Agomelatine Accord 25 mg film-coated tablets

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Agomelatine

Commercializzato da:

Accord Healthcare Ireland Ltd.

Codice ATC:

N06AX22

INN (Nome Internazionale):

Agomelatine

Dosaggio:

25 milligram(s)

Forma farmaceutica:

Film-coated tablet

Tipo di ricetta:

Product subject to prescription which may not be renewed (A)

Area terapeutica:

agomelatine

Stato dell'autorizzazione:

Not marketed

Data dell'autorizzazione:

2018-12-21

Foglio illustrativo

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AGOMELATINE ACCORD 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 Accord is and what it is used for
2.
What you need to know before you take Agomelatine Accord
3.
How to take Agomelatine Accord
4.
Possible side effects
5
How to store Agomelatine Accord
6.
Contents of the pack and other information
1.
WHAT AGOMELATINE ACCORD IS AND WHAT IT IS USED FOR
Agomelatine Accord contains the active ingredient agomelatine. It
belongs to a group of medicines
called antidepressants and you have been given Agomelatine Accord to
treat your depression.
Agomelatine Accord 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 and
changes in weight.
The expected benefits of Agomelatine Accord are to reduce and
gradually remove the symptoms
related to your depression.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AGOMELATINE ACCORD
DO NOT TAKE AGOMELATINE ACCORD
-
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).
W

Scheda tecnica

Health Products Regulatory Authority
27 January 2023
CRN00DD4C
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Agomelatine Accord 25 mg film‐coated tablets
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
Treatment of major depressive episodes. Agomelatine Accord 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/riskbasis 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