ADARTREL 0.50 Milligram Film Coated Tablet
Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Résumé des caractéristiques du produit
(SPC)
16-04-2024
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Ingrédients actifs:
ROPINIROLE HYDROCHLORIDE
Disponible depuis:
GlaxoSmithKline (Ireland) Limited
DCI (Dénomination commune internationale):
ROPINIROLE HYDROCHLORIDE
Dosage:
0.50 Milligram
forme pharmaceutique:
Film Coated Tablet
Type d'ordonnance:
Product subject to prescription which may be renewed (B)
Statut de autorisation:
Withdrawn
Date de l'autorisation:
2010-12-09
Résumé des caractéristiques du produit
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
ADARTREL 0.5mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 0.5 mg of ropinirole (as hydrochloride).
Excipient: 45.0 mg lactose (as monohydrate)
Excipient(s):
Contains Lactose monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Yellow pentagonal-shaped, bevelled edge tablets marked "SB" on one side and "4891" 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.
_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 mg once a day.
The dose may be increased to 1 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 mg once a day. In some patients, to achieve optimal improvement, the dose may be
increased gradually up to a maximum of 4 mg once a day. In clinical trials t
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