ADARTREL 2.0 Milligram Film Coated Tablet
Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Vara einkenni
(SPC)
24-04-2024
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Virkt innihaldsefni:
ROPINIROLE HYDROCHLORIDE
Fáanlegur frá:
GlaxoSmithKline (Ireland) Limited
INN (Alþjóðlegt nafn):
ROPINIROLE HYDROCHLORIDE
Skammtar:
2.0 Milligram
Lyfjaform:
Film Coated Tablet
Gerð lyfseðils:
Product subject to prescription which may be renewed (B)
Leyfisstaða:
Withdrawn
Leyfisdagur:
2010-12-09
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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
ADARTREL 2mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2 mg of ropinirole (as hydrochloride).
Excipient: 44.6mg lactose (as monohydrate)
Excipient(s):
Contains Lactose monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
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.
_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 the dose
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