מדינה: מלטה
שפה: אנגלית
מקור: Medicines Authority
ROPINIROLE
Lambda Therapeutics Limited Sage House, 319, Pinner Road, North Harrow, Middlesex HA1 4HF, United Kingdom
N04BC04
ROPINIROLE 2 mg
FILM-COATED TABLET
ROPINIROLE 2 mg
POM
ANTI-PARKINSON DRUGS
Withdrawn
2012-06-14
PACKAGE LEAFLET: INFORMATION FOR THE USER ROPINIROLE LAMBDA 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, please 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 symptoms are the same as yours. − If any of the side effects get serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What is Ropinirole Lambda Therapeutics 2 mg and what it is used for 2. Before you take Ropinirole Lambda Therapeutics 2 mg 3. How to take Ropinirole Lambda Therapeutics 2 mg 4. Possible side effects 5. How to store Ropinirole Lambda Therapeutics 2 mg 6. Further information 1. WHAT IS ROPINIROLE LAMBDA THERAPEUTICS 2 MG AND WHAT IT IS USED FOR The active substance in Ropinirole Lambda Therapeutics 2 mg is ropinirole which belongs to a group of medicines called dopamine agonists. Dopamine agonists affect the brain in a similar way to a natural substance dopamine. Ropinirole Lambda Therapeutics 2 mg is used to treat Parkinson's disease. People with Parkinson's disease have low concentrations of dopamine in some parts of their brains. Ropinirole has similar effects to those of natural dopamine, so it helps to reduce the symptoms of Parkinson’s disease. Ropinirole Lambda Therapeutics 2 mg is used to treat the symptoms of moderate to severe Restless Legs Syndrome. Patients with moderate to severe Restless Legs Syndrome generally complain of trouble sleeping or severe discomfort in the legs or arms. Patients with Restless Legs Syndrome have an irresistible urge to move their legs, and sometimes their arms and other parts of their body. They usually have an uncomfortable feeling in the legs (sometimes descri קרא את המסמך השלם
Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ropinirole Lambda 2mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 2 mg Ropinirole (as hydrochloride). Excipient (s): Each 2 mg film-coated tablet contains 46.72 mg lactose monohydrate. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Round biconvex, plain on both sides, pink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of Parkinson’s disease under the following conditions: • Initial treatment as monotherapy, in order to delay the introduction of levodopa. • In combination with levodopa, over the course of the disease, when the effect of levodopa wears off or becomes inconsistent and fluctuations in the therapeutic effect occur ("end of dose" or "on-off" type fluctuations). Symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral use. PARKINSON’S DISEASE Adults Individual dose titration against efficacy and tolerability is recommended. Ropinirole tablets should be taken three times a day, preferably with meals to improve gastrointestinal tolerance. _Treatment initiation _ The initial dose of ropinirole should be 0.25 mg three times daily for 1 week. Thereafter, the dose of ropinirole can be increased in 0.25 mg three times daily increments, according to the following regimen: Page 2 of 12 Week 1 2 3 קרא את המסמך השלם