HAEMO XL SYRUP (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:

150 ml

Manufactured by:

XL Laboratories Pvt. Ltd.

Patient Information leaflet

_Consumer Medication Information Leaflet (RiMUP) _
HAEMO XL SYRUP (IRON (III) HYDROXIDE
POLYMALTOSE COMPLEX 37MG/ML EQ. TO ELEMENTAL IRON
10MG/ML)
1
WHAT IS IN THIS LEAFLET
1.
What
_Haemo XL Syrup _
is used
for
2.
How
_Haemo XL Syrup _
works
_3._
_ _
Before you use
_Haemo XL _
_Syrup _
_4._
_ _
How to use
_Haemo XL Syrup _
5.
While you are using it
6.
Side effects
_7._
_ _
Storage and Disposal of
_Haemo _
_XL Syrup _
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT IS _HAEMO XL SYRUP _USED
FOR
_Haemo XL Syrup _
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 SYRUP _WORKS
_Haemo XL Syrup _
is involved in
the formation and functioning of
red blood cells.
BEFORE YOU USE _HAEMO XL SYRUP _
-
_When you must not use it _
•
If you are allergic to iron or any
of the ingredients in
_Haemo XL _
_Syrup. _
•
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 _
_Syrup_
.
-
_Before you start to use it _
Please make sure you have
understood the explanation given by
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 important
if you take one of the following
medicines:
•
anti acids
•
tetracycline
_Pregnancy and breast-feeding _
Haemo XL S

Summary of Product characteristics

PL00000-00
Size: 165x120 mm
165.00 mm
120.00 mm
HAEMO XL SYRUP (IRON (III) HYDROXIDE POLYMALTOSE COMPLEX SYRUP)
COMPOSITION:
Each 1ml contains:
Iron (III) Hydroxide Polymaltose Complex
Eq. to elemental Iron 10mg
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