Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2021 Publisher: Roche Products (New Zealand) Limited, PO Box 109113, Newmarket, Auckland 1149, NEW ZEALAND, Medical enquiries: 0800 276 243
Madopar 62.5 mg capsule.
Madopar 125 mg capsule.
Madopar 250 mg capsule.
Madopar HBS 125 mg Modified release capsule.
Madopar Rapid 62.5 mg Dispersible tablet.
| Pharmaceutical Form |
|---|
|
Madopar 62.5 capsule, a No. 4 size capsule with a “ROCHE” imprint, an opaque light-grey body and an opaque powder-blue cap. Madopar 125 capsule, a No. 2 size capsule with a “ROCHE” imprint, an opaque flesh coloured body and an opaque powder-blue cap. Madopar 250 capsule, a No. 1 size capsule with a “ROCHE” imprint, an opaque caramel coloured body and an opaque powder-blue cap. Madopar 62.5 rapid dispersible tablet is an off-white, cylindrical, bi planar tablet with “ROCHE” and “62.5” imprinted on one side and a breakbar on the other side. Madopar HBS 125 capsule (Hydrodynamically Balanced System with controlled release), a No. 1 size capsule with a “ROCHE” imprint, an opaque light blue body and an opaque dark green cap. Madopar HBS 125 capsules must not be opened before ingestion because the controlledrelease characteristics will be lost. |
Each 62.5 capsule contains 50 mg levodopa and 14.25 mg benserazide hydrochloride (equivalent to 12.5 mg of the base).
Each 125 capsule contains 100 mg levodopa and 28.5 mg benserazide hydrochloride (equivalent to 25 mg of the base).
Each 250 capsule contains 200 mg levodopa and 57 mg benserazide hydrochloride (equivalent to 50 mg of the base).
Each Madopar HBS 125 capsule contains 100 mg levodopa and 28.5 mg benserazide hydrochloride (equivalent to 25 mg of the base).
Each Madopar Rapid 62.5 dispersible tablet contains 50 mg levodopa and 14.25 mg benserazide hydrochloride (equivalent to 12.5 mg of the base).
For the full list of excipients, see section 6.1 List of excipients.
| Active Ingredient | Description | |
|---|---|---|
| Benserazide |
Benserazide (also called Serazide or Ro 4-4602) is a peripherally acting aromatic L-amino acid decarboxylase or DOPA decarboxylase inhibitor, which is unable to cross the blood–brain barrier. |
|
| 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 |
|---|
|
MADOPAR 62.5 capsules: Microcrystalline cellulose MADOPAR 125 and 250 capsules: Microcrystalline cellulose MADOPAR HBS (Hydrodynamically Balanced System) 125 capsules: Hypromellose MADOPAR Rapid 62.5 tablets: Citric acid |
Madopar 62.5, Madopar 125 and Madopar 250 capsules are supplied in amber glass bottles with HDPE cap with integral desiccant (bottle contains 100 capsules).
Madopar HBS 125 capsules are supplied in amber glass bottles with HDPE cap with integral desiccant (bottle contains 100 capsules).
Madopar Rapid 62.5 dispersible tablets are supplied in amber glass bottles with HDPE cap with integral desiccant (bottle contains 100 tablets).
Roche Products (New Zealand) Limited, PO Box 109113, Newmarket, Auckland 1149, NEW ZEALAND, Medical enquiries: 0800 276 243
MADOPAR 62.5, 125, 250 capsules: 19 August 1976
MADOPAR 62.5 Rapid tablets: 16 March 1988
MADOPAR HBS 125 capsules: 15 May 1989
| Drug | Countries | |
|---|---|---|
| MADOPAR | Austria, Australia, Germany, Estonia, Spain, Finland, Hong Kong, Croatia, Ireland, Italy, Japan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, South Africa |
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