Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Carbidopa; Levodopa
Merck Sharp & Dohme Ireland (Human Health) Limited
N04BA; N04BA02
Carbidopa; Levodopa
25 mg/100 milligram(s)
Prolonged-release tablet
Product subject to prescription which may be renewed (B)
Dopa and dopa derivatives; levodopa and decarboxylase inhibitor
Marketed
1993-02-22
1 PACKAGE LEAFLET: INFORMATION FOR THE USER SINEMET ® CR 50 MG/200 MG PROLONGED-RELEASE TABLETS HALF SINEMET ® CR 25 MG/100 MG PROLONGED-RELEASE TABLETS (Carbidopa/levodopa) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1 What Sinemet CR is and what it is used for 2 Before you take Sinemet CR 3 How to take Sinemet CR 4 Possible side effects 5 How to store Sinemet CR 6 Further information 1 WHAT SINEMET CR IS AND WHAT IT IS USED FOR Sinemet CR 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. Sinemet CR 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 BEFORE YOU TAKE SINEMET CR DO NOT TAKE SINEMET CR IF: you are allergic (hypersensitive) to carbidopa or levodopa or any of the other ingredients of Sinemet CR (listed in Section 6) you have ever had skin cancer or you have any unusual moles which have not been examined by your doctor you are taking certain medicines called ‘MAOIs’ (Monoamine Oxidase Inhibitors) used fo Read the complete document
Health Products Regulatory Authority 17 October 2019 CRN0092C6 Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Half Sinemet CR 25mg/100mg Prolonged-Release Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet of Half Sinemet CR contains carbidopa (equivalent to 25mg of anhydrous carbidopa) and 100mg levodopa. For a full list of excipients, _see section 6.1._ 3 PHARMACEUTICAL FORM Prolonged-release tablet. Pink-coloured, oval-shaped, biconvex, prolonged-release tablets, plain on one side and the other side marked ‘601’. The scoreline is not intended to facilitate breaking of the tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Antiparkinson agent. Idiopathic Parkinson's disease, in particular to reduce off-period in patients who previously have been treated with levodopa/decarboxylase inhibitors, or with levodopa alone and who have experienced motor fluctuations. The experience is limited with Sinemet CR and Half Sinemet CR in patients who have not been treated with levodopa before. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION To be taken orally. Sinemet CR and Half Sinemet CR tablets contain a 1:4 ratio of carbidopa to levodopa (Sinemet CR: carbidopa 50 mg/levodopa 200 mg, Half Sinemet CR 25 mg/100 mg per tablet). The daily dosage of Sinemet CR must be determined by careful titration. Patients should be monitored closely during the dose adjustment period, particularly with regard to appearance or worsening of nausea or abnormal involuntary movements, including dyskinesias, chorea and dystonia. Sinemet CR and Half Sinemet CR may only be administered as whole tablets. So that the controlled release properties of the product can be maintained, tablets should not be chewed, crushed, or halved. Standard antiparkinson drugs, other than levodopa alone, may be continued while Sinemet CR or Half Sinemet CR are being administered, although their dosage may have to be adjusted. Since carbidopa prevents the reversal of levodopa effects caused pyridoxine, Sinemet CR or Half Read the complete document