GALFER

For oral administration.

Adults and children over 12 years:

Prophylaxis: one capsule daily. Treatment: one capsule twice daily.

Children under 12 years:

Not recommended.

Elderly patients:

The adult dose is appropriate.

Pregnant women during the second trimester onwards:

The adult dose is appropriate.

Anorexia, nausea, vomiting, gastro-intestinal discomfort, constipation, diarrhoea, dark stools and allergic reactions. These side-effects may be minimised by taking the capsules after food. Iron preparations can be particularly constipating in older patients and occasionally lead to faecal impaction.

Iron preparations can also exacerbate diarrhoea in patients with inflammatory bowel disease; care should be taken with patients who have intestinal strictures or diverticular disease. Haemosiderosis may occur as a result of excessive or mistaken therapy.

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.

(i) Patients post-gastrectomy have poor absorption of iron. (ii) Caution is advised when prescribing iron preparations to individuals with history of peptic ulcer. (iii) Duration of treatment should generally not exceed 3 months after correction of anaemia.

(iv) Co-existing deficiency of vitamin B12 or folic acid should be ruled out since combined deficiencies produce microcytic blood film. (v) Iron deficiency in a male patient warrants careful investigation to determine its cause which forms the basis of primary treatment.

(vi) Iron preparations colour the faeces black, which may interfere with tests used for detection of occult blood in the stools. (vii) Prolonged or excessive use in children without medical supervision may lead to toxic accumulation 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.

(i) Hypersensitivity to the product or ingredients. (ii) Haemosiderosis and haemochromatosis. (iii) Active peptic ulcer. (iv) Repeated blood transfusion. (v) Inflammatory bowel disease, including regional enteritis and ulcerative colitis, intestinal strictures and diverticulae (vi) Anaemias other than those due to iron deficiency.

(vii) Haemoglobinopathies (viii) Concomitant use with parenteral iron (ix) Concomitant use with dimercaprol