AGOMELATINE SANDOZ agomelatine (as agomelatine-citric acid) 25 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

agomelatine-citric acid, Quantity: 44.739 mg (Equivalent: agomelatine, Qty mg)

Available from:

Southern Cross Pharma Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: colloidal anhydrous silica; povidone; sodium stearylfumarate; mannitol; crospovidone; silicified microcrystalline cellulose; magnesium stearate; stearic acid; hypromellose; macrogol 6000; titanium dioxide; purified talc; iron oxide yellow

Administration route:

Oral

Units in package:

28 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of major depression in adults including prevention of relapse.

Product summary:

Visual Identification: yellow, oblong biconvex film coated tablet; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2020-06-26

Patient Information leaflet

AGOMELATINE SANDOZ
1
AGOMELATINE
SANDOZ
_Agomelatine-citric acid _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about AGOMELATINE
SANDOZ. It does not contain all the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking
AGOMELATINE SANDOZ against
the benefits they expect it will 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 AGOMELATINE
SANDOZ IS USED FOR
AGOMELATINE SANDOZ is used
to treat depression or to help prevent
depression returning.
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.
AGOMELATINE SANDOZ can
help regulate your 'body clock'
(circadian rhythm) with positive
benefits on mood and sleep in
depression.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
This medicine is only available with
a doctor's prescription.
In clinical studies AGOMELATINE
SANDOZ had no effect on sexual
function.
AGOMELATINE SANDOZ is not
recommended for children,
adolescents (under 18 years old) or
elderly patients aged 75 or older.
BEFORE YOU TAKE
AGOMELATINE
SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE AGOMELATINE
SANDOZ IF:
•
you suffer from liver disease or
you know your liver does not
work properly (hepatic
impairment)
•
your routine blood tests show
levels of liver enzymes have
increased to more than 3 times
the upper limit of normal
•
yo

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
AGOMELATINE SANDOZ, (AGOMELATINE-CITRIC ACID)
_ _
1. NAME OF THE MEDICINE
Agomelatine
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
AGOMELATINE SANDOZ film-coated tablets contain 44.74 mg
agomelatine-citric acid (equivalent to 25 mg
agomelatine).
For the full list of excipients, see Section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
AGOMELATINE SANDOZ 25 mg are yellow, oblong biconvex film coated
tablet.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Treatment of major depression in adults including prevention of
relapse.
4.2. DOSE 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 AGOMELATINE SANDOZ 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 CONTRAINDICATIONS and Section 4.4 SPECIAL
WARNINGS AND PRECAUTIONS FOR USE.
TREATMENT DURATION
Patients with depression should be treated for a