FERRANATE

Posology:

Adults and the elderly: Prophylactic: 2 tablets daily Therapeutic: 4-6 tablets daily in divided doses Paediatric population Posology: Children (ages 6 to 12 years) Prophylactic: 1-2 tablets daily Therapeutic: 3 tablets daily in divided doses Ferrous Gluconate 300 mg Tablets are best taken about 1 hour before meals.

Method of administration:

Oral.

Gastro-intestinal disorders have been reported with large doses of Iron including gastro-intestinal discomfort, epigastric pain, anorexia, nausea, diarrhoea, constipation, 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 results in constipation and faecal impaction. Darkening of the stools may occur. 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. Contact irritation can occur with high doses of Ferrous Gluconate Tablets resulting in erosion or ulceration on the gastro-intestinal mucosa and necrosis, and perforation may occur; stricture formation may subsequently follow particularly if they become lodged in the upper gastrointestinal tract.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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. Caution is required in the elderly, who may be at increased risk of serious adverse reactions.

g. gastric erosions or colonic carcinoma. Care should be exercised in patients with iron-absorption diseases. 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 and care should be exercised in patients with intestinal strictures and 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.

Patients suffering from iron overload are particularly susceptible to infection. Treatment of iron overload should be with caution. Iron preparations colour the faeces black, which may interfere with tests used for detection of occult blood in the stools.

These tablets contain sugar and should be administered with care to patients with diabetes. This product contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

This product also contains azorubine carmoisine (E 122). This may cause allergic reactions.

The label will state: ‘Important warning:

Contains iron. ’ This will appear on the front of the pack within a rectangle in which there is no other information.

1. Iron preparations are contra-indicated in patients with haemochromatosis, iron storage or absorption diseases such as and haemosiderosis or haemoglobinuria. Iron is contraindicated in patients receiving repeated blood transfusions or in patients receiving 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. Ferrous Gluconate Tablets should not be used in patients with anaemia not produced by iron deficiency unless iron deficiency is also present.