CELTOR TABLETS 50+12.5+200 MG

Pays: Malaisie

Langue: anglais

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

Ingrédients actifs:

CARBIDOPA; ENTACAPONE; LEVODOPA

Disponible depuis:

LABORATORIES TORRENT (MALAYSIA) SDN. BHD.

DCI (Dénomination commune internationale):

CARBIDOPA; ENTACAPONE; LEVODOPA

Unités en paquet:

10 Tablets; 30 Tablets

Fabriqué par:

TORRENT PHARMACEUTICAL LIMITED

Notice patient

CELTOR TABLETS
_ _
Levodopa, Carbidopa and Entacapone (50mg + 12.5mg + 200mg)
_ _
_ _
1
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What is CELTOR used for
2.
How CELTOR works
3.
Before you use CELTOR
4.
How to use CELTOR
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of CELTOR
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT CELTOR IS USED FOR
It
is
used
for
the
treatment
of
Parkinson’s disease.
HOW CELTOR WORKS
Parkinson’s disease is caused by low
levels of a substance called dopamine
in
the
brain.
Levodopa
increases
the
amount of dopamine and hence reduces
the symptoms of Parkinson’s disease.
Carbidopa and Entacapone improve the
anti-Parkinson effects of Levodopa.
BEFORE YOU USE CELTOR
-
_When you must not use it _
Do not take CELTOR:

If
you
are
allergic
to
levodopa,
carbidopa or entacapone, or any of
the
other
ingredients
of
this
medicine.

If you have narrow-angle glaucoma
(an eye disorder).

If you have a tumour of the adrenal
gland.

If you are taking certain medicines
for
treating
depression
(combinations of selective MAO-A
and
MAO-B
inhibitors
or
non-
selective MAO-inhibitors).

If you have ever had neuroleptic
malignant syndrome (NMS - this is
a rare reaction to medicines used to
treat severe mental disorders).

If you have ever had non-traumatic
rhabdomyolysis
(a
rare
muscle
disorder).

If you have a severe liver disease.
_Pregnancy and lactation_
_ _
Do
not
take
CELTOR
if
you
are
pregnant or plan to become pregnant or
think you might be pregnant.
Do not take CELTOR if you are breast-
feeding. Ask your doctor or pharmacist
for advice before taking any medicine.
-
_Before you start use it _
Talk
to
your
doctor
before
taking
CELTOR if you suffer from or you ever
had:-

A heart attack or any other diseases
of
the
heart
including
cardiac
arrhythmias
(irregular
heartbeat),
or of the blood vessels.

A liver problem, because your dose
may need to be adjusted.

Kidney
or
hor

Résumé des caractéristiques du produit

CELTOR TABLETS
(LEVODOPA, CARBIDOPA AND ENTACAPONE TABLETS
50MG + 12.5MG + 200MG)
BRAND OR PRODUCT NAME
CELTOR TABLETS 50+12.5+200mg
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
CELTOR TABLETS 50+12.5+200 MG
Each film-coated tablet contains:
Levodopa USP .......................... 50mg
Carbidopa USP ......................... 12.5mg
Entacapone USP ........................ 200mg
PRODUCT DESCRIPTION
CELTOR TABLETS 50+12.5+200 MG
Light brown to grayish red colored, round, biconvex, film coated
tablets with debossed
"50" on one side and plain on other side.
DOSAGE FORM
Film coated bilayered tablet
PHARMACODYNAMICS
According to the current understanding, the symptoms of Parkinson's
disease are related
to depletion of dopamine in the corpus striatum. Dopamine does not
cross the blood-brain
barrier. Levodopa, the precursor of dopamine, crosses the blood brain
barrier and relieves
the symptoms of the disease. As levodopa is extensively metabolised in
the periphery,
only a small portion of a given dose reaches the central nervous
system when levodopa is
administered without metabolic enzyme inhibitors.
Carbidopa and benserazide are peripheral (dopa decarboxylase) DDC
inhibitors which
reduce the peripheral metabolism of levodopa to dopamine, and thus,
more levodopa is
available to the brain. When decarboxylation of levodopa is reduced
with the co-
administration of a DDC inhibitor, a lower dose of levodopa can be
used and the
incidence of adverse reactions such as nausea is reduced.
With inhibition of the decarboxylase by a DDC inhibitor,
catechol-O-methyltransferase
(COMT) becomes the major peripheral metabolic pathway catalyzing the
conversion of
levodopa to 3-O-methyldopa (3-OMD), a potentially harmful metabolite
of levodopa.
Entacapone is a reversible, specific and mainly peripherally acting
COMT inhibitor
designed for concomitant administration with levodopa. Entacapone
slows the clearance
of levodopa from the bloodstream resulting in an increased area under
the curve (AUC)
in the pharmacokinetic profile of levodopa. Conse