tinal disorders
Abdominal pain (including upper abdomen)
Flatulence
Constipation
Abdominal discomfort/ distension
Diarrhoea
Nausea
Small intestinal bacterial overgrowth
Vomiting
Skin and subcutaneous tissue disorders
Acne
Erythema
Musculoskeletal and connective tissue disorders
Joint stiffness
Pain in extremity
General disorders and administration site conditions
Thirst
Investigations
Blood alkaline phosphatase increased
Blood thyroid stimulating hormone increased
Gamma-glutamyltransferase increased
Reporting of suspected adverse reactions:
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via :-
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
Ireland
HPRA Pharmacovigilance, Earlsfort Terrace IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
4.9 Overdose
Iron overdosage is dangerous and can be life-threatening in young children, requiring immediate attention.
Symptoms of iron overdose
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.
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. Serum iron levels measured at about 4 hours after ingestion is the best laboratory measure of severity.
Management
Supportive and symptomatic measures reflecting best standard medical care should be implemented. The use of desferroxamine should be considered: for detailed information see product information provided by the manufacturer. 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 irondesferroxamine complex.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Iron trivalent, oral preparation, ATC code: B03AB10.
Mechanism of action
Feraccru contains iron in a stable ferric state as a complex with a trimaltol ligand. The complex is designed to provide, in a controlled way, utilisable iron for uptake across the intestinal wall and transfer to the iron transport and storage proteins in the body (transferrin and ferritin, respectively). The complex dissociates on uptake from the gastro-intest |
