Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Mercury Pharma Group Ltd, Capital House, 85 King William Street, London, EC4N 7BL, UK
Prophylaxis and treatment of iron deficiency states.
One tablet daily (the foil enclosing the tablet is printed with days of the week in sequence).
In severe or refractory iron deficiency, one tablet may be given twice a day.
Ferrous Fumarate tablets are not intended for the treatment of children.
Oral.
Ingestion of 20 mg/kg elemental iron is potentially toxic and 200-250 mg/kg is potentially fatal. No single method of assessment is entirely satisfactory – clinical features as well as laboratory analysis must be taken into account. The serum iron taken at about 4 hours after ingestion is the best laboratory measure of severity.
| Serum Iron | Severity |
|---|---|
| <3 mg/L (55 micromol/L) | Mild toxicity |
| 3-5 mg/L (55-90 micromol/L) | Moderate toxicity |
| >5 mg/L (90 micromol/L) | Severe toxicity |
Early signs and symptoms include nausea, vomiting, abdominal pain and diarrhoea. The vomit and stools may be grey or black. In mild cases early features improve but in more serious cases there may be evidence of hypoperfusion (cool peripheries and hypotension), metabolic acidosis and systemic toxicity. In serious cases there can be recurrence of vomiting and gastrointestinal bleeding, 12 hours after ingestion. Shock can result from hypovolaemia or direct cardiotoxicity.
Evidence of hepatocellular necrosis appears at this stage with jaundice, bleeding, hypoglycaemia, encephalopathy and positive anion gap metabolic acidosis. Poor tissue perfusion may lead to renal failure. Rarely, gastric scarring causing stricture or pyloric stenosis (alone or in combination) may lead to partial or complete bowel obstruction 2-5 weeks after ingestion.
Supportive and symptomatic measures include ensuring a clear airway, monitoring of cardiac rhythm, BP and urine output, establishing IV access and administering sufficient fluids to ensure adequate hydration. Consider whole bowel irrigation. If metabolic acidosis persists despite correction of hypoxia and adequate fluid resuscitation, an initial dose of 50 mmol sodium bicarbonate may be given and repeated as necessary, for adults guided by arterial blood gas monitoring (aim for a pH of 7.4). Consider the use of desferrioxamine, if the patient is symptomatic (other than nausea), serum iron concentration is between 3-5 mg/L (55-90 micromol/L) and still rising. Haemodialysis does not remove iron effectively but should be considered on a supportive basis for acute renal failure as this will facilitate removal of the iron-desferrioxamine complex.
36 months.
Protect from light.
Store below 25°C.
Cartons containing two blister packs of 14 tablets, prepared from White 250/60 micron PVC/PVDC film and printed 30 micron hard-tempered aluminium foil. 28 tablets in each carton or dispensing pack of 1000 tablets in Polypropylene container with tamper evident low density polyethylene cap.
No special requirements for disposal.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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