Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland
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.
| 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 film-coated tablets marked with ‘LCE 75’ on one side. 100 mg/25 mg/200 mg: Brownish or greyish red, oval, unscored film-coated tablets marked with ‘LCE 100’ on one side. 125 mg/31.25 mg/200 mg: Light brownish red, oval film-coated tablets marked with ‘LCE 125’ on one side. 150 mg/37.5 mg/200 mg: Brownish or greyish red, elongated-ellipse shaped, unscored film-coated tablets marked with ‘LCE 150’ on one side. 175 mg/43.75 mg/200 mg: Light brownish red, oval, unscored film-coated tablets marked with ‘LCE 175’ on one side. 200 mg/50 mg/200 mg: Dark brownish red, oval, unscored film-coated tablets marked with ‘LCE 200’ on one side. |
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.
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.
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.
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.
Each tablet contains 150 mg of levodopa, 37.5 mg of carbidopa and 200 mg of entacapone.
Excipient with known effect:
Each tablet contains 1.9 mg of sucrose.
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.
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.
| Active Ingredient | Description | |
|---|---|---|
| Carbidopa |
Carbidopa is a peripheral aromatic amino acid decarboxylase inhibitor. It prevents metabolism of levodopa to dopamine in the peripheral circulation, ensuring that a higher proportion of the dose reaches the brain, where dopamine exerts its therapeutic effects. A lower dose of levodopa can be used when it is coadministered with carbidopa, reducing the incidence and severity of peripheral side effects. |
|
| Entacapone |
Entacapone belongs to a new therapeutic class, catechol-O-methyl transferase (COMT) inhibitors. It is a reversible, specific, and mainly peripherally acting COMT inhibitor designed for concomitant administration with levodopa preparations. Entacapone prolongs the clinical response to levodopa. |
|
| Levodopa |
According to the current understanding, the symptoms of Parkinson’s disease are related to depletion of dopamine in the corpus striatum. Dopamine does not cross the blood-brain barrier. Levodopa, the precursor of dopamine, crosses the blood brain barrier and relieves the symptoms of the disease. |
| List of Excipients |
|---|
|
Tablet core: Croscarmellose sodium Film-coating of 50/12.5/200 mg, 100/25/200 mg and 150/37.5/200 mg: Glycerol (85 per cent) (E422) Film-coating of 75/18.75/200 mg, 125/31.25/200 mg, 175/43.75/200 mg and 200/50/200 mg: Glycerol (85 per cent) (E422) |
HDPE bottle with a child resistant PP-closure.
Pack sizes of 50/12.5/200 mg, 100/25/200 mg and 150/37.5/200 mg: 10, 30, 100, 130, 175 and 250 tablets.
Pack sizes of 75/18.75/200 mg, 125/31.25/200 mg, 175/43.75/200 mg and 200/50/200 mg: 10, 30, 100, 130 and 175 tablets.
Not all pack sizes may be marketed.
Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland
50 mg/12.5 mg/200 mg:
EU/1/03/260/001-004
EU/1/03/260/013
EU/1/03/260/016
75 mg/18.75 mg/200 mg:
EU/1/03/260/024-028
100 mg/25 mg/200 mg:
EU/1/03/260/005-008
EU/1/03/260/014
EU/1/03/260/017
125 mg/31.25 mg/200 mg:
EU/1/03/260/029-033
150 mg/37.5 mg/200 mg:
EU/1/03/260/009-012
EU/1/03/260/015
EU/1/03/260/018
175 mg/43.75 mg/200 mg:
EU/1/03/260/034-038
200 mg/50 mg/200 mg:
EU/1/03/260/019-023
Date of first authorisation: 17 October 2003
Date of latest renewal: 17 October 2008
| Drug | Countries | |
|---|---|---|
| STALEVO | Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Singapore, United Kingdom, United States, South Africa |
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