Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
Levodopa; Carbidopa; Entacapone
Rowex Ltd
N04BA; N04BA03
Levodopa; Carbidopa; Entacapone
50mg/12.5mg/200 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Dopa and dopa derivatives; levodopa, decarboxylase inhibitor and COMT inhibitor
Not marketed
2016-01-29
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DAZONAY 50 MG/12.5 MG/200 MG FILM-COATED TABLETS DAZONAY 75 MG/18.75 MG/200 MG FILM-COATED TABLETS DAZONAY 100 MG/25MG/200 MG FILM-COATED TABLETS DAZONAY 125 MG/31.25 MG/200 MG FILM-COATED TABLETS DAZONAY 150 MG/37.5 MG/200 MG FILM-COATED TABLETS DAZONAY 175 MG/43.75 MG/200 MG FILM-COATED TABLETS DAZONAY 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 symptoms 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 Dazonay is and what it is used for 2. What you need to know before you take Dazonay 3. How to take Dazonay 4. Possible side effects 5. How to store Dazonay 6. Contents of the pack and other information 1. WHAT DAZONAY IS AND WHAT IT IS USED FOR Dazonay contains three active substances (levodopa, carbidopa and entacapone) in one film-coated tablet. Dazonay 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 anti-Parkinson effects of levodopa. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DAZONAY DO NOT TAKE DAZONAY 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 and Aqra d-dokument sħiħ
Health Products Regulatory Authority 01 July 2020 CRN009FVL Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dazonay 50mg/12.5mg/200mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg of levodopa, 12.5 mg of carbidopa anhydrous (as 13.5mg carbidopa monohydrate) and 200 mg of entacapone. Excipient with known effect Each film-coated tablet of 50 mg levodopa/12.5 mg carbidopa anhydrous/200 mg entacapone contains 112 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet _50 mg/12.5 mg/200 mg film-coated tablets:_ Brownish red coloured, round shaped, biconvex film coated tablets debossed "50" on one side and plain on the other side. Diameter: 11.1 mm 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dazonay 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 Dazonay 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 Dazonay 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 Dazonay 150 mg/37. Aqra d-dokument sħiħ