Treatment of iron deficiency in adults and adolescents where the use of ferrous iron supplements is not tolerated, or otherwise inappropriate.
Prevention of iron deficiency in adults and adolescents at high risk where the use of ferrous iron supplements is not tolerated, or otherwise inappropriate.”

Adults and Children over 12 years: 10ml, 1 - 2 times daily during or after meals
Children under 12 years: 5ml, 1 - 2 times daily during or after meals
Infants: 2.5-5ml once daily.
IROKID Syrup may be mixed with fruits or vegetable juices or other liquid if desired.
Route of administration
Oral.

- anemias should always be treated under medical supervision.
- All other causes of anemia should be considered and treated prior to initiating therapy with IROKID Syrup
- The response to iron therapy should be regularly monitored.

Studies in rats with tetracycline, aluminum hydroxide, acetylsalicylate, sulfasalazine, calcium carbonate, calcium acetate, calcium phosphate in combination with vitamin D3, bromazepam, magnesium aspartate, D-penicillinamine, methyldopa, paracetamol and auranofin have no interactions with the iron (III) -hydroxide polymaltose complex shown. Likewise, no interactions of the iron (III) hydroxide polymaltose complex with dietary components such as phytic acid, oxalic acid, tannin , sodium alginate, choline and choline salts, vitamin A, vitamin D3 and vitamin E, soybean oil and soybean meal were found in in vitro studies.
These results indicate that the iron (III) hydroxide polymaltose complex can be taken during or immediately after food intake. Interactions of the iron (III) -hydroxide polymaltose complex with tetracycline or aluminum hydroxide were studied in three human studies (cross-over design, 22 patients per study). No significant reduction in the absorption of tetracycline has been shown.
The absorption of iron from iron (III) hydroxide polymaltose complex was not reduced by aluminum hydroxide and tetracycline. The iron (III) hydroxide polymaltose complex can therefore also be administered simultaneously with tetracyclines or other phenolic compounds and with aluminum hydroxide.

Co- administration of parenteral iron preparations and IROKID Syrup is not indicated as the absorption of the oral iron preparation would be massively inhibited and parenteral iron preparations should only be used if oral therapy is not appropriate

This product should only be used in pregnancy after the first thirteen weeks.
Pregnancy Category A
Reproduction studies in animals did not show any foetal risk. Controlled studies in pregnant women after the first trimester have not shown any undesirable effects on mother and neonates. There is no evidence of a risk during the first trimester and a negative influence on the foetus is unlikely.
Breast milk naturally contains iron bound to lactoferrin. It is not known how much iron from the complex is passed into breast milk. The administration of Heafa Tablets is unlikely to cause undesirable effects to the nursed
child. During pregnancy and lactation Heafa Tablets should be used only after consulting a physician.

None stated.

The frequency of side effects described below is divided into very common (≥1 / 10), frequent (<1/10, ≥1 / 100), or uncommon (<1/100, ≥1 / 1000). The most commonly observed adverse reaction is clinically irrelevant stool discoloration (in 23% of patients) due to iron secretion.
- immune system:
Very rare: allergic reactions.

- Gastrointestinal disorders:
Very common: stool discoloration.
Common: diarrhea, nausea, dyspepsia.
Uncommon: abdominal pain, vomiting, constipation, tooth staining.
- skin and subcutaneous tissue
Uncommon: pruritus, rash.
- Disorders of the nervous system
Uncommon: headache. Reporting of suspected reactions:
• Saudi Arabia
The National Pharmacovigilance and Drug Safety Centre (NPC)
o Fax: +966-11-205-7662
o Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.
o Toll free phone: 8002490000
o E-mail: npc.drug@sfda.gov.sa
o Website: www.sfda.gov.sa/npc
• Other GCC States:
− Please contact the relevant competent authority.

In cases of overdosage neither intoxication nor iron overload have been reported to date because the iron from the
active substance Ferric-Hydroxide-Polymaltose Complex is not present in the gastro-intestinal tract as free iron and is
not taken up by the organism by passive diffusion.

The polynuclear iron (III)-hydroxide cores are superficially 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 fluid 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. Heafa tablets do not cause teeth staining.

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 deficiency and the amount of iron absorbed (the higher the iron deficiency, 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 gastro-intestinal tract and the skin as well as perspiration, bile and urine only amount to approximately 1mg of iron per day. For women, iron loss due to menstruation has also to be taken into account.

No LD50 for Ferric hydroxide Polymaltose complex could be determined in animal studies with white mice and rats up to an orally administered dose of 2,000mg of iron per kilogram body weight.

6.1. List of Excipients
Glycerin
Sodium benzoate
Sucrose
Citric Acid Anhydrous
Sodium Citrate
Sorbitol 70% solution
Caramel Toffee Liquid Flavor
Chocolate Liquid Flavor
Purified water

None known

Do not store above 30oC.
Do not refrigerate.

IROKID Syrup is reddish brown coloured syrup with sweet taste and chocolate flavour, available in 100ml pack size, filled in amber glass bottle, sealed with child proof cap. Bottle is packed in a box along with plastic measuring cup and a leaflet.

No special instructions.