Agomelatine betapharm 25 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

AGOMELATINE CITROENZUUR 44,7 mg/stuk SAMENSTELLING overeenkomend met ; AGOMELATINE 25 mg/stuk

Beschikbaar vanaf:

Betapharm Arzneimittel GmbH Kobelweg 95 D-86156 AUGSBURG (DUITSLAND)

ATC-code:

N06AX22

INN (Algemene Internationale Benaming):

AGOMELATINE CITROENZUUR 44,7 mg/stuk SAMENSTELLING overeenkomend met ; AGOMELATINE 25 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; NATRIUMSTEARYLFUMARAAT ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; STEARINEZUUR (E 570) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Agomelatine

Autorisatie datum:

2018-12-07

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE
PATIENT
AGOMELATINE BETAPHARM 25 MG FILMOMHULDE TABLETTEN
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 is and what it is used for
2.
What you need to know before you take Agomelatine
3.
How to take Agomelatine
4.
Possible side effects
5
How to store Agomelatine
6.
Contents of the pack and other information
1.
WHAT AGOMELATINE IS AND WHAT IT IS USED FOR
Agomelatine contains the active ingredient agomelatine. It belongs to
a group of medicines called
antidepressants. You have been given Agomelatine to treat your
depression.
Agomelatine 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 are to reduce and gradually
remove the symptoms related to your
depression.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AGOMELATINE
DO NOT TAKE AGOMELATINE
-
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)
or ciprofloxacin (an antibiotic).
2
WARNINGS AND PRECAUTIONS
There could be some reasons why Agomelatine may not be suitable

Productkenmerken

1
SAMENVATTING VAN DE PRODUCTKENMERKEN
1
NAME OF THE MEDICINAL PRODUCT
Agomelatine betapharm 25 mg filmomhulde tabletten
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains agomelatine-citric acid cocrystal
equivalent to 25 mg of agomelatine.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Yellow, oblong, biconvex film-coated tablets 9 mm long, 4.5 mm wide.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Agomelatine is indicated for the treatment of major depressive
episodes 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
liver function test (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).
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 to agomelatine _
Patients may experience discontinuation symptoms