    anticoagulants (used to prevent blood clots) such as warfarin

•    ropinirole (used to treat Parkinson's disease)

•    tacrine (used to treat Alzheimer's disease)

•    sildenafil (used to treat erectile dysfunction (impotence)).

Please tell your doctor or pharmacist if you are taking,

have recently taken or might take any other medicines.

Fluvoxamine with food, drink and alcohol

•    DO NOT take alcohol while you are taking Fluvoxamine.

•    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

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

Some newborns may also experience other symptoms 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, jitters or fits. If your baby has any of these symptoms when it is born contact your doctor immediately.

•    Fluvoxamine should not be used if you are breast-feeding.

•    If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

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

•    Fluvoxamine may make you feel sleepy. If you are affected, DO NOT drive or operate machinery.

Fluvoxamine contains mannitol

•    Fluvoxamine tablets contain mannitol which may have a mild laxative effect.

HOW TO TAKE FLUVOXAMINE

Always take Fluvoxamine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The tablets should be swallowed preferably with a drink of water. The recommended dose is:

Depression:

•    Adults including the elderly

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.

•    Children and adolescents under the age of 18

Fluvoxamine should not be used in children and adolescents under 18 for the treatment of depression. Obsessive-Compulsive Disorder:

•    Adults including the elderly:

50 mg taken once daily in the evening for the first 3 to 4 days.

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.

•    Children (over 8 years old)

The recommended starting dose is 25 mg daily.

The dose can be increased by 25 mg every 3 to 4 days until a suitable dose has been found.

The maximum daily dose is 200 mg.

•    Children (under 8 years old):

Fluvoxamine is not recommended for use in children under 8 years old for the treatment of Obsessive-Compulsive Disorder.

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 Fluvoxamine than you should

If you (or someone else) swallow 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 is likely to cause nausea, vomiting, diarrhoea, sleepiness, dizziness/light-headedness, changes in heart rhythm and can lead to fits or coma. Please take this leaflet, any remaining tablets, and the container with you to the hospital or doctor so that they know which tablets were consumed.

If you forget to take Fluvoxamine

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. DO NOT take a double dose to make up for a forgotten dose. Take the remaining doses at the correct time.

If you stop taking Fluvoxamine

You should continue to take this medicine for as long as your doctor tells you. If your doctor decides to stop your tablets, he/she will reduce the dose gradually.

DO NOT stop taking your tablets suddenly. If you do, you may suffer from withdrawal symptoms such as headache, anxiety, nausea and/or vomiting, dizziness, pins-and-needles, sleep disturbances, visual disturbances, sweating, shaking, palpitations (awareness of your heart beating), confusion, diarrhoea, emotional instability, irritability and agitation.

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.

Stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital if the following happens:

•    an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives).

This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately if any of the following occur:

•    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.

•    a combination of symptoms known as serotonin syndrome, including a high temperature, muscle stiffness or twitching, confusion, irritability and extreme agitation, or neuroleptic malignant syndrome, which may include fever, sweating, unstable blood pressure, unresponsive state, autonomic dysfunction and muscle stiffness; although these conditions only occur rarely, they can be life-threatening. You may need to stop taking Fluvoxamine.

•    Torsades de pointes, which is a life threatening irregular heart beat

•    bruising or purple patches appear on your skin, or you vomit blood or pass blood in your stool, or you become oversensitive to light (rash or itchy skin following exposure to sunlight)

•    a combination of symptoms known as SIADH, causing tiredness, weakness or confusion and achy, stiff or uncontrolled muscles.

Stopping of fluvoxamine, particularly when this is sudden, can lead to withdrawal symptoms (see section 3, If you stop taking Fluvoxamine).

The following side effects have been reported at the approximate frequencies shown:

Common (affecting less than one person in 10 but more than one person in 100):

•    feeling sick and vomiting (this will usually pass within the first two weeks of taking these tablets)

•    stomach pain

•    loss of appetite, constipation, diarrhoea, dry mouth, indigestion/heartburn

•    headache

•    fast heartbeat, palpitations (awareness of your heart beating)

•    lethargy, anxiety, agitation, dizziness,

•    difficulty sleeping, nervousness, sleepiness, shakiness

•    sweating or feeling unwell.

Uncommon (affecting less than one person in 100 but more than one person in 1,000):

•    low blood pressure on standing

•    joint or muscle pain, muscle spasm

•    loss of co-ordination, confusion, hallucinations

•    extrapyramidal symptoms (shaking, rigidity, body restlessness, muscle contractions and changes in breathing and heart rate)

•    delayed ejaculation

•    rashes or itching.

Rare (affecting less than one person in 1,000 but more than one person in 10,000):

•    liver problems

•    convulsions, mania (overactivity, elation or irritability). If you experience convulsions you should return to your doctor who may discontinue your tablets

•    spontaneous production of breast milk which is not due to pregnancy or breast-feeding

•    skin sensitivity to sunlight.

Other side effects reported:

•    inability to sit still

•    weight gain or loss

•    low sodium levels in your blood and water retention

•    glaucoma

•    tingling or numbness

•    a change in sense of taste

•    inability to have an orgasm.

Side effects related to the treatment for Obsessive-Compulsive Disorder in children and adolescents:

•    mania (a feeling of elation and over excitement)

•    agitation, hyperactivity

•    convulsions

•    difficulty sleeping, drowsiness

•    lack of energy

•    indigestion.

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

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.

HOWTO STORE FLUVOXAMINE

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

Do not store above 30°C. Do not use Fluvoxamine after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month.

Do not throw away via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

What Fluvoxamine tablets contain:

•    The active ingredient is fluvoxamine maleate 50 mg or 100 mg.

•    The other ingredients are mannitol, pregelatinised starch, hydroxypropylcellulose, colloidal silica and sodium stearyl fumarate. The coating contains hypromellose, macrogol, polysorbate 80, and the colourings titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172) and black iron oxide (E172).

What Fluvoxamine tablets look like and contents of the pack:

•    Fluvoxamine 50 mg Tablets are yellow, film coated capsule shaped tablets, scored and debossed "93" on one side ("9" and "3" on either side of the score line) and "56" on the other side.

•    Fluvoxamine 100mg Tablets are pink to light brick, film coated capsule shaped tablets, scored and debossed "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.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation holder and company responsible for manufacture: TEVA UK Limited, Eastbourne, BN22 9AG.

This leaflet was last revised in March 2015 PL 00289/0346-0347

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