FERROUS FUMARATE

Posology Adults and the elderly:

One tablet daily (the foil enclosing the tablet is printed with days of the week in sequence). In severe or refractory iron deficiency, one tablet may be given twice a day.

Paediatric population:

Ferrous Fumarate tablets are not intended for the treatment of children.

Method of administration:

Oral

The following adverse reactions are classified by system organ class and ranked under heading of frequency using the following convention: Rare (≥1/10 000 to <1/1 000): Immune system disorders: • Allergic reactions. 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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’.

1. Paroxysmal nocturnal haemoglobinuria, haemosiderosis, haemochromatosis, active peptic ulcer, repeated blood transfusions, regional enteritis, and ulcerative colitis. Ferasday tablets must not be used in anaemias other than those due to iron deficiency.