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

Logo FERROUS SULPHATE COMPOUND TABLETS

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

FERROUS SULPHATE COMPOUND TABLETS

COMPOSITION:
Per tablet:
Dried Ferrous Sulphate equivalent to FeSO4 170,0 mg
Manganese Sulphate 2,5 mg
Copper Sulphate 2,5 mg
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.
Ferrous Sulphate is one of the most widely used iron salts in the treatment of iron-deficiency anaemia.

INDICATIONS:
Iron-deficiency anaemia.

CONTRA-INDICATIONS:
Patients receiving repeated blood transfussion.
Anaemias not produced by iron deficiency unless iron deficiency is also present.

DOSAGE AND DIRECTIONS FOR USE:
Adults: The usual initial therapeutic dose is three to five tablets daily in divided doses followed by a maintenance dose of two tablets daily.
Children 6 to 12 years: Three tablets daily in divided doses.
Side-effects can be reduced by taking tablets with or immediately after food.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects include gastro-intestinal discomfort, diarrhoea and vomiting.
Continued administration may cause constipation and faeces may be black.
Care should be taken when given to patients with iron-storage or iron-absorption diseases, haemoglobinopathies, or existing gastrointestinal disease.
Ferrous sulphate diminishes the absorption of tetracyclines taken concomitantly by mouth. If treatment with both drugs is required the Ferrous Sulphate should be administered three hours before of two hours after the tetracycline.
The absorption of iron is decreased in the presence of antacids or when taken with tea.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms of overdosage include gastro-intestinal irritation and necrosis, perforation may occur and stricture formation may subsequently follow.
Symptoms, which may not appear for several hours, include epigastric pain, diarrhoea, vomiting and haematemesis. If haemorrhage and diarrhoea are severe circulatory failure may follow, convulsions and coma may occur.
In treating iron poisoning, speed is essential to block absorption of iron from the alimentary tract. A dose of as little as 1 g should be considered toxic in children.
If desferrioxamine is not available, 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 the intravenous administration of Compound Sodium Lactate Injection or Sodium Chloride and Dextrose Injection. Exchange transfusion may be necessary in severe cases.
The following procedure has been recommended if desferrioxamine is available:
Intramuscularly inject 2 g desferrioxamine mesylate dissolved in Water for Injection; wash out the stomach with a 1% Solution of Sodium Bicarbonate; give 5 g desferrioxamine mesylate in 50 to 100 mL water by mouth or by stomach tube; give desferrioxamine mesylate by intravenous infusion at a rate of not more than 15 mg per kg bodymass per hour, maximum dosage 80 mg per kg in 24 hours; repeat intramuscular injections of 2 g desferrioxamine mesylate every 12 hours if necessary.

CONDITIONS OF REGISTRATION OF THE MEDICINES IMPOSED BY THE COUNCIL:
None.

IDENTIFICATION:
A white sugar coated tablet.

PRESENTATION:
28, 500, 1000 and 5000 Tablets

STORAGE DIRECTIONS:
Store below 25°C. Keep well closed. Protect from light.
Keep out of reach of children.

REGISTRATION NUMBER
H825 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANT
PHARMAGEN (PTY) Ltd.
28 Electron Avenue
Isando 1600

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

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