PROZAC

Land: Indonesien

Sprache: Indonesisch

Quelle: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Wirkstoff:

FLUOXETINE HYDROCHLORIDE

Verfügbar ab:

PYRIDAM FARMA TBK - Indonesia

INN (Internationale Bezeichnung):

FLUOXETINE HYDROCHLORIDE

Dosierung:

22.36 MG

Darreichungsform:

KAPSUL

Einheiten im Paket:

DUS, 2 BLISTER @ 14 KAPSUL

Hergestellt von:

PATHEON FRANCE - France

Berechtigungsdatum:

2019-10-12

Fachinformation

Prozac_ID_SAIL2020-4830; 4990; 5205_leaflet for doctor_proposedTC_V1
1
PROZAC

Fluoxetine hydrochloride
1.
NAME OF THE MEDICINAL PRODUCT
PROZAC 20 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains fluoxetine hydrochloride equivalent to 20 mg of
fluoxetine.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsules (opaque green and opaque yellow, coded Lilly 3105) each
containing 20 mg fluoxetine, as
the hydrochloride.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Depression: Prozac is indicated for the treatment of depression.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration to adults only.
Depression: A dose of 20 mg/ day is recommended. A dose of 20 mg/day
is recommended as the initial
dose. Although there may an increased potential for side effect at
higher doses, a dose increase may be
considered after several weeks if there is no response.
The recommended doses may be increased or decreased. Doses above 80
mg/day have not been
systemically evaluated.
Age: There are no data to suggest that alternative dosing is required
on the basis of age alone.
Fluoxetine may be administered with or without food.
When dosing is stopped, active drug substances will persist in the
body for weeks. This should be borne in
mind when starting or stopping treatment. Dosage tapering is
unnecessary in most patients.
Children: The use of Prozac in children is not recommended, as safety
and efficacy have not been
established.
A lower or less frequent dose should be considered in patients with
hepatic impairment, concurrent
diseases (see precautions), or who are taking multiple medication (see
interactions).
4.3 CONTRA-INDICATIONS
Hypersensitivity to fluoxetine or to any of its excipients.
_Monoamine Oxidase Inhibitors: _ Cases of serious and sometimes fatal
reactions have been reported in
patients receiving an SSRI in combination with a monoamine oxidase
inhibitor (MAOI), and in patients who
have recently discontinued an SSRI and have been started o