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Logo FERRIMED® D.S. CHEWABLE TABLETS

SCHEDULING STATUS:
UNSCHEDULED

PROPRIETARY NAME
(and dosage form):

FERRIMED® D.S. CHEWABLE TABLETS

COMPOSITION:
100 mg ELEMENTAL IRON AS
IRON POLYMALTOSE PER TABLET

PHARMACOLOGICAL CLASSIFICATION:
A.8.3 Erythropoietics (haematinics).

PHARMACOLOGICAL ACTION:
Iron is an essential constituent of the body being necessary for haemoglobin formation and for the oxidative processes of living tissue.

INDICATIONS:
Iron deficiency anaemia.

CONTRA-INDICATIONS:
Haemochromatosis; Haemosiderosis; Thalassemia; Sideroblastic anaemia; Chronic Haemolysis. Lead induced Anaemia; Patients who show hypersensitivity to iron; Patients receiving repeated blood transfusions.

WARNINGS:
See side-effects and special precautions.

DIRECTIONS FOR USE:
Up to 3 tablets daily in divided doses depending on the severity of the anaemia being treated. The tablets must be chewed.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Gastro-intestinal discomfort, vomiting. Constipation, diarrhoea, epigastric pain, black stools. Should not be simultaneously administered with tetracyclines which may result in diminished absorption of both ingredients. However, note that in vitro studies have shown that iron polymaltose complex is not incompatible with tetracyclines. Absorption of iron salts is 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:
Gastro intestinal discomfort, diarrhoea and vomiting, constipation. Large doses of iron salts 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 haematemisis; 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 to hepatic coma.

TREATMENT - In acute poisoning use the desferrioxamine procedure. If desferrioxamine is not available, empty the stomach immediately by emesis and lavage using a solution of sodium bicarbonate and leave some of the solution in the stomach. Fluid loss should be replaced by the intravenous administration of compound sodium lactate injection or sodium chloride and dextrose injection. Exchange transfusions may be necessary in severe cases. In treating iron poisoning, speed is essential to block absorption or iron from the alimentary tract.

IDENTIFICATION:
Brown white speckled tablet.

PRESENTATION:
Cartons containing 30 and 90 blister packed tablets.

STORAGE INSTRUCTIONS:
Store in a cool dark dry place below 25°C. Keep out of reach of children.

REGISTRATION NUMBER:
L/8.3/201

NAME AND BUSINESS ADDRESS OF APPLICANT:
SWISSPHARM (PTY) LTD
International Pharmaceutical Marketers
8th Floor, Nedbank Gardens
33 Bath Avenue, Rosebank 2196

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
4/7/85.

Manufactured by: HAUSMANN LABORATORIES SWITZERLAND

989122/3 Jumbo Press

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