Fevarin tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

fluvoxamine (fluvoxamine maleate)

Available from:

Mylan Laboratories SAS

ATC code:

N06AB08

INN (International Name):

fluvoxamine (fluvoxamine maleate)

Dosage:

50mg

Pharmaceutical form:

tablets film-coated

Units in package:

(15/1x15/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2019-04-22

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
_Adults _
The recommended dose is 100 mg. Treatment begins with a dose of 50 mg
or 100 mg (once, in
the evening). If necessary, the dosage regimen should be reviewed and
adjusted during the first 3 to
4 weeks of treatment and during further treatment if this is
clinically justified. Since there is an
increased risk of undesirable effects when taking high doses of the
drug, as well as in the case of
insufficient action after several weeks of use, some patients are
shown to gradually increase the dose
to the maximum daily value of 300 mg (see the section 5.1). A single
dose of 150 mg (the
maximum single dose) can be prescribed, which is preferably taken in
the evening. If the daily dose
exceeds 150 mg, it is recommended to divide it into 2 or 3 doses. The
selection of the effective dose
should be carried out with care on an individual basis and set in such
a way as to constitute the
minimum effective dose for the patient. The treatment period for
patients suffering from depression
should be sufficient to ensure that symptoms disappear (at least 6
months).
_Children and adolescents_
Fluvoxamine is not recommended for use in children and adolescents
under 18 y