Страна: Малта
Език: английски
Източник: Medicines Authority
LEVODOPA, CARBIDOPA
FAIR-MED HEALTHCARE GmbH Planckstr. 13, 22765 Hamburg, Germany
N04BA02
LEVODOPA 27 mg CARBIDOPA 250 mg
TABLET
LEVODOPA 27 mg CARBIDOPA 250 mg
POM
ANTI-PARKINSON DRUGS
Withdrawn
2016-02-18
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER CARBIDOPA/LEVODOPA FAIR-MED 12.5 MG/50 MG TABLETS CARBIDOPA/LEVODOPA FAIR-MED 10 MG/100 MG TABLETS CARBIDOPA/LEVODOPA FAIR-MED 25 MG/100 MG TABLETS CARBIDOPA/LEVODOPA FAIR-MED 25 MG/250 MG TABLETS CARBIDOPA/LEVODOPA 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 Carbidopa/Levodopa Fair-Med is and what it is used for 2. What you need to know before you take Carbidopa/Levodopa Fair-Med 3. How to take Carbidopa/Levodopa Fair-Med 4. Possible side effects 5. How to store Carbidopa/Levodopa Fair-Med 6. Contents of the pack and other information 1. WHAT CARBIDOPA/LEVODOPA FAIR-MED IS AND WHAT IT IS USED FOR Carbidopa/Levodopa Fair-Med improves the signs of Parkinson’s disease. Parkinson's disease is a long- term illness where: • you become slow and unsteady • your muscles feel stiff • you may develop shaking or trembling (called ‘tremor’). If not treated, Parkinson's disease can make it hard for you to continue your normal daily activities. Carbidopa/Levodopa Fair-Med contains two different medicines called: levodopa and carbidopa. • levodopa turns into a material called ‘dopamine’ in your brain. The dopamine helps to improve the signs of your Parkinson’s disease. • carbidopa belongs to a group of medicines called ‘aromatic amino acid decarboxylase inhibitors’. It helps levodopa work more effectively by slowing the speed at which levodopa is broken down in your body. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARBIDOPA/LEVOD Прочетете целия документ
Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Carbidopa/Levodopa Fair-Med 12.5 mg/50 mg tablets Carbidopa/Levodopa Fair-Med 10 mg/100 mg tablets Carbidopa/Levodopa Fair-Med 25 mg/100 mg tablets Carbidopa/Levodopa Fair-Med 25 mg/250 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet of Carbidopa/Levodopa Fair-Med contains 13.5 mg carbidopa monohydrate (equivalent to 12.5 mg of anhydrous carbidopa) and 50 mg levodopa. Each tablet of Carbidopa/Levodopa Fair-Med contains 10.8 mg carbidopa monohydrate (equivalent to 10 mg of anhydrous carbidopa) and 100 mg levodopa. Each tablet of Carbidopa/Levodopa Fair-Med contains 27.0 mg carbidopa monohydrate (equivalent to 25 mg of anhydrous carbidopa) and 100 mg levodopa. Each tablet of Carbidopa/Levodopa Fair-Med contains 27.0 mg carbidopa monohydrate (equivalent to 25 mg of anhydrous carbidopa) and 250 mg levodopa. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Carbidopa/Levodopa Fair-Med 12.5 mg/50 mg tablets are light yellow colored, oval shaped, with dimensions of 9.65 mm x 5.00 mm, with “C” on one side and “17” on other side of tablet. Carbidopa/Levodopa Fair-Med 10 mg/100 mg tablets are light blue colored, round shaped, with a diameter of 8 mm, with “C” on one side and “18” on other side of tablet. Carbidopa/Levodopa Fair-Med 25 mg/100 mg tablets are light yellow colored, round shaped, with a diameter of 8 mm, with “C” on one side and “19” on other side of tablet. Carbidopa/Levodopa Fair-Med 25 mg/250 mg tablets are light blue colored, round shaped, with a diameter of 10.40 mm, with “C” on one side and “20” on other side of tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Antiparkinsonian agent. For treatment of Parkinson's disease and syndrome. Page 2 of 12 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The optimum daily dosage of carbidopa/levodopa must be determined by careful titration in each patient. Carbidopa/Levodopa Fair-Med are avai Прочетете целия документ