Agolek 25 mg filmomhulde tabletten

Maa: Alankomaat

Kieli: hollanti

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

Aktiivinen ainesosa:

AGOMELATINE CITROENZUUR SAMENSTELLING overeenkomend met ; AGOMELATINE

Saatavilla:

Przedsiebiorstwo Farmaceutyczne LEK-AM S.p.z.o.o.

ATC-koodi:

N06AX22

INN (Kansainvälinen yleisnimi):

AGOMELATINE CITRIC acid COMPOSITION corresponding to ; AGOMELATINE

Lääkemuoto:

Filmomhulde tablet

Koostumus:

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)

Antoreitti:

Oraal gebruik

Terapeuttinen alue:

Agomelatine

Valtuutus päivämäärä:

2019-02-08

Pakkausseloste

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AGOLEK 25 MG FILMOMHULDE TABLETTEN
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 Agomelatin is and what it is used for
2.
What you need to know before you take Agomelatin
3.
How to take Agomelatin
4.
Possible side effects
5
How to store Agomelatin
6.
Contents of the pack and other information
1.
WHAT AGOMELATIN IS AND WHAT IT IS USED FOR
Agomelatin contains the active ingredient agomelatine. It belongs to a
group of medicines called
antidepressants and you have been given Agomelatin to treat your
depression.
Agomelatin 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 Agomelatin are to reduce and gradually remove
the symptoms related to your
depression.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AGOMELATIN
DO NOT TAKE AGOMELATIN
-
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 Agomelatin may not be suitable for
you:
-
I

Valmisteyhteenveto

2
1
NAME OF THE MEDICINAL PRODUCT
Agolek 25 mg filmomhulde tabletten
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains agomelatine-citric acid equivalent to
25 mg of agomelatine
Excipient with known effect:
Each tablet contains 0.2 mg sodium.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet. [Tablet]
Yellow, oblong, biconvex film-coated tablets 9.0 mm long, 4.5 mm wide
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of major depressive episodes.
Agomelatin 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
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 after