Ropinirole 250microgram tablets

País: Reino Unido

Idioma: inglés

Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes activos:

Ropinirole hydrochloride

Disponible desde:

Actavis UK Ltd

Código ATC:

N04BC04

Designación común internacional (DCI):

Ropinirole hydrochloride

Dosis:

250microgram

formulario farmacéutico:

Oral tablet

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 04090100; GTIN: 5012617018465

Información para el usuario

T00075-01 Malta Zejtun 190x380 PIL
Ropinirole All strengths Tablets PIL UK
item no:
print proof no:
origination date:
originated by:
revision date:
revised by:
dimensions:
pharmacode:
colours/plates:
approved for print/date
Non Printing Colours
1.
2.
3.
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6.
1.
2.
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date sent:
supplier:
approved:
min pt size:
TECHNICAL APPROVAL
black
AAAI1561
3
22.7.15
db
28.7.15
db
Malta Zejtun
190 x 380
8 pt
n/a
n/a
* Please note that only Actavis Global Artwork Studios are permitted
to make changes to the above
artwork. No changes are permitted by any 3rd party other than added
notes and mark ups for
required changes.
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, 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 possible side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET
1. What Ropinirole Film-coated Tablets are and what they are used for
2. What you need to know before you take Ropinirole Film-coated
Tablets
3. How to take Ropinirole Film-coated Tablets
4. Possible side effects
5. How to store Ropinirole Film-coated Tablets
6. Contents of the pack and other information
1. WHAT ROPINIROLE FILM-COATED TABLETS ARE AND WHAT THEY ARE USED
FOR
Ropinirole belongs to a group of medicines called dopamine agonists.
Dopamine agonists act like a naturally occurring chemical in your
brain
called dopamine.
Ropinirole Film-coated Tablets are used to treat the symptoms of
moderate to severe idiopathic Restless Legs Syndrome.
Moderate to severe Restless Legs Syndrome is typically represented by
patients who have difficulty sleeping or severe discomfort in their
legs
or arms. It is a condition characterised by an irresistible urge to
move t

Ficha técnica

OBJECT 1
ROPINIROLE 0.25 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 06-Nov-2015 | Accord-UK Ltd
1. Name of the medicinal product
Ropinirole 0.25 mg Film-Coated Tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains ropinirole hydrochloride equivalent
to 0.25 mg ropinirole base.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Ropinirole 0.25 mg Film-Coated Tablets are white, round (7mm in
diameter), biconvex, and embossed
with R0.25 on one side.
4. Clinical particulars
4.1 Therapeutic indications
Ropinirole is indicated for the symptomatic treatment of moderate to
severe idiopathic Restless Legs
Syndrome (see Section 5.1).
4.2 Posology and method of administration
Oral use.
Adults
Individual dose titration against efficacy and tolerability is
recommended.
Ropinirole should be taken just before bedtime, however the dose can
be taken up to 3 hours before
retiring. Ropinirole may be taken with food, to improve
gastrointestinal tolerance.
_Treatment initiation (week 1)_
The recommended initial dose is 0.25 mg once daily (administered as
above) for 2 days. If this dose is
well tolerated the dose should be increased to 0.5 mg once daily for
the remainder of week 1.
_Therapeutic regimen (week 2 onwards)_
Following treatment initiation, the daily dose should be increased
until optimal therapeutic response is
achieved. The average dose in clinical trials, in patients with
moderate to severe Restless Legs Syndrome,
was 2.0 mg once a day.
The dose may be increased to 1.0 mg once a day at week 2. The dose may
then be increased by 0.5 mg
per week over the next two weeks to a dose of 2.0 mg once a day. In
some patients, to achieve optimal
improvement, the dose may be increased gradually up to a maximum of
4.0 mg once a day. In clinical
trials the dose was increased by 0.5 mg each week to 3.0 mg once a day
and then by 1.0 mg up to the
maximum recommended dose of 4.0 mg once a day as shown in Table 1.
Doses above 4.0 mg once daily ha