Requip 0.25 mg film-coated Tablets

Pajjiż: Malta

Lingwa: Ingliż

Sors: Malta Medicines Authority

Ingredjent attiv:

ROPINIROLE

Disponibbli minn:

Glaxo SmithKline Ireland Limited 12, Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Kodiċi ATC:

N04BC04

INN (Isem Internazzjonali):

ROPINIROLE 0.25 mg

Għamla farmaċewtika:

FILM-COATED TABLET

Kompożizzjoni:

ROPINIROLE 0.25 mg

Tip ta 'preskrizzjoni:

POM

Żona terapewtika:

ANTI-PARKINSON DRUGS

L-istatus ta 'awtorizzazzjoni:

Authorised

Data ta 'l-awtorizzazzjoni:

2005-10-11

Fuljett ta 'informazzjoni

1
_ _
PACKAGE LEAFLET
2
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
REQUIP 0.25
MG FILM-COATED TABLETS
REQUIP 1
MG FILM-COATED TABLETS
REQUIP 2
MG FILM-COATED TABLETS
REQUIP 5
MG FILM-COATED TABLETS
Ropinirole (as hydrochloride)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU
.
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their
signs of illness are the same as yours.
Keep this leaflet. You may need to read it again.
If you have any more questions, ask your doctor or pharmacist
(chemist).
IF YOU GET ANY SIDE EFFECTS, TALK TO YOUR DOCTOR OR PHARMACIST. THIS
INCLUDES ANY POSSIBLE SIDE EFFECTS NOT
LISTED IN THIS LEAFLET
. See section 4.
WHAT IS IN THIS LEAFLET
1.
WHAT REQUIP IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE REQUIP
3.
HOW TO TAKE REQUIP
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE REQUIP
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT REQUIP IS AND WHAT IT IS USED FOR
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.
REQUIP IS USED TO TREAT PARKINSON’S DISEASE
.
People with Parkinson’s disease have low levels of dopamine in some
parts of their brains. Ropinirole has
effects similar to those of natural dopamine, so it helps to reduce
the symptoms of Parkinson’s disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE REQUIP.
DO NOT TAKE REQUIP:

if you are
ALLERGIC
to ropinirole or any of the other ingredients of this medicine (listed
in section 6)

if you have
SERIOUS KIDNEY DISEASE

if you have
LIVER DISEASE

TELL YOUR DOCTOR
if you think any of these may apply to you.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Requip:

if you are
PREGNANT
or think you may be pregnant

if you are
BREAST FEEDING

if you are
UNDER 18 YEARS OLD

if you have a
SERIO

Karatteristiċi tal-prodott

1
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
2
_ _
1.
NAME OF THE MEDICINAL PRODUCT
Requip 0.25 mg film-coated tablets.
Requip 1 mg film-coated tablets.
Requip 2 mg film-coated tablets.
Requip 5 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Requip 0.25 mg film-coated tablets:
Each film-coated tablet contains 0.25 mg of ropinirole as ropinirole
hydrochloride.
Excipient with known effect
Each tablet contains 45.3 mg lactose
Requip 1 mg film-coated tablets:
Each film-coated tablet contains 1 mg of ropinirole as ropinirole
hydrochloride.
Excipient with known effect
Each tablet contains 44.9 mg lactose
Requip 2 mg film-coated tablets:
Each film-coated tablet contains 2 mg of ropinirole as ropinirole
hydrochloride.
Excipient with known effect
Each tablet contains 44.6 mg lactose
Requip 5 mg film-coated tablets:
Each film-coated tablet contains 5 mg of ropinirole as ropinirole
hydrochloride.
Excipient with known effect
Each tablet contains 43.7 mg lactose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Requip 0.25 mg film-coated tablets:
White, pentagonal-shaped, bevelled edge tablets marked "SB" on one
side and "4890" on the other.
Requip 1 mg film-coated tablets:
Green, pentagonal-shaped, bevelled edge tablets marked "SB" on one
side and "4892" on the other.
Requip 2 mg film-coated tablets:
Pink, pentagonal-shaped, bevelled edge tablets marked "SB" on one side
and "4893" on the other.
Requip 5 mg film-coated tablets:
Blue, pentagonal-shaped, bevelled edge tablets marked "SB" on one side
and "4894" on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of Parkinson's disease under the following conditions:
Initial treatment as monotherapy, in order to delay the introduction
of levodopa
In combination with levodopa, over the course of the disease, when the
effect of levodopa wears off
or becomes inconsistent and fluctuations in the therapeutic effect
occur ("end of dose" or "on-off"
type fluctuations)
4.2
POSOLOGY AND METHOD OF ADMINISTR