Adartrel 250microgram tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ropinirole hydrochloride

Available from:

GlaxoSmithKline UK Ltd

ATC code:

N04BC04

INN (International Name):

Ropinirole hydrochloride

Dosage:

250microgram

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04090100; GTIN: 5000123111923

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ADARTREL 0.25 MG, 0.5 MG, 2 MG
FILM-COATED TABLETS
ROPINIROLE (AS HYDROCHLORIDE)
_ _
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ADARTREL
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 and other limbs.
2
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ADARTREL
DO NOT TAKE A

Summary of Product characteristics

OBJECT 1
ADARTREL 0.25 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 10-Nov-2017 |
GlaxoSmithKline UK
1. Name of the medicinal product
ADARTREL 0.25, 0.5 or 2.0 mg film-coated tablets.
2. Qualitative and quantitative composition
Each film-coated tablet contains 0.25 / 0.5 / 2.0 mg of ropinirole (as
hydrochloride).
Excipient: 45.3 / 45.0 / 44.6mg lactose (as monohydrate)
Excipient(s) with known effect:
Contains Lactose monohydrate
Forthe 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.
2.0 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.
_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