Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
BENSERAZIDE; LEVODOPA
ROCHE SINGAPORE PTE. LTD.
N04BA02
25 mg
TABLET
BENSERAZIDE 25 mg; LEVODOPA 100 mg
ORAL
Prescription Only
Delpharm Milano S.r.l
ACTIVE
1999-08-17
MADOPAR ® Levodopa + benserazide __________________________________ 1. DESCRIPTION 1.1. THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG ATC Code: B04BA02 Madopar is a combination of levodopa and benserazide for treatment of Parkinson’s disease. 1.2. TYPE OF DOSAGE FORM _Standard forms: _ Madopar capsules as Madopar ’62.5’, ‘125’, ‘250’ Madopar cross-scored tablets as Madopar ‘125’, ‘250’ _Dispersible form: _ Madopar single-scored dispersible tablets as Madopar ’62.5’, ‘125’ _Controlled release forms: _ Madopar HBS (Hydrodynamically Balanced System) capsules as Madopar ‘125’ Not all strengths are available. 1.3. ROUTE OF ADMINISTRATION Oral administration. 1.4. COMPOSITION Madopar is a combination of levodopa and the decarboxylase inhibitor benserazide (as hydrochloride) in the ratio of 4:1. The following strengths are available: • Madopar ‘62.5’ = levodopa 50 mg + benserazide 12.5 mg • Madopar ‘125’ = levodopa 100 mg + benserazide 25 mg • Madopar ‘250’ = levodopa 200 mg + benserazide 50 mg _Excipients:_ Madopar contains the colorants indigotine (E 132), titanium dioxide (E 171) or iron oxide (E 172) depending on the formulation. The preparation is available as capsules of three different strengths, as cross-scored tablets of two different strengths, as dispersible tablets of two different strengths and as capsules with a controlled-release action: Madopar ‘62.5’(blue and light grey capsules) with 50 mg levodo Read the complete document
Please visit www.roche.com.sg/pharma/madopar for a printable version of this leaflet ORAL-MAD-2023 06 MADOPAR ® Levodopa + Benserazide __________________________________ 1. DESCRIPTION 1.1. THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG ATC Code: N04BA02 Madopar is a combination of levodopa and the decarboxylase inhibitor benserazide. 1.2. TYPE OF DOSAGE FORM _Standard forms: _ Capsules as Madopar ‘125’ Cross-scored tablets as Madopar ‘250’ _Dispersible form: _ Single-scored dispersible tablets as Madopar ‘125’ _Controlled release forms: _ Capsules (Hydrodynamically Balanced System (HBS)) as Madopar ‘125’ Not all strengths are available. 1.3. ROUTE OF ADMINISTRATION Oral. 1.4. COMPOSITION _Active ingredients: _ Madopar is a combination of levodopa and the decarboxylase inhibitor benserazide (as hydrochloride) in the ratio of 4:1. The following strengths are available: Madopar ‘125’ = levodopa 100 mg + benserazide 25 mg Madopar ‘250’ = levodopa 200 mg + benserazide 50 mg _Excipients:_ Madopar contains the colorants indigotine (E 132), titanium dioxide (E 171) or iron oxide (E 172) depending on the formulation. The preparation is available as capsules, cross-scored tablets, dispersible tablets and capsules with a controlled-release action: Madopar ‘125’ (blue and pink capsules) with 100 mg levodopa + 25 mg benserazide (as hydrochloride); Madopar ‘250’ cross scored (pink tablets) with 200 mg levodopa + 50 mg benserazide (as hydrochloride); Madopar ‘dispersible 125’ scored (off-white tablets) with 100 mg levodopa + 25 mg benserazide (as hydrochloride); Madopar HBS (Hydrodynamically Balanced System) (controlled-release green and light blue capsules) with 100 mg levodopa + 25 mg benserazide (as hydrochloride). _Madopar HBS capsules must not be opened or chewed before _ _swallowing because the controlled-release characteristics _ _will be lost! _ _ _ 2. CLINICAL PARTICULARS 2.1. THERAPEUTIC INDICATIONS _Parkinson’s disease: _ Madopar is indicated for the treatment of Parkinson Read the complete document