patient information leaflet fluvoxamine tablets

INFORMATION FOR PATIENTS

Please read this leaflet carefully before you start to take this medicine. It gives an outline of the more important things you should know. If you want to know more about this medicine, or you are not sure about anything, ask your doctor or pharmacist. You should keep this leaflet throughout your course of treatment.

THE NAME OF YOUR MEDICINE IS FLUVOXAMINE TABLETS BP

Fluvoxamine Tablets BP contain the active ingredient fluvoxamine maleate. The tablets come in two strengths, 50mg and 100mg.

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

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

Fluvoxamine Tablets BP 100mg are white to off-white capsule shaped tablets marked with FX100 and a breakline on one side and CP on the other.

Fluvoxamine Tablets BP 50mg and 100mg are available in strip packs of 30, 60 and 90 tablets.

HOW DOES YOUR MEDICINE WORK ?

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

Low levels of serotonin, a substance found naturally in the nervous system, are thought to cause depression.

These medicines bring the levels of serotonin back to normal and therefore treat depression.

WHAT ARE FLUVOXAMINE TABLETS BP FOR?

Fluvoxamine Tablets BP are used to treat depression and obsessive-compulsive disorder (in which the need to repeat or check tasks excessively disrupts everyday life).

BEFORE TAKING THIS MEDICINE

You should not take Fluvoxamine Tablets BP if :

You have ever had a reaction or been told that you are allergic to fluvoxamine or any other SSRI or any of the other ingredients in the tablets. Check by reading the list of ingredients above.
You are currently taking the reversible MAOI (known as RIMA), moclobemide (also used to treat depression) or have taken it within the last 24 hours.
You are taking other MAOIs such as phenelzine or have been taking them in the last two weeks.

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.

Before taking this medicine, you should let your doctor know if:

you are pregnant or breast-feeding or wish to become pregnant or start breast-feeding
you have recently had a heart attack or suffer from heart problems
you suffer with any kidney or liver problems

Taking another medicine while you are taking Fluvoxamine Tablets BP can affect how it or the other medicine works. Make sure that your doctor knows what other medicines you are taking. Do not take any other medicines while you are taking Fluvoxamine Tablets BP unless you have told your doctor or pharmacist and asked their advice. This includes medicines you may have bought yourself. Examples of medicines that can affect Fluvoxamine Tablets BP are;

Theophylline, used to treat asthma.
Drugs used to thin the blood such as warfarin and nicoumalone.
Drugs used to treat epilepsy such as carbamazepine and phenytoin.
Drugs used to treat other mental problems such as chlorpromazine, clozapine, olanzapine, thioridazine, haloperidol, tryptophan, lithium, reboxetine and tricyclic antidepressants (e.g. clomipramine, imipramine, amitriptyline).
Propranolol, a beta blocker used to treat high blood pressure.
Benzodiazepines, such as triazolam, midazolam, alprazolam and diazepam, used to treat anxiety.
Sumatriptan, zolmitriptan and tramadol, used to treat migraine.
Aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs), used to treat pain and inflammation.
Methadone, used in drug dependency
Mexiltene, used to control the beating of the heart
Ciclosporin, used to affect the immune response
Terfenadine and astemizole, used to treat hayfever and other allergies
Tacrine, used in the treatment of Alzheimer’s Disease
Proguanil, used to treat malaria
Selegiline and ropinirole, used to treat Parkinson’s disease.
Ropivacaine, a local anaesthetic
Sibutramine, an appetite suppressant

The herbal remedy St John’s Wort (Hypericum perforatum) should not be taken at the same time as fluvoxamine tablets. If you are already taking a St John’s Wort preparation, stop taking it and mention this to your doctor at your next visit.

If you have any doubts about whether you should take this medicine then talk to your doctor.

ADVICE WHEN TAKING FLUVOXAMINE TABLETS BP

You should be closely monitored by your doctor during the first two weeks of your treatment.
Care is required if you are epileptic, are receiving ECT, have a bleeding disorder (particularly bleeding from the stomach or bowel) or have problems with your liver or kidneys.
If you have diabetes, your dose of insulin or tablets for diabetes may need to be adjusted.
If you have glaucoma.
If you have been treated for an obsessive –compulsive disorder with fluvoxamine for ten weeks and think that you are not getting any better, you should talk to your doctor.
If you become manic (very overexcitable or hyperactive) your fluvoxamine treatment should be stopped.
You should not drive or operate machinery if you feel that the tablets are affecting your concentration or alertness.
You should not drink alcohol when you are taking fluvoxamine.
You should try not to drink too much coffee while taking fluvoxamine.

