LURASIDONE SANDOZ lurasidone hydrochloride 40 mg film-coated tablet blister pack

Pajjiż: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

lurasidone hydrochloride, Quantity: 40 mg

Disponibbli minn:

Sandoz Pty Ltd

Għamla farmaċewtika:

Tablet, film coated

Kompożizzjoni:

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

Rotta amministrattiva:

Oral

Unitajiet fil-pakkett:

28 tablets, 30 Tablets

Tip ta 'preskrizzjoni:

(S4) Prescription Only Medicine

Indikazzjonijiet terapewtiċi:

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

Sommarju tal-prodott:

Visual Identification: White to off white, round shaped, biconvex, film-coated tablets debossed with 516 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

L-istatus ta 'awtorizzazzjoni:

Registered

Data ta 'l-awtorizzazzjoni:

2020-06-24

Fuljett ta 'informazzjoni

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.
LURASIDONE SANDOZ
®
1
LURASIDONE
SANDOZ
®
_lurasidone hydrochloride _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Lurasidone Sandoz.
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
Sandoz 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
SANDOZ IS USED
FOR
Lurasidone Sandoz 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 Sandoz for another
reason. Ask your doctor if you have
any questions about why Lurasidone
Sandoz has been prescribed for you.
Lurasidone Sandoz 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
Sandoz is addictive or habit forming.
This medicine is available only with
a doctor's prescription.
Lurasidone Sandoz 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
SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE LURASIDONE SANDOZ IF:
•
you have an allergy to lurasidone
hydrochloride (the active
ingredient in Lurasidone Sandoz)
or any of the ingredients listed at
the end of this leaflet.
•
you are taking medicines that

Karatteristiċi tal-prodott

210429-lurasidone sandoz-pi
Page 1 of 24
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
LURASIDONE SANDOZ (LURASIDONE HYDROCHLORIDE) TABLETS
1.
NAME OF THE MEDICINE
Lurasidone hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
Lurasidone
Sandoz
film-coated
tablet
contains
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.
LURASIDONE SANDOZ 40 MG TABLET:
White to off white, round shaped, biconvex, film-coated
tablets debossed with ‘516’ on one side and ‘L’ on other side.
LURASIDONE SANDOZ 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
Lurasidone Sandoz 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.
Lurasidone hydrochloride 20 mg is unavailable in this brand but
available in other brands.
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
compared to lower dos