For the prevention and treatment of iron-deficiency anaemias.

The recommended dose is Adults and the elderly
Treatment: 2-3 tablets a day in divided doses.
Prevention: 1 tablet a day.
Children 6-12 years
Children weighing over 22kg: one tablet a day.
Children weighing over 44kg: one tablet twice a day.
Children weighing over 66kg: one tablet three times a day.
Children under 6 years or weighing less than 22kg
Not recommended.

Hypersensitivity to the product and its ingredients; haemosiderosis and haemochromatosis; active peptic ulcer; repeated blood transfusion; haemolytic anaemia. Oral and parenteral iron preparations should not be used concomitantly. Patients with rare hereditary problems of fructose intolerance, glucose- galactose malabsorption or sucrase- isomaltase insufficiency should not take this medicine

Patients post-gastrectomy have poor absorption of iron. Caution is advised when prescribing iron preparations to individuals with history of peptic ulcer, and inflammatory bowel disease, including regional enteritis and ulcerative colitis. Care should be taken in patients with intestinal strictures
or diverticulae. Duration of treatment should generally not exceed 3 months after correction of anaemia. Co-existing deficiency of vitamin B12 or folic acid should be ruled out since combined deficiency produces microcytic blood film. Dental caries is a definite risk following long term treatment with this product. These tablets contain sugar and should be administered with care to patients with diabetes. Patients suffering from iron overload are particularly susceptible to infection. Treatment of iron overload should be with caution.
Due to the risk of mouth ulcerations and tooth discolouration, tablets should not be sucked, chewed or kept in the mouth, but swallowed whole with water.
The label will state “Important warning: Contains iron. Keep out of the reach and sight of children, as overdose may be fatal”.
This will appear on the front of the pack within a rectangle in which there is no other information.

Antacids and mineral supplements: Compounds containing calcium, magnesium (including antacids and mineral supplements), bicarbonates, carbonates, oxalates or phosphates may impair the absorption of iron. Administration of iron preparations with such compounds should be separated by at least 2 hours. Antibacterials: Iron and tetracyclines reduce the absorption of each other when administered concomitantly. Administration of iron preparations and tetracyclines should be separated by 2 to 3 hours. Iron may reduce the absorption of quinolones. Administration of iron preparations and quinolones should be separated by at least 2 hours. Chloramphenicol delays plasma clearance of
iron, incorporation into red blood cells by interfering with erythropoiesis.
Biphosphonates: The absorption of biphosphonates is reduced when taken concurrently with iron preparations. Administration should be separated by at least 2 hours.
Cholestyramine: Absorption of iron is impaired by cholestyramine.
Dimercaprol: Concomitant administration of oral iron preparations and dimercaprol should be avoided.
Dopaminergics: Oral iron preparations may reduce the absorption of dopaminergics such as cocareldopa,
entacapone and levodopa.
Food Products: Absorption of iron is impaired by tea, eggs or milk.
Methyldopa: Oral iron preparations may antagonise the antihypertensive effect of methyldopa.
Mycophenolate mofetil: Oral iron preparations significantly reduce the absorption of mycophenolate mofetil.
Penicillamine: Oral iron preparations can reduce the absorption of penicillamine. Also the absorption of iron is impaired by penicillamine.
Thyroid hormone: Ferrous sulfate reduces the absorption of levothyroxine and so should be taken at least 2 hours apart.

Trientine: the absorption of oral iron preparations is reduced by trientine. Administration should be separated by at least 2 hours.
Zinc: iron preparations and zinc preparations can reduce the absorption of each other.

Use of any drug during the first trimester of pregnancy should be avoided if possible. Thus administration of iron during the first trimester requires definite evidence of iron deficiency. Prophylaxis of iron deficiency during the remainder of pregnancy is justified.

No studies on the effect on the ability to drive and use machines have been performed.

