CIPRALEX

Land: Indonesien

Språk: indonesiska

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

Aktiva substanser:

ESCITALOPRAM OXALATE

Tillgänglig från:

PYRIDAM FARMA TBK - Indonesia

INN (International namn):

ESCITALOPRAM OXALATE

Dos:

12,77 MG

Läkemedelsform:

TABLET SALUT SELAPUT

Enheter i paketet:

DUS, 2 BLISTER @ 14 TABLET SALUT SELAPUT

Tillverkad av:

H. LUNDBECK A/S - Denmark

Tillstånd datum:

2021-10-21

Produktens egenskaper

Cipralex
5mg, 10mg, 20mg
Film-coated tablet
escitalopram (as oxalate)
1.
NAME OF THE MEDICINAL PRODUCT
CIPRALEX 5 mg film-coated tablets
CIPRALEX 10 mg film-coated tablets
CIPRALEX 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cipralex 5 mg: Each tablet contains 5 mg escitalopram (as 6.39 mg
escitalopram oxalate)
Cipralex 10 mg: Each tablet contains 10 mg escitalopram (as 12.77 mg
escitalopram oxalate)
Cipralex 20 mg: Each tablet contains 20 mg escitalopram (as 25.54 mg
escitalopram oxalate)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets
Cipralex 5 mg: Round, white, film-coated tablet marked with "EK" on
one side.
Cipralex 10 mg: Oval, white, scored, film-coated tablet marked with
"E” and “L" on each side of the
score on one side of the tablet.
Cipralex 20 mg: Oval, white, scored, film-coated tablet marked with
"E” and “N" on each side of the
score on one side of the tablet.
The 10 and 20 mg tablets can be divided into equal doses
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Treatment of major depressive episodes.
Treatment of panic disorder with or without agoraphobia.
Treatment of social anxiety disorder (social phobia).
Treatment of generalised anxiety disorder.
Treatment of obsessive-compulsive disorder.
4.2
Posology and method of administration
Safety of daily doses above 20 mg has not been demonstrated.
Cipralex is administered as a single daily dose and may be taken with
or without food.
Major depressive episodes
Usual dosage is 10 mg once daily. Depending on individual patient
response, the dose may be increased
to a maximum of 20 mg daily.
Usually 2-4 weeks are necessary to obtain antidepressant response.
After the symptoms resolve,
DISETUJUI OLEH BPOM: 06/09/2021
ID: EREG10019312100130-32
EREG10019312100078-80
treatment for at least 6 months is required for consolidation of the
response.
Panic disorder with or without agoraphobia
An initial dose of 5 mg is recommended for the first week before
increasing the dose to 10