Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Carbidopa monohydrate; Levodopa
Organon Pharma (UK) Ltd
N04BA02
Carbidopa monohydrate; Levodopa
10mg ; 100mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04090100; GTIN: 5013945002126 5013945300475
PACKAGE LEAFLET: INFORMATION FOR THE USER SINEMET ® 10 MG/100 MG TABLETS SINEMET ® PLUS 25 MG/100 MG TABLETS SINEMET ® 25 MG/250 MG 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 is and what it is used for 2 Before you take Sinemet 3 How to take Sinemet 4 Possible side effects 5 How to store Sinemet 6 Further information 1 WHAT SINEMET IS AND WHAT IT IS USED FOR Sinemet 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 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 DO NOT TAKE SINEMET IF: • you are allergic (hypersensitive) to carbidopa or levodopa or any of the other ingredients of Sinemet (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 for depression. You need to stop using these Read the complete document
OBJECT 1 SINEMET 12.5MG/50MG TABLETS Summary of Product Characteristics Updated 25-Oct-2017 | Merck Sharp & Dohme Limited 1. Name of the medicinal product SINEMET ® 12.5 mg/50 mg Tablets SINEMET ® 10 mg/100 mg Tablets SINEMET ® Plus 25 mg/100 mg Tablets SINEMET ® 25 mg/250 mg Tablets 2. Qualitative and quantitative composition Each tablet of 'Sinemet 12.5 mg/50 mg Tablets' contains 13.5 mg carbidopa (equivalent to 12.5 mg of anhydrous carbidopa) and 50 mg levodopa. Each tablet of 'Sinemet 10 mg/100 mg Tablets' contains 10.8 mg carbidopa (equivalent to 10 mg of anhydrous carbidopa) and 100 mg levodopa. Each tablet of 'Sinemet Plus 25 mg/100 mg Tablets' contains 27.0 mg carbidopa (equivalent to 25 mg of anhydrous carbidopa) and 100 mg levodopa. Each tablet of 'Sinemet 25 mg/250 mg Tablets' contains 27.0 mg carbidopa (equivalent to 25 mg of anhydrous carbidopa) and 250 mg levodopa. 3. Pharmaceutical form Tablets. 'Sinemet 12.5 mg/50 mg Tablets': yellow, oval-shaped tablets, one side scored and the other marked '520'. 'Sinemet 10 mg/100 mg Tablets': light dapple blue, round tablets, with '647' on one side and plain on the other. 'Sinemet Plus 25 mg/100 mg Tablets ': yellow, round tablets with '650 on one side and plain on the other.' 'Sinemet 25 mg/250 mg Tablets ': light dapple blue, round tablets,with '654' on one side and plain on the other. For excipients see 6.1. 4. Clinical particulars 4.1 Therapeutic indications Antiparkinsonian agent. For treatment of Parkinson's disease and syndrome. 4.2 Posology and method of administration To be taken orally. The optimum daily dosage of 'Sinemet' must be determined by careful titration in each patient. 'Sinemet' Tablets are available in a ratio of 1:4 or 1:10 of carbidopa to levodopa to provide facility for fine dosage titration for each patient. GENERAL CONSIDERATIONS Studies show that the peripheral dopa-decarboxylase is fully inhibited (saturated) by carbidopa at doses between 70 and 100 mg a day. Patients receiving less than this amount of carbidopa are more likely Read the complete document