País: Nova Zelanda
Idioma: anglès
Font: Medsafe (Medicines Safety Authority)
Carbidopa monohydrate 20.25mg equivalent to 18.75 mg carbidopa; ; Entacapone 200mg; Levodopa 75mg
Orion Pharma (NZ) Limited
Carbidopa monohydrate 20.25 mg (equivalent to 18.75 mg carbidopa)
75mg/18.75mg/200mg
Film coated tablet
Active: Carbidopa monohydrate 20.25mg equivalent to 18.75 mg carbidopa Entacapone 200mg Levodopa 75mg Excipient: Croscarmellose sodium Ethanol Glycerol Hypromellose Iron oxide red Magnesium stearate Maize starch Mannitol Polysorbate 80 Povidone Purified water Sucrose Titanium dioxide
Bottle, plastic, HDPE bottle with PP closure ( 100 tablets), 100 tablets
Prescription
Prescription
Sicor (Societa Italiana Corticosteroidi) Srl
Stalevo is indicated for the treatment of patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa/dopa decarboxylase (DDC) inhibitor treatment.
Package - Contents - Shelf Life: Bottle, plastic, HDPE bottle with PP closure ( 100 tablets) - 100 tablets - 3 years unopened stored at or below 30°C
2008-12-19
New Zealand Consumer Medicine Information 1 STALEVO ® LEVODOPA/CARBIDOPA/ENTACAPONE 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 further questions, please ask your doctor or pharmacist. This medicine has been prescribed only for you. Do not give it to anybody else or use it for any other illnesses. If any of the side effects affects you severely, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET 1 What Stalevo is and what it is used for ..........................................................................1 2 Before you take Stalevo ................................................................................................2 3 How to take Stalevo ......................................................................................................5 4 Possible side effects .....................................................................................................6 5 Storing Stalevo .............................................................................................................8 6 Sponsor....................................................................................................................... 8 STALEVO 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 FILM-COATED TABLETS The ACTIVE SUBSTANCES of Stalevo are levodopa, carbidopa and entacapone. The OTHER INGREDIENTS are croscarmellose sodium, magnesium stearate, maize starch, mannitol, povidone, glycerol 85%, hypromellose, polysorbate 80, red iron oxide (E 172), sucrose, titanium dioxide (E 171), yellow iron oxide (E 172). 1 WHAT STALEVO IS AND WHAT IT IS USED FOR Stalevo contains three active substances in one film-coated tablet. Each tablet contains levodopa, used to treat Parkinson’s disease. The two other active substances: carbidopa and entacapone improve the antiparkinson effects of levodopa. Stalevo is available i Llegiu el document complet
Page 1 of 14 NEW ZEALAND DATA SHEET STALEVO FILM-COATED TABLETS 1. PRODUCT NAME 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. 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. Stalevo® 100 mg/25 mg/200 mg: each tablet contains 100 mg of levodopa, 25 mg of carbidopa and 200 mg of entacapone. 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. 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. 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: Stalevo 50 mg/12.5 mg/200 mg: Each tablet contains 1.2 mg of sucrose. Stalevo 75 mg/18.75 mg/200 mg: Each tablet contains 1.4 mg of sucrose. Stalevo 100 mg/25 mg/200 mg: Each tablet contains 1.6 mg of sucrose. Stalevo 125 mg/31.25 mg/200 mg: Each tablet contains 1.6 mg of sucrose. Stalevo 150 mg/37.5 mg/200 mg: Each tablet contains 1.9 mg of sucrose. Stalevo 200 mg/50 mg/200 mg: Each tablet contains 2.3 mg of sucrose/tablet. For a full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Film-coated tablet. 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 Page 2 of 14 Stalevo 100 mg/25 mg/200 mg: brownish- or g Llegiu el document complet