Agomelatine Biogaran Tablet, film coated 25mg

Krajina: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktívna zložka:

AGOMELATINE

Dostupné z:

Biogaran 15, boulevard Charles de Gaulle, Colombes 92700, France

ATC kód:

N06AX22

INN (Medzinárodný Name):

AGOMELATINE 25 mg

Forma lieku:

FILM-COATED TABLET

Zloženie:

AGOMELATINE 25 mg

Typ predpisu:

POM

Terapeutické oblasti:

PSYCHOANALEPTICS

Stav Autorizácia:

Withdrawn

Dátum Autorizácia:

2018-09-03

Príbalový leták

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AGOMELATINE BIOGARAN 25 MG FILM-COATED TABLETS
Agomelatine
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 Agomelatine Biogaran is and what it is used for
2.
What you need to know before you take Agomelatine Biogaran
3.
How to take Agomelatine Biogaran
4.
Possible side effects
5
How to store Agomelatine Biogaran
6.
Contents of the pack and other information
1.
WHAT AGOMELATINE BIOGARAN IS AND WHAT IT IS USED FOR
Agomelatine Biogaran contains the active ingredient agomelatine. It
belongs to a group of medicines
called antidepressants and you have been given Agomelatine Biogaran to
treat your depression.
Agomelatine Biogaran is used in adults.
Depression is a continuing disturbance of mood that interferes with
everyday life. The symptoms of
depression vary from one person to another, but often include deep
sadness, feelings of worthlessness, loss
of interest in favourite activities, sleep disturbances, feeling of
being slowed down, feelings of anxiety,
changes in weight.
The expected benefits of Agomelatine Biogaran are to reduce and
gradually remove the symptoms related
to your depression.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AGOMELATINE BIOGARAN
DO NOT TAKE AGOMELATINE BIOGARAN
-
if you are allergic to agomelatine or any of the other ingredients of
this medicine (listed in section
6).
-
IF YOUR LIVER DOES NOT WORK PROPERLY (HEPATIC IMPAIRMENT).
-
if
you
are
taking
fluvoxamine
(another
medicine
used
in
the
treatment
of
depression)

Súhrn charakteristických

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Agomelatine Biogaran 25 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 25 mg of agomelatine.
Excipient with known effect: each tablet contains 61.8 mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Orange-yellow, oblong, 9.5 mm long, 5.1 mm wide film-coated tablet
with blue imprint of company logo
on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of major depressive episodes.
Agomelatine 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.
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 LFT
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).
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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