Madopar 100mg+25mg capsules hard

Država: Armenija

Jezik: engleski

Izvor: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivni sastojci:

levodopa, benserazide (benserazide hydrochloride)

Dostupno od:

F. Hoffmann-La Roche Ltd.

ATC koda:

N04BA02

INN (International ime):

levodopa, benserazide (benserazide hydrochloride)

Doziranje:

100mg+25mg

Farmaceutski oblik:

capsules hard

Jedinice u paketu:

(100) in glass bottle

Tip recepta:

Prescription

Status autorizacije:

Registered

Datum autorizacije:

2015-08-14

Svojstava lijeka

MADOPAR
® (RO 08-0576) SUMMARY OF PRODUCT CHARACTERISTICS
1
MADOPAR
®
(INTERNATIONAL TRADENAME)
MADOPARK
®
, MODOPAR
®
, PROLOPA
®
, RESTEX
®
(OTHER
TRADENAMES)
Levodopa+benserazide
September 2014
1.
DESCRIPTION
1.1
THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG
ATC code: N04BA
Madopar is a combination of levodopa and benserazide for the treatment
of Parkinson’s
disease and for the treatment of Restless Legs Syndrome.
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’
Dual Release (DR) form as Madopar DR ‘250’
1.3
ROUTE OF ADMINISTRATION
Oral administration.
1.4
STERILE / RADIOACTIVE COMPOSITION
No text.
1.5
QUALITATIVE AND QUANTITATIVE COMPOSITION
Madopar is a combination of levodopa and the decarboxylase inhibitor
benserazide (as
hydrochloride) in a 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
MADOPAR
® (RO 08-0576) SUMMARY OF PRODUCT CHARACTERISTICS
2
2.
CLINICAL
PARTICULARS
2.1
THERAPEUTIC INDICATIONS
_Parkinson’s disease: _
Madopar is indicated in the treatment of Parkinson’s disease [4, 5,
6].
Madopar dispersible is a formulation which is suitable for patients
with dysphagia
(difficulties in swallowing) [7, 8] or who require a formulation with
a more rapid onset of
action [9], e.g. patients suffering from early morning and afternoon
akinesia [10], or who
exhibit “delayed on” or “wearing off” phenomena [7, 11, 12,
13].
Madopar HBS is indicated for patients presenting with all types of
fluctuations (e.g.
“peak-dose dyskinesia” and “end of dose deterioration” - such
as nocturnal immobil