DOMION 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:

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

2016-11-15

Patient Information leaflet

DOMION 25MG
_Agomelatine (pronounced a-go-mel-a-tin)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about DOMION. It does
not contain all the available
information. You can obtain more
information about DOMION by
talking to your doctor or pharmacist.
All medications have risks and
benefits. Your doctor has weighed
the risks of you taking DOMION
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 DOMION IS
USED FOR
DOMION 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.
DOMION can help regulate your
'body clock' (circadian rhythm) with
positive benefits on mood and sleep
in depression.
DOMION is not addictive.
DOMION does not cause
discontinuation symptoms and can be
stopped without the need to taper
dose.
In clinical studies DOMION had no
effect on sexual function.
DOMION is not recommended for
children, adolescents (under 18 years
old) or elderly patients aged 75 or
older.
Your doctor may prescribe DOMION
for another purpose. Ask your doctor
if you have any questions about why
DOMION has been prescribed for
you.
BEFORE YOU TAKE
DOMION
There are some people who shouldn't
take DOMION. 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_
_DOMION_
•
DO NOT TAKE DOMION IF:
•
YOU SUFFER FROM LIVER DISEASE OR
YOU KNOW YO

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – DOMION (AGOMELATINE)
Version: 5
1/21
AUSTRALIAN PRODUCT INFORMATION – DOMION (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 DOMION (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 – Contrain