TAKING THIS MEDICINE

The usual adult starting dose is 50 – 100mg in the treatment of depression and in obsessive compulsive disorder the adult starting dose is 50mg for the first three to four days.

Patients with liver problems should start on a low dose and be monitored by their doctor.

Fluvoxamine Tablets BP are not recommended for children and should not be used to treat depression in adolescents under 18 years of age.

To obtain a tablet, press on the tablet from the blister (or bubble) side, pushing it through the foil.

Do not remove the tablet from the blister until you are ready to take it.

Your doctor will decide the dose that is best for you. Always follow your doctor's instructions completely.

Also, follow any instructions or warnings that appear on the label that the pharmacist has put on the pack.

If you do not understand, or are in any doubt, ask your doctor or pharmacist.

Unless told otherwise, take your tablets with water.

You should take your medicine for as long as your doctor tells you to. If you forget to take a dose, take another as soon as you remember. If it is almost time for your next dose, then do not take the missed dose at all. Never double the next dose to make up for the one missed. Do not stop taking the medicine without talking to your doctor first.

If you accidentally take too many tablets you should contact your doctor, pharmacist or nearest hospital casualty department immediately. Take this leaflet and any tablets you have left to show the doctor or pharmacist.

ARE THERE ANY SIDE-EFFECTS?

Like many medicines Fluvoxamine Tablets BP may cause side-effects in some patients, particularly when you first start taking them. The side-effects that some other patients have had with Fluvoxamine Tablets BP include the following:

Effects on the digestive system: feeling sick, being sick, heartburn, indigestion, stomach pains, diarrhoea, constipation, dry mouth, loss of appetite, weight gain, weight loss, feeling thirsty and altered taste.
Effects on the cardiac system: palpitations, fast or slow pulse.
Effects on the skin: bruising and bleeding under the skin, rash, itching and swelling of the skin, sweating.
Effects on muscles and joints: aching muscles and joints.
Effects on the nervous system: nervousness, feeling anxious, headache, confusion, hallucinations, shaking, dizziness, difficulty sleeping, drowsiness, feeling weak and tired, fits, overactive behaviour, unsteadiness, twitching and jerking movements, numbness and tingling.
Reproductive disorders: failure to achieve orgasm, delayed ejaculation, reduced libido, difficulties with erection, discharge from the nipples.
Effects on the urinary tract: difficulty passing water (urine).
Effects on the eyes: abnormal or blurred vision, glaucoma.
Allergic reactions: rash, itching, breathing difficulties, swelling of the face and tongue and sensitivity to sunlight can occur.
Others: generally feeling unwell, lacking energy, problems with salt levels, liver problems, low blood glucose (causing shaking, sweating, confusion and light headedness).

Rare reports of serotonin syndrome, which leads to muscle stiffness and spasms, reduced body temperature, sweating, loss of control of bodily movements, mood swings, confusion, feeling panicky and possibly coma. If you experience any of the symptoms stop taking your tablets immediately and tell your doctor.

Occasionally, thoughts of suicide or self harm may occur or may 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.

After stopping fluvoxamine you may experience some temporary withdrawal symptoms, such as headache, anxiety, feeling sick, dizziness, shaking, confusion and "pins and needles".

If you experience any other side-effects or feel that the medicine is affecting you badly, tell your doctor or pharmacist.

SAFE KEEPING FOR THIS MEDICINE

Do not take this medicine if the expiry date on the label has passed or if the tablets show signs of "going off" such as discoloration.

Do not store these tablets above 25°C. Keep the tablets in the package or container in which they were given to you. Do not transfer Fluvoxamine Tablets BP to another container.

Keep your tablets in a secure place where children cannot get at them.

Remember this medicine is for you only. Never give it to anyone else. It may harm them, even if their symptoms are the same as yours.

Unless your doctor tells you to, do not keep medicines that you no longer need. Give them back to your pharmacist.

Medicine: fluvoxamine tablets