LEVOMED Tablet Ref.[28237] Active ingredients: Carbidopa Levodopa

Source: Υπουργείο Υγείας (CY)  Revision Year: 2017  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

Levomed 100/10 mg tablets.

Levomed 100/25 mg tablets.

Levomed 250/25 mg tablets.

Pharmaceutical Form

Tablet.

Levomed 250/25 mg tablets: blue, round, flat, scored tablets.

Levomed 100/25 mg tablets: yellow, round flat, scored tablets.

Levomed 100/10mg tablets: blue, round, flat, scored tablets.

Qualitative and quantitative composition

Levomed 100/10mg tablets: Each tablet contains 100mg Levodopa and 10mg Carbidopa.

Levomed 100/25mg tablets: Each tablet contains 100mg Levodopa and 25mg Carbidopa.

Levomed 250/25mg tablets: Each tablet contains 250mg Levodopa and 25mg Carbidopa.

Excipient with known effect: tartrazine (Levomed 100/25mg tablets).

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.

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

Levomed 250/25 mg tablets: Pregelatinised starch, microcrystalline cellulose, powdered cellulose, Blue Lake E132, povidone K25, magnesium stearate.

Levomed 100/25 mg tablets: Pregelatinised starch, microcrystalline cellulose, Tartrazine Lake E102, povidone K25, magnesium stearate.

Levomed 100/10 mg tablets: Pregelatinised starch, microcrystalline cellulose, Blue Lake E132, povidone K25, magnesium stearate.

Pack sizes and marketing

PVC/AL blister packs 100 tablets.
Levomed 250/25mg tablets are also marketed in PVC/AL blister packs of 30.
Levomed 100/25mg tablets are also marketed in PVC/AL blister packs of 10, 50.

Not all pack sizes may be marketed.

Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

Levomed 10/100mg tablets: 19853
Levomed 25/100mg tablets: 19837
Levomed 25/250mg tablets: 19836

Levomed 10/100 mg tablets: 19.12.2005 / 14.05.2013
Levomed 25/100 mg tablets: 19.12.2005 / 14.05.2013
Levomed 25/250 mg tablets: 19.12.2005

Drugs

Drug Countries
LEVOMED Cyprus, Hong Kong, Lithuania, Malta

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