Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
carbidopa monohydrate,levodopa
Merck Sharp & Dohme (Australia) Pty Ltd
carbidopa monohydrate,Levodopa
Registered
SINEMET ® _Levodopa-Carbidopa_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about SINEMET. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking SINEMET against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT SINEMET IS USED FOR SINEMET is used to treat some of the symptoms of Parkinson's disease. This is a disease of the nervous system that mainly affects body movement. The three main symptoms are shaking (tremor), muscle stiffness and slow and unsteady movement. People with Parkinson's disease often walk with a shuffle as they have difficulty in initiating movement. If untreated, Parkinson's disease can cause difficulty in performing normal daily activities. SINEMET is most helpful in improving slow movement and muscle stiffness. It is also frequently helpful in treating shaking, difficulty in swallowing and drooling. The symptoms of Parkinson's disease are caused by a lack of dopamine, a naturally occurring chemical produced by certain brain cells. Dopamine relays messages in the part of the brain that controls muscle movement. When too little dopamine is produced slowness of movement results. SINEMET contains two active ingredients, levodopa and carbidopa. Levodopa is a chemical closely related to dopamine which allows the body to make its own dopamine. Carbidopa makes sure that enough levodopa gets to the brain where it is needed. In many patients, SINEMET reduces some of the symptoms of Parkinson's disease. Your doctor may have prescribed SINEMET for another reason. Ask your doctor if you have any questions about why SINEMET has been prescribed for you. BEFORE YOU TAKE SINEMET _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE SINEMET IF: • YOU HAVE AN ALLERGY T Read the complete document
SINEMET Tablet PI 20190906 (S-IPC-MK0295B-T-082013) Page 1 of 12 AUSTRALIAN PRODUCT INFORMATION SINEMET ® (LEVODOPA AND CARBIDOPA) TABLET 1 NAME OF THE MEDICINE Levodopa and carbidopa 2 QUALITATIVE AND QUANTITATIVE COMPOSITION _Carbidopa _ Carbidopa, an inhibitor of aromatic amino acid decarboxylase, is a white, crystalline compound, slightly soluble in water. _Levodopa _ Levodopa, an aromatic amino acid, is a white, crystalline compound, slightly soluble in water. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM SINEMET is supplied as tablets for oral administration. SINEMET 250/25, light dapple blue round tablet, containing levodopa 250 mg and carbidopa 25 mg, with 654 on one side and plain on the other. SINEMET 100/25, yellow round tablet, containing levodopa 100 mg and carbidopa 25 mg, with 650 on one side and plain on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS SINEMET is indicated for the treatment of Parkinson's disease and syndrome. It is useful in relieving many of the symptoms of parkinsonism, particularly rigidity and bradykinesia. SINEMET frequently is helpful in the management of tremor, dysphagia, sialorrhoea and postural instability associated with Parkinson's disease and syndrome. 4.2 DOSE AND METHOD OF ADMINISTRATION The optimum daily dosage of SINEMET must be determined by careful titration in each patient. SINEMET tablets are available in a 1:4 ratio of carbidopa to levodopa (SINEMET 100/25) as well as a 1:10 ratio (SINEMET 250/25). Tablets of the two ratios may be given separately or combined as needed to provide the optimum dosage. GENERAL CONSIDERATIONS Dosage should be titrated to individual patient needs and this may require adjusting both the individual dose and the frequency of administration. Studies show that peripheral dopa decarboxylase is saturated by carbidopa at approximately 70 to 100 mg a day. Patients receiving less than this amount of carbidopa are more likely to experience nausea and vomiting. SINEMET Tablet PI 2019 Read the complete document