REQUIP 0.5 Milligram Film Coated Tablet

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

ROPINIROLE HYDROCHLORIDE

Beszerezhető a:

GlaxoSmithKline (Ireland) Limited

INN (nemzetközi neve):

ROPINIROLE HYDROCHLORIDE

Adagolás:

0.5 Milligram

Gyógyszerészeti forma:

Film Coated Tablet

Recept típusa:

Product subject to prescription which may be renewed (B)

Engedélyezési státusz:

Authorised

Engedély dátuma:

0000-00-00

Betegtájékoztató

_ _
1 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

REQUIP 0.25 MG FILM-COATED TABLETS 
REQUIP 0.5 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. 

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 (hypersensitive) to ropinirole
or any of the other ingredients of this medicine 
(listed in sections 4 and 6) 
 
if you have SERIOUS KIDNEY DISEASE 
 
if you have LIVER DISEASE 

  TELL YOUR DOCTOR if you

Termékjellemzők

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Requip 0.5 mg film-coated tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 0.5 mg of ropinirole as ropinirole hydrochloride.
Excipient: 45.0 mg lactose
For the full list of excipients, see section 6.1_._
3 PHARMACEUTICAL FORM
Film-coated tablet.
Yellow, pentagonal-shaped bevelled edge tablets marked “SB” on one side and “4891” on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of Parkinson's disease under the following conditions:
o
Initial treatment as monotherapy, in order to delay the introduction of levodopa
o
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 ADMINISTRATION
Oral use.
Adults
Individual dose titration against efficacy and tolerability is recommended.
Requip should be taken three times a day, preferably with meals to improve gastrointestinal tolerance.
_Treatment initiation_
The initial dose of ropinirole should be 0.25 mg three times daily for 1 week. Thereafter, the dose of ropinirole can be
increased in 0.25 mg three times daily increments, according to the following regimen:
_Therapeutic regimen_
After the initial titration, weekly increments of 0.5 to 1 mg three times daily (1.5 to 3 mg/day) of ropinirole may be
given.
A therapeutic response may be seen between 3 and 9 mg/day of ropinirole. If sufficient symptomatic control is not
achieved, or maintained after the initial titration as described above, the dose of ropinirole may be increased up to
24 mg/day.
Week
1
2
3
4
Unit dose (mg) of ropinirole
0.25
0.5
0.75
1.0
Total daily dose (