VALDOXAN agomelatine 25 mg film coated tablet blister pack.

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

agomelatine, Quantity: 25 mg

Available from:

Servier Laboratories (Aust) Pty Ltd

INN (International Name):

Agomelatine

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; povidone; stearic acid; colloidal anhydrous silica; sodium starch glycollate type A; maize starch; lactose monohydrate; propylene glycol; butan-1-ol; ethanol; isopropyl alcohol; Shellac; strong ammonia solution; indigo carmine aluminium lake; titanium dioxide; hypromellose; iron oxide yellow; macrogol 6000; glycerol

Administration route:

Oral

Units in package:

7 tablets (medical sample), 28 tablets (commercial pack), 56 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment in adults of: - of major depression (MDD) including prevention of relapse - generalised anxiety disorder (GAD)

Product summary:

Visual Identification: Orange-yellow, oblong film-coated tablet with blue imprint of Servier logo on one face; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2010-08-09

Patient Information leaflet

VALDOXAN
® 25MG
_Agomelatine (pronounced a-go-mel-a-tin)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about VALDOXAN. It
does not contain all the available
information. You can obtain more
information about VALDOXAN by
talking to your doctor or pharmacist.
All medications have risks and
benefits. Your doctor has weighed
the risks of you taking VALDOXAN
against the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST. KEEP THIS
LEAFLET WITH THE MEDICINE.
YOU MAY NEED TO READ IT AGAIN.
WHAT VALDOXAN IS
USED FOR
VALDOXAN is used in the
treatment of depression or to help
prevent depression returning, and is
only available with a doctor's
prescription. The symptoms of
depression vary from one person to
another, but commonly include
persistent sadness, loss of interest in
favourite activities, feelings of
worthlessness, sleep problems,
feeling of being slowed down,
feelings of anxiety or changes in
appetite and weight. Changes in your
daily sleep and appetite patterns are
examples of disturbances of your
'body clock' that occur commonly in
depression.
VALDOXAN can help regulate your
'body clock' (circadian rhythm) with
positive benefits on mood and sleep
in depression.
VALDOXAN is not addictive.
VALDOXAN does not cause
discontinuation symptoms and can be
stopped without the need to taper
dose.
In clinical studies VALDOXAN had
no effect on sexual function.
VALDOXAN is not recommended
for children, adolescents (under 18
years old) or elderly patients aged 75
or older.
Your doctor may prescribe
VALDOXAN for another purpose.
Ask your doctor if you have any
questions about why VALDOXAN
has been prescribed for you.
BEFORE YOU TAKE
VALDOXAN
There are some people who shouldn't
take VALDOXAN. Please read the
list below. If you think any of these
situations apply to you or you have
any questions, please see your
doctor.
_WHEN YOU MUST NOT TAKE_
_VALDOXAN_
•
DO NOT TAKE VALDOXAN IF:
•
YOU SUF

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – VALDOXAN (AGOMELATINE)
Version: 21
1/21
AUSTRALIAN PRODUCT INFORMATION - VALDOXAN (AGOMELATINE)
FILM-COATED TABLETS
1
NAME OF THE MEDICINE
Agomelatine.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 25 mg of agomelatine.
Excipient with known effect: contains sugars as lactose . For the full
list of excipients, see_ section 6.1 - List of _
_excipients_.
3
PHARMACEUTICAL FORM
Orange-yellow, oblong, 9.5 mm long, 5.1 mm wide film-coated tablet
with blue imprint of Servier logo on
one face.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Treatment of major depression in adults including prevention of
relapse.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The recommended daily dose is one tablet taken orally at bedtime.
After two weeks of treatment, if there is no improvement in symptoms,
the dose may be increased to
50 mg once daily, taken as a single dose of two tablets at bedtime.
The maximum recommended dose
should not be exceeded.
Dose escalation has been associated with an increased incidence of
serum transaminase elevations. Dose
increases to 50 mg should only occur following an assessment of the
benefits and risk and assessment of
liver function.
Liver function tests should be performed in all patients before
initiation of treatment and before a dose
increase to 50 mg. Treatment with VALDOXAN (agomelatine) should not be
initiated if serum transaminase
levels are > 3 times the upper limit of normal range (see _section 4.3
– Contraindications_ and _section 4.4 - _
_Special warnings and precautions for use_).
During treatment transaminases should be monitored periodically after
around 3, 6 (end of acute phase),
12, and 24 (end of maintenance phase) weeks with regimen to be
repeated following dose increase to
50 mg and thereafter when clinically indicated (see_ section 4.4 -
Special warnings and precautions for use_).
Treatment should be discontinued if serum transaminase levels are > 3
times the upper limit of the normal
range (see _section 4.3 – Con