HAEMO XL CAPSULE (IRON (III) HYDROXIDE POLYMALTOSE COMPLEX)

Country: Malaysia

Language: English

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

Active ingredient:

Iron (III) Hydroxide polymaltose complex

Available from:

UNIMED SDN BHD

INN (International Name):

Iron (III) Hydroxide polymaltose complex

Units in package:

30 Capsules

Manufactured by:

XL Laboratories Pvt. Ltd.

Patient Information leaflet

_Consumer Medication Information Leaflet (RiMUP) _
1
HAEMO XL CAPSULE (IRON (III) HYDROXIDE
POLYMALTOSE COMPLEX 370MG EQ. TO ELEMENTAL IRON
100MG)
WHAT IS IN THIS LEAFLET
1.
What
_Haemo XL Capsule _
is used
for
2.
How
_Haemo XL Capsule _
works
_3._
_ _
Before you use
_Haemo XL _
_Capsule _
_4._
_ _
How to use
_Haemo XL Capsule _
5.
While you are using it
6.
Side effects
_7._
_ _
Storage and Disposal of
_Haemo _
_XL Capsule _
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT IS _HAEMO XL CAPSULE _USED
FOR
_Haemo XL Capsule _
contains Iron
(III) Hydroxide Polymaltose
Complex. It is used for treatment
& prevention of Iron deficiency in
pregnancy (after first 13 weeks)
and Iron deficiency anaemia.
HOW _HAEMO XL CAPSULE _WORKS
_Haemo XL Capsule _
is involved
in the formation and functioning
of red blood cells.
BEFORE YOU USE _HAEMO XL CAPSULE _
-
_When you must not use it _
•
If you are allergic to iron or any
of the ingredients in
_Haemo XL _
_Capsule. _
•
If you are having hemosiderosis,
hemochromatosis, thalassemia,
sideroachresticanaemia, or lead-
induced anaemia.
•
If you are having anaemia
not caused by iron
deficiency
(haemolyticanaemia or
megaloblastic anaemia due
to vitamin B12 deficiency
Do not use this medicine if any of the
above applies to you. If you are not
sure, talk to your doctor or
pharmacist before using
_Haemo XL _
_Capsule_
.
-
_Before you start to use it _
Please make sure you have
understood the explanation given by
your doctor or pharmacist before
taking this medicine. Speak to your
doctor/pharmacist if you have one of
following conditions:
•
If you have hemosiderosis,
hemochromatosis, thalassemia,
sideroblastic anaemia, chronic
haemolysis, or lead-induced
anaemia.
-
_Taking other medications _
Please tell your doctor or pharmacist
if you are taking or have recently
taken any other medicines. This
includes medicines that you buy
without a prescription, herbal
medicines, dietary supplements or
vitamins. This is especially

Summary of Product characteristics

PL00000-00
Size: 165x120 mm
165.00 mm
120.00 mm
COMPOSITION:
Each hard gelatin capsule contains:
Iron (III) Hydroxide Polymaltose Complex
Eq. to elemental Iron 100mg
PHARMACODYNAMICS:
The polynuclear iron (III)-hydroxide cores are supercially
surrounded by a
number of non-covalently bound polymaltose molecules resulting in an
overall complex molecular mass (Mw) of approximately 50 kD, which is
so
large that diffusion through the membrane of mucosa is about 40 times
smaller than that of the hexaqua-iron(II) units.
The complex is stable and does not release ionic iron under
physiological
conditions. The iron in the poly-nuclear cores is bound in a similar
structure
as in the case of physiologically occurring ferritin. Due to this
similarity, only
the iron (III) of the complex is absorbed by an active absorption
process. By
means of competitive ligand exchange, any iron binding protein in the
gastro-
intestinal uid and on the surface of the epithelium, take up iron
(III). The
absorbed iron is stored mainly in the liver, where it is bound to
ferritin. Later
in the bone marrow, it is incorporated into haemoglobin.
Iron (III)-Hydroxide Polymaltose Complex has no pro-oxidative
properties
such as there are in iron II) salts. The susceptibility of
lipoproteins such as
Very Low Density Lipoprotein (VLDL) + Low Density Lipoprotein (LDL) to
oxidation is reduced. Iron (III) Hydroxide Polymaltose Complex does
not
cause teeth staining.
PHARMACOKINETICS:
Studies using the twin-isotope technique (55Fe and 59Fe) show that
absorption of iron measured as haemoglobin in erythrocytes is
inversely proportional to the dose given (the higher the dose, the
lower the absorption). There is a statistically negative correlation
between the extent of iron deciency and the amount of iron
absorbed (the higher the
iron deciency, the better the absorption). The highest absorption
of iron is in the duodenum and jejunum. Iron which is not absorbed is
excreted via the faeces. Excretion via the exfoliation of the
epithelial cells of
the ga