FAVERIN TABLET 100 MG (WHITE) [SIN09491P]

Product Info

FAVERIN TABLET 100 MG (WHITE)

[SIN09491P]

4.1 Therapeutic Indications

• Major depressive episode.

• Obsessive Compulsive Disorder (OCD).

4.2 Posology and Method of Administration
Depression
The recommended starting dose is 50 or 100 mg, given as a single dose in the evening. It is recommended to increase the dose gradually until an effective dose is reached. The usual effective dose is 100 mg per day, however, this should be adjusted according to individual’s response. Doses of up to 300 mg per day have been given. Dosages above 150 mg should be given in divided doses.
In agreement with the consensus statement of the WHO, antidepressant medication should be continued for at least 6 months after recovery from a depressive episode.
Fluvoxamine at a fixed single daily dose of 100 mg is the recommended dose for the prevention of recurrence of depression.

Obsessive compulsive disorder
Adults
The recommended starting dose is 50 mg per day for 3 – 4 days. The effective dosage usually lies between 100 mg and 300 mg per day. The dosage should be increased gradually until the effective dosage is reached, with a maximum of 300 mg per day.

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 2 or 3 divided doses.

If a good therapeutic response has been obtained, treatment can be continued at the patient’s adjusted dosage. If no improvement is observed within 10 weeks, treatment with fluvoxamine should be reconsidered. While there are no systematic studies on how long fluvoxamine treatment should be continued, 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 patient 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.

Children and adolescents
The starting dose for children from 8 years on and adolescents is 25 mg per day, preferably at bedtime. Increase every 4–7 days in 25 mg increments as tolerated until an effective dose is achieved. The effective dosage usually lies between 50 mg and 200 mg per day, the maximum dose in children should not exceed 200 mg per day. 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 section 4.4 and section 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). 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.

4.3 Contraindications
Faverin® tablets are contraindicated in combination with tizanidine and monoamine oxidase inhibitors (MAOIs) (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Treatment with fluvoxamine can be initiated:

• two weeks after discontinuation of an irreversible MAOI, or

• the following day after discontinuation of a reversible MAOI (e.g. moclobemide, linezolid).

Discontinue fluvoxamine therapy at least one week before initiating therapy with any MAOI.

Fluvoxamine immediate-release tablets should not be used in combination with pimozide and ramelteon (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hypersensitivity to the active substance or to any of the excipients.