Haematinics (iron supplements) / folate supplements.

Ferrous fumarate, folic acid

Each tablets contains Ferrous Fumarate EP 322.00 mg and Folic Acid EP 0.35 mg.

Film-coated tablet

There is evidence that a daily intake of 100mg of elemental iron in the ferrous form is adequate to prevent development of iron deficiency in expectant mothers. If a mild iron deficiency is present when Pregaday administration is started, this will be corrected by increased absorption of iron. The daily folate requirement rises steeply during the final trimester of pregnancy, and evidence of maternal depletion may be found. To ensure normal tissue folate levels in the mother after delivery a daily supplement of about 300 micrograms is required during the second and third trimester of pregnancy. This does not obscure the blood picture of addisonian pernicious anaemia. Pregaday Tablets are indicated during the second and third trimester of pregnancy for prophylaxis against iron deficiency and megaloblastic anaemia of pregnancy. Pregaday Tablets are not intended as a treatment for established megaloblastic anaemia.

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/100 ml (less than 75% normal).

One tablet should be taken daily by mouth.

Children: Not applicable

Not applicable.

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 must not be used in the treatment of anaemias other than those due to iron deficiency.

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.

Pregaday tablets should be kept out of the reach of children.

Iron reduces the absorption of penicillamine. Iron compounds impair the bioavailability of fluoroquinolones, levodopa, carbidopa, thyroxine and bisphosphonates.

Absorption of both iron and antibiotic may be reduced if Pregaday is given with tetracycline.

Absorption of both iron and zinc are reduced if taken concomitantly.

Concurrent administration of antacids may reduce absorption of iron. Co-trimoxazole, chloramphenicol, sulphasalazine, aminopterin, methotrexate, pyrimethamine or sulphonamides may interfere with folate metabolism.

Serum levels of anticonvulsant drugs may be reduced by administration of folate.

Oral 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, trientine, tea, eggs or milk.

Administration of oral iron may increase blood pressure in patients receiving methyldopa.

Coffee may be a factor in reducing iron bioavailability.

Neomycin may alter the absorption of iron.

Gastro-intestinal disorders have been reported including gastro-intestinal discomfort, anorexia, nausea, vomiting, constipation, diarrhoea. Darkening of the stools may occur.

Rarely allergic reactions may occur.

UCB Pharma Limited

(P- Pharmacy)

08 June 2009