Stalevo
Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Patient Information leaflet
(PIL)
23-02-2023
Summary of Product characteristics
(SPC)
23-02-2023
Public Assessment Report
(PAR)
13-10-2011
Active ingredient:
levodopa, carbidopa, entacapone
Available from:
Orion Corporation
ATC code:
N04BA03
INN (International Name):
levodopa, carbidopa, entacapone
Therapeutic group:
Anti-Parkinson drugs
Therapeutic area:
Parkinson Disease
Therapeutic indications:
Stalevo is indicated for the treatment of adult patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa / dopa-decarboxylase (DDC)-inhibitor treatment.
Product summary:
Revision: 29
Authorization status:
Authorised
Authorization date:
2003-10-17
Patient Information leaflet
41
B. PACKAGE LEAFLET
42
PACKAGE LEAFLET: INFORMATION FOR THE USER
STALEVO 50 MG/12.5 MG/200 MG FILM-COATED TABLETS
levodopa/carbidopa/entacapone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Stalevo is and what it is used for
2.
What you need to know before you take Stalevo
3.
How to take Stalevo
4.
Possible side effects
5.
How to store Stalevo
6.
Contents of the pack and other information
1.
WHAT STALEVO IS AND WHAT IT IS USED FOR
Stalevo contains three active substances (levodopa, carbidopa and
entacapone) in one film-coated
tablet. Stalevo is used for the treatment of Parkinson’s disease.
Parkinson’s disease is caused by low levels of a substance called
dopamine in the brain. Levodopa
increases the amount of dopamine and hence reduces the symptoms of
Parkinson’s disease. Carbidopa
and entacapone improve the antiparkinson effects of levodopa.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE STALEVO
DO NOT TAKE STALEVO IF YOU:
-
are allergic to levodopa, carbidopa or entacapone, or any of the other
ingredients of this
medicine (listed in section 6)
-
have narrow-angle glaucoma (an eye disorder)
-
have a tumour of the adrenal gland
-
are taking certain medicines for treating depression (combinations of
selective MAO-A and
MAO-B inhibitors, or non-selective MAO-inhibitors)
-
have ever had neuroleptic malignant syndrome (NMS – this is a rare
reaction to medicines used
to treat severe mental disorders)
-
have ever had non-traumatic rhabdomyolysis (a rare muscle disorder)
-
have a severe liver d
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Summary of Product characteristics
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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 175 mg/43.75 mg/200 mg film-coated tablets
Stalevo 200 mg/50 mg/200 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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 1.2 mg of sucrose.
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 1.4 mg of sucrose.
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 1.6 mg of sucrose.
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 1.6 mg of sucrose.
150 mg/37.5 mg/200 mg
Each tablet contains 150 mg of levodopa, 37.5 mg of carbidopa and 200
mg of entacapone.
Excipients with known effect:
Each tablet contains 1.9 mg of sucrose and 2.6 mg sodium as a
constituent of an excipient.
175 mg/43.75 mg/200 mg
Each tablet contains 175 mg of levodopa, 43.75 mg of carbidopa and 200
mg of entacapone.
Excipient with known effect:
Each tablet contains 1.89 mg of sucrose.
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 2.3 mg of sucrose.
For the full list of excipients, see section 6.1.
3
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
50 mg/12.5 mg/200 mg
Brownish or greyish red, round, convex, unscored film-coated tablets
marked with “LCE 50” on one
side.
75 mg/18.75 mg/200 mg
Light brownish red, oval
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