Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
levodopa, carbidopa, entacapone
Orion Corporation
N04BA03
levodopa, carbidopa, entacapone
Nervous system
Parkinson Disease
Levodopa/Carbidopa/Entacapone Orion 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: 13
Authorised
2011-08-23
41 B. PACKAGE LEAFLET 42 PACKAGE LEAFLET: INFORMATION FOR THE USER LEVODOPA/CARBIDOPA/ENTACAPONE ORION 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 Levodopa/Carbidopa/Entacapone Orion is and what it is used for 2. What you need to know before you take Levodopa/Carbidopa/Entacapone Orion 3. How to take Levodopa/Carbidopa/Entacapone Orion 4. Possible side effects 5. How to store Levodopa/Carbidopa/Entacapone Orion 6. Contents of the pack and other information 1. WHAT LEVODOPA/CARBIDOPA/ENTACAPONE ORION IS AND WHAT IT IS USED FOR Levodopa/Carbidopa/Entacapone Orion contains three active substances (levodopa, carbidopa and entacapone) in one film-coated tablet. Levodopa/Carbidopa/Entacapone Orion 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 LEVODOPA/CARBIDOPA/ENTACAPONE ORION DO NOT TAKE LEVODOPA/CARBIDOPA/ENTACAPONE ORION 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 Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Levodopa/Carbidopa/Entacapone Orion 50 mg/12.5 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 75 mg/18.75 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 100 mg/25 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 125 mg/31.25 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 150 mg/37.5 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 175 mg/43.75 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Orion 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-c Pročitajte cijeli dokument