Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
levodopa, carbidopa, entacapone
Orion Corporation
N04BA03
levodopa, carbidopa, entacapone
Anti-Parkinson drugs
Parkinson Disease
Stalevo is indicated for the treatment of adult patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa / dopa-decarboxylase (DDC)-inhibitor treatment.
Revision: 29
Authorised
2003-10-17
41 B. PACKAGE LEAFLET 42 PACKAGE LEAFLET: INFORMATION FOR THE USER STALEVO 50 MG/12.5 MG/200 MG FILM-COATED TABLETS levodopa/carbidopa/entacapone 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. See section 4. WHAT IS IN THIS LEAFLET: 1. What Stalevo is and what it is used for 2. What you need to know before you take Stalevo 3. How to take Stalevo 4. Possible side effects 5. How to store Stalevo 6. Contents of the pack and other information 1. WHAT STALEVO IS AND WHAT IT IS USED FOR Stalevo contains three active substances (levodopa, carbidopa and entacapone) in one film-coated tablet. Stalevo is used for the treatment of Parkinson’s disease. Parkinson’s disease is caused by low levels of a substance called dopamine in the brain. Levodopa increases the amount of dopamine and hence reduces the symptoms of Parkinson’s disease. Carbidopa and entacapone improve the antiparkinson effects of levodopa. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE STALEVO DO NOT TAKE STALEVO IF YOU: - are allergic to levodopa, carbidopa or entacapone, or any of the other ingredients of this medicine (listed in section 6) - have narrow-angle glaucoma (an eye disorder) - have a tumour of the adrenal gland - are taking certain medicines for treating depression (combinations of selective MAO-A and MAO-B inhibitors, or non-selective MAO-inhibitors) - have ever had neuroleptic malignant syndrome (NMS – this is a rare reaction to medicines used to treat severe mental disorders) - have ever had non-traumatic rhabdomyolysis (a rare muscle disorder) - have a severe liver d Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Stalevo 50 mg/12.5 mg/200 mg film-coated tablets Stalevo 75 mg/18.75 mg/200 mg film-coated tablets Stalevo 100 mg/25 mg/200 mg film-coated tablets Stalevo 125 mg/31.25 mg/200 mg film-coated tablets Stalevo 150 mg/37.5 mg/200 mg film-coated tablets Stalevo 175 mg/43.75 mg/200 mg film-coated tablets Stalevo 200 mg/50 mg/200 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 50 mg/12.5 mg/200 mg Each tablet contains 50 mg of levodopa, 12.5 mg of carbidopa and 200 mg of entacapone. Excipient with known effect: Each tablet contains 1.2 mg of sucrose. 75 mg/18.75 mg/200 mg Each tablet contains 75 mg of levodopa, 18.75 mg of carbidopa and 200 mg of entacapone. Excipient with known effect: Each tablet contains 1.4 mg of sucrose. 100 mg/25 mg/200 mg Each tablet contains 100 mg of levodopa, 25 mg of carbidopa and 200 mg of entacapone. Excipient with known effect: Each tablet contains 1.6 mg of sucrose. 125 mg/31.25 mg/200 mg Each tablet contains 125 mg of levodopa, 31.25 mg of carbidopa and 200 mg of entacapone. Excipient with known effect: Each tablet contains 1.6 mg of sucrose. 150 mg/37.5 mg/200 mg Each tablet contains 150 mg of levodopa, 37.5 mg of carbidopa and 200 mg of entacapone. Excipients with known effect: Each tablet contains 1.9 mg of sucrose and 2.6 mg sodium as a constituent of an excipient. 175 mg/43.75 mg/200 mg Each tablet contains 175 mg of levodopa, 43.75 mg of carbidopa and 200 mg of entacapone. Excipient with known effect: Each tablet contains 1.89 mg of sucrose. 200 mg/50 mg/200 mg Each tablet contains 200 mg of levodopa, 50 mg of carbidopa and 200 mg of entacapone. Excipient with known effect: Each tablet contains 2.3 mg of sucrose. For the full list of excipients, see section 6.1. 3 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) 50 mg/12.5 mg/200 mg Brownish or greyish red, round, convex, unscored film-coated tablets marked with “LCE 50” on one side. 75 mg/18.75 mg/200 mg Light brownish red, oval Przeczytaj cały dokument