PACKAGE LEAFLET: INFORMATION FOR THE USER

Fluvoxamine 50mg Film-Coated Tablets Fluvoxamine 100mg Film-Coated Tablets

Fluvoxamine maleate

(Refer to as Fluvoxamine Tablets in this leaflet)

Fluvoxamine Tablets treat depression and anxiety disorders. Like all medicines it can have unwanted effects. It is therefore important that you and your doctor weigh up

the benefits of treatment against the possible unwanted effects, before starting treatment. Fluvoxamine Tablets are not Tor use In children and adolescents under 18. See section 2, Use in children and adolescents aged 8 to 18 years.

Fluvoxamine Tablets won’t work straight away. Some people taking antidepressants feel worse before feeling better. Your doctor should ask to see you again a couple of weeks after you first start treatment. Tell your doctor if you haven’t started feeling better. See section 3, How to take Fluvoxamine Tablets.

Some people who are depressed or anxious think of harming or killing themselves. If you

start to feel worse, or think of harming or killing yourself, see your doctor or go to a hospital straight away. See section 2 Don’t stop taking Fluvoxamine Tablets without talking to your doctor. If you stop taking Fluvoxamine Tablets suddenly or miss a dose, you may get withdrawal effects. See section 3 for further information.

If you feel restless and feel like you can’t sit or stand still, tell your doctor.

Increasing the dose of Fluvoxamine Tablets may make these feelings worse. See section 4, Possible side-effects.

Taking some other medicines with Fluvoxamine Tablets can cause problems. You

may need to talk to your doctor. See section 2, Taking other medicines.

If you are pregnant or planning to get pregnant, talk to your doctor. See section 2 Pregnancy and breastfeeding.

Read all of this leaflet carefully before you start to take this medicine.

-    Keep this leaflet. You may need to read it again while you are receiving your treatment.

-    If you have any further questions, please 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Fluvoxamine Tablets are and what they are used for

2.    Before you take Fluvoxamine Tablets

3.    How to take Fluvoxamine Tablets

4.    Possible side effects

5.    How to store Fluvoxamine Tablets

6.    Further information

1. What Fluvoxamine Tablets are and what they are used for

Fluvoxamine Tablets belong to a group of medicines called selective serotonin re-uptake inhibitor (SSRI) antidepressants.

This medicine is used to treat:

•    Depression

•    Obsessive-compulsive disorder (OOD)

2. Before you take Fluvoxamine Tablets

Do not take if:

•    you are allergic (hypersensitive) to fluvoxamine, or any of the other ingredients (see list of ingredients, Section 6). If you develop a rash or other allergic reactions (such as itching, swollen lips or face or shortness of breath), stop taking fluvoxamine and contact your doctor

•    you are taking other medicines used to treat depression, known as monoamine oxidase inhibitors (MAOIs) or you have stopped taking one within the last two weeks. Serious of even fatal reactions can occur. (See Taking other medicines’, Section 2).

•    You are taking pimozide, used to treat schizophrenia

•    You are taking tizanidine, used to treat spasticity

Treatment with Fluvoxamine Tablets should only be started two weeks after

discontinuing of an irreversible MAOl (such as tranylcypromine)

Take special care If:

•    you have kidney or liver problems (a lower dose may be required)

•    you have controlled epilepsy (needs to be carefully monitored by your doctor)

•    you develop fits (seizures) or epilepsy or experience an increase in seizure frequency, contact your doctor immediately as you might need to stop taking Fluvoxamine Tablets

•    you have diabetes as fluvoxamine can raise or lower your blood sugar (see Taking other medicines’, section 2)

•    you have heart problems or have recently had a heart attack

•    you are pregnant, think you may be pregnant or are breast-feeding (see ‘Pregnancy and breast-feeding’, section 2)

•    you have a feeling of being elated or over-excited, which causes unusual behaviour (mania) or a history of mania. If you have a manic episode, contact your doctor immediately as you might need to stop taking Fluvoxamine Tablets

•    you have a history of bleeding disorders

•    you are taking medicines which may increase the risk of bleeding e.g. medicines for thinning the blood (anticoagulants), some medicines used to treat mental disorders, medicines for pain and inflammation (NSAlDs) (see Taking other medicines')

•    you are having ECT (electro-convulsive therapy) treatment

•    you start to experience fever, probably with faster breathing, sweating, muscle stiffness or tremor, confusion, extreme agitation and sleepiness. Although rare, you may have serotonin syndrome or neuroleptic malignant syndrome. If you have any of these symptoms contact your doctor immediately as you might need to stop taking Fluvoxamine Tablets

•    you have glaucoma

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 aged 8 to 18 years of age:

Fluvoxamine should not normally 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 attempts, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines.

