Ropinirole 5mg Film-Coated Tablets

Country: Малта

Језик: Енглески

Извор: Medicines Authority

Активни састојак:

ROPINIROLE

Доступно од:

Wockhardt UK Limited Ash Road North, Wrexham, LL13 9UF, United Kingdom

АТЦ код:

N04BC04

INN (Међународно име):

ROPINIROLE 5 mg

Фармацеутски облик:

FILM-COATED TABLET

Састав:

ROPINIROLE 5 mg

Тип рецептора:

POM

Терапеутска област:

ANTI-PARKINSON DRUGS

Статус ауторизације:

Withdrawn

Датум одобрења:

2011-02-21

Информативни летак

Page
1
of
8
PACKAGE LEAFLET: INFORMATION FOR THE USER
ROPINIROLE 0.25MG, 0.5MG, 1MG AND 2MG FILM-COATED TABLETS
ROPINIROLE HYDROCHLORIDE
(REFERRED TO AS ROPINIROLE TABLETS IN THE REMAINDER OF THE LEAFLET)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
− Keep this leaflet you may need to read it again.
− If you have any further questions, please ask your doctor or
pharmacist.
− 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.
− If you get any side effects, talk to your doctor or pharmacist.
This includes any side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Ropinirole Tablets are and what they are used for
2.
What you need to know before you take Ropinirole Tablets
3.
How to take Ropinirole Tablets
4.
Possible side effects
5.
How to store Ropinirole Tablets
6.
Contents of the pack and other information
1.
WHAT ROPINIROLE TABLETS ARE AND WHAT THEY ARE USED FOR
The active ingredient in Ropinirole Tablets 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.
Ropinirole Tablets are 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.
•
moderate to severe Restless Legs Syndrome. People with Restless Legs
Syndrome have an
irresistible urge to move their legs, and sometimes their arms and
other parts of their body.
Usually, they have unpleasant sensations in their limbs – sometimes
described as ‘crawling’
or ‘bubbling’ – which can begin as soon as they sit or lie down,
and are relieved only by
movement. So they often have problems with sitting still, and
especially with sle

Карактеристике производа

Page
1
of
9
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ropinirole 5mg Film-Coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 5.7mg ropinirole hydrochloride,
equivalent to 5mg ropinirole.
Excipient(s) with known effect
Lactose monohydrate – 113.2mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Blue, irregular hexagonal shape film-coated tablets, debossed with
‘W’ on one side and ‘177’ on the other
side.
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 ADMINISTRATION
Posology
Adults
Individual dose titration against efficacy and tolerability is
recommended.
Ropinirole 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
one week.
Thereafter, the dose of ropinirole can be increased in 0.25mg 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
Page
2
of
9
_THERAPEUTIC REGIMEN_
: After the initial titration, weekly increments of 0.5 to 1mg three
times daily (1.5 to
3mg/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 24mg/day.
_ _
Doses of ropinirole
_ _
above 24 mg/day have not been studied.
If treatment i