REXOM VITAMIN B-12 TABLET 50MCG

Country: Malaysia

Language: English

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

Active ingredient:

Cyanocobalamin

Available from:

KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.

INN (International Name):

Cyanocobalamin

Units in package:

100 Tablets; 100 Tablets; 1000 Tablets; 100 Tablets; 1000 Tablets

Manufactured by:

KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
REXOM TM VITAMIN B-12 TABLET 50MCG
Cyanocobalamin (Vitamin B12) (50 mcg)
1
WHAT IS IN THIS LEAFLET
1.
What REXOM
TM
Vitamin B-12 is
used for
2.
How
REXOM
TM
Vitamin
B-12
works
3.
Before you use REXOM
TM
Vitamin
B-12
4.
How to use REXOM
TM
Vitamin B-
12
5.
While
you
are
using
REXOM
TM
Vitamin B-12
6.
Side effects
7.
Storage and disposal of REXOM
TM
Vitamin B-12
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT REXOM
TM VITAMIN B-12 IS USED
FOR
REXOM
TM
Vitamin B-12 is used to treat
vitamin
B-12
deficiency
of
dietary
origin.
HOW REXOM
TM VITAMIN B-12 WORKS
REXOM
TM
Vitamin
B-12
contains
cyanocobalamin which is vitamin B-12.
It helps to treat vitamin B-12 deficiency
in the body.
BEFORE YOU USE REXOM
TM VITAMIN
B-12
_-When you must not use it _
Do not take this medicine if you have:
•
An allergy to any of the ingredients
listed in this leaflet.
•
It should not be given to individuals
without first confirm the diagnosis.
•
It
should
not
be
used
to
treat
megaloblastic anemia (blood disorder)
of pregnancy.
_-Before you start to use it_
_Pregnancy and lactation_
Talk to you doctor before taking this
medicine
if
you
are
pregnant,
might
become pregnant or are breastfeeding.
_-Taking other medicines _
Inform your doctor or pharmacist before
taking this medicines, including any that
you get without a prescription from your
pharmacy, supermarket or health food
shop.
Some
medicines
and
REXOM
TM
Vitamin B-12 may interfere with each
other.
They
may
be
affected
by
REXOM
TM
Vitamin B-12 or may affect
how well it works.
Absorption
may
be
reduced
by
Para-
aminosalicyclic
acid,
colchicine
,
biguanides,
neomycin,
cholestyramine,
potassium
chloride,
methyldopa
and
cimetidine.
Patient
treated
with
Chloramphenicol
may respond poorly to this medicine.
HOW TO USE REXOM
TM VITAMIN B-12
_-How much to use _
Always use REXOM
TM
Vitamin B-12
exactly as your doctor has prescribed.
You should check with your doctor or
pharmacist if in doubt.
Th

Summary of Product characteristics

REXOM
TM VITAMIN B-12 TABLET 50MCG
NAME AND STRENGTH OF ACTIVE INGREDIENT(S)
Each tablet contains:
Cyanocobalamin…………………...……………………………………….………..50
mcg
PRODUCT DESCRIPTION
Pink colour, round with top score tablet
PHARMACODYNAMICS
This medicine contain cyanocobalamin vitamin B-12, which is used for
the treatment of
pernicious anaemia, and nutritional deficiencies of vitamin B-12 which
results in macrocytic
anaemia.
PHARMACOKINETICS
Absorption
The absorption of cobalamins from the gut is dependent upon the
glycoprotein intrinsic
factor.
Distribution
Cobalamins are transported rapidly into the blood bound to protein,
known as
transcobalamins.
Elimination
Cobalamins are stored in the liver and excreted in the bile. They are
known to cross the
placenta.
INDICATIONS
Vitamin B-12 deficiency of dietary origin
RECOMMENDED DOSE
Adults and Elderly: One to three tablets daily.
Children: One tablet daily.
REXOM
TM
Vitamin B-12 tablet should be swallowed with water and taken between
meals.
Do not stop taking this medicine, except from doctor’s advice. Your
doctor may change the
dose, depending on how you react to it.
ROUTE OF ADMINISTRATION
Oral.
CONTRAINDICATIONS
Hypersensitivity to the product or any of the excipients.
WARNING AND PRECAUTIONS
For pernicious anaemia, an adequate dose must be used and the blood
picture must be
examined regularly at least every three months for 18 months until
stabilised, and then
annually.
Indiscriminate administration of this medicine may mask precise
diagnosis.
Patients with rare hereditary problems of galactose intolerance, total
lactase deficiency or
glucose-galactose malabsorption should not take this medicine.
INTERACTIONS WITH OTHER MEDICAMENTS
Absorption may be reduced by Para-aminosalicylic acid, colchinine,
biguanides, neomycin,
cholestyramine, potassium chloride, methyldopa, and cimetidine.
Patients treated with chloramphenicol may respond poorly to this
medicine.
Serum levels of this medicine may be lowered by oral contraceptives.