Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ROPINIROLE HYDROCHLORIDE
Glenmark Pharmaceuticals Europe Limited
ROPINIROLE HYDROCHLORIDE
0.5 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Withdrawn
2014-01-17
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 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. WHAT IS IN THIS LEAFLET: 1. What Ropinirole Glenmark is and what it is used for 2. What you need to know before you take Ropinirole Glenmark 3. How to take Ropinirole Glenmark 4. Possible side effects 5. How to store Ropinirole Glenmark 6. Contents of the pack and other information 1. WHAT ROPINIROLE GLENMARK IS AND WHAT IT IS USED FOR ROPINIROLE GLENMARK belongs to a group of medicines called dopamine agonists. Dopamine agonists act like a naturally occurring chemical in your brain called dopamine. Ropinirole Glenmark is used to treat Parkinson’s disease. The cause of Parkinson’s disease is a lack of the substance dopamine in the brain. Ropinirole Glenmark may be used alone or in combination with other medicines against Parkinson’s disease to achieve a more effective treatment. Ropinirole Glenmark is also used to treat the symptoms of moderate to severe idiopathic Restless Legs Syndrome (RLS), 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 occurs during Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ropinirole Glenmark 0.5mg film coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains ropinirole hydrochloride equivalent to 0.25 / 0.5 / 1.0/2.0 mg of ropinirole. Ropinirole Glenmark 0.5 mg film-coated tablets: Each film-coated tablet contains ropinirole hydrochloride equivalent to 0.5 mg of ropinirole Excipient: 72.68 mg lactose (as lactose monohydrate and lactose anhydrous) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. 0.50 mg Pale Yellow to Yellow, circular, bevelled edged, biconvex film coated tablets with ‘254’ debossed on one side and ‘G’ on the other side. 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) Or 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. Parkinson’s Disease: Adults Individual dose titration against efficacy and tolerability is recommended. Ropinirole Glenmark 0.25, 0.5, 1.0 and 2.0 mg film-coated 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: IRISH MEDICINES B Read the complete document