STALEVO 5012.5200 MG

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

CARBIDOPA; ENTACAPONE; LEVODOPA

Commercializzato da:

INOVAMED PHARMA LTD, ISRAEL

Codice ATC:

N04BA02

Forma farmaceutica:

FILM COATED TABLETS

Composizione:

LEVODOPA 50 MG; CARBIDOPA 12.5 MG; ENTACAPONE 200 MG

Via di somministrazione:

PER OS

Tipo di ricetta:

Required

Prodotto da:

ORION CORPORATION ORION PHARMA,FINLAND

Gruppo terapeutico:

LEVODOPA AND DECARBOXYLASE INHIBITOR

Area terapeutica:

LEVODOPA AND DECARBOXYLASE INHIBITOR

Indicazioni terapeutiche:

Treatment of patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa/dopa decarboxylase (DDC) inhibitor treatment.

Data dell'autorizzazione:

2014-12-31

Foglio illustrativo

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

Scheda tecnica

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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
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EU SmPC Sep.2019
marked with ‘LC