CREDANIL Tablet Ref.[116791] Active ingredients: Carbidopa Levodopa Levodopa and Carbidopa

Source: Υπουργείο Υγείας (CY)  Revision Year: 2026  Publisher: Remedica Ltd, Aharnon Street, Limassol Industrial Estate 3056 Limassol, Cyprus, EU

Product name and form

Credanil 100 mg/10 mg tablets.

Credanil 250 mg/25 mg tablets.

Pharmaceutical Form

Tablet.

Credanil 100 mg/10 mg tablets: Light blue dapple, oval tablets, plain on both sides, with dimensions 10.0 mm x 5.0 mm ± 5%.

Credanil 250 mg/25 mg tablets: Light blue dapple, oval tablets, with R logo on one side and score line on the other side, with dimensions 14.8 mm x 8.0 mm ± 5%.

The tablet can be divided into equal doses.

Qualitative and quantitative composition

Credanil 100 mg/10 mg tablets: Each tablet contains 100 mg levodopa and carbidopa monohydrate equivalent to 10 mg carbidopa.

Credanil 250 mg/25 mg tablets: Each tablet contains 250 mg levodopa and carbidopa monohydrate equivalent to 25 mg carbidopa.

For the full list of excipients, see section 6.1.

Active Ingredient

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.

Levodopa is a precursor of dopamine, and is given as dopamine replacement therapy in Parkinson's disease.

List of Excipients

Cellulose, microcrystalline 200
Starch, pregelatinised
Maize starch
Indigotine, indigo carmine E132
Magnesium stearate

Pack sizes and marketing

Cardboard box containing aluminium-OPA/Alu/PVC blisters, of 10 tablets. Pack sizes of 20, 30, 50, 90 or 100 tablets.

Cardboard box containing one high density polyethylene (HDPE) bottle closed with a plastic child-resistant closure. Pack size of 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Remedica Ltd, Aharnon Street, Limassol Industrial Estate 3056 Limassol, Cyprus, EU

Marketing authorization dates and numbers

Credanil 100 mg/10 mg tablets: 14411
Credanil 250 mg/25 mg tablets: 14410

Credanil 100 mg/10 mg tablets:

Date of first authorization: 21 October 1993
Date of latest renewal: 27 February 2009

Credanil 250 mg/25 mg tablets:

Date of first authorization: 21 October 1993
Date of latest renewal: 13 November 2009

Drugs

Drug Countries
CREDANIL Cyprus, Malta, Singapore

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