AGOMELATINE LUPIN 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 25 mg)

Available from:

Southern Cross Pharma Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: mannitol; silicified microcrystalline cellulose; sodium stearylfumarate; colloidal anhydrous silica; povidone; crospovidone; 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

CONSUMER MEDICINE INFORMATION
AGOMELATINE LUPIN
(AGOMELATINE (AS CITRIC ACID CO-CRYSTAL)) FILM-COATED TABLET
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Agomelatine Lupin.
It does not contain all of the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed
the risks of you taking
Agomelatine Lupin against the
benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
TALK TO YOUR DOCTOR OR
PHARMACIST.
Keep this leaflet with your
medicine. You may need to read
it again.
WHAT AGOMELATINE LUPIN
IS USED FOR
Agomelatine Lupin 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.
Agomelatine Lupin can help
regulate your ‘body clock’
(circadian rhythm) with positive
benefits on mood and sleep in
depression.
Agomelatine Lupin is not
addictive. In clinical studies
Agomelatine Lupin had no effect
on sexual function. Agomelatine
Lupin is not recommended for
children, adolescents (under 18
years old) or elderly patients
aged 75 or older.
Your doctor may prescribe
Agomelatine Lupin for another
purpose. Ask your doctor if you
have any questions about why
Agomelatine Lupin has been
prescribed for you.
BEFORE YOU TAKE
AGOMELATINE LUPIN
There are some people who
shouldn't take Agomelatine
Lupin. 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 IT _
DO NOT TAKE AGOMELATINE
LUPIN IF

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
AGOMELATINE LUPIN, (AGOMELATINE-CITRIC ACID)
_ _
1. NAME OF THE MEDICINE
Agomelatine
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
AGOMELATINE LUPIN 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 LUPIN 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 LUPIN 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 suff