VALDOXAN Tablet 25mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Agomelatine

Available from:

SERVIER (S) PTE LTD

ATC code:

N06AX22

Dosage:

25 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

Agomelatine 25 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

LES LABORATOIRES SERVIER INDUSTRIE [LSI]

Authorization status:

ACTIVE

Authorization date:

2010-02-26

Patient Information leaflet

PACKAGE INSERT 

VALDOXAN 25 MG 

1 
NAME OF THE MEDICINAL PRODUCT 

Valdoxan 25 mg film-coated tablets 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each film-coated tablet contains 25 mg of agomelatine. 

Excipient: lactose monohydrate 61.84 mg 

For a full list of excipients, see section 6.1. 

3 
PHARMACEUTICAL FORM 

Film-coated tablet [tablet]. 
Orange-yellow, oblong, film-coated tablet with
blue imprint of company logo on one side. 

4 
CLINICAL PARTICULARS 

4.1 
THERAPEUTIC INDICATIONS 

Treatment of major depressive episodes in adults 
Valdoxan is indicated in adults. 

4.2 
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. 

Liver function tests should be performed in all
patients : at initiation of treatment, and then 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
also section 4.4). 
When increasing the dosage, liver function tests should again be
performed at the same frequency as when 
initiating treatment. 

Patients with depression should be treated for a sufficient
period of at least 6 months to ensure that they 
are free of symptoms. 

Valdoxan tablets may be taken with or without food. 

_Paediatric population :_ 
The safety and efficacy of Valdoxan in children
aged below 18 years have not been established. No data 
are available. (see section 4.4). 

_Elderly patients:  _
Efficacy has not been clearly demonstrated in the elderly (
≥ 65 years). Only limited clinical data is 
availa

Summary of Product characteristics

PACKAGE INSERT
VALDOXAN 25 MG
1.
NAME OF THE MEDICINAL PRODUCT
Valdoxan 25 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE 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)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Orange-yellow, oblong, 9.5 mm long, 5.1 mm wide film-coated tablet
with blue imprint of Servier logo on
one side.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Valdoxan is indicated for the treatment of:
-
major depressive episodes (MDE);
-
generalised anxiety disorder (GAD).
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 25 mg once daily taken orally at bedtime.
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
-
2 weeks after treatment initiation in major depressive episode;
-
4 weeks after treatment initiation in generalized anxiety disorder.
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
sections 4.3 and 4.4).
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 also section 4.4). Treatment should be
discontinued if transaminases exceed 3 X
upper limit of normal (see sections 4.3 and 4.4).
When increasing the dosage, liver function tests should again be
performed at the same frequency as when
initiating treatment.
_ _
_Treatment duration _
Patients should be treated for a s