LURACOR lurasidone hydrochloride 40 mg film-coated tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lurasidone hydrochloride, Quantity: 40 mg

Available from:

Pharmacor Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: citric acid; lactose monohydrate; magnesium stearate; povidone; croscarmellose sodium; mannitol; pregelatinised maize starch; titanium dioxide; hypromellose; 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: White to off white, round shaped, film coated tablets debossed with '40' 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

LURACOR
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.
LURACOR (LURASIDONE HYDROCHLORIDE) FILM-COATED
TABLETS
LURASIDONE HYDROCHLORIDE
CONSUMER MEDICINE INFORMATION(CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
LURACOR.
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
LURACOR 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 LURACOR
IS USED
FOR
LURACOR 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
LURACOR for another reason.
Ask your doctor if you have any
questions about why LURACOR
has been prescribed for you.
LURACOR 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
LURACOR is addictive or habit
forming.
This medicine is available only
with a doctor's prescription.
LURACOR 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
LURACOR
_WHEN YOU MUST NOT TAKE IT _
Do not take LURACOR if:
• YOU HAVE AN ALLERGY TO
LURASIDONE HYDROCHLORIDE (THE
ACTIVE INGREDIENT IN
LURACOR ) OR ANY OF THE
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET.
• YOU ARE TAKING MEDICINES THAT
CAN AFFECT HOW YOUR BODY
PROCESSES LURACOR SUCH
AS:
-
KETOCONAZOLE OR

Summary of Product characteristics

LURACOR
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 - LURACOR (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.
LURACOR 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
LURACOR 20 mg: White to off white, round shaped, film coated tablets
debossed with “20”
on one side and “L” on other side.
LURACOR 40 mg: White to off white, round shaped, film coated tablets
debossed with “40”
on one side and “L” on other side.
LURACOR 80 mg: Light-green to green, oval shaped, film coated tablets
debossed with “80”
on one side and “L” on other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
LURACOR is indicated for the treatment of schizophrenia in adults and
adolescents (aged
13 to 17 years).
LURACOR
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4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
The efficacy of lurasidone has been established at doses of 40, 80,