Stalevo Film Coated Tablet 20050200mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Carbidopa monohydrate 54.1mg corresponds to carbidopa; Entacapone; Levodopa

Available from:

ORION PHARMA (SG) PTE. LTD.

ATC code:

N04BA03

Dosage:

50mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

Carbidopa monohydrate 54.1mg corresponds to carbidopa 50mg; Entacapone 200mg; Levodopa 200mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Orion Corporation, Orion Pharma (Espoo site)

Authorization status:

ACTIVE

Authorization date:

2008-11-03

Patient Information leaflet

STALEVO


Pharmacotherapeutic group: Anti-parkinsonian dopaminergic medicinal
product (ATC code: 
N04B A03). 
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 100 mg/25 mg/200 mg  each tablet contains 100 mg of
levodopa, 25 mg of carbidopa 
and 200 mg of entacapone. They brownish- or greyish-red,
oval-shaped, unscored film-coated 
tablets marked with ‘LCE 100’ 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, elongated-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 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. 
DOSAGE AND ADMINISTRATION 
METHOD OF ADMINISTRATION 
Each tablet is to be taken orally either with or without food
(see section 
PHARMACOKINETICS). One tablet
contains one treatment dose. The tablets should always 
be swallowed whole. 
The optimum daily dosage must be determined
by careful titration of levodopa in each 
patient. The daily dose should preferably be optimised using one
of the four available tablet 
strengths (50/12.5

Summary of Product characteristics

NAME OF THE MEDICINAL PRODUCT
Stalevo
®
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 100 mg/25 mg/200 mg each tablet contains
100 mg of levodopa, 25 mg of carbidopa and 200 mg
of entacapone. They brownish- or greyish-red, oval-
shaped, unscored film-coated tablets marked with ‘LCE
100’ 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,
elongated-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 LIST OF
EXCIPIENTS. Certain dosage strengths may not be
available in all countries.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
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.
POSOLOGY AND METHOD OF ADMINISTRATION
METHOD OF ADMINISTRATION
Each tablet is to be taken orally either with or without
food (see section PHARMACOKINETICS PROPERTIES).
One tablet contains one treatment dose. The tablets
should always be swallowed whole.
The optimum daily dosage must be determined by
careful titration of levodopa in each patient. The daily
dose should preferably be optimised using one of
the four available tablet strengths (50/12.5/200 mg,
100/25/200 mg, 150/37.5/200 mg or 200/50/200mg
levodopa/
carbidopa/ entacapone).
Patients should be instructed to take only one Stalevo
tablet per dose administration. Patients receiving less
than 70-100 mg carbid