FERROUS FUMARATE

Posology Adults and the elderly:

Iron deficiency anaemia: One tablet two to three times a day.

Prophylaxis:

One tablet once or twice a day.

Paediatric population:

This product is not recommended in children. Method of administration For oral use.

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 most common 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.

Very rare (<1/10,000):

Immune system disorders: Rarely allergic reactions may occur. 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.

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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.

Paediatric population Ferrous Fumarate should be kept out of the 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 prominently on the front face of the packaging. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

1. • Paroxysmal nocturnal haemoglobinuria. • Haemosiderosis, haemochromatosis. • Active peptic ulcer. • Repeated blood transfusions. • Regional enteritis and ulcerative colitis. • Contraindicated in anaemias other than those due to iron deficiency.