NP Ferrous Fumarate 200mg Tablet

Country: Malaysia

Language: English

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

Active ingredient:

FERROUS FUMARATE

Available from:

Noripharma Sdn. Bhd.

INN (International Name):

FERROUS FUMARATE

Units in package:

30 Tablets; 100 Tablets; 300 Tablets; 500 Tablets; 1000 Tablets; 50 Tablets

Manufactured by:

Noripharma Sdn. Bhd.

Patient Information leaflet

_Consumer Medication Information Leaflet (RiMUP)_
_ _
NP FERROUS FUMARATE 200MG TABLET
Ferrous Fumarate 200mg
1 | P a g e
WHAT IS IN THIS LEAFLET?
1.
What
NP
Ferrous
Fumarate
200mg used for
2.
How NP Ferrous Fumarate 200mg
works
3.
Before
you
use
NP
Ferrous
Fumarate 200mg
4.
How to use NP Ferrous Fumarate
200mg
5.
While you are using NP Ferrous
Fumarate 200mg
6.
Side effects
7.
Storage
and
Disposal
of
NP
Ferrous Fumarate 200mg
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision RiMUP
WHAT NP FERROUS FUMARATE 200MG
USED FOR
NP Ferrous Fumarate 200mg are used
for
prophylaxis
and
treatment
iron
deficiency anaemia
The medicine contain a form of iron
called ferrous fumarate. Iron is usually
found in foods and is necessary for the
normal development of red blood cells.
A lack of iron affects the development
of the red blood cells and causes a
reduction in the number of red blood
cells found in the body (iron deficiency
anemia).
HOW NP FERROUS FUMARATE 200MG
WORKS
Ferrous fumarate is an essential body
mineral. It works by providing iron to
the body.
Iron plays a vital role in production of
hemoglobin,
which
is
the
oxygen-
transporting
substance
found
in
red
blood cells. If the diet does not contain
enough iron, the body cannot make
enough
new
red
blood
cells.
This
results in iron deficiency anemia, with
symptoms
such
as
tiredness,
palpitations, and shortness of breath,
dizziness and fainting. To treat iron
deficiency anemia, iron supplements
such
as
this
one
are
needed.
The
increased iron intake allows the body to
increase its production of red blood
cells.
BEFORE
YOU
USE
NP
FERROUS
FUMARATE 200MG
_When you must not use it_
• You are sensitive/allergic to ferrous
fumarate, any other forms of iron or
any other ingredients found in these
tablets
• You have a condition where there is
too much iron build-up in the body
(Hemochromatosis, Hemosiderosis)
•
You
have
any
form
of
anaemia
conditions not due to iron deficiency
• You are undergoing repeated blood
transfusions
_Before y

Summary of Product characteristics

Package Insert
PRODUCT NAME
NP Ferrous Fumarate 200mg Tablet
COMPOSITION
Ferrous Fumarate
200mg/tablet
PRODUCT DESCRIPTION
A brown coloured, round shaped film coated tablet
PHARMACODYNAMICS
Iron and iron salts should be given for the treatment or prophylaxis
of iron deficiency anaemias.
Iron is an essential component in the physiological formation of
haemoglobin, adequate
amounts of which are necessary for effective erythropoiesis and the
resultant oxygen transport
capacity of the blood. A similar function is provided by iron in
myoglobin production. Iron also
serves as a co-factor of several essential enzymes. Ferrous fumarate
is an easily absorbed
source of iron for replacement therapy. It is a salt of ferrous iron
with an organic acid and is less
irritant to the gastro-intestinal tract than salts with inorganic
acids.
PHARMACOKINETICS
Absorption
In the acid conditions of the gastric contents, ferrous fumarate is
dissociated and ferrous ions
are liberated. These irons are absorbed in the proximal portion of the
duodenum.
The ferrous iron absorbed by the mucosal cells of the duodenum is
oxidized to the ferric form,
and this is bound to a protein to form ferritin.
Absorption is most efficient when iron is ingested in its ferrous
rather than ferric form on empty
stomach when taken with food, the amount of iron absorbed may be
reduced by ½ to 1/3 as
when taken on empty stomach.
Distribution
Ferritin in the mucosal cells releases iron into the blood, where it
is bound to transferrin and
passed into the iron stores - liver, spleen, and bone marrow.
Protein binding: Very High
Haemoglobin – High
Myoglobin, enzymes and Transferrin – Low
Ferritin and Hemosiderin – Low
These stores are a reserve of iron for synthesis of hemoglobin,
myoglobin, and iron containing
enzymes.
Excretion:
Iron is lost from the body through loss of cells in urine, faeces,
hair, skin, sputum, nails, and
mucosal cells, and through blood loss.
Ferrous fumarate has the same pattern of absorption and excretion as
dietary iron.
INDICATION
Prophy