GALFER Capsule Ref.[49965] Active ingredients: Ferrous fumarate

(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) Iron and tetracyclines reduce the absorption of each other. Iron reduces absorption of zinc, and absorption of oral iron is reduced by zinc.

(ii) Iron reduces the absorption of penicillamine, fluoroquinolones, levodopa, carbidopa, entacapone, bisphosphonates, and levothyroxine.

(iii) Absorption of iron is reduced with calcium, magnesium and other mineral supplements, bicarbonates, carbonates, zinc and trientine and impaired by antacids, cholestyramine, tea, eggs or milk, but may be increased by ascorbic or citric acid.

(iv) Chloramphenicol delays plasma iron clearance, incorporation of iron into red blood cells and interferes with erythropoiesis.

(v) Reduced hypotensive effect of methyldopa.

Pregnant women also need to take folic acid.

Administration of drugs during the first trimester of pregnancy requires careful assessment of the potential risks versus the benefits to be gained and should not be administered unless clearly indicated. For the remainder of the pregnancy, iron therapy may be indicated but only on the advice of a physician.

No adverse effects of ferrous fumarate have been shown in breastfed infants of treated mothers. Ferrous fumarate can be used during breast-feeding if clinically indicated.

Galfer Capsules do not affect the ability to drive or operate machinery.

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

None stated.