B-cobal Film-coated tab

Country: Malaysia

Language: English

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

Active ingredient:

Mecobalamin; Pyridoxine HCL-; THIAMINE HCI

Available from:

AV MANUFACTURING SDN.BHD

INN (International Name):

Mecobalamin; Pyridoxine HCL-; THIAMINE HCI

Units in package:

30 Tablets; 15 Tablets

Manufactured by:

AV MANUFACTURING SDN.BHD

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
B-COBAL FILM-COATED TAB
Mecobalamin/ Vitamin B1/ Vitamin B6 (0.5mg/ 100mg/ 200 mg)
1
WHAT IS IN THIS LEAFLET
1.
What B-cobal is used for
2.
How B -cobal works
3.
Before you use B-cobal
4.
How to use B-cobal
5.
While you are using B-cobal
6.
Side effects
7.
Storage and disposal
8.
Product description
9.
Manufacturer and product
registration holder
10.
Date of revision
1. WHAT B-COBAL IS USED FOR
B-cobal is used for neurological and
other disorders associated with
disturbance of the nerve cell
metabolism in which high dose B-
complex vitamins play a role. These
include: Polyneuritis (inflammation of
several nerves at one time): neuralgias
(pain due to nerve damage) eg: lumbago
(waist pain), sciatica (pain on lower
back, hip to leg), root irritation due to
degenerative changes of the vertebral
column, shoulder arm syndrome (pain,
stiffness of shoulder and arm), herpes
zoster (chicken pox), cervical syndrome
(neck pain), ischialgia (pain in the hip),
etc: diabetic neuropathy, metabolic and
neuropathic changes due to pregnancy
and oral contraceptives: convalescence.
It also treats megaloblastic anemia due
to vitamin B12 deficiency.
2. HOW B-COBAL WORKS?
B-cobal is a combination of the 3
essential neurotropic vitamin B
groups vitamin B1, B6 and B12 are
indispensable to normal nerve cell
metabolism. Vit B1 is involved in
carbohydrate metabolisme and in
nerve transmission. Vit B6 need to
make cells of the immune system.
Mecobalamin acts to repair damaged
nerve tissue in nerve disorders. This
combination greatly enhances their
therapeutic efficacy as compared to
the effect of the respective factors
given individually.
3. BEFORE YOU USE B-COBAL
_-When you must not use it_
If you are allergic to vitamin B,
mecobalamin or any other
ingredients in the product.
_-Before you start to use it_
Read the product instructions
and this leaflet carefully to
understand how this
medication to be taken.
_-Take other medicines_
Talk
to
your
doctor
or
a
pharmacist, if you are taking

t

Summary of Product characteristics

B-COBAL FILM-COATED TABLET
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
Mecobalamin 0.5mg, Vitamin B1 100mg, and Vitamin B6 200mg.
PRODUCT DESCRIPTION: A round, red film-coated tablet with diameter
about 12mm.
PHARMACODYNAMICS:
ACTIONS:
B-cobal is a combination of the 3 essential neurotropic vitamin B
group.
Thiamine (Vit B1) is involved in carbohydrate metabolisme and in nerve
transmission. Pyridoxine (Vit B6) is involved in amino acid
metabolism and in protein metabolism. Thiamine combines with adenosine
triphosphate (ATP) to form a coenzyme, thiamine
pyrophosphate (thiamine diphosphate, cocarboxylase), which is
necessary for carbohydrate metabolism.
The body needs pyridoxine hydrochloride in order to make cells of the
immune system. Pyridoxine hydrochloride helps to improve
immune response to the increase in production of antibodies and also
helps in communicative interactions between cytokines and
chemokines.
Mecobalamin is a B12 containing co-enzyme with an active methyl base.
It participates in transmethylation reactions and is the most
active of all B12 homologs in the body with respect to nucleic acid,
protein and lipid metabolism.
Mecobalamin acts to repair damaged nerve tissue in nerve disorders eg:
axonal degeneration and demylination; and it is involved in
erythroblast maturation, promotion of erythroblast division, and heme
synthesis, thus acting to improve the status of the blood in
megablastic anemia.
Vitamin B1, B6, B12 are indispensable to normal nerve cell metabolism
and this combination greatly enhances their therapeutic
efficacy as compared to the effect of the respective factors given
individually.
PHARMACOLOGY:
(1) _Mecobalamin is a kind of endogenous coenzyme B12:_
As a coenzyme of methionine synthetase, mecobalamin plays an important
role in transmethylation in the synthesis of
methionine from homocysteine.
(2) _ Mecobalamin is well transported to nerve cell organelles, and
promotes nucleic acid and protein synthesis:_
Experiments in rats show that mecobalamin is better transported to
nerve ce