REQUIP TABLET 1MG

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:

21 Tablets

Dikeluarkan oleh:

GLAXO WELLCOME S.A.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
REQUIP TABLET
Ropinirole hydrochloride (0.25mg, 1mg)
WHAT IS IN THIS LEAFLET
1.
What REQUIP is used for
2.
How REQUIP works
3.
Before you use REQUIP
4.
How to use REQUIP
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of REQUIP
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT REQUIP IS USED FOR
REQUIP is used to treat Parkinson’s
disease and restless legs syndrome
(RLS).
HOW REQUIP WORKS
The active ingredient in REQUIP 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 part
of their brain. Ropinirole has effects
similar to those of natural dopamine,
so it helps to reduce the symptoms of
Parkinson’s disease.
Restless legs syndrome is also called
Ekbom syndrome. People with restless
legs syndrome have an irresistible
urge to move their legs, and
sometimes their arms and other parts
of their body. They can often have
unpleasant sensations in their limbs —
sometimes described as ‘crawling’ or
‘bubbling’ — which can begin as soon
as they sit or lie down, and which are
only relieved by movement. This can
often cause problems with sitting still,
and especially with sleeping.
REQUIP relieves the unpleasant
sensations, and so reduces the urge to
move the legs and other limbs. This
can help you sleep better at night.
BEFORE YOU USE REQUIP
-
_When you must not use it _
Don’t take REQUIP if you are allergic
(hypersensitive) to ropinirole or any of
the other ingredients of REQUIP. If
you think this applies to you, don’t
take REQUIP until you have checked
with your doctor.
-
_Before you start to use it _
Before you take REQUIP 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 s

Ciri produk

CONFIDENTIAL
[GSK logo]
REQUIP
ROPINIROLE IMMEDIATE RELEASE TABLETS_ _
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each immediate release tablet contains ropinirole hydrochloride
equivalent to 0.25 mg or
1.0 mg ropinirole free base.
CLINICAL INFORMATION
INDICATIONS
REQUIP is indicated for the treatment of idiopathic Parkinson's
disease:
•
REQUIP may be used alone (without levodopa [L-Dopa]) in the treatment
of
idiopathic Parkinson's disease.
•
Addition of REQUIP to levodopa may be used to control "on-off"
fluctuations and
permit a reduction in the total daily dose of L-Dopa.
Treatment of Restless Legs Syndrome:
•
Ropinirole is indicated for the treatment of idiopathic/primary
Restless Legs
Syndrome.
DOSAGE AND ADMINISTRATION
PHARMACEUTICAL FORM:
Film-coated, pentagonal-shaped tablets for oral administration. The
tablet strengths are
distinguished by colour and debossing;
0.25 mg: white, pentagonal-shaped, film-coated tablets marked "SB" on
one side and
"4890" on the other.
1.0 mg: green, pentagonal-shaped, film-coated tablets marked "SB" on
one side and
"4892" on the other.
When switching treatment from another dopamine agonist to REQUIP, the
manufacturer's
guidance on discontinuation should be followed before initiating
REQUIP.
Individual dose titration against efficacy and tolerability is
recommended.
Patients should be down-titrated if they experience disabling
somnolence at any dose
level. For other adverse events, down-titration followed by more
gradual up-titration has
been shown to be beneficial.
CONFIDENTIAL
_Parkinson's Disease _
•
ADULTS
REQUIP should be taken three times a day and may be taken with or
without food (see
Pharmacokinetics).
_TREATMENT INITIATION: _
The initial dose should be 0.25 mg t.i.d (three times a day). A guide
for the titration regimen for the first four weeks of treatment is
given in the table below:
Week
1
2
3
4
Unit dose (mg)
0.25
0.5
0.75
1.0
Total daily dose (mg)
0.75
1.5
2.25
3.0
_THERAPEUTIC REGIMEN_
: After the initial titration, weekly increments of up to 3 mg/day may