PHARMACOR LURASIDONE lurasidone hydrochloride 80 mg film-coated tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lurasidone hydrochloride, Quantity: 80 mg

Available from:

Pharmacor Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: citric acid; croscarmellose sodium; povidone; pregelatinised maize starch; mannitol; lactose monohydrate; magnesium stearate; titanium dioxide; hypromellose; iron oxide yellow; brilliant blue FCF aluminium lake; macrogol 400

Administration route:

Oral

Units in package:

30 tablets, 90 tablets, 500 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Lurasidone hydrochloride film-coated tablets are indicated for the treatment of schizophrenia in adults and adolescents (aged 13 to 17 years).

Product summary:

Visual Identification: Light-green to green, oval shaped, film coated tablets debossed with '80' on one side and 'L' on other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2020-10-16

Patient Information leaflet

PHAEMACOR LURASIDONE
Ver: 01
1
▼
This medicinal product 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 effect to your doctor, or directly at
https://www.tga.gov.au/reporting-problems.
PHARMACOR LURASIDONE (LURASIDONE
HYDROCHLORIDE) FILM-COATED TABLETS
LURASIDONE HYDROCHLORIDE
CONSUMER MEDICINE INFORMATION(CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
PHARMACOR LURASIDONE.
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
PHARMACOR LURASIDONE
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 PHARMACOR
LURASIDONE
IS USED FOR
PHARMACOR LURASIDONE
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
PHARMACOR LURASIDONE
for another reason. Ask your
doctor if you have any questions
about why PHARMACOR
LURASIDONE has been
prescribed for you.
PHARMACOR LURASIDONE
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
PHARMACOR LURASIDONE
is addictive or habit forming.
This medicine is available only
with a doctor's prescription.
PHARMACOR LURASIDONE
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
PHARMACOR
LURASIDONE
_WHEN YOU MUST NOT TAKE IT _
Do not take PHARMACOR
LURASIDONE if:
• YOU HAVE AN ALLERGY TO
LURASIDONE HYDROCHLORIDE (THE
ACTIVE INGREDIENT IN
PHARM

Summary of Product characteristics

PHARMACOR LURASIDONE
Ver: 01
1
▼
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 - PHARMACOR LURASIDONE
(LURASIDONE HYDROCHLORIDE) FILM-COATED TABLETS
1.
NAME OF THE MEDICINE
Lurasidone Hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lurasidone hydrochloride (HCl) is chemically identified as
(3a_R_,4_S_,7_R_,7a_S_)-2-{(1_R_,2_R_)-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 insoluble in water, slightly soluble in methanol,
and has a pKa of 7.6.
PHARMACOR LURASIDONE 20 mg, 40 mg and 80 mg tablets contain 20 mg
lurasidone
hydrochloride
(equivalent
to
18.62
mg
lurasidone),
40
mg
lurasidone
hydrochloride
(equivalent to 37.24 mg lurasidone) or 80 mg lurasidone hydrochloride
(equivalent to
74.49 mg lurasidone).”
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
PHARMACOR LURASIDONE 20 mg: White to off white, round shaped, film
coated tablets
debossed with “20” on one side and “L” on other side.
PHARMACOR LURASIDONE 40 mg: White to off white, round shaped, film
coated tablets
debossed with “40” on one side and “L” on other side.
PHARMACOR LURASIDONE 80 mg: Light-green to green, oval shaped, film
coated
tablets debossed with “80” on one side and “L” on other side.
PHARMACOR LURASIDONE
Ver: 01
2
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PHARMACOR LURASIDONE is indicated for the treatment of schizophrenia
in adults and
adolescents (aged 13 to 17 years).
4.2
DOSE