Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland
Corbilta 50 mg/12.5 mg/200 mg film-coated tablets.
Corbilta 75 mg/18.75 mg/200 mg film-coated tablets.
Corbilta 100 mg/25 mg/200 mg film-coated tablets.
Corbilta 125 mg/31.25 mg/200 mg film-coated tablets.
Corbilta 150 mg/37.5 mg/200 mg film-coated tablets.
Corbilta 175 mg/43.75 mg/200 mg film-coated tablets.
Corbilta 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.
Excipients with known effect: Each tablet contains 1.9 mg of sucrose and 2.6 mg sodium as a constituent of an excipient.
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/1/13/859/001-006
75 mg/18.75 mg/200 mg:
EU/1/13/859/007-011
100 mg/25 mg/200 mg:
EU/1/13/859/012-017
125 mg/31.25 mg/200 mg:
EU/1/13/859/018-022
150 mg/37.5 mg/200 mg:
EU/1/13/859/023-028
175 mg/43.75 mg/200 mg:
EU/1/13/859/029-033
200 mg/50 mg/200 mg:
EU/1/13/859/034-038
Date of first authorisation: 11 November 2013
Date of latest renewal: 6 July 2018
| Drug | Countries | |
|---|---|---|
| CORBILTA | Austria, Estonia, France, Croatia, Italy, Lithuania, Netherlands, Poland |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
