Stablon 12.5 mg coated tablets

País: Malta

Língua: inglês

Origem: Medicines Authority

Ingredientes ativos:

TIANEPTINE

Disponível em:

Les Laboratoires Servier 50 Rue Carnot, 92284 Suresnes Cedex, France

Código ATC:

N06AX14

DCI (Denominação Comum Internacional):

TIANEPTINE 12.5 mg

Forma farmacêutica:

COATED TABLET

Composição:

TIANEPTINE 12.5 mg

Tipo de prescrição:

POM

Área terapêutica:

PSYCHOANALEPTICS

Status de autorização:

Authorised

Data de autorização:

2005-08-19

Folheto informativo - Bula

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
STABLON
® 12.5 MG COATED TABLETS
Tianeptine, sodium salt
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION
FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Stablon is and what it is used for
2.
What you need to know before you take Stablon
3.
How to take Stablon
4.
Possible side effects
5.
How to store Stablon
6.
Contents of the pack and other information
1.
WHAT STABLON IS AND WHAT IT IS USED FOR
Stablon is an antidepressant.
This medicine is recommended in major depressive disorders (i.e.
typical).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE STABLON
DO NOT TAKE STABLON
-
if you are allergic to tianeptine or any of the other ingredients of
this medicine (listed in Section 6),
-
in children under 15 years of age,
-
if you are pregnant or breastfeeding,
If you have any doubt, you must consult your doctor or pharmacist for
advice.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Stablon.
-
Thoughts of suicide and worsening of your depression
If you are depressed you can sometimes have thoughts of harming or
killing yourself. These may be increased
when first starting antidepressants, since these medicines all take
time to work, usually about two weeks but
sometimes longer.
You may be more likely to think like this:
-
If you have previously had thoughts about killing or harming yourself.
-
If you are a young adult. Information from clinical trials has shown
an increased risk of suicidal
behaviour in adults aged less than 25 years with psychiatric
conditions who were treated with an
a

Características técnicas

Page 1 of 10
1.
NAME OF THE MEDICINAL PRODUCT
Stablon 12.5 mg coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tianeptine (INN), sodium salt
.............................................................................................
12.5 mg
Excipient(s) with known effect: 24 mg sucrose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
White, oval coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Major depressive episodes (i.e. typical).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dosage is 1 tablet (12.5 mg) three times a day
(morning, midday and evening)
before the main meals of the days.
Method of administration
Oral use.
Special populations
_Elderly _
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/day (see section 5.2).
_ _
_Renal impairment _
In patients with severe renal impairment (CLCR<19ml/min), the dosage
should be 2 tablets/day (see
section 5.2).
_Hepatic impairment _
In patients with severe cirrhosis (Class C, Child Pugh’s Scale), the
dosage should be 2 tablets/day
(see section 5.2).
In chronic alcoholics, whether mildly or moderately cirrhotic or not
cirrhotic at all, no dosage
adaptation is needed (see section 5.2).
_Paediatric population _
The safety and efficacy of tianeptine in children and adolescents
below 18 years have not been
established. No data are available (see section 4.4).
Page 2 of 10
_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 the active substance or to any of the excipients
listed in section 6.1.
Children under 15 years old.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
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