Thymanax
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
08-08-2023
Fachinformation
(SPC)
08-08-2023
Öffentlichen Beurteilungsberichts
(PAR)
08-08-2023
Wirkstoff:
Agomelatine
Verfügbar ab:
Servier (Ireland) Industries Ltd
ATC-Code:
N06AX22
INN (Internationale Bezeichnung):
Agomelatine
Therapiegruppe:
Psychoanaleptics,
Therapiebereich:
Depressive Disorder, Major
Anwendungsgebiete:
Treatment of major depressive episodes in adults.
Produktbesonderheiten:
Revision: 24
Berechtigungsstatus:
Withdrawn
Berechtigungsdatum:
2009-02-19
Gebrauchsinformation
_ _
23
_ _
B. PACKAGE LEAFLET
Medicinal product no longer authorised
_ _
24
_ _
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
THYMANAX 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 Thymanax is and what it is used for
2.
What you need to know before you take Thymanax
3.
How to take Thymanax
4.
Possible side effects
5
How to store Thymanax
6.
Contents of the pack and other information
1.
WHAT THYMANAX IS AND WHAT IT IS USED FOR
Thymanax contains the active ingredient agomelatine. It belongs to a
group of medicines called
antidepressants. You have been given Thymanax to treat your
depression.
Thymanax 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 Thymanax are to reduce and gradually remove
the symptoms related to your
depression.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE THYMANAX
DO NOT TAKE THYMANAX
-
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 PRECAUTIONS
There could be some reas
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Fachinformation
1
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
_ _
2
_ _
1
NAME OF THE MEDICINAL PRODUCT
Thymanax 25 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 25 mg of agomelatine.
Excipient with known effect
Each film-coated tablet contains 61.8 mg lactose (as monohydrate)
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Orange-yellow, oblong, 9.5 mm long, 5.1 mm wide film-coated tablet
with blue imprint of company
logo on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Thymanax 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 o
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