PREGADAY

Adults It is usual to begin therapy with Pregaday Tablets about the thirteenth week of pregnancy (see precautions) either as routine prophylaxis or selectively if the haemoglobin concentration is less than 11g/100ml (less than 75% normal).

One tablet should be taken daily by mouth. Paediatric Population There is no relevant use of Pregaday Tablets in the paediatric population.

Very rare (<1/10,000) Very rare (<1/10,000):

Rarely allergic reactions may occur.

Not known (cannot be estimated from the available data) Not known:

Gastrointestinal disorders Gastro-intestinal discomfort, anorexia, nausea, vomiting, constipation, diarrhoea.

Not known:

Renal and urinary disorders Darkening of the stools 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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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. Some post-gastrectomy patients show poor absorption of iron.

Care is needed when treating iron deficiency anaemia in patients with treated or controlled peptic ulceration. Caution should be exercised when administering folic acid to patients who may have folate dependent tumours. Since anaemia due to combined iron and vitamin B12 or folate deficiencies may be microcytic in type, patients with microcytic anaemia resistant to therapy with iron alone should be screened for vitamin B12 or folate deficiency.

Paediatric population Pregaday Tablets should be kept out of the reach of children.

1. Known hypersensitivity to the product, Vitamin B12 deficiency, paroxysmal nocturnal haemoglobinuria, haemosiderosis, haemochromatosis, active peptic ulcer, repeated blood transfusion, regional enteritis and ulcerative colitis. Pregaday Tablets must not be used in the treatment of anaemias other than those due to iron deficiency.