Requip 0.25 mg film-coated tablets

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Ropinirole hydrochloride

Beszerezhető a:

GlaxoSmithKline (Ireland) Limited

ATC-kód:

N04BC; N04BC04

INN (nemzetközi neve):

Ropinirole hydrochloride

Adagolás:

0.25 milligram(s)

Gyógyszerészeti forma:

Film-coated tablet

Recept típusa:

Product subject to prescription which may be renewed (B)

Terápiás terület:

Dopamine agonists; ropinirole

Engedélyezési státusz:

Marketed

Engedély dátuma:

1996-12-03

Betegtájékoztató

Reason for Update: PRAC Recommendation PSUSA/00002661/202207
Market: IE
Agency Approval Date: 05Jun23 (Type IAIN)
Text Date: 18May2023
Issue and Draft No.: Issue 11 Draft 1
1
REQUIP
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 ta

Termékjellemzők

Health Products Regulatory Authority
17 July 2023
CRN00DM78
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Requip 0.25 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 0.25 mg of ropinirole (as ropinirole
hydrochloride).
Excipient with known effect
Each tablet contains 45.3 mg lactose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, pentagonal-shaped bevelled edge tablets marked SB on one side
and 4890 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:
Week ​ ​ ​
1
2
3
4
Unit dose (mg) of ropinirole
0.25
0.5
0.75
1.0
Total daily dose (mg) of ropinirole
0.75
1.5
2.25
3.0
_ _
_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.
Doses of ropinirole above 24 mg/day have not been studied.
Health Products Regulatory