Accrufer is an iron replacement product that is used in adults used to treat iron deficiency.

Accrufer may also be used for purposes not listed in this medication guide.

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

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

Take 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.

Accrufer is usually taken for 12 weeks.

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

Store at room temperature away from moisture and heat.

You should not use Accrufer 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.

Accrufer is absorbed in a way that is not likely to be harmful to 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 this medicine may outweigh any risks to the baby.

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

Not approved for use by anyone younger than 18 years old.

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.

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 Accrufer and call your doctor at once if you have inflammatory bowel disease and you have a flare of symptoms such as diarrhea, stomach cramps, blood in your stools, loss of appetite, or weight loss.

Common side effects of Accrufer 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.

Taking Accrufer at the same time with other oral medications can interfere with how your body absorbs each drug. Take your this medicine dose 4 hours before or 4 hours after taking any other medications by mouth.

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