FERROUS SULPHATE TABLETS BP 200mg

Each tablet contains 200mg Dried Ferrous Sulphate BP equivalent to 65mg elemental iron.

This product also contains glucose, sucrose and lactose.

For full list of excipients see Section 6.1.

Sugar-coated tablet.

White, circular, biconvex sugar-coated tablets.

1) For the prevention and treatment of iron-deficiency anaemias.

Each 200mg ferrous sulphate tablet is equivalent to 65mg of ferrous iron.

Children 6-12 years:

Treatment: Children weighing over 22kg – one tablet daily.

Children weighing over 44kg – one tablet twice daily.

Children weighing over 66kg – one tablet three times daily.

Children under 6 years or weighing less than 22kg: Not recommended.

Method of Administration

For oral administration.

Hypersensitivity to any ingredients in the formulation; patients receiving repeated blood transfusions; concomitant parenteral iron; haemochromatosis and other iron overload syndromes.

Administer with caution in patients with haemolytic anaemia, haemoglobinopathies, iron-storage or iron-absorption diseases, existing gastrointestinal disease.

Patients with rare heriditary problems of galactose intolerance or fructose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

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.

Concurrent administration with tetracyclines may impair absorption of both agents. The absorption of ciprofloxacin, norfloxacin and ofloxacin is reduced by oral iron. Cholestyramine may bind iron to the gastrointestinal tract, thus preventing its absorption. The absorption of iron salts is also decreased in the presence of antacids, preparations containing zinc, calcium, phosphorus, trientine, or when taken with tea, coffee, milk, eggs and whole grains. Iron supplements should not be taken within one hour before or two hours after ingestion of these products. Iron salts may reduce the bioavailability of methyldopa. The absorption of levodopa and penicillamine may be reduced. Absorption of iron salts is enhanced by ascorbic acid and meat.

No special requirements are to be anticipated.

None known.

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.

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 sulphate 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 sulphate is used in the treatment of iron deficiency anaemias.

Iron preparations have no intrinsic therapeutic activity except as a nutrient source: their use without evidence of iron deficiency, or reasonable expectation of its occurrence, is to be deprecated. Iron, in excess, is toxic and haemochromatosis may result from chronic injection of iron preparations used as tonics, especially in individuals with undiagnosed blood disorders. Patients with chronic anaemia are particularly at risk from iron storage disease. Recently a severe iron overload myopathy has been described in patients given prophylactic iron indiscriminately while receiving haemodialysis. Genetic factors probably contribute to the risk of iron overload.

It should be clear that although iron deficiency is readily treated, its detection does not constitute a complete diagnosis. Every effort should be made to determine why the patient has entered a state of negative iron balance. Attention should be given to hidden sources of haemorrhage (which may indicate serious urinary or gastrointestinal conditions) and also the possibility of malabsorption of iron caused by latent disease of the small intestine.

Iron is irregularly and incompletely absorbed from the gastrointestinal tract, the main sites of absorption being the duodenum and jejunum. Absorption is aided by the acid secretion of the stomach or by dietary acids and is more readily effected when the iron is in the ferrous state or is part of the haem complex (haem-iron). Absorption is also increased in conditions of iron deficiency or in the fasting state but is decreased if the body stores are overloaded. Only about 5-15% of the iron ingested in food is normally absorbed.

Not applicable.

The tablet core contains:

Spray dried liquid glucose

Stearic acid

Magnesium stearate

Microcrystalline cellulose (101) (E460)

Lactose granules containing lactose

Maize starch

Pregelatinised maize starch

The coating contains:

Purified talc (E553)

Acacia (E414)

Gelatin

Sucrose

Titanium dioxide (E171)

Beeswax

The tablets may also contain:

Yellow carnauba wax

Polysorbate

Sorbic acid (E200)

None known.

Shelf-life

Two years from the date of manufacture.

Shelf-life after dilution/reconstitution

Not applicable.

Shelf-life after first opening

Not applicable.

Store below 25°C in a dry place.

Child-resistant blister pack: (i) 250µm white rigid PVC (ii) 9µm soft aluminium / 35g/m² glassine paper. Compliant with BS8404.

Pack size: 28, 30, 60.

PE tablet container with a child-resistant PP closure. Compliant with ISO8317.

Pack size: 30, 60, 100.

Not applicable.

Actavis UK Limited

(Trading styles: Actavis)

Whiddon Valley

BARNSTAPLE

N Devon EX32 8NS

PL 0142/6422 R

July 1990 (Renewed February 1999)

04.04.11

Not applicable.

Not applicable.