Adartrel 2.0mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ROPINIROLE

Available from:

GlaxoSmithKline Consumer Health-care UK Trading Limited 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

ATC code:

N04BC04

INN (International Name):

ROPINIROLE 2 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

ROPINIROLE 2 mg

Prescription type:

POM

Therapeutic area:

ANTI-PARKINSON DRUGS

Authorization status:

Withdrawn

Authorization date:

2006-07-27

Patient Information leaflet

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
ADARTREL
® (LOGO) 0.25 MG, 0.5 MG, 2 MG
FILM-COATED TABLETS
ROPINIROLE (AS HYDROCHLORIDE)
_(banner heading at right angles to rest of leaflet) _
------------------------------------------------------------------------------------------------------------------------
--------
ADARTREL
®
(LOGO)
FILM-COATED TABLETS
ROPINIROLE
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. 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 OF THE 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 ADARTREL IS AND WHAT IT IS USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ADARTREL
3
HOW TO TAKE ADARTREL
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE ADARTREL
6
CONTENTS OF THE PACK AND OTHER INFORMATION
1
WHAT ADARTREL IS AND WHAT IT IS USED FOR
The active ingredient in Adartrel is ropinirole, which belongs to a
group of medicines called
DOPAMINE AGONISTS. Dopamine agonists act in a similar way to a natural
substance called
dopamine, in the brain.
ADARTREL IS USED TO TREAT THE SYMPTOMS OF MODERATE TO SEVERE RESTLESS
LEGS SYNDROME.
Restless legs syndrome (RLS) is also called Ekbom syndrome. People
with restless legs syndrome
have an irresistible urge to move their legs, and sometimes their arms
and other parts of their
bodies. 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
sleeping.
Adartrel relieves the unpleasant sensations, and so reduces the urge
to move the legs an

Summary of Product characteristics

Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
ADARTREL 0.25 mg film-coated tablets.
ADARTREL 0.5 mg film-coated tablets.
ADARTREL 2 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 0.25 mg of ropinirole (as
hydrochloride).
Excipient: 45.3 mg lactose (as monohydrate)
Each film-coated tablet contains 0.5 mg of ropinirole (as
hydrochloride).
Excipient: 45.0 mg lactose (as monohydrate)
Each film-coated tablet contains 2 mg of ropinirole (as
hydrochloride).
Excipient: 44.6 mg lactose (as monohydrate)
Excipient(s) with known effect
Contains Lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
0.25 mg :
White pentagonal-shaped, bevelled edge tablets, marked "SB" on one
side and
"4890" on the other.
0.5 mg :
Yellow pentagonal-shaped, bevelled edge tablets, marked "SB" on one
side and
"4891" on the other.
2 mg :
Pink pentagonal-shaped, bevelled edge tablets, marked "SB" on one side
and "4893"
on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ADARTREL 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.
Page 2 of 12
_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