FLUVOXAMINE Film-coated tablets Ref.[7257] Active ingredients: Fluvoxamine

Depression

Adults

The recommended dose is 100mg daily. Patients should start on 50 or 100mg, given as a single dose in the evening. Dosage should be reviewed and adjusted if necessary within three to four weeks of initiation of therapy and thereafter as judged clinically appropriate. Although there may be an increased potential for undesirable effects at higher doses, if after some weeks on the recommended dose insufficient response is seen some patients may benefit from having their dose increased gradually up to a maximum of 300mg a day (see section 5.1). Doses up to 150 mg can be given as a single dose, preferably in the evening. It is advisable that a total daily dose of more than 150 mg is given in two or three divided doses. Dosage adjustments should be made carefully on an individual patient basis, to maintain the patients at the lowest effective dose.

Patients with depression should be treated for a sufficient period of at least six months to ensure that they are free from symptoms.

Children/adolescents

Fluvoxamine should not be used in children and adolescents under the age of 18 years for the treatment of major depressive episode. The efficacy and safety of Fluvoxamine have not been established in the treatment of paediatric major depressive episode (see section 4.4).

Obsessive Compulsive Disorder

Adults

The recommended dose is between 100-300mg daily. Patients should start at 50mg per day. Although there may be an increased potential for undesirable effects at higher doses, if after some weeks on the recommended dose insufficient response is seen some patients may benefit from having their dose increased gradually up to maximum of 300mg a day (see section 5.1). Doses up to 150 mg can be given as a single dose, preferably in the evening. It is advisable that a total daily dose of more than 150 mg is given in two or three divided doses. If a good therapeutic response has been obtained, treatment can be continued at a dosage adjusted on an individual basis.

While there are no systematic studies to answer the question of how long to continue fluvoxamine treatment, OCD is a chronic condition and it is reasonable to consider continuation beyond 10 weeks in responding patients. Dosage adjustments should be made carefully on an individual patient basis, to maintain the patients at the lowest effective dose. The need for treatment should be reassessed periodically. Some clinicians advocate concomitant behavioural psychotherapy for patients who have done well on pharmacotherapy. Long-term efficacy (more than 24 weeks) has not been demonstrated in OCD.

Children/adolescents

In children over eight years and adolescents there is limited data on a dose of up to 100 mg b.i.d for 10 weeks. The starting dose is 25 mg per day. Increase every 4-7 days in 25 mg increments as tolerated until an effective dose is achieved. The maximum dose in children should not exceed 200 mg/day. (For further details see sections 5.1 and 5.2). It is advisable that a total daily dose of more than 50 mg should be given in two divided doses. If the two divided doses are not equal, the larger dose should be given at bedtime.

Withdrawal symptoms seen on discontinuation of fluvoxamine:

Abrupt discontinuation should be avoided. When stopping treatment with fluvoxamine the dose should be gradually reduced over a period of at least one or two weeks in order to reduce the risk of withdrawal reactions (see sections 4.4 and 4.8). If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.

Hepatic or renal insufficiency

Patients suffering from hepatic or renal insufficiency should start on a low dose and be carefully monitored.

Method of administration

Fluvoxamine tablets should be swallowed with water and without chewing.

Symptoms

Symptoms include gastro-intestinal complaints (nausea, vomiting and diarrhoea), somnolence and dizziness. Cardiac events (tachycardia, bradycardia, hypotension), liver function disturbances, convulsions, and coma have also been reported.

Fluvoxamine has a wide margin of safety in overdose. Since market introduction, reports of deaths attributed to overdose of fluvoxamine alone have been extremely rare. The highest documented dose of fluvoxamine ingested by a patient is 12 grams. This patient recovered completely. Occasionally, more serious complications were observed in cases of deliberate overdose of fluvoxamine in combination with other drugs.

Treatment

There is no specific antidote to fluvoxamine. In case of overdose the stomach should be emptied as soon as possible after tablet ingestion and symptomatic treatment should be given. The repeated use of medicinal charcoal, if necessary accompanied by an osmotic laxative, is also recommended. Forced diuresis or dialysis is unlikely to be of benefit.

Shelf life: 36 months.

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

Blister strip consisting of hard tempered aluminium foil (20 micron) and PVC film (250 micron) containing 30, 60 and 90 tablets in cartons.

Not all pack sizes may be marketed.

No special requirements.