FERROUS FUMARATE

Posology Adults and the elderly:

Iron deficiency anaemia - 1 tablet two to three times a day; prophylaxis - 1 tablet once or twice a day.

Paediatric population:

Not recommended, suggest use of Fersamal syrup. The tablets are easy to swallow but may also be crushed or chewed being almost tasteless.

Rationale:

Taking into account the content of elemental iron and the referenced recommended daily dose of the same in deficiency states and for prophylaxis, the Fersamal dosing is in need of revision. Each Fersamal tablet contains 210mg ferrous fumarate which approximates to 65-70mg of elemental iron- reference: (1) Goodman & Gilman’s The pharmacological Basis of Therapeutics, 10th Edition, page no.

1499 (2) BNF Recommended Doses: (a) Iron Deficiency anaemia: 100 to 200mg elemental iron per day- [reference 1) BNF (2) G&G]. This equates to Fersamal 1 tablet two or three times a day. e. 60 to 120mg elemental iron per day. This equates to Fersamal 1 tablet once or twice daily.

Method of administration:

Oral

The following adverse reactions are classified by system organ class and ranked under heading of frequency using the following convention: Common (≥1/100 to <1/10) Gastrointestinal disorders: The commonest side effects relate to gastrointestinal irritation (nausea, epigastric pain, constipation or diarrhoea).

In the event of these ADRs, it may be helpful to reduce the dose or switch to an alternative iron salt. Darkening of stools may also occur Rare (≥1/10 000 to <1/1 000) Immune system disorders: Allergic reactions. 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 required when treating patients with iron deficiency anaemia who have treated or controlled peptic ulceration. Duration of treatment of uncomplicated iron deficiency anaemia should not usually exceed 6 months (3 months after reversal of the anaemia has been achieved).

Because anaemia due to combined iron and Vitamin B12 or folate deficiencies may be microcytic in type, patients with microcytic anaemia resistant to treatment with iron alone should be screened for Vitamin B12 or folate deficiency.

This medicine contains less than 1 mmol sodium (23 mg) in each tablet that is to say essentially ‘sodium-free’. Paediatric population Fersamal should be kept out of the reach of children.

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.

1. Paroxysmal nocturnal haemoglobinuria. Haemosiderosis, haemochromatosis. Active peptic ulcer. Repeated blood transfusions. Regional enteritis and ulcerative colitis. Must not be used in anaemias other than those due to iron deficiency.