VALDOXAN

Pays: Indonésie

Langue: indonésien

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

Ingrédients actifs:

AGOMELATINE

Disponible depuis:

DARYA-VARIA LABORATORIA TBK - Indonesia

DCI (Dénomination commune internationale):

AGOMELATINE

Dosage:

25 MG

forme pharmaceutique:

TABLET SALUT SELAPUT

Unités en paquet:

DUS, 2 BLISTER @ 14 TABLET SALUT SELAPUT

Fabriqué par:

LES LABORATORIES SERVIER - France

Date de l'autorisation:

2017-08-28

Résumé des caractéristiques du produit

VALDOXAN
COMPOSITION
Each film-coated tablet contains 25 mg of agomelatine.
Excipient with known effect
Each film-coated tablet contains 61.8 mg lactose (as monohydrate)
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Orange-yellow, oblong, film-coated tablet with blue imprint of company
logo on
one side.
THERAPEUTIC INDICATIONS
Valdoxan is indicated for the treatment of major depressive episodes
in adults.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 25 mg once daily taken orally at bedtime.
After two weeks of treatment, if there is no improvement of symptoms,
the dose
may be increased to 50 mg once daily, i.e. two 25 mg tablets, taken
together at
bedtime.
Decision of dose increase has to be balanced with a higher risk of
transaminases
elevation. Any dose increase to 50 mg should be made on an individual
patient
benefit/risk basis and with strict respect of Liver Function Test
monitoring.
Liver function tests should be performed in all patients before
starting treatment.
Treatment should not be initiated if transaminases exceed 3 X upper
limit of
normal (see “Contraindication” and “Special warnings and
precautions for use”).
During treatment transaminases should be monitored periodically after
around
three weeks, six weeks (end of acute phase), twelve weeks and twenty
four
weeks (end of maintenance phase) and thereafter when clinically
indicated (see
“Special warnings and precautions for use”). Treatment should be
discontinued if
transaminases exceed 3 X upper limit of normal (see
“Contraindication” and
“Special warnings and precautions for use”).
When increasing the dosage, liver function tests should again be
performed at
the same frequency as when initiating treatment.
_Treatment duration _
Patients with depression should be treated for a sufficient period of
at least 6
months to ensure that they are free of symptoms.
_Switching therapy from SSRI/SNRI antidepressant to agomelatine _
Patients may experience discontinuation symptoms after cessation from
an
SSRI/ SNR