Despite this, your doctor may prescribe Fluvoxamine Tablets for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed Fluvoxamine Tablets 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 Tablets. 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.

If any of the above under 'Do not take’ or Take Special care’ applies to you, please consult your doctor or pharmacist.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including those obtained without prescription.

Certain medicines can affect or be affected by Fluvoxamine. In particular, you should ask your doctor for advice if you are taking the following:

Medicines not to be taken with Fluvoxamine Tablets:

Monoamine oxidase inhibitors (MAOIs)

•    You must not take Fluvoxamine Tablets if you are taking certain MAOIs, used to treat depression or you have stopped taking one within the last two weeks, as serious or even fatal reactions (serotonin syndrome) can occur

•    Fluvoxamine Tablets must not be used with non-selective MAOIs, such as phenelzine (e.g Nardil), tranylcypromine (e g Parnate or Parstelin) and isocarboxazide (e.g Marplan) and reversible MAOIs, such as moclobemide

•    Treatment with Fluvoxamine Tablets should only be started two weeks after you have stopped taking an irreversible MAOl, such as tranylcypromine. However, treatment with Fluvoxamine can be started the following day after stopping reversible MAOIs, such as moclobemide

•    Do not take any MAOIs for at least one week after you stop taking Fluvoxamine.

Your doctor may recommend a longer period if you have taken Fluvoxamine for a long time and/or at a high dose.

St John’s Wort

•    The herbal remedy St John’s Wort, used to treat depression, should not be taken with Fluvoxamine Tablets. It may result in an increase in undesirable effects

•    If you are already taking St John’s Wort, stop taking it and tell your doctor at your next visit

Other medicines, which may Interact

•    Selegeline (MAOl type B), or ropinirole used to treat Parkinson’s Disease

•    Lithium, used to treat mental illness or tryptophan, used to treat depression

•    Drugs used to treat other mental problems such as chlorpromazine, olanzapine, thioridazine, haloperidol, and reboxetine

•    Propranolol, a beta blocker used to treat high blood pressure

•    Phenytoin, used to treat epilepsy

•    Medicines for thinning the blood, such as warfarin (anticoagulants)

•    Other medicines which may increase the risk of bleeding, such as;

-    clozapine, used to treat certain mental disorders

-    medicines used for anxiety, feeling sick (nausea) or being sick (vomiting) or mental disorders, such as trifluoperazine (phenothiazines)

-    aspirin, used to relieve pain

-    medicines to reduce inflammation, such as ibuprofen & indometacin (NSAlDs)

-    medicines used to treat depression, such as amitriptyline, clomipramine, imipramine (tricyclic antidepressants). Your doctor may need to lower the dose

•    Tramadol, used to relieve pain

•    Medicines for migraine, such as sumatriptan and zolmitriptan (triptans)

•    Ropivacaine, a local anaesthetic

•    Sibutramine, an appetite suppressant

•    Pimozide, used to treat schizophrenia

•    Tizanidine, used to treat spasticity

•    Nevirapine, used in the treatment of AIDS Medicines, which may need the dosage adjusted

•    Carbamazepine, used to treat epilepsy

•    Medicines for depression (tricyclic antidepressants - see above)

•    Benzodiazepines, such as triazolam, midazolam, alprazolam and diazepam, used to treat anxiety.

•    Methadone, used in drug dependency

•    Tacrine, used in the treatment of Alzheimer’s Disease

•    Mexilitene, used to control the beating of the heart

•    Theophylline, used to treat asthma

•    Ciclosporin, used to affect the immune response

•    Proguanil, used to treat malaria Taking with food and drink

•    It is recommended that you do not drink alcohol with this medicine. Although Fluvoxamine does not increase the effect of alcohol, it might affect your judgment or co-ordination.

