ACCRUFER is an iron replacement product containing the active ingredient ferric maltol, in the form of 3-hydroxy-2-methyl-4H-pyrane-4-one iron (III) complex. It is available as oral capsules with 30 mg of iron. Key inactive ingredients include lactose monohydrate, magnesium stearate, and sodium lauryl sulfate.

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. Swallow the capsules whole. Take this medication on an empty stomach, at least 1 hour before or 2 hours after food. Keep taking it unless your care team tells you to stop. Take products with antacids in them at a different time of day than this medication. Talk to your care team if you have questions. Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medication?

Keep out of the reach of children and pets. Even small amounts of iron can be harmful to a child. Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep container tightly closed. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome): -Constipation -Dark stools -Metallic taste in mouth -Nausea -Upset stomach

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -High levels of iron in the blood -Receiving repeated blood transfusions -Stomach or intestine problems -An unusual or allergic reaction to ferric maltol, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breast-feeding

What may interact with this medication?

Do not take this medication with any of the following: -Medications or supplements that contain iron This medication may also interact with the following: -Antacids -Carbidopa; levodopa -Cefdinir -Certain medications for bones, such as alendronate or risedronate -Certain medications for HIV or hepatitis -Certain medications for stomach problems, such as cimetidine, famotidine, omeprazole, or lansoprazole -Cholestyramine -Deferoxamine -Dimercaprol -Methyldopa -Quinolone antibiotics, such as ciprofloxacin, levofloxacin, or moxifloxacin -Tetracycline antibiotics, such as doxycycline, minocycline, or tetracycline -Thyroid hormones -Zinc supplements

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Use iron supplements only as directed by your care team. Visit your care team for regular check-ups. You will need important blood work while you are taking this medication. It may take 3 to 6 months of therapy to treat low iron levels. Do not use iron longer than prescribed, and do not take a higher dose than recommended. Long-term use may cause excess iron to build-up in the body.