Malifa 30

Ferric maltol provides iron that is absorbed through the intestinal wall. The absorbed iron is subsequently incorporated into transferrin and ferritin, helping replenish the body’s iron stores.

Treatment with ferric maltol can increase important iron-related laboratory parameters, including serum ferritin and transferrin saturation (TSAT).

Malifa Capsule is an oral iron preparation used to treat iron deficiency in adults. It supplies iron that can be absorbed through the intestine and used by the body to restore iron stores and improve iron-related blood parameters.

The recommended adult dose is:

30 mg twice daily.

Malifa should preferably be taken on an empty stomach, at least 1 hour before or 2 hours after food, because food may reduce iron absorption.

• Swallow the capsule whole.
• Do not open, crush, break, or chew the capsule.
• Treatment generally continues for at least 12 weeks, although the duration depends on the severity of iron deficiency and response to therapy.
• Treatment may be continued as needed until iron stores, including ferritin levels, return to the normal range.

Use in Children

The safety and effectiveness of ferric maltol have not been established in children and adolescents. Therefore, Malifa should not be used in pediatric patients unless specifically recommended by a healthcare professional.

Drug Interactions

Medicines:

• Dimercaprol: Concurrent use with iron may increase the risk of kidney toxicity and should be avoided.
• Malifa may reduce the absorption or bioavailability of certain medicines, including mycophenolate, ethinyl estradiol, ciprofloxacin, and doxycycline.
• For oral medicines where reduced absorption could significantly affect treatment, administration should generally be separated from Malifa by at least 4 hours.

Food:
Food may reduce the absorption of iron from ferric maltol. Taking Malifa on an empty stomach, as directed, can help optimize absorption.

Inform your doctor or pharmacist about all medicines, vitamins, and supplements you are taking.

Contraindications

Malifa should not be used in patients with:

• Known hypersensitivity to ferric maltol or any component of the formulation
• Hemochromatosis
• Other disorders associated with iron overload
• A history of repeated blood transfusions associated with increased iron stores

Common Side Effects

Possible side effects of ferric maltol include:

• Flatulence
• Diarrhea
• Constipation
• Abdominal pain
• Nausea
• Vomiting
• Discoloration of stools

Dark or discolored stools can occur with oral iron therapy and are generally expected.

Pregnancy and Breastfeeding

Ferric maltol is not absorbed into the bloodstream as an intact complex after oral administration, so significant fetal exposure is not expected from maternal use.

There is limited information regarding whether ferric maltol is present in human breast milk or its effects on breastfed infants or milk production. Because the intact complex is not systemically absorbed by the mother, significant exposure of a breastfed infant is not expected.

Pregnant or breastfeeding women should nevertheless consult their doctor before using Malifa.

Precautions and Warnings

• Avoid Malifa during an active flare of inflammatory bowel disease (IBD) because iron may potentially worsen gastrointestinal inflammation.
• Do not use it in patients with evidence of iron overload.
• Malifa should not be used together with intravenous iron unless specifically directed by a healthcare professional.
• Iron levels and other relevant iron parameters should be assessed before starting treatment and monitored during therapy.
• Keep iron-containing medicines safely out of children’s reach. Accidental iron overdose is a major cause of potentially fatal poisoning in children under 6 years of age.
• Seek immediate medical attention if a child accidentally swallows Malifa or another iron-containing product.

Overdose

There is limited information specifically regarding ferric maltol overdose. Early symptoms of iron poisoning may include:

• Nausea
• Vomiting
• Abdominal pain
• Diarrhea

Severe poisoning can lead to reduced blood circulation, metabolic acidosis, and systemic toxicity. Excessive iron intake may also cause iron accumulation in storage tissues and potentially result in hemosiderosis.

A suspected iron overdose requires immediate medical assessment, particularly in children.

• Store below 25°C.
• Keep in a cool, dry place.
• Protect from light.
• Keep out of the reach of children.