•    If you normally drink a lot of tea, coffee and soft drinks with caffeine in them, you may have symptoms such as your hands shaking, fast heart rate (palpitations), feeling sick, restlessness and difficulty sleeping (insomnia). If you lower how much caffeine you drink, these symptoms may disappear.

Pregnancy and breast-feeding

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

There is only limited experience concerning the use of fluvoxamine during pregnancy. Do not take fluvoxamine while you are pregnant or planning to become pregnant, unless your doctor considers it absolutely necessary.

Fluvoxamine passes into breast milk and there is a risk that it could affect the baby. You must not breastfeed your baby during treatment with Fluvoxamine Tablets.

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. You should not discontinue treatment with fluvoxamine abruptly. If you are taking fluvoxamine in the last 3 months of pregnancy, other symptoms newborns may experience include difficulty in feeding and/or breathing, seizures, a change in temperature, low blood sugar, tremor, unusual appearance of the muscle, a blue appearance of the skin, irritability, being sick, drowsiness, difficulty sleeping, and constant crying. If this happens to your baby you should contact your midwife and/or doctor immediately.

Fluoxamine 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

Antidepressants, such as Fluvoxamine Tablets, may affect your judgment or coordination. Do not drive or operate machinery unless you are sure you are not affected. Important Information about some of the Ingredients of Fluvoxamine Tablets:

This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, i.e. essentially ‘sodium free’.

3. How to take Fluvoxamine Tablets

You should always take this medicine as prescribed by your doctor. Read and follow the Instructions on the pharmacist’s label. If you are not sure about anything please ask your doctor or pharmacist.

Fluvoxamine Tablets are for oral use only. Swallow the tablets whole with water.

Usual doses Depression:

Adults: The usual adult starting dose is 50 - 100mg

Fluvoxamine Tablets should not be used to treat depression in children and

adolescents under 18 years of age.

Obsessive-compulsive disorder - (OCD):

Adults: The usual adult starting dose is 50mg for the first three to four days.

Children and adolescents aged 8 to 18 years: start with 25mg (half a tablet) per day. Your doctor may increase the dose every four to seven days in 25mg increments as tolerated until an effective dose is achieved. The highest daily dose is 200mg.

Patients with liver problems:

Patients with liver problems should start on a low dose and be monitored by their doctor. If there is no improvement within 10 weeks, treatment with Fluvoxamine Tablets should be reconsidered.

However, if response is good, treatment may be continued beyond 10 weeks. Your doctor may adjust your dose to ensure that you receive the lowest effective dose and may also recommend treatment is combined with psychological therapy.

If you forget to take Fluvoxamine Tablets

If you forget to take a dose, take one as soon as you remember. Then go on as before. Do not take a double dose to make up for forgotten individual dose.

If you take more Fluvoxamine Tablets than you should If you take too many tablets or if a child has taken any consult your doctor or the nearest hospital casualty department immediately. Take this leaflet and the container with you so they know what you have taken.

Symptoms of an overdose include: feeling sick, being sick, diarrhoea, fits, heart problems (e.g. irregular heart beat and cardiac arrest), lung problems and change in mental condition ranging from agitation to coma.

If you stop taking Fluvoxamine Tablets

Do not stop taking Fluvoxamine Tablets until your doctor tells you to. It is

important to keep taking your medicine, even when you feel better.

Treatment with Fluvoxamine should not be stopped suddenly. When stopping Fluvoxamine, your doctor will help you to reduce your dose slowly over one to two weeks - this should reduce the risk of having withdrawal effects.

The most common effects when stopping Fluvoxamine include: dizziness, sleep disturbances (e.g. inability to sleep, vivid dreams), irritability, confusion, feeling emotionally unstable, feeling sick, being sick, diarrhoea, sweating, an increase in or an abnormal heart rate, headache, feeling weak, feeling agitated or anxious, shaking and sensory disturbances (including tingling feeling like pins and needles, visual disturbances and the feeling as if you are having an electric shock).

The symptoms above are usually mild and go away within two weeks. However, some people may find they are more severe and last two to three months. If the symptoms are very severe, your doctor may recommend you start taking your previous prescribed dose again and reduce it more slowly.

