Agomelatine Aurobindo 25 mg, filmomhulde tabletten

देश: नीदरलैंड

भाषा: डच

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

सक्रिय संघटक:

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

थमां उपलब्ध:

Aurobindo Pharma B.V. Baarnsche Dijk 1 3741 LN BAARN

ए.टी.सी कोड:

N06AX22

INN (इंटरनेशनल नाम):

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

फार्मास्यूटिकल फॉर्म:

Filmomhulde tablet

रचना:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; 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), 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)

प्रशासन का मार्ग:

Oraal gebruik

चिकित्सीय क्षेत्र:

Agomelatine

प्राधिकरण की तारीख:

2018-12-07

सूचना पत्रक

1
AGOMELATINE AUROBINDO 25 MG, FILMOMHULDE TABLETTEN
RVG 122599
MODULE 1 Administrative information and prescribing information
1.3.1 BIJSLUITER
Rev.nr.2101
Pag. 1 van 7
PACKAGE LEAFLET: INFORMATION FOR THE
PATIENT
AGOMELATINE AUROBINDO 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 AurobindoAgomelatine Aurobindois and what it is used
for
2.
What you need to know before you take Agomelatine Aurobindo
3.
How to take Agomelatine Aurobindo
4.
Possible side effects
5
How to store Agomelatine Aurobindo
6.
Contents of the pack and other information
1.
WHAT AGOMELATINE AUROBINDOAGOMELATINE AUROBINDOIS AND WHAT IT IS USED
FOR
Agomelatine Aurobindo Agomelatine Aurobindocontains the active
ingredient agomelatine. It belongs to
a group of medicines called
antidepressants. You have been given Agomelatine Aurobindoto treat
your
depression.
Agomelatine Aurobindois 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 Aurobindoare to reduce and
gradually remove the symptoms
related to your depression.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AGOMELATINE AUROBINDO
DO NOT TAKE AGOMELATINE AUROBINDO
-
if you are allergic to agomelatin

उत्पाद विशेषताएं

2
AGOMELATINE AUROBINDO 25 MG, FILMOMHULDE TABLETTEN RVG 122599
MODULE 1
Administrative information and prescribing information
1.3.1 SAMENVATTING VAN DE PRODUCTKENMERKEN
Rev.nr. 2301
Pag. 2 van 16
1
NAME OF THE MEDICINAL PRODUCT
Agomelatine Aurobindo 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.
Yellow, oblong, biconvex film-coated tablets 9.0 mm long, 4.5 mm wide
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Agomelatine
Aurobindo
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 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