FERROGRAD C

Adults including the elderly 1 tablet daily. Take before food. Children Not recommended for children under 12 years. Above this age, as for adults.

Method of administration:

The tablets should not be sucked, chewed or kept in the mouth, but swallowed whole with water. Tablets should be taken before meals or during meals, depending on gastrointestinal tolerance.

e. nausea, vomiting, abdominal pain or discomfort, blackening of stools, diarrhoea and/or constipation, but the incidence of side-effects is less owing to the prolonged release nature of the formulation. Isolated cases of allergic reaction have been reported ranging from rash to anaphylaxis.

Gastrointestinal disorders:

Not known: nausea, vomiting, abdominal pain or discomfort, blackening of stools, diarrhoea and/or constipation, 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).

Ascorbic acid is usually well tolerated. However, large doses are reported to cause diarrhoea and other gastrointestinal disturbances and are associated with the formation of renal calcium oxalate calculi. 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Ferrograd C tablets should be kept out of children's reach. Acute iron poisoning occurs rarely in adults, however it could happen if children swallow this medication.

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. The prolonged release tablet and its inert plastic matrix may cause a safety hazard in some elderly or other patients suffering from delayed intestinal transit.

Iron preparations colour the faeces black, which may interfere with tests used for detection of occult blood in the stools. The guaiac test occasionally yields false positive tests for blood. 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 iron 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.

Intestinal diverticular disease or any intestinal obstruction. Iron preparations are contra-indicated in patients with haemochromatosis and haemosiderosis. Iron is contra-indicated in patients receiving repeated blood transfusions. Oral iron preparations are contra-indicated when used concomitantly with parenteral iron therapy.