Ferric maltol

Ferric maltol is an iron replacement product used in adults and children 10 years and older to treat iron deficiency.

Ferric maltol may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

• The recommended dosage of ferric maltol in adults and children 10 years and older is 30 mg taken by mouth twice daily.
• Take it on an empty stomach, at least 1 hour before or 2 hours after a meal.
• Swallow the capsule whole and do not crush, chew, break, or open it.

Ferric maltol is usually taken for 12 weeks.

You may need medical tests to help determine how long you should use ferric maltol.

Store at room temperature away from moisture and heat.

Use only as directed. Inform your doctor if you are taking other medicines or have other medical conditions or allergies.

You should not use ferric maltol if you are allergic to it, or if you have:

• hemochromatosis or iron overload (the buildup of excess iron); or
• if you have repeated blood transfusions.

Tell your doctor if you have ever had inflammatory bowel disease.

Tell your doctor if you are pregnant or plan to become pregnant.

Ferric maltol is absorbed in a way that is not likely to harm an unborn baby. Having untreated iron deficiency during pregnancy may increase the risk of anemia (low red blood cells), premature birth, or low birth weight. The benefit of treating iron deficiency with ferric maltol may outweigh any risks to the baby.

Ferric maltol is not likely to pass into breast milk. Ask your doctor about using ferric maltol if you are breastfeeding.

Not approved for use by anyone younger than 10 years old.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop taking ferric maltol and call your doctor right away if you have inflammatory bowel disease and you experience a flare-up of symptoms such as diarrhea, stomach cramps, blood in your stools, loss of appetite, or weight loss.

Common side effects of ferric maltol may include:

• stomach pain, bloating, gas, nausea, vomiting;
• diarrhea, constipation; or
• changes in the color of your bowel movements.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult and Pediatric 10+ Dose for Iron Deficiency:

30 mg orally twice a day, 1 hour before or 2 hours after a mealDuration of therapy:Comments:-Treatment duration depends on the severity of iron deficiency but generally at least 12 weeks of therapy are required.-Continue treatment until ferritin levels are within normal range.Use: Iron deficiency

Call your doctor for instructions if you miss a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Get emergency medical help if a child has accidentally swallowed a tablet. An overdose of iron can be fatal to a young child.

Overdose symptoms may include stomach pain, nausea, vomiting, diarrhea, cold or clammy skin, confusion, agitation, feeling light-headed, rapid breathing, or irregular heartbeats.

Do not take dimercaprol or iron supplements or a vitamin/mineral supplement that your doctor has not prescribed or recommended.

Taking ferric maltol at the same time as other oral medications can affect how your body absorbs each drug. Take your ferric maltol dose 4 hours before or 4 hours after taking any other medications by mouth.

Other drugs may affect ferric maltol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you are using.