国家: 马耳他
语言: 英文
来源: Medicines Authority
ROPINIROLE
Day Zero ehf Reykjavikurvegur 62, 220, Hafnarfjordur, Iceland
N04BC04
ROPINIROLE 4 mg
FILM-COATED TABLET
ROPINIROLE 4 mg
POM
ANTI-PARKINSON DRUGS
Withdrawn
2009-05-04
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 Ropinir 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. Ropinir 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 o 阅读完整的文件
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 Page 2 of 阅读完整的文件