MADOPAR 250 TABLET 250 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Benserazide HCl 57mg equivalent to benserazide; LEVODOPA

Available from:

ROCHE SINGAPORE PTE. LTD.

ATC code:

N04BA02

Dosage:

50 mg

Pharmaceutical form:

TABLET

Composition:

Benserazide HCl 57mg equivalent to benserazide 50 mg; LEVODOPA 200 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Delpharm Milano S.r.l (Primary Packager)

Authorization status:

ACTIVE

Authorization date:

1991-05-17

Patient Information leaflet

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

Summary of Product characteristics

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