Pays: Israël
Langue: anglais
Source: Ministry of Health
CARBIDOPA AS MONOHYDRATE; LEVODOPA
ORGANON PHARMA ISRAEL LTD., ISRAEL
N04BA02
TABLETS CONTROLLED RELEASE
LEVODOPA 200 MG; CARBIDOPA AS MONOHYDRATE 50 MG
PER OS
Required
ORGANON LLC, USA
LEVODOPA AND DECARBOXYLASE INHIBITOR
LEVODOPA AND DECARBOXYLASE INHIBITOR
Idiopathic parkinson's disease. Postencephalitic parkinsonism. Symptomatic parkinsonism. To reduce "off" time in patients previously treated with levodopa/decarboxylase inhibitor preparations, or with levodopa alone, who have had motor fluctuations characterized by end-of-dose deterioration ("wearing-off" phenomenon), peak dose dyskinesias, akinesia, or similar evidence of short-duration motor disturbances.
2013-02-28
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS (PREPARATIONS) 1986 This medicine is marketed upon physician’s prescription only SINEMET ® CR CARBIDOPA 50 MG/ LEVODOPA 200 MG CONTROLLED RELEASE TABLETS EACH TABLET CONTAINS: ACTIVE INGREDIENTS: Carbidopa 50 mg/ Levodopa 200 mg INACTIVE INGREDIENTS: see section 6 "What SINEMET CR contains". READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. • This leaflet contains concise information about SINEMET CR. 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 ailment seems similar. • This medicine is not suitable for children and adolescents under 18 years of age 1. WHAT IS SINEMET CR INTENDED FOR? SINEMET CR is used for the treatment of Parkinson’s disease and Parkinsonism symptoms. THERAPEUTIC GROUP: Anti-Parkinson agent. 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 the 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 the body. 2. BEFORE USING SINEMET CR 2.1 DO NOT USE SINEMET CR IF: • You are hypersensitive (allergic) to carbidopa or levodopa or any of the other ingredients of SINEMET CR (for a list of inactive ingredients, see 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 Lire le document complet
1. NAME OF THE MEDICINAL PRODUCT SINEMET CR 50 mg/200 mg Controlled-Release Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet of 'Sinemet CR' contains carbidopa (equivalent to 50 mg of anhydrous carbidopa) and 200 mg levodopa. 3. PHARMACEUTICAL FORM Controlled-release tablets. A peach-coloured, oval shaped tablet marked "521" on one side and scored on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Idiopathic Parkinson's disease. • Postencephalitic parkinsonism. • Symptomatic parkinsonism. • To reduce "off" time in patients previously treated with levodopa/decarboxylase inhibitor preparations, or with levodopa alone, who have had motor fluctuations characterized by end-of-dose deterioration ("wearing-off" phenomenon), peak dose dyskinesias, akinesia, or similar evidence of short-duration motor disturbances. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 'Sinemet CR' tablets contain a 1:4 ratio of carbidopa to levodopa ('Sinemet CR': carbidopa 50 mg/levodopa 200 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. ROUTE OF ADMINISTRATION: ORAL 'Sinemet CR' may be administered as whole or broken in half. So that the controlled release properties of the product can be maintained, tablets should not be chewed or crushed. Standard antiparkinson drugs, other than levodopa alone, may be continued while 'Sinemet CR' is being administered, although their dosage may have to be adjusted. Since carbidopa prevents the reversal of levodopa effects caused by pyridoxine, 'Sinemet CR' can be given to patients receiving supplemental pyridoxine (vitamin B6). INITIAL DOSE PATIENTS CURRENTLY TREATED WITH CONVENTIONAL LEVODOPA/DECARBOXYLASE INHIBITOR COMBINATIONS Dosage with 'Sinemet CR' should be substituted initially at an amount that provides no mor Lire le document complet