Ország: Izrael
Nyelv: angol
Forrás: Ministry of Health
CARBIDOPA AS MONOHYDRATE; ENTACAPONE; LEVODOPA
INOVAMED PHARMA LTD, ISRAEL
N04BA01
FILM COATED TABLETS
CARBIDOPA AS MONOHYDRATE 18.75 MG; ENTACAPONE 200 MG; LEVODOPA 75 MG
PER OS
Required
ORION CORPORATION ORION PHARMA,FINLAND
LEVODOPA
LEVODOPA
Treatment of patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa/dopa/decarboxylase (DDC) inhibitor treatment.
2015-08-31
STAL CTAB PL SH 290920 STAL CTAB PL SH 290920 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS )PREPARATIONS( – 1986 THE MEDICINE IS DISPENSED WITH A DOCTOR’S PRESCRIPTION ONLY STALEVO ® 50/12.5/200 MG Film-coated tablets STALEVO ® 75/18.75/200 MG Film-coated tablets STALEVO ® 100/25/200 MG Film-coated tablets STALEVO ® 125/31.25/200 MG Film-coated tablets STALEVO ® 150/37.5/200 MG Film-coated tablets STALEVO ® 200/50/200 MG Film-coated tablets ACTIVE INGREDIENTS Stalevo 50/12.5/200 mg Each tablet contains levodopa/ carbidopa/entacapone 50/12.5/200 mg Stalevo 75/18.75/200 mg Each tablet contains levodopa/ carbidopa/entacapone 75/18.75/200 mg Stalevo 100/25/200 mg Each tablet contains levodopa/ carbidopa/entacapone 100/25/200 mg Stalevo 125/31.25/200 mg Each tablet contains levodopa/ carbidopa/entacapone 125/31.25/200 mg Stalevo 150/37.5/200 mg Each tablet contains levodopa/ carbidopa/entacapone 150/37.5/200 mg Stalevo 200/50/200 mg Each tablet contains levodopa/ carbidopa/entacapone 200/50/200 mg INACTIVE INGREDIENTS See section 6 ‘Further Information’ and section 2 ‘Before using the medicine’ in section ‘Important information about some of the ingredients of the medicine’. READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed to treat your ailment. Do not pass it on to others. It may harm them even if it seems to you that their ailment is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? For treatment of Parkinson’s disease. THERAPEUTIC GROUP: Anti-Parkinson medicines, dopa and dopa derivatives. Stalevo contains 3 active ingredients )levodopa, carbidopa and entacapone( in one film-coated tablet. Parkinson’s disease is caused by low brain levels of a substance called dopamine. Levodopa increases the amount of dopamine, thereby reducing the symptoms of Parkinson’s disease. Carbidopa and enta Olvassa el a teljes dokumentumot
Page 1 EU SmPC Sep.2019 PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT Stalevo 50 mg/12.5 mg/200 mg film-coated tablets Stalevo 75 mg/18.75 mg/200 mg film-coated tablets Stalevo 100 mg/25 mg/200 mg film-coated tablets Stalevo 125 mg/31.25 mg/200 mg film-coated tablets Stalevo 150 mg/37.5 mg/200 mg film-coated tablets Stalevo 200 mg/50 mg/200 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 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. Excipient with known effect: Each tablet contains 1.18 mg of sucrose. 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. Excipient with known effect: Each tablet contains 1.35 mg of sucrose. Stalevo 100 mg/25 mg/200 mg: each tablet contains 100 mg of levodopa, 25 mg of carbidopa and 200 mg of entacapone. Excipient with known effect: Each tablet contains 1.55 mg of sucrose. 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. Excipient with known effect: Each tablet contains 1.62 mg of sucrose. 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. Excipient with known effect: Each tablet contains 1.91 mg of sucrose. Stalevo 200 mg/50 mg/200 mg: each tablet contains 200 mg of levodopa, 50 mg of carbidopa and 200 mg of entacapone. Excipient with known effect: Each tablet contains 2.26 mg of sucrose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets. Stalevo 50 mg/12.5 mg/200 mg: 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: light brownish red, oval-shaped, unscored film-coated tablets marked with ‘LCE 75’ on one side. Stalevo 100 mg/25 mg/200 mg: brownish- or greyish-red, oval-shaped, unscored film-coated tablets Page 2 EU SmPC Sep.2019 marked with ‘LC Olvassa el a teljes dokumentumot