Stalevo

Nazione: Nuova Zelanda

Lingua: inglese

Fonte: Medsafe (Medicines Safety Authority)

Principio attivo:

Carbidopa monohydrate 20.25mg equivalent to 18.75 mg carbidopa;  ; Entacapone 200mg; Levodopa 75mg

Commercializzato da:

Orion Pharma (NZ) Limited

INN (Nome Internazionale):

Carbidopa monohydrate 20.25 mg (equivalent to 18.75 mg carbidopa)

Dosaggio:

75mg/18.75mg/200mg

Forma farmaceutica:

Film coated tablet

Composizione:

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

Confezione:

Bottle, plastic, HDPE bottle with PP closure ( 100 tablets), 100 tablets

Classe:

Prescription

Tipo di ricetta:

Prescription

Prodotto da:

Sicor (Societa Italiana Corticosteroidi) Srl

Indicazioni terapeutiche:

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.

Dettagli prodotto:

Package - Contents - Shelf Life: Bottle, plastic, HDPE bottle with PP closure ( 100 tablets) - 100 tablets - 3 years unopened stored at or below 30°C

Data dell'autorizzazione:

2008-12-19

Foglio illustrativo

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

Scheda tecnica

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