Agomaval 25 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Available from:

TAD Pharma GmbH Heinz-Lohmann-Strasse 5, 27472 Cuxhaven, Germany

ATC code:

N06AX22

INN (International Name):

AGOMELATINE 25 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

AGOMELATINE 25 mg

Prescription type:

POM

Therapeutic area:

PSYCHOANALEPTICS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2021-05-17

Patient Information leaflet

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AGOMAVAL 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.
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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 Agomaval is and what it is used for
2.
What you need to know before you take Agomaval
3.
How to take Agomaval
4.
Possible side effects
5.
How to store Agomaval
6.
Contents of the pack and other information
1.
WHAT AGOMAVAL IS AND WHAT IT IS USED FOR
Agomaval contains the active ingredient agomelatine. It belongs to a
group of medicines called
antidepressants and you have been given Agomaval to treat your
depression.
Agomaval 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 Agomaval are to reduce and gradually remove
the symptoms related to your
depression.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AGOMAVAL
DO NOT TAKE AGOMAVAL
-
if you are allergic to agomelatine or any of the other ingredients of
this medicine (listed in section
6).
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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 PRECAUTIONS
There could be some reasons why Agomaval may not be suitable

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Agomaval 25 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains agomelatine-citric acid equivalent to
25 mg agomelatine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (Tablet)
Yellow, oblong, biconvex film-coated tablets 9.0 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 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.
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_Switching therapy from SSRI/SNRI antidepressant to agomelatine_
Patients
may
experience
discontinuation
symp