LURATA 80 mg Film-Coated Tablet

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Lurasidone Hydrochloride

Boleh didapati daripada:

Mansa Healthcare Sdn Bhd

INN (Nama Antarabangsa):

Lurasidone Hydrochloride

Unit dalam pakej:

1x10 Tablets; 3x10 Tablets; 10x10 Tablets

Dikeluarkan oleh:

MSN Laboratories Private Limited

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
LURATA
Lurasidone Hydrochloride (40mg, 80mg)
_ _
1
WHAT IS IN THIS LEAFLET
NPRA (R1) 23/006
1.
What
_Lurata _
is used for and how
_Lurata_
works
2.
Before you use
_Lurata_
3.
How to use
_Lurata_
4.
While you are using it
5.
Side effects
6.
Storage and Disposal of
_Lurata_
7.
Product Description
8.
Manufacturer and Product
Registration Holder
9.
Date of revision
WHAT _LURATA _IS USED FOR AND HOW
_LURATA_ WORKS
_Lurata_
contains the active ingredient
lurasidone, an atypical antipsychotic
used in the treatment of schizophrenia
in adults and adolescents (aged 13 to 17
over).
Schizophrenia is characterized by
symptoms such as:
•
Hearing, seeing, or sensing things
that are not there
•
Suspiciousness and/or mistaken
beliefs
•
Incoherent speech and behavior
•
Emotional flatness
People may also feel depressed, guilty,
anxious or tense.
_Lurata_
reduce the symptoms of
schizophrenia by blocking receptors in
the brain to which dopamine and
serotonin attach, thereby, normalizing
the activity of the brain.
Your doctor may have prescribed
_Lurata_
for another reason. Ask your
doctor if you have any questions about
why
_Lurata_
has been prescribed for
you.
BEFORE YOU USE _LURATA _
_ _
_When you must not use it _
Do not take
_Lurata_
if you
•
Are allergic to lurasidone or any of
the ingredients in
_Lurata_
•
Taking drugs that significantly affect
the way
_Lurata_
is broken down in
your body such as
o
Medications for fungal infections
such as itraconazole, ketoconazole
(except as a shampoo),
fluconazole, posaconazole or
voriconazole
o
Medicines for an infection such as
clarithromycin or telithromycin
o
Medicines for HIV infections such
as cobicistat, indinavir, nelfinavir,
ritonavir, and saquinavir
o
Medicines for chronic hepatitis:
boceprevir and telaprevir
o
Medicine for depression:
nefazodone
o
Medicine for tuberculosis:
rifampicin
o
Medicines for seizures:
carbamazepine, phenobarbital and
phenytoin
o
Diuretics (water pills)
Do not take
_Lurata_
after the expiry date

Ciri produk

LURATA (LURASIDONE HYDROCHLORIDE TABLETS 40 MG AND 80 MG)
NAME OF THE MEDICINAL PRODUCT
LURATA (Lurasidone hydrochloride Tablets 40 mg / 80 mg)
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains
Lurasidone hydrochloride 40 mg / 80 mg
PHARMACEUTICAL FORM
Film-coated tablet.
40 mg: White colored, round shaped biconvex, film coated tablets,
debossed with “40” on one side and
“ML” on other side.
80 mg: Pale green colored, oval shaped biconvex, film coated tablets,
debossed with “80” on one side
and “ML” on other side.
INDICATION AND UAGE
Lurata (lurasidone HCl) is indicated for the treatment of
schizophrenia in adults and adolescents (aged
13 - 17 years)
DOSAGE AND ADMINISTRATION
Lurasidone film-coated tablets are intended for oral administration
only.
The efficacy of lurasidone 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
doses. Doses above 80 mg may be
considered for certain patients based on individual clinical judgment.
The maximum recommended
dose is 160 mg/day. Lurasidone should be taken with food.
CHILDREN AND ADOLESCENTS
The recommended starting dose of lurasidone in adolescent patients 13
to 17 years of age with
schizophrenia is 40 mg/day. The maximum recommended dose in adolescent
patients is 80 mg/day.
Lurasidone was studied in adolescent patients 13 to 17 years of age
with schizophrenia at daily doses of
40 mg and 80 mg. The safety and efficacy of lurasidone in children
aged less than 13 yea