Agomelatine Mylan 25 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Agomelatine

Available from:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATC code:

N06AX22

INN (International Name):

Agomelatine

Dosage:

25 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

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

Therapeutic area:

agomelatine

Authorization status:

Marketed

Authorization date:

2018-10-26

Patient Information leaflet

22
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AGOMELATINE MYLAN 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 Mylan is and what it is used for
2.
What you need to know before you take Agomelatine Mylan
3.
How to take Agomelatine Mylan
4.
Possible side effects
5
How to store Agomelatine Mylan
6.
Contents of the pack and other information
1.
WHAT AGOMELATINE MYLAN IS AND WHAT IT IS USED FOR
Agomelatine Mylan contains the active ingredient agomelatine. It
belongs to a group of medicines called
antidepressants and you have been given this medicine to treat your
depression.
Agomelatine Mylan 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 Mylan is to reduce and gradually
remove the symptoms related to
your depression.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AGOMELATINE MYLAN
DO NOT TAKE AGOMELATINE MYLAN
-
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).
WARNINGS AND PRECAUT

Summary of Product characteristics

Health Products Regulatory Authority
17 November 2023
CRN00D6XD
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Agomelatine Mylan 25 mg film‐coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film‐coated tablet contains agomelatine‐citric acid
co‐crystal 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 tablet, 9.0 mm long by 4.5 mm
wide.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Agomelatine Mylan is indicated in adults for the treatment of major
depressive episodes.
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