FERACCRU Capsules, hard Ref.[7648] Active ingredients: Ferric maltol

Posology

The recommended dose is one capsule twice daily, morning and evening, on an empty stomach (see section 4.5).

Treatment duration will depend on the severity of iron deficiency but generally at least 12-weeks treatment is required. The treatment should be continued as long as necessary to replenish the body iron stores according to blood tests.

Paediatric population

The safety and efficacy of Feraccru in children (17 years and under) has not yet been established. No data are available (see section 4.4).

The elderly and patients with Hepatic or renal impairment

No dose adjustment is needed in elderly patients or patients with renal impairment (eGFR ≥15 ml/min/1.73 m²).

No clinical data on the need to adjust the dosage in patients with impaired hepatic function and/or renal impairment (eGFR <15 ml/min/1.73 m²) are available (see section 4.4).

Method of administration

Oral use.

Feraccru capsules should be taken whole on an empty stomach (with half a glass of water), as the absorption of iron is reduced when Feraccru is taken with food (see section 4.5).

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 iron-desferroxamine complex.

Shelf life: 21 months.

Shelf-life after first opening container: 45 days.

Store below 25°C.

HDPE bottles with a child-proof polypropylene push-lock. Each bottle contains 56 capsules.

No special requirements for disposal.