Fevarin

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

fluvoxamine (fluvoxamine maleate)

Available from:

Abbott Healthcare SAS

INN (International Name):

fluvoxamine (fluvoxamine maleate)

Dosage:

100mg

Pharmaceutical form:

tablets film-coated

Prescription type:

Prescription

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTIC (SMPC)
FLUVOXAMINE
1
NAME OF THE MEDICINAL PRODUCT
Fevarin®, film-coated tablets, 50 mg
Fevarin®, film-coated tablets, 100 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: fluvoxamine maleate
Each tablet contains 50 mg or 100 mg of fluvoxamine maleate. For a
full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablets 50mg
Round, biconvex, scored, white to off-white film coated tablets for
oral administration.
The tablets can be divided into equal halves.
Film-coated tablets 100mg
Oval, biconvex, scored, white to off-white film coated tablets for
oral administration.
The tablets can be divided into equal halves.
4
CLINICAL PARTICULARS
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 and should be adjusted on individual patient 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
SUMMARY OF PRODUCT CHARACTERISTIC (SMPC)
FLUVOXAMINE
_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
achieved, 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