FERROUS FUMARATE Film-coated tablet Ref.[7682] Active ingredients: Ferrous fumarate

Some post gastrectomy patients show poor absorption of iron. Care is needed when treating patients with iron deficiency anaemia in patients with treated or controlled peptic ulceration. Duration of treatment of uncomplicated iron deficiency anaemia should not usually exceed 6 months (or 3 months after reversal of the anaemia has been achieved).

Since anaemia due to combined iron and vitamin B12 or folate deficiencies may be microcytic in type, patients with microytic anaemia resistant to therapy with iron alone should be screened for vitamin B12 or folate deficiency.

Paediatric Population

Ferrous Fumarate tablets should be kept out of the sight and reach of children.

The label will state:

Important Warning: Contains Iron.

Keep out of the sight and reach 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.

This medicine contains less than 1 mmol sodium (23 mg) per dosage, that is to say essentially ‘sodium-free’.

Iron reduces the absorption of penicillamine, bisphosphonates, ciprofloxacin, entacapone, levodopa, levofloxacin, levothyroxine (thyroxine) (give at least 2 hours apart), moxifloxacin, mycophenolate, norfloxacin, ofloxacin, zinc. Absorption of both iron and antibiotic may be reduced if Ferrous Fumarate tablet is given with tetracycline. Absorption of oral iron is reduced by calcium salts, Magnesium salts (as magnesium trisilicate), Trientine.

Chloramphenicol delays plasma iron clearance, incorporation of iron into red blood cells and interferes with erythropoiesis. Some inhibition of iron absorption may occur if it is taken with cholestyramine, tea, eggs or milk.

Avoid concomitant use of iron with dimercaprol.

Oral iron antagonises hypotensive effect of methyldopa.

Pregnancy

Ferrous fumarate tablets can be used during pregnancy if clinically indicated.

Breast-feeding

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

Not relevant.

The following adverse reactions are classified by system organ class and ranked under heading of frequency using the following convention:

Not known: frequency cannot be estimated from the available data

Gastrointestinal disorders:

• Gastro-intestinal irritation and darkening of stools can occur with iron salts. Nausea and epigastric pain are dose-related but the relationship between dose and altered bowel habit (constipation or diarrhoea) is less clear. Oral iron, particularly modified-release preparations, can exacerbate diarrhoea in patients with inflammatory bowel disease; care is also needed in patients with intestinal strictures and diverticular disease.
• Iron preparations taken orally can be constipating, particularly in older patients and occasionally lead to faecal impaction.
• If side-effects occur, the dose may be reduced; alternatively, another iron salt may be used but an improvement in tolerance may simply be a result of a lower content of elemental iron.

Paediatric population

Iron preparations are a common cause of accidental overdose in children.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

Not applicable.