ACCRUFER

1 Dosing Considerations • ACCRUFER should be initiated under the supervision of a healthcare professional who is experienced in the management of iron deficiency anemia. • Iron deficiency anaemia (IDA) diagnosis and subsequent monitoring should be made based on blood tests; it is important to investigate the cause of the IDA and to exclude underlying causes of anaemia other than iron deficiency.

2 Recommended Dose and Dosage Adjustment The recommended dosage of ACCRUFER is 30 mg twice daily, morning and evening, on an empty stomach. Product Monograph July 16, 2024 ACCRUFER (ferric maltol) Page 5 of 22 Treatment duration will depend on the severity of iron deficiency but generally at least 12 weeks of treatment is required.

The treatment should be continued as long as necessary to replenish the body iron stores according to blood tests. Geriatric population No dose adjustment is needed in elderly patients. Pediatric population Health Canada has not authorized an indication for pediatric use (see 1 INDICATIONS, 7 WARNINGS AND PRECAUTIONS; and 10 CLINICAL PHARMACOLOGY).

73 m2). 73 m2) are available. Hepatic impairment No clinical data on the need to adjust the dose in patients with impaired hepatic function are available. 3 Reconstitution Not applicable. 4 Administration ACCRUFER capsules should be taken whole on an empty stomach (1 hour before or 2 hours after a meal) with half a glass of water, as the absorption of iron is reduced when it is taken with food.

Do not open, break, or chew ACCRUFER capsules. 5 Missed Dose If a dose of ACCRUFER is missed, skip the missed dose and take the next dose as normal. Do not take a double dose to make up for a missed dose.

and 10 CLINICAL PHARMACOLOGY). 2 Geriatrics Geriatrics (≥65 years): Evidence from clinical studies suggests that use of ACCRUFER in the geriatric population is not associated with differences in safety and effectiveness. 2 CONTRAINDICATIONS Ferric maltol is contraindicated in patients • with hypersensitivity to this drug or to any ingredient in the formulation, including any non- medicinal ingredient, or component of the container.

For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • with hemochromatosis and other iron overload syndromes (see 7 WARNINGS AND PRECAUTIONS). Use may result in iron overdose (see 5 OVERDOSAGE). • receiving repeated blood transfusions.

Use may result in iron overload (see 7 WARNINGS AND PRECAUTIONS and 5 OVERDOSAGE). 1 Dosing Considerations • ACCRUFER should be initiated under the supervision of a healthcare professional who is experienced in the management of iron deficiency anemia.

• Iron deficiency anaemia (IDA) diagnosis and subsequent monitoring should be made based on blood tests; it is important to investigate the cause of the IDA and to exclude underlying causes of anaemia other than iron deficiency. 2 Recommended Dose and Dosage Adjustment The recommended dosage of ACCRUFER is 30 mg twice daily, morning and evening, on an empty stomach.

Product Monograph July 16, 2024 ACCRUFER (ferric maltol) Page 5 of 22 Treatment duration will depend on the severity of iron deficiency but generally at least 12 weeks of treatment is required. The treatment should be continued as long as necessary to replenish the body iron stores according to blood tests.

Geriatric population No dose adjustment is needed in elderly patients. Pediatric population Health Canada has not authorized an indication for pediatric use (see 1 INDICATIONS, 7 WARNINGS AND PRECAUTIONS; and 10 CLINICAL PHARMACOLOGY).

Ferric maltol is contraindicated in patients • with hypersensitivity to this drug or to any ingredient in the formulation, including any non- medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.

• with hemochromatosis and other iron overload syndromes (see 7 WARNINGS AND PRECAUTIONS). Use may result in iron overdose (see 5 OVERDOSAGE). • receiving repeated blood transfusions. Use may result in iron overload (see 7 WARNINGS AND PRECAUTIONS and 5 OVERDOSAGE).