Indications

For the treatment of iron-deficiency anaemia. For the treatment of folate deficient megaloblastic anaemia due to malnutrition, malabsorption syndromes and increased utilisation as in pregnancy. For the prophylaxis of drug induced folate deficiency e.g. caused by administration of phenytoin, phenobarbital and primidone. For the prophylaxis against folate deficiency in chronic haemolytic states or in renal dialysis. For the prevention of neural tube defects for women planning a pregnancy and known to be at risk

Dosage and Administration

Usage:Oral

The usual recommended dose for non-pregnant and pregnant is one tablet once a day. It has to be taken on an empty stomach, at least 1 hour before or 2 hours after a meal.

Precautions & Warning:

1.Ferrous Sulphate tablets should be kept out of children reach. Acute iron poisoning occur rarely in adults; however it could happen if children swallow this medication. 2.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. Ø

3.Before starting treatment, it is important to exclude any underlying cause of the anaemia (e.g. gastric erosion, colonic carcinoma). Ø

4. Patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose – galactose mal absorption should not take this medicine Ø

5. Caution should be exercised when administering Folic Acid to patients who may have folate dependent tumours.

Contraindications:

1. Ferrous Sulphate and Folic Acid are contraindicated in patients with a hypersensitivity to any of the ingredients in the formulation. Ø

2. Iron preparations are contraindicated in patients with haemochromatosis and haemosiderosis. Iron is contraindicated in patients receiving repeated blood transfusions. Ø

3. Oral iron preparations are contraindicated when used concomitantly with parental iron therapy. Ø

4. Long-term folate therapy is contraindicated in any patient with untreated cobalamin deficiency.

5. Folic acid should not be used in malignant disease unless megaloblastic anaemia owing to folate deficiency is an important complication.

Adverse Reactions:

1. Large doses may produce gastro-intestinal irritation, nausea, vomiting, epigastric pain, diarrhoea abdominal distension and flatulence and anorexia

2. Constipation may be caused by continual administration; iron supplementation may cause the blackening of stool. Ø

3. Hypersensitivity reactions have been reported. These ranges from rashes, sometimes severe, to anaphylaxis, erythema, pruritus, urticaria and dyspnoea.

Drug interactions:

1. Ferrous Sulphate reduces absorption of tetracyclines, ciprofloxacin, levofloxacin, norfloxacin, ofloxacin, bisphosphates, zinc salts and penicillamine. It may also reduce the absorption of entacapone and levodopa.

2. The absorbtion of ferrous sulphate is reduced by magnesium trisilicate, trientine, zinc and tetracyclines.

3. Ferrous Sulphate also reduces the hypotensive effect of methyldopa. Ø

4. If folic acid supplements are given to treat folate deficiency, which can be caused by the use of antiepileptics (phenytoin, phenobarbital and primidone), the serum antiepileptic levels may fall, leading to decreased seizure control in some patients.

5. Chloramphenicol and co-trimoxazole may interfere with folate metabolism. ØSulfasalazine can reduce the absorption of folic acid. Ø

6. Folic acid may interfere with the toxic and therapeutic effects of methotrexate.

Storage instructions:

Store at a temperature not exceeding 25°C in a dry place. Protect from light.