País: Suécia
Língua: sueco
Origem: Läkemedelsverket (Medical Products Agency)
entakapon; karbidopa (vattenfri); levodopa
Mylan AB
N04BA03
entacapone; carbidopa (anhydrous); levodopa
150 mg/37,5 mg/200 mg
Filmdragerad tablett
karbidopa (vattenfri) 37,5 mg Aktiv substans; entakapon 200 mg Aktiv substans; levodopa 150 mg Aktiv substans
Receptbelagt
Förpacknings: Blister, 30 tabletter (Al); Blister, 100 tabletter (Al); Blister, 30 tabletter (plast/Al); Blister, 100 tabletter (plast/Al); Burk, 30 tabletter; Burk, 175 tabletter; Burk, 100 tabletter
Avregistrerad
2017-02-13
Page 1 of 10 PACKAGE LEAFLET Page 2 of 10 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LEVODOPA/CARBIDOPA/ENTACAPONE MYLAN50 MG/12.5 MG/200 MG FILM-COATED TABLETS LEVODOPA/CARBIDOPA/ENTACAPONE MYLAN 75 MG/18.75 MG/200 MG FILM-COATED TABLETS LEVODOPA/CARBIDOPA/ENTACAPONE MYLAN 100 MG/25 MG/200 MG FILM-COATED TABLETS LEVODOPA/CARBIDOPA/ENTACAPONE MYLAN 125 MG/31.25 MG/200 MG FILM-COATED TABLETS LEVODOPA/CARBIDOPA/ENTACAPONE MYLAN 150 MG/37.5 MG/200 MG FILM-COATED TABLETS LEVODOPA/CARBIDOPA/ENTACAPONE MYLAN 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. What Levodopa/Carbidopa/Entacapone Mylan is and what it is used for 2. What you need to know before you take Levodopa/Carbidopa/Entacapone Mylan 3. How to take Levodopa/Carbidopa/Entacapone Mylan 4. Possible side effects 5. How to store Levodopa/Carbidopa/Entacapone Mylan 6. Contents of the pack and other information 1. WHAT LEVODOPA/CARBIDOPA/ENTACAPONE MYLAN IS AND WHAT IT IS USED FOR Levodopa/Carbidopa/Entacapone Mylan contains three active substances (levodopa, carbidopa and entacapone) in one film-coated tablet. Levodopa/Carbidopa/Entacapone Mylan 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 Leia o documento completo
Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Levodopa/Carbidopa/Entacapone Mylan 50 mg/12.5 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Mylan 75 mg/18.75 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Mylan 100 mg/25 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Mylan 125 mg/31.25 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Mylan 150 mg/37.5 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Mylan 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 A grey-purple film-coated, round shaped, biconvex, bevelled edge tablet debossed with ‘M’ on one side of the tablet and ‘LCE1’ on the other side, approximately 10.7 mm in diameter. A brown-pink film-coated, round shaped, biconvex, bevelled edge tablet debossed with ‘M’ on one side of the tablet and ‘LCE2’ on the other side, approximately 11.1 mm in diameter. A grey-purple film-coated, round shaped, biconvex, bevelled edge tablet debossed with ‘M’ on one side of the tablet and ‘LCE3’ on the other side, approximately 11.5 mm in diameter. A brown-pink film-coated, round shaped, biconvex, bevelled edge tablet debossed with ‘M’ on one side of the tablet and ‘LCE4’ on the other side, approximately 11.9 mm in diameter. A grey-purple fil Leia o documento completo