מדינה: מלזיה
שפה: אנגלית
מקור: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CARBIDOPA; LEVODOPA; ENTACAPONE
ORION PHARMA (MY) SDN. BHD.
CARBIDOPA; LEVODOPA; ENTACAPONE
30Tablet Tablets; 100Tablet Tablets; 250Tablet Tablets
ORION CORP
_Consumer Medication Information Leaflet (RiMUP) _ STALEVO ® FILM COATED TABLET LEVODOPA/CARBIDOPA/ENTACAPONE (50/12.5/200 MG, 75/18.75/200 MG, 100/25/200 MG, 125/31.25/200 MG, 150/37.5/200 MG, 200/50/200 MG) 1 WHAT IS IN THIS LEAFLET 1. WHAT STALEVO IS USED FOR 2. HOW STALEVO WORKS 3. BEFORE YOU USE STALEVO 4. HOW TO USE STALEVO 5. WHILE USING STALEVO 6. SIDE EFFECTS 7. STORAGE AND DISPOSAL OF STALEVO 8. PRODUCT DESCRIPTION 9. MANUFACTURER AND PRODUCT REGISTRATION HOLDER 10. DATE OF REVISION WHAT STALEVO IS USED FOR Stalevo contains three active substances in one film-coated tablet. Each tablet contains levodopa, used to treat the symptoms of Parkinson’s disease. The two other active substances: carbidopa and entacapone improve the antiparkinson effects of levodopa. HOW STALEVO WORKS Your doctor has prescribed Stalevo to treat your Parkinson's disease. Parkinson's disease is a disorder of the nervous system. It is caused by a lack of dopamine, a natural substance that is produced in the brain. Dopamine relays messages in the part of the brain that controls muscle movement. When too little dopamine is produced, problems with movement result. Levodopa works by increasing the level of dopamine in the brain. Stalevo helps in relieving the symptoms of Parkinson’s disease, such as shaking of the limbs, and stiffness and slowness of movement, which make it difficult to perform normal daily activities. You may also be given other medicines to help treat this condition. Ask your doctor if you have any questions about how this medicine works or why this medicine has been prescribed for you. BEFORE YOU USE STALEVO _When you must not use it: _ • If you are allergic (hypersensitive) to levodopa, carbidopa or entacapone or any of the other ingredients of Stalevo. • If you have a severe liver impairment. • If you have narrow-angle glaucoma (an eye disorder). • If you have a tumour of the adrenal gland (known as pheochromocytoma; this may increase the risk of severe high blood pressure) . • If you are taking, or קרא את המסמך השלם
Stalevo Anti-parkinson drugs, dopa and dopa derivatives COMPOSITION AND PHARMACEUTICAL FORM Stalevo 50 mg/12.5 mg/200 mg : each tablet contains 50 mg of levodopa, 12.5 mg of carbidopa and 200 mg of entacapone. They are brownish- or greyish -red, round, convex, unscored film - coated tablets marked with ‘LCE 50’ on one side . Stalevo 75 mg/18.75 mg/200 mg: each tablet contains 75 mg of levodopa, 18.75 mg of carbidopa and 200 mg of entacapone . They are light brownish red, oval-shaped, film-coated tablets marked with ‘LCE 75’ on one side . Stalevo 100 mg/25 mg/200 mg : each tablet contains 100 mg of levodopa, 25 mg of carbidopa and 200 mg of entacapone. They are brownish- or greyish -red, oval -shaped, unscored film - coated tablets marked with ‘LCE 100’ on one side. Stalevo 125 mg/31.25 mg/200 mg: each tablet contains 125 mg of levodopa, 31.25 mg of carbidopa and 200 mg of entacapone . They are light brownish red, oval-shaped, film-coated tablets marked with ‘LCE 125’ on one side . Stalevo 150 mg/37.5 mg/200 mg : each tablet contains 150 mg of levodopa, 37.5 mg of carbidopa and 200 mg of entacapone . They are brownish- or greyish -red, el ongated -ellipse shaped unscored film -coated tablets marked with ‘LCE 150’ on one side. Stalevo 200 mg/50 mg/200 mg : each tablet contains 200 mg of levodopa, 50 mg of carbidopa and 200 mg of entacapone. They are dark brownish- or greyish -red, oval -shaped unscored film - coated tablets marked with ‘LCE 200’ on one side. For a full list of excipients, see section EXCIPIENTS. Certain dosage strengths may not be available in all countries. INDICATIONS Stalevo ® (carbidopa, levodopa and entacapone) is indicated to treat patients with idiopathic Parkinson’s disease : 1) To substitute (with equivalent strength of each of the three components) for immediate release carbidopa/levodopa and entacapone previously administered as individual products. 2) To replace immediate release carbidopa/levodopa therapy (without entacapone) when patients experience the קרא את המסמך השלם