MADOPAR 100/25 benserazide hydrochloride / levodopa tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

levodopa, Quantity: 100 mg; benserazide hydrochloride, Quantity: 28.5 mg (Equivalent: benserazide, Qty 25 mg)

Available from:

Roche Products Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: crospovidone; microcrystalline cellulose; colloidal anhydrous silica; pregelatinised maize starch; docusate sodium; iron oxide red; calcium hydrogen phosphate; magnesium stearate; ethylcellulose; mannitol

Administration route:

Oral

Units in package:

100 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Parkinson's disease and parkinsonian symptoms including post- encephalitic and toxic forms, but excluding drug induced parkinsonism.

Product summary:

Visual Identification: Cylindrical, biconvex, pale red tablet, cross-scored on both sides; Container Type: Bottle; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1993-09-28

Patient Information leaflet

MADOPAR
®
_(levodopa and benserazide)_
CONSUMER MEDICINE INFORMATION
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.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
MADOPAR
_DO NOT TAKE MADOPAR IF:_
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 breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
DO NOT TAKE MADOPAR IF:
�

Summary of Product characteristics

Madopar 190620
1
AUSTRALIAN PRODUCT INFORMATION
MADOPAR (LEVODOPA AND BENSERAZIDE HYDROCHLORIDE)
1.
NAME OF THE MEDICINE
Levodopa and benserazide hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Madopar 62.5 capsule contains 50 mg Levodopa and 14.25 mg
Benserazide (equivalent
to 12.5 mg of the base)
Each Madopar 125 capsule contains 100 mg Levodopa and 28.5 mg
Benserazide (equivalent
to 25 mg of the base)
Each Madopar 250 capsule contains 200 mg Levodopa and 57 mg
Benserazide (equivalent to
50 mg of the base)
Each Madopar HBS 125 capsule contains 100 mg Levodopa and 28.5 mg
Benserazide
(equivalent to 25 mg of the base)
Each Madopar 125 tablet contains 100 mg Levodopa and 28.5 mg
Benserazide (equivalent to
25 mg of the base)
Each Madopar 250 tablet contains 200 mg Levodopa and 57 mg Benserazide
(equivalent to 50
mg of the base)
Each Madopar Rapid 62.5 dispersible tablet contains 50 mg Levodopa and
14.25 mg
Benserazide (equivalent to 12.5 mg of the base)
Each
Madopar
Rapid
125
dispersible
tablet
contains
100
mg
Levodopa
and
28.5
mg
Benserazide (equivalent to 25 mg of the base)
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Madopar 62.5 capsules have a light grey opaque body with powder blue
opaque cap,
imprinted with 'ROCHE' on both ends
Madopar 125 capsules have a flesh coloured opaque body and powder blue
opaque cap,
imprinted with 'ROCHE' on both ends
Madopar 250 capsules have a caramel coloured opaque body and
powder-blue opaque cap,
imprinted with 'ROCHE' on both ends
Madopar HBS (Hydrodynamically Balanced System) 125 capsules have a
light blue opaque
body and dark green opaque cap imprinted with ‘ROCHE’ in red ink
on both ends
Madopar 125 tablets are cylindrical, biconvex, pale red tablets,
cross-scored on both sides
Madopar 250 tablets are cylindrical, biconvex, pale red tablets,
imprinted with ‘ROCHE’ and
a hexagon on one side, cross-scored on both sides
Madopar 190620
2
Madopar Rapid 62.5 dispersible tablets are off-white, cylindrical,
bi-p