Nchi: Uswidi
Lugha: Kiswidi
Chanzo: Läkemedelsverket (Medical Products Agency)
entakapon; karbidopa (monohydrat); levodopa
Accord Healthcare B.V.
N04BA03
entacapone; carbidopa (monohydrate); levodopa
100 mg/25 mg/200 mg
Filmdragerad tablett
levodopa 100 mg Aktiv substans; entakapon 200 mg Aktiv substans; karbidopa (monohydrat) 27 mg Aktiv substans
Receptbelagt
Förpacknings: Burk, 30 tabletter; Burk, 130 tabletter; Burk, 100 tabletter
Avregistrerad
2016-03-31
PACKAGE LEAFLET: INFORMATION FOR THE USER Levodopa/Carbidopa/Entacapone Accord 50 mg/12.5 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Accord 75 mg/18.75 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Accord 100 mg/25 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Accord 125 mg/31.25 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Accord 150 mg/37.5 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Accord 200 mg/50 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. Whatis and what it is used for 2. What you need to know before you take Soma hati kamili3. How to take 4. Possible side effects 5. How to store 6. Contents of the pack and other information 1. WHAT IS AND WHAT IT IS USED FOR contains three active substances (levodopa, carbidopa and entacapone) in one film-coated tablet. 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 DO NOT TAKE IF YOU - are allergic to levodopa, carbidopa or entacapone, or any of the other ingredients of this medicine (listed
Module 1 Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Levodopa/Carbidopa/Entacapone Accord 50 mg/12.5 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Accord 75 mg/18.75 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Accord 100 mg/25 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Accord 125 mg/31.25 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Accord 150 mg/37.5 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Accord 200 mg/50 mg/200 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg of levodopa, 12.5 mg of carbidopa and 200 mg of entacapone. Each film-coated tablet contains 75 mg of levodopa, 18.75 mg of carbidopa and 200 mg of entacapone. Each film-coated tablet contains 100 mg of levodopa, 25 mg of carbidopa and 200 mg of entacapone. Each film-coated tablet contains 125 mg of levodopa, 31.25 mg of carbidopa and 200 mg of entacapone. Each film-coated tablet contains 150 mg of levodopa, 37.5 mg of carbidopa and 200 mg of entacapone. Each film-coated tablet contains 200 mg of levodopa, 50 mg of carbidopa and 200 mg of entacapone. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet 50 mg/12.5 mg/200 mg: Light brown to grayish red colored, round, approximately 11.3 mm in diameter, biconvex, film-coated tablets with debossed “50” on one side and plain on other side. 75 mg/18.75 mg/200 mg: Light brown to light pink colored, oval shaped, approximately 15.2 mm in length and 7.2 mm in width, film-coated tablets with debossed “75” on one side and plain on other side. 100 mg/25 mg/200 mg: Light brown to grayish red colored, oval shaped, approximately 16.7 mm in length and 7.7 mm in width, film-coated tablets with debossed “100” on one side and plain on other side. 125 mg/31.25 mg/200 mg: Light brown to light pink colored, elongated-ellipse shaped, approximately 15.2 mm in length and 9.7 mm in width, film-coated tablets Soma hati kamili