Although iron preparations are best absorbed on an empty stomach, they may be taken after food to reduce gastrointestinal side-effects; they may discolour (blacken) stools.
Nausea and epigastric pain are dose related but the relationship between dose and altered bowel habit (constipation, diarrhoea) is less clear.
Iron preparations taken orally may have a constipating effect, particularly in older patients, occasionally leading to faecal impaction.
Post marketing: The following ADRs have been reported during post-marketing surveillance. Thefrequency of these reactions is considered not known (cannot be estimated from the available data).
Gastrointestinal disorders:
Mouth ulceration*
*in the context of incorrect administration, when the tablets are chewed, sucked or kept in the mouth. Elderly patients and patients with deglutition disorders may also be at risk of oesophageal lesions or of bronchial necrosis, in case of false route.

To reports any side effect(s):
• Saudi Arabia
-The National Pharmacovigilance and Drug Safety Centre (NPC)
Fax: +966-11-205-7662
Call NPC at +966-11-2038222, Exts: 2317-2356-2340.
Toll free phone: 19999
E-mail: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc.
• Other GCC States:
− Please contact the relevant competent authority.

Acute iron overdosage can be divided into four stages. In the first phase, which occurs up to 6 hours after oral ingestion, gastrointestinal toxicity, notably vomiting and diarrhoea, predominates.
Other effects may include cardiovascular disorders such as hypotension and tachycardia, metabolic changes including acidosis and hyperglycaemia, and CNS depression ranging from lethargy to coma. Patients with only mild to moderate poisoning do not generally pass this first phase. The second phase may occur at 6-24 hours after ingestion and is characterised by a temporary remission or clinical stabilisation. In the third phase gastrointestinal toxicity recurs together with shock,metabolic acidosis, convulsions, coma, hepatic necrosis and jaundice, hypoglycaemia, coagulation disorders, oliguria or renal failure, and pulmonary oedema. The fourth phase may occur several
weeks after ingestion and is characterised by gastrointestinal obstruction and possibly late hepatic damage.
Overdosage of ferrous salts is particularly dangerous to young children.
Treatment consists of gastric lavage followed by the introduction of 5g desferrioxamine into the stomach. Serum iron levels should be monitored and in severe cases iv desferrioxamine should be given together with supportive and symptomatic measures as required. Gastric lavage with 5% sodium bicarbonate and saline cathartics (eg sodium sulfate 30g for adults); milk and eggs with 5g bismuth carbonate every hour as demulcents. Blood or plasma transfusion for shock, oxygen for respiratory embarrassment. Chelating agents (eg disodium calcium edetate) may be tried (500mg/500ml by continuous iv infusion). Dimercaprol should not be used since it forms a toxic
complex with iron. Desferrioxamine is a specific iron chelating agent and severe acute poisoning in infants should always be treated with desferrioxamine at a dose of 90mg/kg im followed by 15mg/kg per hour iv until the serum iron is within the plasma binding capacity.

ATC CODE: B03A A07
Ferrous Sulfate contains iron. Most of the iron in the body is present as haemoglobin. The remainder is present in the storage forms ferritin or haemosiderin, in the reticuloendothelial system or as myoglobin with smaller amounts occurring in haem-containing enzymes or in plasma bound to transferrin.

Iron is absorbed mainly in the small intestine, but can be absorbed along the entire length of the alimentary canal. It is absorbed most easily in the ferrous state, passing into and through the mucosal cells directly into the blood stream where it is immediately attached to transferrin.

None Stated

Dicalcium Phosphate Anhydrous
Microcrystalline Cellulose (Avicel PH112)
Croscarmellose Sodium
Colloidal Silicon Dioxide-Aerosil 200
Magnesium Stearate
Opadry II Green (85F110045)
Purified Water

Not applicable.

2 years. Discard the bottles 3 months after opening

Do not store above 30 °C.
For HDPE Bottle: Do not use if aluminum seal under closure is broken.

Immediate Container: HDPE 120’s bottle with Duma twist cap
Secondary Container: Carton, label & PIL

No special requirements.