REQUIP PD 24 HOUR™ 4mg Prolonged Release Tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ROPINIROLE HYDROCHLORIDE

Boleh didapati daripada:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (Nama Antarabangsa):

ROPINIROLE HYDROCHLORIDE

Unit dalam pakej:

84 Tablets; 28 Tablets

Dikeluarkan oleh:

GLAXO WELLCOME S.A.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
REQUIP PD 24 HOUR
PROLONGED RELEASE
TABLET
Ropinirole hydrochloride (2mg, 4mg)
WHAT IS IN THIS LEAFLET
1.
What REQUIP PD is used for
2.
How REQUIP PD works
3.
Before you use REQUIP PD
4.
How to use REQUIP PD
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of REQUIP
PD
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT REQUIP PD IS USED FOR
REQUIP PD is used to treat
Parkinson’s disease.
HOW REQUIP PD WORKS
The active ingredient in REQUIP PD
is ropinirole, which belongs to a group
of medicines called dopamine
agonists. Dopamine agonists affect the
brain in a similar way to a natural
substance called dopamine. People
with Parkinson’s disease have low
levels of dopamine in some parts of
their brain. Ropinirole has effects
similar to those of natural dopamine,
so it helps to reduce the symptoms of
Parkinson’s disease.
BEFORE YOU USE REQUIP PD
-
_When you must not use it _
Don’t take REQUIP PD if you are
allergic (hypersensitive) to ropinirole
or any of the other ingredients of
REQUIP PD. If you think this applies
to you, don’t take REQUIP PD until
you have checked with your doctor.
-
_Before you start to use it _
Before you take REQUIP PD your
doctor needs to know:
•
If you’re under 18
•
If you have heart disease
•
If you have liver disease
•
If you have kidney disease
•
If you have a serious mental health
problem
•
If you have experienced any unusual
urges or behaviours (such as
excessive gambling or excessive
sexual behaviour)
•
If you have an intolerance to some
sugars (such as lactose)
Check with your doctor if you think
any of these may apply to you. Your
doctor will decide whether REQUIP
PD is suitable for you.
REQUIP PD is not usually
recommended for use during
pregnancy. If you are pregnant or
think you could be, or if you are
planning to become pregnant don’t
take REQUIP PD without checking
with your doctor. Your doctor will
weigh up the benefit to

Ciri produk

CONFIDENTIAL
1
[GSK LOGO]
REQUIP PD 24 HOUR
ROPINIROLE PROLONGED RELEASE TABLETS
PARKINSON’S DISEASE
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged release tablet contains ropinirole hydrochloride
equivalent to 2mg or
4mg ropinirole free base.
CLINICAL INFORMATION
INDICATIONS
•
_REQUIP PD 24 HOUR_
is indicated for the treatment of idiopathic Parkinson's
disease.
•
_REQUIP PD 24 HOUR may be used alone (without levodopa [L-dopa]) in
the _
_treatment of idiopathic Parkinson’s disease. _
•
_Addition of REQUIP PD 24 HOUR to levodopa may be used to control
‘on-off’ _
_fluctuations and permit a reduction in the total daily dose of
L-Dopa._
DOSAGE AND ADMINISTRATION
_PHARMACEUTICAL FORM _
Film-coated, capsule-shaped tablets for oral administration. The
tablet strengths are
distinguished by colour and debossing;
2mg: pink, capsule-shaped, film-coated tablets marked "GS” on one
side and "3V2" on
the other.
4mg: light brown, capsule-shaped, film-coated tablets marked "GS" on
one side and
"WXG" on the other.
Oral use.
Individual dose titration against efficacy and tolerability is
recommended.
_REQUIP PD _
_24 HOUR_
prolonged-release tablets should be taken once a day and at a similar
time each
day. The tablets must be swallowed whole and must not be chewed,
crushed or divided.
The tablets may be taken with or without food (see Pharmacokinetics).
_ADULTS _
_ _
_INITIAL TITRATION _
CONFIDENTIAL
2
The starting dose of
_REQUIP PD 24 HOUR_
prolonged-release tablets is 2 mg once daily
for the first week; this should be increased to 4 mg once daily from
the second week of
treatment. A therapeutic response may be seen at a dose of 4 mg once
daily of
_REQUIP _
_PD 24 HOUR_
prolonged-release tablets.
Patients who initiate treatment with a dose of 2 mg/day of ropinirole
prolonged-release
tablets and who experience side effects that they cannot tolerate, may
benefit from
switching to treatment with
_REQUIP IR_
(immediate release) tablets at a lower daily dose,
divided into three equal doses.
_THERAPEUTIC REGIMEN