MADOPAR 'ROCHE' HBS CAPSULE

Quốc gia: Malaysia

Ngôn ngữ: Tiếng Anh

Nguồn: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

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Tờ rơi thông tin Tờ rơi thông tin (PIL)
16-06-2020

Thành phần hoạt chất:

LEVODOPA; BENSERAZIDE HYDROCHLORIDE

Sẵn có từ:

ROCHE (MALAYSIA) SDN. BHD.

INN (Tên quốc tế):

LEVODOPA; BENSERAZIDE HYDROCHLORIDE

Các đơn vị trong gói:

30Capsule Capsules; 100Capsule Capsules

Sản xuất bởi:

Delpharm Milano s.r.l

Tờ rơi thông tin

                                _ _
_ _
_Consumer Medication Information Leaflet (RiMUP) _
_ _
MADOPAR
®
_Contains active ingredient Levodopa and Benserazide _
_ _
1
WHAT IS IN THIS LEAFLET
1.
What Madopar is used for
2.
How Madopar works
3.
Before you use Madopar
4.
How to use Madopar
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Madopar
8.
Product Description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of Revision
12.
Serial Number
WHAT MADOPAR IS USED FOR
The name of your medicine is
Madopar. It contains two active
ingredients called levodopa and
benserazide.
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 why Madopar has been
prescribed for you.
This medicine is available only with
a doctor's prescription.
HOW MADOPAR WORKS
Madopar belongs to a group of
medicines called antiparkinsonian
agents and is used for the treatment
of Parkinson’s disease.
Antiparkinsonian agents are used to
treat Parkinson's disease and 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.
BEFORE YOU USE MADOPAR
-
_WHEN YOU MUST NOT USE IT _
Do not take Madopar if:

you have had an allergic
reaction to any of the
ingredients listed in the
Ingredients section of this
leaflet

you have taken a non- selective
monoamine oxidase inhibitor
(MAOI) medicine

you have taken a combination of
a selective MAO-A inhibitor
such as moclobemide with a
selective MAO-B inhibitor such
as selegiline

you have untreated heart, liver,
kidney, lung, blood or endocrine
(hormonal) disease

you have narrow (closed) angle
glaucoma (high pressu
                                
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Đặc tính sản phẩm

                                PACK INSERT FOR MALAYSIA	
Madopar	P
®
P
Levodopa + Benserazide
	 For the treatment of parkinsonian patients Composition	Active ingredient:	Madopar is a combination of levodopa and the decarboxylase inhibitor	benserazide (as hydrochloride) in the ratio of 4:1.	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 diff	erent 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 levodopa + 12.5 mg benserazide (as hydrochloride);	Madopar ‘125’ (blue and pink cap	sules) with 100 mg levodopa + 25 mg benserazide (as	hydrochloride);	Madopar ‘250’ (blue and brown capsules) with 200 mg levodopa + 50 mg benserazide (as hydrochloride);	Madopar ‘125’ cross scored (pink tablets) 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 62.5’ scored (off	-white tablets) with 50 mg levodopa + 12.5 mg	benserazide (as hydrochloride);	Madopar ‘dispersible	125’ scored (off	-white tablets) with 100 mg levodopa + 25 mg bens	e-	razide (as hydrochloride);	Madopar HBS (Hydrodynamically Balanced System) (controlled	-release green and light	blue capsules) with 100 mg levodopa + 25 mg benserazide (as hydrochloride).	Mad	opar HBS capsules must not be opened or chewed before swallowing because the	controlled	-release characteristics will be lost! Pharmacological Properties and E	ffects	Pharmacotherapeutic group: Anti	-parkinson drugs, ATC code: N04BA02	Pharmacodynamics Proper	ties	Mechanism of Action	Dopamine, which acts as a neurotransmitter in the brain, is not present in sufficient quant	i-	ties in the basal ganglia of parkinsonian patients.	Replacement therapy is performed by	ad
                                
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