Ropinirole 2mg Film-Coated Tablets

País: Malta

Idioma: anglès

Font: Medicines Authority

ingredients actius:

ROPINIROLE

Disponible des:

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

Codi ATC:

N04BC04

Designació comuna internacional (DCI):

ROPINIROLE 2 mg

formulario farmacéutico:

FILM-COATED TABLET

Composición:

ROPINIROLE 2 mg

tipo de receta:

POM

Área terapéutica:

ANTI-PARKINSON DRUGS

Estat d'Autorització:

Withdrawn

Data d'autorització:

2011-02-21

Informació per a l'usuari

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

Fitxa tècnica

Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ropinirole 2mg Film-Coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 2.28mg ropinirole hydrochloride,
equivalent to 2mg ropinirole.
Excipient(s) with known effect
Lactose monohydrate – 116.6mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Pale yellowish pink, irregular hexagonal shape film-coated tablets,
debossed with ‘W’ on one side
and ‘172’ 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).
Ropinirole is also indicated for the symptomatic treatment of moderate
to severe idiopathic Restless
Legs Syndrome (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
TREATMENT OF IDIOPATHIC PARKINSON’S DISEASE
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.
Page
2
of
13
_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
_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, o