STABLON TABLET

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

TIANEPTINE SODIUM

Available from:

SERVIER MALAYSIA SDN BHD

INN (International Name):

TIANEPTINE SODIUM

Units in package:

30Tablet Tablets

Manufactured by:

LES LABS SERVIER INDUSTRIE

Patient Information leaflet

_Consumer Medication Information Leaflet (RiMUP) _
1
STABLON 12.5MG COATED TABLETS
Sodium tianeptine 12.5mg
WHAT IS IN THIS LEAFLET
1.
What STABLON 12.5mg is and
what it is used for
2.
How Stablon 12.5mg works
3.
Before
you
use
STABLON
12.5mg
4.
How to use STABLON 12.5mg
5.
While you are using STABLON
12.5mg
6.
Side
effects
of
STABLON
12.5mg
7.
Storage
and
Disposal
of
STABLON 12.5mg
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT STABLON 12.5MG IS AND
WHAT IT IS USED FOR
STABLON
12.5mg
is
an
antidepressant.
This medicine is recommended in :
-
Neurotic and reactive depression
-
Anxio-depressive
states
with
psychosomatic
manifestations,
especially gastrointestinal
-
Anxio-depressive
states
in
alcoholic
during
withdrawal
stage.
HOW STABLON 12.5MG WORKS
The active ingredient of STABLON
12.5mg,
tianeptine
increases
the
activity of cells in the brain and
increases
the
rate
of
serotonin
(a
type of brain chemical) reuptake by
neurones in the brain. Serotonin is
important
for
nerve
cells
to
communicate, which controls many
body activities, including regulating
mood.
BEFORE YOU USE STABLON 12.5MG
-
_When you must not use it _
DO NOT TAKE STABLON 12.5MG
-
if
you
are
allergic
(hypersensitive) to tianeptine or
any of the other ingredients of
STABLON 12.5mg,
-
in
children
under
15
years
of
age,
-
in
combination
with
drugs for
depression of the non-selective
MAOI
class
(see
section
“Taking other medicines”).
IF YOU ARE IN ANY DOUBT,
YOU
MUST
CONSULT
YOUR
DOCTOR
OR
YOUR
PHARMACIST FOR ADVICE.
-
_Before you start to use it _
WARNINGS AND PRECAUTIONS
-
Prolonged use at high doses may
lead to dependency.
-
Do not exceed the recommended
doses.
-
Do not discontinue the treatment
suddenly, but reduce the dosage
over a period of 7 to 14 days.
-
If
you
must
undergo
general
anaesthesia,
it
is
advisable
to
notify
the
anaesthetist
and
to
discontinue the treatment 24 or
48 hours before the operation.
-
Notify
your
doctor
in
case
of
kidney or liver failures.
-
As
with
any
psychotropic
trea

Summary of Product characteristics

Final PI_Stablon_17.05.2022
_ _
_1 _
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 the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Coated tablet.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
-
Neurotic and reactive depression
-
Anxio-depressive states with psychosomatic manifestations, especially
gastrointestinal
-
Anxio-depressive states in alcoholic during withdrawal stage.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The recommended dosage is one tablet containing 12.5 mg, three times a
day (morning, midday and
evening) at the beginning of the main meals.
SPECIAL POPULATIONS
_Elderly subjects _
The efficacy and safety of tianeptine have been established in elderly
depressed patients (≥ 65 years)
(see section 5.1). No dose adjustment is required in relation to age
In frail elderly patients (< 55 kg), the dosage should be restricted
to 2 tablets per day (see section 5.2).
_Renal failure _
In patients with severe renal failure (ClCr < 19 ml/min), the posology
should be restricted to 2 tablets
per day (see section 5.2).
_Hepatic impairment _
In patients with severe cirrhosis (Class C, Child Pugh Score), the
posology should be restricted to 2
tablets per day (see section 5.2).
In chronic alcoholic patients, irrespective of whether they have mild
or moderate cirrhosis or no cirrhosis,
the posology does not need to be adjusted (see section 5.2).
_Paediatric population _
The safety and efficacy of tianeptine in children and adolescents
under 18 years of age have not been
determined. There is no data available (see section 4.4).
Tianeptine is contraindicated in children and adolescents under 15
years old (see section 4.3).
_Discontinuation of treatment _
Final PI_Stablon_17.05.2022
_ _
_2