Madopar

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Benserazide hydrochloride 28.5mg equivalent to to 25 mg benserazide base; Levodopa 100mg;  

Tilgjengelig fra:

Roche Products (NZ) Ltd

INN (International Name):

Benserazide hydrochloride 28.5 mg (equiv. to 25 mg benserazide base)

Dosering :

125 mg

Legemiddelform:

Capsule

Sammensetning:

Active: Benserazide hydrochloride 28.5mg equivalent to to 25 mg benserazide base Levodopa 100mg   Excipient: Gelatin Indigo carmine Iron oxide red Magnesium stearate Microcrystalline cellulose Povidone Purified talc Titanium dioxide

Enheter i pakken:

Bottle, glass, 100 capsules

Klasse:

Prescription

Resept typen:

Prescription

Produsert av:

DSM Nutritional Products Ltd

Indikasjoner:

Madopar is indicated for the treatment of all forms of parkinson's syndrome with the exception of medicine-induced parkinsonism.

Produkt oppsummering:

Package - Contents - Shelf Life: Bottle, glass, - 100 capsules - 36 months from date of manufacture stored at or below 30°C. Keep the bottle tightly closed

Autorisasjon dato:

1976-08-19

Informasjon til brukeren

Madopar 20210520
1
CONSUMER MEDICINE INFORMATION
MADOPAR
LEVODOPA + BENSERAZIDE
62.5 mg, 125 mg or 250 mg capsules
62.5 mg Rapid tablet (dispersible tablet)
125 mg HBS capsule (controlled release capsule)
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Madopar tablets and
capsules.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you taking Madopar
against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT MADOPAR IS USED FOR
The name of your medicine is Madopar. It contains two active
ingredients called _levodopa _and
_benserazide_.
Madopar belongs to a group of medicines called antiparkinsonian agents
and is used for the treatment
of Parkinson’s disease.
Antiparkinsonian agents work on the central nervous system. The
symptoms of Parkinson's disease
are caused by a deficiency of a natural substance in the brain called
dopamine. Madopar helps to
replace this substance. By improving muscle control, Madopar allows
more normal movements of the
body.
The symptoms of patients suffering from Parkinson’s disease can be
reduced by taking this medicine.
Madopar does not, however, cure the disease, since the cause of the
dopamine deficiency within the
brain is not removed.
Your doctor, however, may have prescribed Madopar for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY MADOPAR HAS BEEN
PRESCRIBED FOR YOU.
Madopar 20210520
2
This medicine is available only with a doctor’s prescription.
BEFORE YOU TAKE MADOPAR
DO NOT TAKE MADOPAR IF YOU HAVE AN ALLERGY TO:
•
any medicine containing levodopa or benserazide
•
any of the ingredients listed at the end of this leaflet
Some of the symptoms of an allergic reaction may include:
•
shortness of breath
•
wheezing or difficulty br

Preparatomtale

Madopar 20210520
1
NEW ZEALAND DATA SHEET
MADOPAR (LEVODOPA + BENSERAZIDE)
1.
PRODUCT NAME
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
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
3.
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 20210520
2
Madopar HBS 125 capsules must not be opened before ingestion because
the controlled-
release characteristics will be lost.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Madopar is indicated for the treatment of all forms of Parkinson's
syndrome with the
exception of