Valdoxan

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Agomelatine

Available from:

Les Laboratoires Servier

ATC code:

N06AX22

INN (International Name):

Agomelatine

Therapeutic group:

Psychoanaleptics,

Therapeutic area:

Depressive Disorder, Major

Therapeutic indications:

Treatment of major depressive episodes in adults.,

Product summary:

Revision: 24

Authorization status:

Authorised

Authorization date:

2009-02-19

Patient Information leaflet

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23
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B. PACKAGE LEAFLET
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24
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VALDOXAN 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.
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Keep this leaflet. You may need to read it again.
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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.
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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 Valdoxan is and what it is used for
2.
What you need to know before you take Valdoxan
3.
How to take Valdoxan
4.
Possible side effects
5
How to store Valdoxan
6.
Contents of the pack and other information
1.
WHAT VALDOXAN IS AND WHAT IT IS USED FOR
Valdoxan contains the active ingredient agomelatine. It belongs to a
group of medicines called
antidepressants. You have been given Valdoxan to treat your
depression.
Valdoxan 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 Valdoxan are to reduce and gradually remove
the symptoms related to your
depression.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VALDOXAN
DO NOT TAKE VALDOXAN
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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).
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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 Valdoxan may not be suitable fo

Summary of Product characteristics

1
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ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
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2
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1
NAME OF THE MEDICINAL PRODUCT
Valdoxan 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
Valdoxan 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.
_Switching therapy from SSR