FERROGRAD Prolonged release tablet Ref.[49982] Active ingredients: Ferrous sulfate

The label will state “Important warning: Contains iron. Keep out of 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.

As with all iron preparations, this product should be used with caution in patients with haemochromatosis, haemolytic anaemia or haemoglobinopathies. The sustained release tablet and its inert plastic matrix may cause a safety hazard in patients suffering from delayed intestinal transit. There may also be a further delay in release of the iron.

Caution is advised in individuals with a family history of haemochromatosis or iron overload syndromes. It should be noted these conditions may be underdiagnosed. Overdose may be fatal.

Ferrograd contains the colour E110, which may cause allergic type reactions including asthma; allergy is more common in those people who are allergic to aspirin.

This product should only be used for the prevention and treatment of iron deficiency anaemia diagnosed by laboratory testing under the supervision of a medical doctor.

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.

Iron salts diminish the absorption of tetracyclines.Tetracycline antibiotics should be taken at least 2 hours before or 3 hours after taking Ferrograd.

Concurrent administration of oral iron preparations may interfere with the oral absorption of some quinolone anti-infective agents (e.g. ciprofloxacin, norfloxacin, ofloxacin), resulting in decreased serum and urine concentrations of the quinolones. Therefore, oral iron preparations should not be ingested within one hour before or within four hours of a dose of an oral quinolone.

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

Iron salts may reduce the bioavailability of metyldopa, the absorption of levodopa and penicillamine may also be reduced.

The absorption of iron salts is decreased in the presence of antacids and preparations containing zinc, calcium, phosphorus or when taken with tea, coffee, milk, eggs, wholegrain cereals and dietary fibre. Therefore, oral iron preparations should not be taken within one hour before or two hours after ingestion of these products. Iron absorption may be increased by ascorbic or citric acid.

Iron containing products if required, should be used during pregnancy after the first 13 weeks.

Iron is excreted in breast milk so consult your doctor if you intend breast feeding.

Ferrograd has no influence on the ability to drive and use machines.

Those associated with conventional oral iron preparations, i.e. nausea, vomiting, abdominal pain or discomfort, diarrhoea and/or constipation, are less likely to occur because of the sustained release nature of the formulation. Haematemesis and ileus have been reported.

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).

Respiratory, thoracic and mediastinal disorders: Bronchial stenosis (see section 4.4)

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.

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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

Not applicable.