Dried Ferrous sulphate equivalent to Ferrous Sulphate (FeSO4):
Manganese sulphate monohydrate:
PHARMACOLOGICAL CLASSIFICATION: A 8.3 Erythropoietics (Haematinics).
PHARMACOLOGICAL ACTION: Ferrous sulphate is one of the most widely used iron salts in the treatment of iron deficiency anaemias. Copper and manganese in trace quantities are thought to enhance the absorption of iron.
INDICATIONS: For the treatment of iron-deficiency anaemias.
DOSAGE AND DIRECTIONS FOR USE: One to two tablets three times a day with or immediately after meals.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS: The oral administration of iron preparations produces gastro-intestinal irritation and abdominal pain with nausea, vomiting, diarrhoea, or constipation. These side-effects are related to the amount of elemental iron taken. Side-effects may be reduced by administration immediately after food or by beginning therapy with a small dose and increasing gradually. Continued use may cause constipation and the faeces may be coloured black. Iron salts should not be given to patients receiving repeated blood transfusions or to patients with anaemias not produced by iron deficiency unless iron deficiency is also present. Oral iron therapy should not be administered concomitantly with parenteral iron. Care should be taken when given to patients with iron-storage or iron-absorption diseases, haemoglobinopathies, or existing gastro-intestinal disease.
The absorption of iron salts and tetracyclines is diminished when they are taken concomitantly by mouth. If treatment with both drugs is required, the iron salt should be administered 2 hours before or 3 hours after the tetracycline. The absorption of iron salts may also be decreased by some antacids. Iron salts reduce the effects of penicillamine. The response to iron may be delayed in patients receiving concomitant chloramphenicol therapy.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: Iron overdosage may have corrosive effects on the gastro-intestinal mucosa; necrosis and perforation may occur; stricture formation may subsequently follow. Symptoms which may not appear for several hours include epigastric pain, diarrhoea, vomiting and haematemesis. Circulatory failure may follow if the diarrhoea and haemorrhage are severe. Hours or days later, after apparent recovery, metabolic acidosis, convulsions, and coma may occur. If the patient survives, symptoms of acute liver necrosis may develop and may lead to death due to hepatic coma.
Iron overload with increased storage of iron in various tissues (haemosiderosis) may occur as a result of excessive oral and parenteral therapy or multiple blood transfusions. Patients mistakenly given iron therapy when not suffering from iron-deficiency anaemia are also at risk as are those with pre-existing iron storage or absorption diseases. Empty the stomach immediately by emesis and lavage using a 1 to 5 % solution of sodium bicarbonate, and leave about 300 mL of the solution in the stomach. Fluid loss should be replaced by intravenous administration of compound sodium lactate injection or sodium chloride and dextrose injection. Treatment is supportive and symptomatic.
IDENTIFICATION: White sugar-coated tablets.
PRESENTATION: Packs of 500, 1000 and 5000 tablets.
STORAGE INSTRUCTIONS: Store below 25°C. Protect from light and moisture.
KEEP OUT OF REACH OF CHILDREN.
APPLICATION NUMBER: H829 (Act 101/1965)
NAME AND BUSINESS ADDRESS OF APPLICANT. Pharmacare Limited
7 Fairclough Road
DATE OF PUBLICATION OF THIS PACKAGE INSERT: 25/11/1974
KOHLER C&P P.E.
Updated on this site: April 2005
Source: Hospital Pharmacy