INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo DR WILLIAMS' PINK PILLS

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

DR WILLIAMS' PINK PILLS

COMPOSITION:
Each pill contains:
Ferrous Sulphate dried   12,500 mg
Manganese Sulphate   3,456 mg
Copper Sulphate   0,162 mg

PHARMACOLOGICAL CLASSIFICATION:
A 33 Tonics.

PHARMACOLOGICAL ACTION:
Dr Williams' Pink Pills is a general tonic.

INDICATIONS:
Dr Williams' Pink Pills is indicated as a general tonic.

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients. 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. Copper sulphate should not be used in patients with hepatolenticular degeneration.

WARNINGS:
Prolonged administration of doses in excess of those recommended may result in iron overload. In patients receiving oral iron therapy additional parenteral administration of iron may result in an iron overloading and toxicity. A dose of as little as 1 g of iron should be considered toxic in children.

DOSAGE AND DIRECTIONS FOR USE:
Children 7-14 years:
Start with ONE pill per day and after a few days increase to TWO pills per day and then to a maximum of THREE pills per day - one after each meal.
Children under 7 years: The pills should only be given on medical advice.
Adults: TWO pills three times a day with or after meals. Consult your doctor if you still feel no improvements after a reasonable time.

NOTE: IT IS NOT ADVISABLE TO TAKE THE PILLS ON AN EMPTY STOMACH.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Gastro-intestinal discomfort, diarrhoea, constipation and vomiting may occur. Side-effects may be reduced by taking the medication with or immediately after food. As a result of iron therapy stools may become darkened or black in colour. 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 taken concomitantly by mouth. If treatment with both is required, the iron salt should be administered 3 hours before or 2 hours after the tetracyclines. 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 OVERDOSE AND PARTICULARS OF ITS TREATMENT:
Large doses of iron have irritant and corrosive effects on the gastro-intestinal mucosa and necrosis and perforation may occur. Stricture formation may subsequently occur. Symptoms, which may not occur 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. Acute poisoning due to ingestion of manganese is rare owing to poor absorption. The ingestion of a large quantity of copper sulphate is rapidly followed by nausea and vomiting, a metallic taste and a burning sensation in the oesophagus and stomach. Colic and bloody diarrhoea may follow, with convulsions, hypotension and coma. Renal damage may occur with acute kidney necrosis. Jaundice may be associated with liver injury and haemolysis. Owing to its emetic action, fatal poisoning is rare.

TREATMENT:
Desferrioxamine is used in the treatment of acute iron poisoning. In treating acute iron poisoning, speed is essential to block absorption of iron from the alimentary tract. If desferrioxamine is not available, empty the stomach immediately by emesis and lavage using 1-5% solution of sodium bicarbonate and leave about 300 mL 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 transfusion may be necessary in severe cases.

IDENTIFICATION:
Pink sugar-coated pills.

PRESENTATION:
Packs of 24, 42 and 84 pills.

STORAGE INSTRUCTIONS:
Store below 25°C and protect from light and moisture.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
G 2458 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF APPLICANT:
Mentholatum South Africa (Pty) Ltd
80 Bonza Bay Road
Beacon Bay
5241.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
July 1996

OWNERS OF THE TRADEMARK:
"Dr Williams' Pink Pills" is a registered trademark of Mentholatum Co. Inc., Buffalo, NY USA.
Manufactured on behalf of Mentholatum South Africa (Pty) Ltd., registered user of the trademark.

Code 4004

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