4. Possible side effects

Like all medicines Fluvoxamine Tablets can cause side effects, although not everyone

gets them.

Contact the doctor Immediately If you have any of the following side effects:

•    Distressing thoughts of harming yourself or committing suicide (read the section of this leaflet “Thoughts of suicide and worsening of your depression or anxiety disorder for further information).

•    Fits (seizures) or epilepsy or experience an increase in seizure frequency

•    Feel restless and cannot keep still. You may have akathisia. Increasing your dose may make you feel worse

•    Fever, probably with faster breathing, sweating, muscle stiffness or tremor, confusion, extreme agitation and sleepiness. Although rare, you may have serotonin syndrome or neuroleptic malignant syndrome

•    Skin rash or other allergic reactions such as itching or shortness of breath, fever or swollen face or throat

•    Feel elated or over-excited, which causes unusual behaviour (mania)

•    Feel tired, confused, have muscles that twitch, have fits or a coma. This may be due to a low level of sodium in your blood and it more likely to happen if you are elderly or taking water tablets (diuretics)

Other side effects

(Digestive system)

•    feeling sick

•    stomach pain

•    constipation

•    diarrhoea

•    dry mouth

•    indigestion

•    being sick

•    difficulty swallowing or a change in taste

•    feeling thirsty

•    low blood glucose (causing shaking, sweating, confusion and light headedness).

•    liver problems

•    abnormal liver function tests (Nervous system)

•    headache

•    difficulty sleeping

•    drowsiness

•    anxiety

•    dizziness

•    loss of appetite

•    fits

•    fatigue

•    feeling agitated

•    change in body temperature

•    change in vital signs

•    panic attacks

•    confusion

•    nervousness

•    abnormally high mood

•    seeing or hearing things that are not real

•    abnormal movements (twitching, shaky movements, shaking, sudden muscle spasm)

•    numbness and tingling

•    depersonalisation

(Urogenital system or reproductive disorders)

•    difficulty passing urine

•    frequent urination

•    the need to urinate in the night

•    difficulty controlling urination

•    prolonged erections

•    poor sexual performance

•    production of breast milk (Whole body/Other)

•    weight gain

•    weight loss

•    sensitivity to sun light

•    weakness

•    headache

•    bleeding into he gut or bleeding from the vagina, bleeding from the mouth, bleeding from under the skin

•    blurred vision

•    glaucoma

•    sweating

•    joint of muscle pain

•    unexplained bruising

•    tiredness

•    palpitations

•    fast or slow pulse

•    feeling dizzy when you stand up

An increased risk of bone fractures has been observed in patients taking this type of medicine. 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 national reporting systems listed below:

United Kingdom: Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard Malta: ADR Reporting, Website: www.medicinesauthority.gov.mt/adrportal By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Fluvoxamine Tablets

•    Keep out of the reach and sight of children

•    Do not store above 25°C. Store in the original container

•    Do not use after the expiry date (EXP) on the label

When your doctor has told you to stop taking this medicine return any unused tablets to the pharmacist for safe disposal.

6. Further Information

What Fluvoxamine Tablets contain:

Active ingredient: Fluvoxamine maleate. The tablets come in two strengths, 50mg and 100mg.

Other ingredients: mannitol (E421), pregelatinised maize starch, maize starch, sodium stearyl fumarate and Opadry whiteY-1-7000 (containing E464 hydroxypropyl methyl cellulose (HPMC), polyethylene glycol (PEG) and titanium dioxide E171).

What Fluvoxamine Tablets look like and the contents of the pack:

Fluvoxamine 50mg Film-Coated Tablets are round white to off-white tablets marked with FX50 and a breakline on one side and CP on the other.

Fluvoxamine lOOmg Film-Coated Tablets are white to off-white capsule shaped tablets marked with FX100 and a breakline on one side and CP on the other.

Fluvoxamine 50mg and lOOmg Film-Coated Tablets are available in strip packs of 30, 60 and 90 tablets.

Marketing Authorisation Holder: Wockhardt UK Limited, Ash Road North, Wrexham, LL13 9UF, UK.

Manufacturer: CP Pharmaceuticals Limited, Ash Road North, Wrexham, LL13 9UF, UK. Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only).

Please be ready to give the following information:

This leaflet was last revised In June 2015.

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