FESOFOR Spansule Capsules
(and dosage form):
FESOFOR Spansule Capsules
Each Spansule sustained release capsule contains 150 mg dried ferrous sulphate (45 mg elemental iron - Fe++).
A.8.3 Erythropoietics (haematinics)
Fesofor is a haematinic. Four-fifths of the dose of iron is specially formulated for sustained release over a period of several hours. Fesofor capsules are formulated to release most of the iron in the upper small intestine where absorption is greatest, and not in the stomach where gastric irritation may be caused.
Fesofor is a haematinic for the prevention of iron deficiency anaemia in pregnancy/lactation and the treatment of iron deficiency anaemia.
There are no specific contra-indications, but do not use in patients with known iron overload.
Prolonged administration of doses in excess of those recommended may result in iron overload especially in children. In patients receiving oral iron therapy additional parenteral administration of iron may result in an iron overload and toxicity.
DOSAGE AND DIRECTIONS FOR USE:
Prophylaxis of iron deficiency anaemia in pregnancy/lactation:
One Fesofor capsule a day.
Treatment of established iron deficiency anaemia:
Three Fesofor capsules a day.
Children over 1 year of age:
Therapeutic: One Fesofor capsule a day.
The capsule may be opened and the pellets mixed with soft, cool food, but they must not be chewed.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Therapeutic doses of iron may cause gastrointestinal discomfort, diarrhoea, and vomiting. These side-effects have been reported to occur in up to 20 % or more of patients treated and are related to the amount of elemental iron. Although iron is better absorbed between meals, side-effects can be reduced by taking it with, or immediately after, food. Continued administration may sometimes cause constipation.
Large doses of ferrous sulphate may have irritant and corrosive effects on the gastro-intestinal mucosa and 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.
Ferrous sulphate and other 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. 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 ad ministered 3 hours before or 2 hours after the tetracycline. The absorption of iron salts is also decreased in the presence of antacids or when taken with tea. Iron salts appear to reduce the effects of penicillamine.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Signs and symptoms of overdosage with ferrous sulphate include acute epigastric pain and nausea and vomiting; haematemesis is common and shock may develop. Hours or days may elapse with no further signs or symptoms; offensive black stools may then be passed, and signs of acute encephalopathy may appear with headache and confusion progressing to coma. If the patient survives, liver necrosis may develop with a fatal outcome. Treatment consists of the induction of vomiting and/or gastric lavage except when the patient is severely shocked, together with supportive and symptomatic measures. Desferrioxamine, 10 g in 50 mL water, should be introduced into the stomach, this compound may also be given intravenously or intramuscularly if indicated. As the ferrous sulphate in Fesofor is in delayed-release form, absorption may be prolonged. Saline cathartics may be of use for hastening the evacuation of the spansulepellets.
Clear, colourless capsules, ruby-red-capped and filled with a mixture of white and coral-red pellets.
Fesofor capsules are available in containers of 50 and 250.
Fesofor capsules should be stored below 25° C in a dry place, and dispensed in moisture-proof containers.
KEEP OUT OF REACH OF CHILDREN.
H.687 (Act 101/1965)
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
SmithKline Beecham Pharmaceuticals (Pty) Ltd.
6 Carey Street Wynberg Ext. 6,
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
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