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

Logo FEFOL Spansule Capsules.

SCHEDULING STATUS:
Not scheduled.

PROPRIETARY NAME
(and dosage form):

FEFOL Spansule Capsules.

COMPOSITION:
Each spansule sustained-release capsule contains 150 mg dried
ferrous sulphate (45 mg elemental iron -Fe++) and 0,5 mg folic acid.

PHARMACOLOGICAL CLASSIFICATION:
A.22.1.2 Vitamins for pre-natal use.

PHARMACOLOGICAL ACTION:
Fefol
is a haematinic. Four-fifths of the dose of iron is specially formulated for sustained release over a period of several hours. Fefol Spansule 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.

INDICATIONS:
Fefol
is a haematinic preparation of prophylaxis of iron and folic-acid deficiency during pregnancy.

CONTRA-INDICATIONS:
The folic acid content of one capsule a day is unlikely to mask pernicious anaemia should this condition be present; pregnancy during pernicious anaemia is very rare.

WARNING:
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:
Adults only:
One Fefol capsule a day throughout pregnancy. Some pregnant patients may need a higher prophylactic dose of iron because of dietary or other factors.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Therapeutic doses of iron may cause gastro-intestinal 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.

Precautions:
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 administered 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 is in delayed-release form absorption may be prolonged. Saline cathartics may be of use for hastening the evacuation of the spansule pellets.

IDENTIFICATION:
Clear, colourless capsules, transparent green-capped and filled with a mixture of coral-red, pale yellow, and white pellets.

PRESENTATION:
Fefol
capsules are available in containers of 50 and 250.

STORAGE INSTRUCTIONS:
Fefol
capsules should be stored below 25°C in a dry place, and dispensed in moisture-proof containers.
KEEP OUT OF REACH OF CHILDREN.

REFERENCE NUMBER:
H.2395 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
SmithKline Beecham Pharmaceuticals (Pty) Ltd.
6 Carey Street, Wynberg Ext. 6, Johannesburg 2090.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
18.10.1974.

P0218

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