Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
LEVODOPA, CARBIDOPA, ENTACAPONE
Teva Pharma B.V.
N04BA03
LEVODOPA, CARBIDOPA, ENTACAPONE
50/12.5/200 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Dopa and dopa derivatives Dopa and dopa derivatives
Authorised
2014-11-03
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LEVODOPA/CARBIDOPA/ENTACAPONE TEVA 50 MG/12.5 MG/200 MG FILM-COATED TABLETS LEVODOPA/CARBIDOPA/ENTACAPONE TEVA 75 MG/18.75 MG/200 MG FILM-COATED TABLETS LEVODOPA/CARBIDOPA/ENTACAPONE TEVA 100 MG/25 MG/200 MG FILM-COATED TABLETS LEVODOPA/CARBIDOPA/ENTACAPONE TEVA 125 MG/31.25 MG/200 MG FILM-COATED TABLETS LEVODOPA/CARBIDOPA/ENTACAPONE TEVA 150 MG/37.5 MG/200 MG FILM-COATED TABLETS LEVODOPA/CARBIDOPA/ENTACAPONE TEVA 175 MG/43.75 MG/200 MG FILM-COATED TABLETS LEVODOPA/CARBIDOPA/ENTACAPONE TEVA 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 Teva is and what it is used for 2. What you need to know before you take Levodopa/Carbidopa/Entacapone Teva 3. How to take Levodopa/Carbidopa/Entacapone Teva 4. Possible side effects 5. How to store Levodopa/Carbidopa/Entacapone Teva 6. Contents of the pack and other information 1. WHAT LEVODOPA/CARBIDOPA/ENTACAPONE TEVA IS AND WHAT IT IS USED FOR Levodopa/Carbidopa/Entacapone Teva contains three active substances (levodopa, carbidopa and entacapone) in one film-coated tablet. Levodopa/Carbidopa/Entacapone Teva is used for the treatment of Parkinson’s disease. Parkinson’s disease is caused by low levels of a Прочитать полный документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Levodopa/Carbidopa/Entacapone Teva 50 mg/ 12.5 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. Excipient with known effect: Each film-coated tablet contains 80 mg of lactose anhydrous. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Round, biconvex, light brown tablet, marked with “50” on one side, plain on the other. Dimension: approx. 14 mm diameter. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Levodopa/Carbidopa/Entacapone Teva 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 Teva 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 Teva 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/37.5 mg/200 mg. Ten tablets of Levodopa/Carbidopa/Entacapone Teva 150 mg/37.5 mg/200 mg equals 375 mg of carbidopa a day. According to this daily carbidopa dose, the maximum reco Прочитать полный документ