FERROUS SULFATE TABLETS Coated tablet Ref.[6380] Active ingredients: Ferrous sulfate

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

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.

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

Before starting treatment, it is important to exclude any underlying cause of the anaemia (e.g. gastric erosion, colonic carcinoma).

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.

Aspiration of ferrous sulfate tablets can cause necrosis of the bronchial mucosa which may result in coughing, haemoptysis, bronchostenosis and/or pulmonary infection (even if aspiration happened days to months before these symptoms occurred). Elderly patients and patients who have difficulties swallowing should only be treated with iron sulfate tablets after a careful evaluation of the individual patient’s risk of aspiration. Alternative formulations should be considered. Patients should seek medical attention in case of suspected aspiration.

Concurrent administration with tetracyclines may impair absorption of both agents. The absorption of ciprofloxacin, norfloxacin and ofloxacin and bisphosphonates 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.

Dimercaprol: Avoid the concomitant use of iron with dimercaprol.

Thyroid hormones: Oral iron reduces the absorption of levothyroxine (thyroxine) thus should be given at least 2 hours apart.

Ferrous salts are recommended for use in pregnancy and lactation, and no contraindications to such are known.

None known.

Although iron preparations are best absorbed on an empty stomach, they may be taken after food to reduce gastrointestinal side-effects.

Large doses may produce gastro-intestinal irritation, nausea, vomiting, epigastric pain, diarrhoea.

Constipation may be caused by continual administration, particularly in older patients, and may lead to faecal impaction.

Iron supplementation may cause the blackening of stool.

Hypersensitivity reactions have been reported. These range from rashes, sometimes severe, to anaphylaxis.

Bronchial stenosis (see section 4.4).

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme (www.mhra.gov.uk/yellowcard).

Post-marketing

The following ADRs have been reported during post-marketing surveillance. The frequency 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 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.

None known.