FLUVOXAMINE MALEATE TABLET 50 mg

Land: Singapur

Sprache: Englisch

Quelle: HSA (Health Sciences Authority)

Wirkstoff:

FLUVOXAMINE MALEATE

Verfügbar ab:

PHARMLINE MARKETING PTE. LTD.

ATC-Code:

N06AB08

Dosierung:

50 mg

Darreichungsform:

TABLET, FILM COATED

Zusammensetzung:

FLUVOXAMINE MALEATE 50 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

Prescription Only

Hergestellt von:

ROTTENDORF PHARMA GMBH

Berechtigungsstatus:

ACTIVE

Berechtigungsdatum:

2002-02-26

Fachinformation

FLUVOXAMINE MALEATE TABLETS 50 MG
FLUVOXAMINE MALEATE TABLETS 100 MG
Page 1 of 14
1.
NAME OF THE MEDICINAL PRODUCT
Fluvoxamine Maleate Tablets 50 mg
Fluvoxamine Maleate Tablets 100 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg or 100 mg fluvoxamine maleate.
Excipients with known effect:
Each 50 mg tablet contains 151.5 mg mannitol and each 100 mg tablet
contains 303 mg mannitol.
Each tablet contains less than 1 mmol (23 mg) sodium.
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
White to off-white, round biconvex, film-coated tablets. The tablets
are scored with a division
mark on both sides and debossed with “FLM 50” on one side.
White to off-white, round biconvex, film-coated tablets. The tablets
are scored with a division mark on both sides
and debossed with “FLM 100” on one side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Major depressive episode.
-
Obsessive Compulsive Disorder (OCD).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Depression _
_Adults _
The recommended dose is 100 mg daily. Patients should start on 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 100mg per day and should be adjusted on individual patient
responses. 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.
FLUVOXAMI