Ferric Maltol

Ferric maltol is used to treat or prevent anemia (a lower-than-normal number of red blood cells) when the amount of iron taken in from your diet is not enough. Ferric maltol is in a class of medications called iron replacement products. It works by providing iron to help the body to produce red blood cells.

Ferric maltol comes as a capsule to take by mouth. Take on an empty stomach (1 hour before or 2 hours after meals) twice a day. Take ferric maltol at around the same time(s) every day.

Take ferric maltol exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole; do not open, break, or chew them.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking ferric maltol,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• some medications should not be taken with ferric maltol. Other medications may cause dosing changes, extra monitoring, or changing the time you take them when taken with ferric maltol. Make sure you have discussed any medications you are currently taking or plan to take before starting ferric maltol with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking ferric maltol, please get the advice of your doctor or pharmacist.
• tell your doctor if you have an illness that causes you to store too much iron in your body or if you are receiving blood transfusions. Your doctor will probably tell you not to take ferric maltol.
• tell your doctor if you have or have ever had inflammatory bowel disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking ferric maltol, call your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Ferric maltol may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea, vomiting
• gas, abdominal discomfort or pain
• constipation
• discolored stools

Some side effects can be serious. If you experience any of these symptoms call your doctor immediately or get emergency medical treatment:

• rash, itching, hives, shortness of breath

Ferric maltol may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

If someone swallows Ferric maltol, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• nausea, vomiting, abdominal pain, diarrhea

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to ferric maltol.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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