LEVOMED TABLET (25025)

Country: Малезија

Језик: Енглески

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

Активни састојак:

LEVODOPA; CARBIDOPA

Доступно од:

KOMEDIC SDN BHD

INN (Међународно име):

LEVODOPA; CARBIDOPA

Јединице у пакету:

20Tablet Tablets; 100Tablet Tablets; 100Tablet Tablets

Произведен од:

MEDOCHEMIE LTD

Информативни летак

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
LEVOMED TABLET
Levodopa/ Carbidopa (250mg/ 25mg)
WHAT IS IN THIS LEAFLET
1.
What LEVOMED is used for
2.
How LEVOMED works
3.
Before you use LEVOMED
4.
How to use LEVOMED
5.
While you are using it
6.
Side effects
7.
Storage and disposal of LEVOMED
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT LEVOMED IS USED FOR
Your doctor has prescribed LEVOMED
to
treat
the
signs
and
symptoms
of
Parkinson’s disease. Parkinson’s disease
is a long term illness where:
-
You become slow and unsteady.
-
Your muscles feel stiff.
-
You
may
develop
shaking
or
trembling (called ‘tremor’).
If not treated, Parkinson's disease can
make it hard for you to continue your
normal daily activities.
HOW LEVOMED WORKS
LEVOMED
contains
two
different
medicines
called:
levodopa
and
carbidopa.
Parkinson's disease may be caused by
low levels of a chemical called dopamine
in the brain. Dopamine has the role of
relaying messages in certain regions of
the brain that control muscle movement.
Difficulty in movement results when too
little dopamine is produced.
Levodopa is converted to dopamine in
the brain, while carbidopa helps prevent
the breakdown of levodopa before it can
reach the brain and take effect. In many
patients, this reduces the symptoms of
Parkinson's disease.
BEFORE YOU USE LEVOMED
_- When you must not use it _
Do not take LEVOMED if:
-
You are allergic (hypersensitive) to
carbidopa or levodopa or any of the
other
ingredients
of
LEVOMED
(listed in Section 6).
-
You have ever had skin cancer or
you have any unusual moles which
have not been examined by
your
doctor.
-
You
are
taking
certain
medicines
called
‘MAOIs’
(Monoamine
Oxidase
Inhibitors)
used
for
depression. You need to stop using
these medicines at least two weeks
before
you
start
LEVOMED (see
also
under
‘TAKING
OTHER
MEDICINES’ below).
-
You
have
a
condition
called
‘narrow-angle glaucoma’ that may
cause a sudden build up of pressure
in the eye.
-
You have a severe

Карактеристике производа

1
PACKAGE INSERT – LEVOMED
1. NAME OF THE MEDICINAL PRODUCT
LEVOMED Tablet 250/25 mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
LEVOMED Tablet 250/25mg: Each tablet contains 250mg Levodopa and 25mg
Carbidopa.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet
LEVOMED Tablet 250/25mg: blue, round, flat, scored tablets with
diameter 10.5mm
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For treatment of Parkinson's disease and syndrome, particularly
rigidity and bradykinesia. It is frequently helpful in
the management of tremor, dysphagia, sialorrhoea, and postural
instability associated with Parkinson's disease and
syndrome.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration
To be taken orally.
Posology
Dosage should be titrated to the individual patient needs and this may
require adjusting both the individual dose and
the frequency of administration. Each tablet of LEVOMED is designed to
divide in half with minimal pressure.
Response has been observed in one day, and sometime after one dose.
Fully effective doses usually are reached
within seven days as compared to weeks or months with Levodopa alone.
Studies show that the peripheral enzyme dopa decarboxylase is fully
inhibited (saturated) by carbidopa at doses
between 70 and 150mg daily. Patients receiving less than this amount
of Carbidopa are more likely to experience
nausea and vomiting.
Because both therapeutic and adverse responses occur more rapidly with
LEVOMED than when levodopa is given,
patients should be monitored closely during the dose adjustment
period. Specifically, involuntary movements will
occur more rapidly with LEVOMED than with Levodopa. The occurrence of
involuntary movements may require
dosage reduction. Blepharospasm may be useful early sign of excess
dosage in some patients.
_Patients Not Receiving Levodopa _
One tablet 3x a day, if the patient remains uncontrolled, increase
dose by one tablet every day or every other day
until a maximum of 8 tablets.
_Patients Receiving Levodopa _
Levo