CITREX MECOLAMIN 500MCG TABLET

Country: Malaysia

Language: English

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

Active ingredient:

Mecobalamin

Available from:

IDAMAN PHARMA MANUFACTURING SDN BHD

INN (International Name):

Mecobalamin

Units in package:

500 Tablets

Manufactured by:

IDAMAN PHARMA MANUFACTURING SDN BHD

Patient Information leaflet

_Consumer Medication Information Leaflet (RiMUP)_
CITREX MECOLAMIN 500MCG TABLET
Mecobalamin
1
WHAT IS IN THIS LEAFLET:
1.
What Citrex Mecolamin 500mcg
Tablet is used for?
2.
How
Citrex Mecolamin 500mcg
Tablet works
3.
Before you use Citrex Mecolamin
500mcg Tablet
4.
How
to use Citrex Mecolamin
500mcg Tablet
5.
While you are using Citrex
Mecolamin 500mcg Tablet
6.
Side Effects
7.
Storage and Disposal of Citrex
Mecolamin 500mcg Tablet
8.
Product Description
9.
Product Registration Holder and
Manufacturer
10.
Date of Revision
WHAT CITREX MECOLAMIN 500MCG
TABLET IS USED FOR?
Citrex
Mecolamin
500mcg
Tablet
contains
the
active
ingredient
Mecobalamin.
Citrex Mecolamin 500mcg Tablet is
used in the
treatment of
peripheral
neuropathies
(damage to peripheral
nerves).
HOW CITREX MECOLAMIN 500MCG
TABLET WORKS?
Mecobalamin
is
a
coenzyme
of
Vitamin B12. It plays an important
role
in
assisting
the
restoration
process of damaged nerve cells and
also
in
maintaining
proper
functioning of nerve cells.
BEFORE YOU USE CITREX MECOLAMIN
500MCG TABLET
_Do not take if you_
•
Have ever had a reaction or been
told
that
you
are
allergic
to
Mecobalamin or any of the other
ingredient in this
preparation.
_Before you start to take it_
Tell your doctor if you have allergies
to
any
other
medicines,
foods,
preservative or dyes.
Tell your doctor if:
•
Your occupation required you to
handle mercury or its compound.
If you are not sure whether you should
start taking this medicine, talk to your
doctor.
_ _
_ _
_ _
_ _
_Taking other medicines _
Inform your doctor or pharmacist if
you
are
taking
or
if
you
have
recently taken any other medicines,
including
medicines
obtained
without a prescription.
Some
medicines
and
Citrex
Mecolamin
500mcg
Tablet
may
interfere
with
each
other.
It
is
important
to
tell
your
doctor
or
pharmacist if you are taking:
•
Antibiotics e.g. chloramphenicol
_, _
neomycin, aminosalicylic
_ _
acid and
aminoglycosides group e.g.
gentamicin.
•
Medicine for gastric ulcers e.g.
cimetidine, ranitidine.
•
Medicine for epilepsy

Summary of Product characteristics

IDAMAN PHARMA MANUFACTURING SDN BHD
CITREX MECOLAMIN 500MCG TABLET
PRODUCT DESCRIPTION
Round,film coated tablet and plain on both sides.
Colour: Pink
Each tablet contains Mecobalamin 500 mcg
Source of Lactose: Bovine
ROUTE OF ADMINISTRATION
Oral
PHARMACODYNAMICS
Vitamin B12 in the form of Mecobalamin is a cofactor in the
methionine
synthase
reaction.
The
enzyme
converts
homocysteine to methionine. Methionine is a precursor of S-
adenosylmethionine
(SAMe).
SAMe
is
the
principal
transmethylating agent and involved in among many other
things,
the
synthesis
of
myelin
basic
protein.
Abnormal
myelin basic protein resulting in defective myelination, is
thought
to
be
responsible
for
many
of
the
neurological
effects of B12 deficiency.
B12 deficiency results in decreased formation of thymidylic
acid and purine nucleotides, precursors of DNA synthesis
and which are necessary for normal cell division.
Mecobalamin acts to repair damaged nerve tissue in nerve
disorder e.g., axonal degeneration and demyelination and it
is
involved
in
erythroblast
maturation,
promotion
of
erythroblast division, and heme synthesis, thus acting to
improve the status of the blood in megaloblastic anemia.
PHARMACOKINETICS
Single
Dose
Administration:
After
oral
administration
of
single dose of 500 mcg and 1500 mcg of Mecobalamin to
healthy
adult
subjects,
dose
related
peak
plasma
concentrations were both achieved after 3 hours. From 40-
80% of the cumulative amount of total B12 recovered in the
urine by 24 hours after oral administrations were excreted
within the first 8 hours.
Repeated-Dose Administration: The percentage increase in
the plasma concentration of total B12 were determined in
healthy subjects given an oral daily dose of 1500 mcg of
Mecobalamin for 12 consecutive weeks. The changes in the
plasma level were also measured in the same patients for a
period of the first 4 weeks after the last administration.
The plasma concentration increased for the first 4 weeks
after administration, reaching twice as high as the initial
concentration.
The