Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
LEVODOPA ; CARBIDOPA ; ENTACAPONE
Generics (UK) Limited
N04BA03
LEVODOPA ; CARBIDOPA ; ENTACAPONE
100/25/200 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
levodopa, decarboxylase inhibitor and COMT inhibitor
Not Marketed
2016-02-19
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 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 175 MG/43.75 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 Perskaitykite visą dokumentą
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Levodopa/Carbidopa/Entacapone Mylan 100mg/25mg/200mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 100 mg of levodopa, 25 mg of carbidopa anhydrous (as 27 mg carbidopa monohydrate) and 200 mg of entacapone. Excipient with known effect: Each film-coated tablet of 100 mg levodopa/25 mg of carbidopa anhydrous/200 mg entacapone contains 139 mg of lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet 100 mg levodopa/25 mg carbidopa anhydrous/200 mg entacapone: Brownish red coloured, oval shaped, biconvex film coated tablets debossed “100” on one side and plain on the other side. Size: 16.6 mm x 7.8 mm 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Levodopa/Carbidopa/Entacapone Mylan 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The optimum daily dose must be determined by careful titration of levodopa in each patient. The daily dose should be preferably optimised using one of the seven available tablet strengths (50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg 100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg 150 mg/37.5 mg/200 mg, 175 mg/43.75 mg/200 mg or 200 mg/50 mg/200 mg levodopa/carbidopa/entacapone). Patients should be instructed to take only one Levodopa/Carbidopa/Entacapone Mylan tablet per dose administration. Patients receiving less than 70-100 mg carbidopa a day are more likely to experience nausea and vomiting. While the experience with total daily dose greater than 200 mg carbidopa is limited, the maximum recommended daily dose of entacapone is 2,000 mg and therefore the maximum dose is 10 tablets per day for the Levodopa/Carbidopa/Entacapone Mylan strengths of 50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg 100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg and 150 mg/3 Perskaitykite visą dokumentą