Ropinir 4mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ROPINIROLE

Available from:

Actavis Group PTC ehf

ATC code:

N04BC04

INN (International Name):

ROPINIROLE

Pharmaceutical form:

COATED TABLET

Composition:

ROPINIROLE 4 mg

Prescription type:

POM

Therapeutic area:

ANTI-PARKINSON DRUGS

Authorization status:

Authorised

Authorization date:

2009-05-04

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ROPINIR 0.25 MG FILM-COATED TABLETS
ROPINIR 0.5 MG FILM-COATED TABLETS
ROPINIR 1 MG FILM-COATED TABLETS
ROPINIR 2 MG FILM-COATED TABLETS
ROPINIR 3 MG FILM-COATED TABLETS
ROPINIR 4 MG FILM-COATED TABLETS
ROPINIR 5 MG FILM-COATED TABLETS
Ropinirole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
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. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ropinir is and what it is used for
2.
What you need to know before you take Ropinir
3.
How to take Ropinir
4.
Possible side effects
5.
How to store Ropinir
6.
Contents of the pack and other information
1.
WHAT ROPINIR IS AND WHAT IT IS USED FOR
/.../ belongs to a group of medicines called dopamine agonists.
Dopamine agonists act like a naturally
occurring chemical in your brain called dopamine.
Ropinir is used to treat Parkinson’s disease. The cause of
Parkinson’s disease is a lack of the substance
dopamine in the brain. Ropinir may be used alone or in combination
with other medicines against
Parkinson’s disease, to achieve a more effective treatment.
/.../ in 0.25, 0.5, 1, 2, 3 and 4 mg strengths is also used to treat
the symptoms of moderate to severe
idiopathic Restless Legs Syndrome, a condition characterised by an
irresistible urge to move the legs
and occasionally the arms, usually accompanied by uncomfortable
sensations such as tingling, burning
or prickling. These feelings occur during periods of rest or
inactivity such as sitting or lying down,
especially in bed, and are worse in the evening or at night. Usually
the only relief is obtained by
walking about or moving the affected limbs, which often

Summary of Product characteristics

Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ropinir 0.25 mg film-coated tablets
Ropinir 0.5 mg film-coated tablets
Ropinir 1 mg film-coated tablets
Ropinir 2 mg film-coated tablets
Ropinir 3 mg film-coated tablets
Ropinir 4 mg film-coated tablets
Ropinir 5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4
mg or 5 mg ropinirole (as
hydrochloride).
Excipient with known effect:
Ropinir 0.25 mg film-coated tablet contains 88.615 mg lactose (as
lactose monohydrate).
Ropinir 0.5 mg film-coated tablet contains 88.344 mg lactose (as
lactose monohydrate).
Ropinir 1 mg film-coated tablet contains 87.803 mg lactose (as lactose
monohydrate).
Ropinir 2 mg film-coated tablet contains 86.720 mg lactose (as lactose
monohydrate).
Ropinir 3 mg film-coated tablet contains 130.080 mg lactose (as
lactose monohydrate).
Ropinir 4 mg film-coated tablet contains 173.440 mg lactose (as
lactose monohydrate).
Ropinir 5 mg film-coated tablet contains 216.800 mg lactose (as
lactose monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Ropinir 0.25 mg film-coated tablet is round (7 mm in diameter), white
and biconvex embossed with R0.25 on
one side.
Ropinir 0.5 mg film-coated tablet is round (7 mm in diameter), yellow
and biconvex embossed with R0.5 on
one side.
Ropinir 1 mg film-coated tablet is round (7 mm in diameter), green and
biconvex embossed with R1 on one
side.
Ropinir 2 mg film-coated tablet is round (7 mm in diameter), pink and
biconvex embossed with R2 on one side.
Ropinir 3 mg film-coated tablet is round (8.5 mm in diameter), purple
and biconvex embossed with R3 on one
side.
Ropinir 4 mg film-coated tablet is round (9.5 mm in diameter), orange
and biconvex embossed with R4 on one
side.
Ropinir 5 mg film-coated tablet is round (10.5 mm in diameter), blue
and biconvex embossed with R5 on one
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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