APO-LURASIDONE 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:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: hypromellose; maize starch; mannitol; croscarmellose sodium; magnesium stearate; titanium dioxide; macrogol 8000

Administration route:

Oral

Units in package:

28 tablets, 30 Tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

APO- Lurasidone is 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 biconvex film-coated tablets debossed with 515 on one side and L on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2020-06-24

Patient Information leaflet

APO-LURASIDONE
1
APO-LURASIDONE
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
1.
WHY AM I USING APO-LURASIDONE?
APO-LURASIDONE contains the active ingredient lurasidone
hydrochloride. APO-LURASIDONE is used to treat adults and
adolescents (aged 13 years and over) with schizophrenia. It is only
available with a doctor’s prescription. For more information,
see Section 1. Why am I using APO-LURASIDONE?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE APO-LURASIDONE?
Do not use if you have ever had an allergic reaction to APO-LURASIDONE
or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING. APO-LURASIDONE IS NOT APPROVED FOR
TREATMENT OF ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS OR BEHAVIOURAL DISORDERS. For more information, see Section
2. What should I know before I use APO-LURASIDONE?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with APO-LURASIDONE and affect how it
works. A list of these medicines is in Section 3. What if
I am taking other medicines? in the full CMI.
4.
HOW DO I USE APO-LURASIDONE?
Your doctor or pharmacist will tell you how many tablets you will need
to take each day. This depends on your condition and
whether or not you are taking any other medicines. Unless your doctor
gives you other directions, you should take APO-
LURASIDONE only once a day. Take APO-LURASIDONE during or immediately
after food, consider evening meal. More
instructions can be found in Section 4. How do I use APO-LURASIDONE?
in the full CMI. CONTINUE TAKING THE TABLETS FOR AS LONG
AS YOUR DOCTOR TELLS YOU.
5.
WHAT SHOULD I KNOW WHILE USING APO-LURASIDONE?
THINGS YOU
SHOULD DO
•
Remin

Summary of Product characteristics

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 www.tga.gov.au/reporting-problems.
AUSTRALIAN
PRODUCT
INFORMATION
–
APO-LURASIDONE
(LURASIDONE HYDROCHLORIDE) TABLETS
1
NAME OF THE MEDICINE
Lurasidone hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each APO-LURASIDONE
film coated tablet contains 20 mg, 40 mg, or 80 mg of lurasidone
hydrochloride.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Film-coated tablet.
APO-LURASIDONE 20 MG TABLET:
White to off white, round shaped, biconvex, film-coated tablets
debossed with ‘515’ on one side and ‘L’ on other side.
APO-LURASIDONE 40 MG TABLET:
White to off white, round shaped, biconvex, film-coated tablets
debossed with ‘516’ on one side and ‘L’ on other side.
APO-LURASIDONE 80 MG TABLET:
Pale green, oval shaped, biconvex, film-coated tablets debossed
with ‘L 517’ on one side and plain on other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
APO-Lurasidone
is
indicated
for
the
treatment
of
schizophrenia
in
adults
and
adolescents
(aged 13 to 17 years).
4.2
D
OSE AND METHOD OF ADMINISTRATION
Lurasidone hydrochloride film-coated tablets are intended for oral
administration only.
The efficacy of Lurasidone hydrochloride has been established at doses
of 40, 80, 120 and
160 mg/day. The recommended starting dose is 40 mg once daily. Initial
dose titration is not
required. Patients should be treated with the lowest effective dose
that provides optimal clinical
response and tolerability, which is expected to be 40 mg or 80 mg once
daily for most patients.
Dose increase should be based on physician judgement and observed
clinical response. In the six
week controlled trials, there was no suggestion of added benefit with
the 120 mg/day dose
compared to 40 and 80 mg/day. In the pooled analyses, added benefit
occurred at 160 mg/day
compa