CORBILTA Film-coated tablet Ref.[44645] Active ingredients: Carbidopa Entacapone Levodopa

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland

Product name and form

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.

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.

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
Magnesium stearate
Maize starch
Mannitol (E421)
Povidone K30 (E1201)

Film-coating of 50/12.5/200 mg, 100/25/200 mg and 150/37.5/200 mg:

Glycerol (85 per cent) (E422)
Hypromellose
Magnesium stearate
Polysorbate 80
Red iron oxide (E172)
Sucrose
Titanium dioxide (E171)
Yellow iron oxide (E172)

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)
Hypromellose
Magnesium stearate
Polysorbate 80
Red iron oxide (E172)
Sucrose
Titanium dioxide (E171)

Pack sizes and marketing

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.

Marketing authorization holder

Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland

Marketing authorization dates and numbers

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

Drugs

Drug Countries
CORBILTA Austria, Estonia, France, Italy, Lithuania, Netherlands, Poland

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