FERROGRAD FOLIC

Adults including the elderly 1 tablet daily throughout pregnancy and the first month of the puerperium. Take before food. Children Not recommended for children under 12 years.

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.

Allergy is more common in those people who are allergic to aspirin. Allergic sensitisation has been reported following both oral and parenteral administration of folic acid. 4) 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. 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 Folic 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 controlled release tablet and its inert plastic matrix may cause a safety hazard in some elderly or other patients suffering from delayed intestinal transit.

Pernicious anaemia is rare in women of childbearing age and is less likely in pregnancy as vitamin B12 deficiency reduces fertility. However, folic acid, at the recommended dosage, may obscure the neurological manifestations of pernicious anaemia.

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. This product contains the excipient lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Megaloblastic anaemia due to primary vitamin B12 deficiency. Ferrograd Folic is contraindicated in patients with pernicious anaemia. 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. Ferrograd Folic is contraindicated in the rare instance of hypersensitivity to folic acid.