FERROUS GLUCONATE

Adults:

Prevention: Two tablets daily Treatment: Four to six tablets daily in divided doses Children 6-12 years: Prevention and treatment: One to three tablets daily in divided doses. Ferrous gluconate 300 mg coated tablets are best taken about one hour before meals.

Large doses of iron may cause gastro-intestinal discomfort, anorexia, diarrhoea, nausea, heartburn and vomiting. These side effects have been reported to occur in up to 20% or more of patients treated and are related to the amount of elemental iron taken rather than the type of preparation.

Continued administration of Ferrous gluconate may result in constipation and faecal impaction. Darkening of stools may occur. Higher doses of Ferrous gluconate may have irritant and corrosive effects on the gastro-intestinal mucosa and necrosis and perforation may occur; stricture formation may subsequently follow.

Symptoms which may not appear for several hours, include epigastric pain, diarrhoea, vomiting and haematemesis. Circulatory failure may follow if diarrhoea and haemorrhage are severe. Rarely allergic reactions may occur. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.

Large doses may have irritant/corrosive effect on gastro-intestinal mucosa which can lead to necrosis and perforation. Ferrous gluconate should be used with caution in patients with haemolytic anaemia. Care should be exercised in patients with iron-absorption diseases, existing gastro-intestinal disease, intestinal strictures and diverticulae.

Caution is required in the elderly, who may be at risk of serious adverse reactions. This product contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.

g. gastric erosions or colonic carcinoma.

The label will state: “Important warning:

Contains iron. Keep out of the sight and reach 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.

Hypersensitivity to iron preparations or to any of the excipients. Iron preparations are contraindicated in patients with haemochromatosis, haemosiderosis or haemoglobinuria. Iron salts should not be given to patients receiving repeated blood transfusions or parenteral iron therapy or to patients with anaemias not produced by iron deficiency (some conditions, such as thalassemia may cause excess storage of iron).

Alcoholism and hepatitis. Iron preparations are contraindicated in active peptic ulcer, regional enteritis and ulcerative colitis.