Methycobal 500mcg Tablets

מדינה: מלזיה

שפה: אנגלית

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

מרכיב פעיל:

Mecobalamin

זמין מ:

EISAI (MALAYSIA) SDN BHD (18039-D)

INN (שם בינלאומי):

Mecobalamin

יחידות באריזה:

100 Tablets

תוצרת:

Bushu Pharmaceuticals Ltd. Misato factory

עלון מידע

METHYCOBAL
®
TABLET 0.5MG
Mecobalamin (0.5mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_Methycobal®_
is used for
2.
How
_Methycobal®_
_ _
works
3.
Before you use
_Methycobal®_
4.
How to use
_Methycobal®_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Methycobal®_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _METHYCOBAL®_
_ _
IS USED FOR
_Methycobal®_
is intended for peripheral
neuropathies (refers to the conditions that
result when nerves that carry messages to
and from the brain and spinal cord from
and to the rest of the body are damaged
or diseased).
HOW _METHYCOBAL®_
_ _
WORKS
_Methycobal®_
is a kind of coenzyme B
12
naturally
found
in
our
body.
It
is
transported to nerve cells and promotes
production of nucleic acid, protein and
phospholipid.
_Methycobal®_
normalizes
neurological function for sustenance of
healthy nervous system.
BEFORE YOU USE _METHYCOBAL®_
-
_When you must not use it _
Do
not
take
_Methycobal®_
if
you
are
allergic
to
mecobalamin
or
any
other
ingredient in this product.
_ _
_Pregnancy and lactation _
Do
not
take
_Methycobal®_
if
you
are
pregnant, trying to get pregnant or think
you may be pregnant.
Do
not
take
_Methycobal®_
if
you
are
breast-feeding.
Ask
your
doctor
or
pharmacist for advice before taking any
medicine.
_ _
-
_Before you start to use it _
Consult your doctor or pharmacist before
starting to use this product.
-
_Taking other medicines _
Tell your doctor or pharmacist if you are
taking
any
other
medicines,
including
any that you buy without a prescription
from a pharmacy, supermarket or health
food shop.
HOW TO USE _METHYCOBAL®_
-
_How much to use _
The usual daily dose for adults is 1 tablet
taken 3 times daily.
-
_When to use it _
Use
as
directed
by
your
doctor
or
pharmacist.
-
_How long to use it _
Use
for
as
long
as
directed
by
your
doctor or pharmacist.
Stop taking
_Methycobal®_
_ _
if you see no
results
after
prolonged
consumption
(months)

מאפייני מוצר

A Drug for Peripheral Neuropathies
_ _
TABLETS
(Mecobalamin Preparation)
COMPOSITION
Each tablet contains 500 µg of mecobalamin.
It also contains carnauba wax, microcrystalline cellulose, titanium
oxide, stearic acid, calcium stearate, su-
crose, talc, precipitated calcium carbonate, corn starch, lactose
hydrate, white shellac, hydroxypropylcellulose,
pullulan, povidone, macrogol 6000 and hydrated silicon dioxide as
inactive ingredients.
INDICATIONS
Peripheral neuropathies
DOSAGE AND ADMINISTRATION
The usual daily dose for adults is 3 tablets, equivalent to a total of
1,500 µg of mecobalamin, administered
orally in 3 divided doses. The dose may be adjusted according to the
age of patient and severity of symptoms.
PRECAUTIONS
1.
GENERAL
Methycobal should not be administered for extensive periods (months)
to patients who show no clinical
response.
2.
PRECAUTIONS CONCERNING USE
CAUTION IN HANDING OVER DRUG
For drugs that are dispensed in a press-through package (PTP),
instruct the patient to remove the drug
from the package prior to use. [It has been reported that, if the PTP
sheet is swallowed, the sharp corners
of the sheet may puncture the esophageal mucosa, causing perforation
and resulting in serious complica-
tions such as mediastinitis.]
3.
OTHER PRECAUTIONS
Prolonged use of larger doses of Methycobal is not recommended for
patients whose occupation requires
handling mercury or its compounds.
ADVERSE REACTIONS
Adverse reactions were reported in 146 of 15,180 patients (0.96%). (At
the end of the investigation for inci-
dence of adverse reactions)
5% >

0.1%
<0.1%
Gastrointestinal
Anorexia, nausea/vomiting and diarrhea
Hypersensitivity
note)
Rash
Note) In the event of such symptoms, Methycobal should be
discontinued. PHARMACOLOGY
1.
MECOBALAMIN IS A KIND OF ENDOGENOUS COENZYME B
12
Mecobalamin plays an important role in transmethylation as a coenzyme
of methionine synthetase in the
synthesis of methionine from homocysteine.
2.
MECOBALAMIN IS WELL TRANSPORTED TO NERVE CELL ORGANELLES, AND PROMOTES
NUCLEIC A