Levodopa/Carbidopa/Entacapone Orion

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

levodopa, carbidopa, entacapone

Available from:

Orion Corporation

ATC code:

N04BA03

INN (International Name):

levodopa, carbidopa, entacapone

Therapeutic group:

Nervous system

Therapeutic area:

Parkinson Disease

Therapeutic indications:

Levodopa/Carbidopa/Entacapone Orion 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: 13

Authorization status:

Authorised

Authorization date:

2011-08-23

Patient Information leaflet

41
B. PACKAGE LEAFLET
42
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEVODOPA/CARBIDOPA/ENTACAPONE ORION 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 Levodopa/Carbidopa/Entacapone Orion is and what it is used for
2.
What you need to know before you take Levodopa/Carbidopa/Entacapone
Orion
3.
How to take Levodopa/Carbidopa/Entacapone Orion
4.
Possible side effects
5.
How to store Levodopa/Carbidopa/Entacapone Orion
6.
Contents of the pack and other information
1.
WHAT LEVODOPA/CARBIDOPA/ENTACAPONE ORION IS AND WHAT IT IS USED FOR
Levodopa/Carbidopa/Entacapone Orion contains three active substances
(levodopa, carbidopa and
entacapone) in one film-coated tablet. Levodopa/Carbidopa/Entacapone
Orion 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 LEVODOPA/CARBIDOPA/ENTACAPONE
ORION
DO NOT TAKE LEVODOPA/CARBIDOPA/ENTACAPONE ORION 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

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Levodopa/Carbidopa/Entacapone Orion 50 mg/12.5 mg/200 mg film-coated
tablets
Levodopa/Carbidopa/Entacapone Orion 75 mg/18.75 mg/200 mg film-coated
tablets
Levodopa/Carbidopa/Entacapone Orion 100 mg/25 mg/200 mg film-coated
tablets
Levodopa/Carbidopa/Entacapone Orion 125 mg/31.25 mg/200 mg film-coated
tablets
Levodopa/Carbidopa/Entacapone Orion 150 mg/37.5 mg/200 mg film-coated
tablets
Levodopa/Carbidopa/Entacapone Orion 175 mg/43.75 mg/200 mg film-coated
tablets
Levodopa/Carbidopa/Entacapone Orion 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-c