VALDOXAN 25MG FILM-COATED TABLETS

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

AGOMELATINE

Available from:

SERVIER MALAYSIA SDN BHD

INN (International Name):

AGOMELATINE

Units in package:

28Tablet Tablets

Manufactured by:

LES LABS SERVIER INDUSTRIE

Patient Information leaflet

_Consumer Medication Information Leaflet (RIMUP)_
VALDOXAN 25MG FILM-COATED TABLETS
_Agomelatine 25mg _
1
WHAT IS IN THIS LEAFLET
1.
What is Valdoxan used for
2.
How Valdoxan works
3.
Before you take Valdoxan
4.
How to take Valdoxan
5.
While you are taking Valdoxan
6.
Side effects
7.
Storage
and
Disposal
of
Valdoxan
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT VALDOXAN IS USED FOR
You have been given Valdoxan to
treat your depression or generalised
anxiety disorder.
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.
Generalised
anxiety
disorder
is
a
chronic
feeling
of
anxiety
or
nervousness with sleep disorders, and
physical symptoms such as fatigue
and muscle tension.
HOW
VALDOXAN WORKS
Valdoxan contains the active
ingredient agomelatine. It belongs to
a
group
of
medicines
called
antidepressants.
The expected benefits of Valdoxan
are to reduce and gradually remove
the
symptoms
related
to
your
depression
or
generalised
anxiety
disorder.
BEFORE YOU TAKE VALDOXAN
-
_When you must not use it _
DO NOT TAKE VALDOXAN
-
if you are allergic to agomelatine or
any of the other ingredients of this
medicine (listed in section 8).
-
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).
-
_ _
_ _
_PREGNANCY AND BREAST FEEDING _
If
you
are
pregnant
or
breast-
feeding, think you may be pregnant
or are planning to have a baby, ask
your doctor or pharmacist for advice
before taking this medicine.
Breastfeeding should be discontinued
if you take Valdoxan.
-
_Before you start to take it _
WARNINGS AND PRECAUTIONS
There could be some reasons why
Valdoxan
may
not
b

Summary of Product characteristics

__________________________________________________________________________________
Final PI_Valdoxan_08.07.2022
1
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;
-
generalised anxiety disorder (GAD).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 25 mg once daily taken orally at bedtime.
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:
-
2 weeks after treatment initiation in major depressive episode;
-
4 weeks after treatment initiation in generalised anxiety disorder.
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
whe