LURASIDONE LUPIN lurasidone hydrochloride 20 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lurasidone hydrochloride, Quantity: 20 mg

Available from:

Lupin Australia Pty Limited

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: hypromellose; mannitol; magnesium stearate; croscarmellose sodium; titanium dioxide; macrogol 6000

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Lurasidone Lupin is indicated for the treatment of schizophrenia in adults and adolescents (aged 13 to 17 years).

Product summary:

Visual Identification: White to off-white colored, round shaped, biconvex, film-coated tablets debossed with 'F' on one side and '1' on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2020-05-07

Patient Information leaflet

This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
You can report side effects to your
doctor, or directly at www.tga.gov.au/ reporting-problems.
CONSUMER MEDICINE INFORMATION
LURASIDONE LUPIN
(LURASIDONE HYDROCHLORIDE) TABLETS
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Lurasidone LUPIN.
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
Lurasidone LUPIN 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 LURASIDONE
LUPIN IS USED FOR
Lurasidone LUPIN is used to
treat adults and adolescents
(aged 13 years or over) with
schizophrenia. Schizophrenia is
a mental illness with
disturbances in thinking, feelings
and behaviour.
Your doctor may have
prescribed Lurasidone LUPIN
for another reason. Ask your
doctor if you have any questions
about why Lurasidone LUPIN
has been prescribed for you.
Lurasidone LUPIN belongs to a
group of medicines called
atypical antipsychotics. It helps
to correct chemical imbalances
in the brain, which may cause
mental illness.
There is no evidence that
Lurasidone LUPIN is addictive
or habit forming.
This medicine is available only
with a doctor's prescription.
Lurasidone LUPIN is not
recommended for use in
children or adolescents under
13 years of age, as safety and
effectiveness have not been
established in this age group.
BEFORE YOU TAKE
LURASIDONE LUPIN
_WHEN YOU MUST NOT TAKE IT _
Do not take Lurasidone LUPIN
if:
YOU HAVE AN ALLERGY TO
LURASIDONE HYDROCHLORIDE
(THE ACTIVE INGREDIENT IN
LURASIDONE LUPIN) OR ANY
OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET.
•
YOU ARE TAKING MEDICINES
THAT CAN AFFECT HOW YOUR
BODY PROCESSES
L

Summary of Product characteristics

Lurasidone LUPIN v1.0
Page 1 of 24
(lurasidone hydrochloride) tablets
▼
This medicinal product is subject to additional monitoring in
Australia. This will allow quick identification
of new safety information. Healthcare professionals are asked to
report any suspected adverse events at
https://www.tga.gov.au/reporting-problems.
AUSTRALIAN
PRODUCT
INFORMATION
–
LURASIDONE
LUPIN
(LURASIDONE
HYDROCHLORIDE) TABLETS
1
NAME OF THE MEDICINE
Lurasidone hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Lurasidone LUPIN tablet contains 20 mg, 40 mg, or 80 mg of
lurasidone hydrochloride.
Lurasidone
hydrochloride
(HCl)
is
chemically
identified
as
(3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-
benzisothiazol-3-yl)piperazin-1-ylmethyl]cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole-1,3-
dione
hydrochloride.
Lurasidone
is
an
atypical
antipsychotic
belonging
to
the
chemical
class
of
benzisothiazol derivatives. It has antagonist activity on the dopamine
2 (D2) and serotonin (5-HT)-2A
receptors.
Lurasidone HCl (active entity) is a white to off-white powder. It is
very slightly soluble in water, practically
insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol,
sparingly soluble in methanol, practically
insoluble or insoluble in toluene very slightly soluble in acetone and
has a pKa of 7.6.
Lurasidone
LUPIN
tablets
contain
20
mg
lurasidone
hydrochloride
(equivalent
to
18.62
mg
of
lurasidone), 40 mg (equivalent to 37.24 mg lurasidone), or 80 mg
(equivalent to 74.49 mg lurasidone).
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Lurasidone LUPIN 20 mg: White to off-white colored, round shaped,
biconvex, film-coated tablets
debossed with “F” on one side and “1” on the other side.
Lurasidone LUPIN 40 mg: White to off-white colored, round shaped,
biconvex, film-coated tablets
debossed with “F” on one side and “2” on the other side.
Lurasidone LUPIN 80 mg: Green colored, oval shaped, biconvex,
film-coated tablets debossed with “F”
on one side and “4”