Important Safety Information

What is ACCRUFeR?

ACCRUFeR is a prescription medicine used in adults to treat low iron stores in your body.

It is not known if ACCRUFeR is safe and effective for use in children.

IMPORTANT SAFETY INFORMATION

Do not take ACCRUFeR if you are allergic to ferric maltol or any of the ingredients in ACCRUFeR; have any illness that causes you to store too much iron in your body or if you have a problem with how your body uses iron; are receiving repeated blood transfusions.

Before you take ACCRUFeR, tell your doctor about all your medical conditions, including if you have inflammatory bowel disease (IBD); are pregnant or plan to become pregnant (it is not known if ACCRUFeR will harm your unborn baby; talk to your doctor if you are pregnant or plan to become pregnant); are breastfeeding or plan to breastfeed (it is not known if ACCRUFeR passes into your breast milk); talk to your doctor about the best way to feed your baby if you take ACCRUFeR.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking ACCRUFeR and certain other medicines may interact, which could potentially cause serious side effects. Some medicines may need to be taken at least 4 hours before or 4 hours after you have taken ACCRUFeR. Ask your healthcare provider for a list of these medicines if you are not sure if you take one of these medicines.

Especially tell your healthcare provider if you take:

Dimercaprol
Other oral iron tablets or health supplements containing iron

Ask your healthcare provider if you are not sure if you take one of these medicines. Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

What are the possible side effects of ACCRUFeR?

ACCRUFeR may cause serious side effects including:

Increased risk of inflammatory bowel disease (IBD) flare. You should avoid taking ACCRUFeR if you have IBD and are experiencing a flare
Too much iron stored in your body (iron overload). Your healthcare provider should check the iron level in your blood before you start treatment with ACCRUFeR
Risk of overdose in children due to accidental swallowing. Accidental overdose of iron-containing products is a leading cause of death from poisoning in children under 6. Keep ACCRUFeR in a safe place and out of the reach of children

The most common side effects of ACCRUFeR include gas, diarrhea, constipation, discolored stools, stomach pain, nausea, vomiting, and stomach area discomfort or bloating. These are not all the possible side effects of ACCRUFeR. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Product Information about ACCRUFeR.

IMPORTANT SAFETY INFORMATION

Before you take ACCRUFeR, tell your doctor about all your medical conditions, including if you have inflammatory bowel disease (IBD); are pregnant or plan to become pregnant (it is not known if ACCRUFeR will harm your unborn baby; talk to your doctor if you are pregnant or plan to become pregnant); are breastfeeding or plan to breastfeed (it is not known if ACCRUFeR passes into your breast milk); talk to your doctor about the best way to feed your baby if you take ACCRUFeR.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your healthcare provider if you take:

Dimercaprol

Other oral iron tablets or health supplements containing iron

What are the possible side effects of ACCRUFeR?

ACCRUFeR may cause serious side effects including:

Increased risk of inflammatory bowel disease (IBD) flare. You should avoid taking ACCRUFeR if you have IBD and are experiencing a flare

Too much iron stored in your body (iron overload). Your healthcare provider should check the iron level in your blood before you start treatment with ACCRUFeR

Risk of overdose in children due to accidental swallowing. Accidental overdose of iron-containing products is a leading cause of death from poisoning in children under 6. Keep ACCRUFeR in a safe place and out of the reach of children

Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088.