STABLON TABLET 12.5 mg

Land: Singapore

Språk: engelsk

Kilde: HSA (Health Sciences Authority)

Aktiv ingrediens:

TIANEPTINE SODIUM

Tilgjengelig fra:

SERVIER (S) PTE LTD

ATC-kode:

N06AX14

Dosering :

12.5 mg

Legemiddelform:

TABLET, SUGAR COATED

Sammensetning:

TIANEPTINE SODIUM 12.5 mg

Administreringsrute:

ORAL

Resept typen:

Prescription Only

Produsert av:

LES LABORATOIRES SERVIER INDUSTRIE

Autorisasjon status:

ACTIVE

Autorisasjon dato:

1999-10-07

Informasjon til brukeren

 
SPC_20.08.2012 1 

PACKAGE INSERT 
STABLON 
INN : TIANEPTINE 

1. 
NAME OF THE MEDICINAL PRODUCT 
STABLON 12.5 MG, COATED TABLET 
2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Tianeptine (sodium
salt) ...............................................................................................................
12.5 mg 
For one coated tablet. 
Excipient: sucrose. 
For a full list of excipients, see section 6.1. 
3. PHARMACEUTICAL 
FORM 
Coated tablet. 
4. CLINICAL 
DATA 
4.1 THERAPEUTIC 
INDICATIONS 
This drug is recommended in depressive states of mild, moderate or
severe intensity. 
4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
The recommended dosage is one 12.5 mg tablet three times a day
(morning, midday and evening) at 
the beginning of the main meals. 
In chronic alcoholics, whether cirrhotic or not, no alteration of
the dosage is necessary. 
In subjects aged over 70 years, and in subjects with renal
insufficiency, the dosage should be 
restricted to 2 tablets per day. 
4.3 CONTRAINDICATIONS 
ƒ 
Hypersensitivity to tianeptine or to any of the excipients 
ƒ 
Children under 15 years old. 
ƒ 
Association with MAOIs. 
ƒ 
A wash-out period of two weeks is required between treatment with
MAOIs and treatment with 
tianeptine. A wash-out period of only 24 hours
is required when replacing tianeptine with an 
MAOI. 
4.4 
SPECIAL WARNINGS AND PRECAUTIONS FOR USE 
SUICIDE/SUICIDAL THOUGHTS OR CLINICAL WORSENING 
Depression is associated with an increased risk
of suicidal thoughts, self-harming and suicidality 
(suicidal behaviour). This risk persists until a significant
remission has been obtained. Clinical 
improvement may not be obtained until after several weeks of
treatment, and so patients must be 
closely monitored until this improvement has been achieved.
Clinical experience shows that the risk of 
suicide can increase during the very early stages of recovery. 
Patients with a history of 

Preparatomtale

_ _
1
PACKAGE INSERT
STABLON
INN: TIANEPTINE
1.
NAME OF THE MEDICINAL PRODUCT
STABLON 12.5 MG, COATED TABLET
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tianeptine (sodium salt)
...............................................................................................................
12.5 mg
For one coated tablet.
Excipients with known effect: sucrose.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Coated tablet.
4.
CLINICAL DATA
4.1
THERAPEUTIC INDICATIONS
This drug is recommended in depressive states of mild, moderate or
severe intensity.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The recommended dosage is one 12.5 mg tablet three times a day
(morning, midday and evening) at
the beginning of the main meals.
In chronic alcoholics, whether cirrhotic or not, no alteration of the
dosage is necessary.
In subjects aged over 70 years, and in subjects with renal
insufficiency, the dosage should be
restricted to 2 tablets per day.
_Discontinuation of treatment _
Abrupt discontinuation of the treatment should be avoided. The dosage
should be gradually reduced
over a period of 7 to 14 days in order to reduce the risk of
withdrawal reactions (see sections 4.4).
4.3
CONTRAINDICATIONS
▪
Hypersensitivity to drug substance or to any of the excipients
mentioned in section 6.1.
▪
Children and adolescents under 15 years old.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
SUICIDE/SUICIDAL THOUGHTS OR CLINICAL WORSENING
Depression is associated with an increased risk of suicidal thoughts,
self-harming and suicide (suicidal
behaviour). This risk persists until a significant remission has been
obtained. Clinical improvement
may not be obtained until after several weeks of treatment, therefore,
patients must be closely
monitored until this improvement has been achieved. Clinical
experience shows that the risk of suicide
can increase during the very early stages of recovery.
Patients with a history of suicidal type behaviour or those expressing
significant suicidal thoughts
before starting the treatment fa