IROFAS Syrup

Country: Malaysia

Language: English

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

Active ingredient:

Iron(III) Hydroxide Polymaltose Complex; Folic Acid; Ascorbic Acid

Available from:

HEALOL PHARMACEUTICALS SDN. BHD.

INN (International Name):

Iron(III) Hydroxide Polymaltose Complex; Folic Acid; Ascorbic Acid

Units in package:

150 ml

Manufactured by:

GRACURE PHARMACEUTICALS LTD.

Patient Information leaflet

IROFAS SYRUP
_Consumer Medication Information Leaflet (RiMUP)_
1
WHAT IS IN THIS LEAFLET
1.
What
_IROFAS Syrup_
is used for
2.
How
_IROFAS Syrup_
works
3.
Before you use
_IROFAS Syrup_
4.
How to use
_IROFAS Syrup_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_IROFAS _
_Syrup_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT IS _IROFAS SYRUP_ USED FOR
_IROFAS Syrup_
contains Iron (III)
Hydroxide Polymaltose Complex,
Folic Acid and Ascorbic Acid. It is
used for treatment of latent Iron
deficiency and Iron deficiency
anaemia.
HOW _IROFAS SYRUP_ WORKS
_IROFAS Syrup_
is involved in the
formation and functioning of red
blood cells.
BEFORE YOU USE _IROFAS SYRUP_
-
_When you must not use it _
•
If you are allergic to iron or any
of the ingredients in
_IROFAS _
_Syrup. _
•
If you are having hemosiderosis,
hemochromatosis, thalassemia,
sideroblastic anaemia, chronic
haemolysis, or lead-induced
anaemia.
•
If you are receiving repeated
blood transfusions.
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
_IROFAS _
_Syrup_
.
-
_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 are under epileptic
treatment.
•
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:
•
other ferrous preparations
•
anti-acidity stomach drugs
•
tetracycline
•
levodopa
•
methyldopa
•
penicillamine
•
fluoroqu

Summary of Product characteristics

Zinc salts can reduce absorption of iron.
An excessive consumption of tea can inhibit the absorption of iron.
The resorption of folic acid is reduced by ethanol and phenytoin.
Barbiturics, cycloserine and oral contraceptives induce a decrease in
the plasma concentration of folic
acid.
Folic acid antagonists such as methotrexate, pyrimethamine,
trimethoprim and triamterene can induce
anaemia.
Folic acid has an antagonist action with sulfamides.
Some tuberculostatic drugs can interfere with the folic acid action.
PREGNANCY AND LACTATION :
Irofas Syrup does not represent any risk for pregnant and
breastfeeding women at prescribed doses.
SIDE EFFECTS
In addition to its desired action, this medication may cause some side
effects, notably:
It may cause constipation- to prevent this, plenty of water or juice
and more dietary fibre should be
taken.
It may cause nausea or rarely vomiting
It may give stool a black colour
Each person may react differently to a treatment. If one think this
medication may be causing side effects
(including those described here, or others), doctor or pharmacist
should be consulted.
SYMPTOMS AND TREATMENT OF OVERDOSE :
Iron (III) hydroxide Polymaltose has a low toxicity. The preparation
is well tolerated and has a minimal
risk of accidental overdosing. Irofas syrup should not be used more
than prescribed dose. Overdosage
can cause acute iron overloading which may manifest itself as
haemosiderosis. Iron overload refers to
the gradual build up too much iron in the body. It is caused by the
body’s regulatory system failing to keep
iron levels within healthy limits. For most people, iron overload is
not a concern. However, it is a
problem for those who are genetically predisposed to excessive
absorption of iron from digestive tract.
Early symptoms of iron poisoning may include stomach pain, nausea and
vomiting. Gradually, the
excess iron accumulates in internal organs, causing potential fatal
damage to the brain and liver. Early
recognition and treatment is crucial for a better outcome. If it is