Accrufer

Read the Patient Information Leaflet if available from your pharmacist before you start taking ferric maltol and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth on an empty stomach (at least 1 hour before or 2 hours after meals) as directed by your doctor, usually twice daily. Swallow the capsules whole. Do not open, break, or chew the capsules. Take this medication with a full glass of water (8 ounces/240 milliliters) unless your doctor directs you otherwise. Do not lie down for at least 10 minutes after taking this medication.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Constipation, diarrhea, gas, nausea, and stomach/abdominal pain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Iron may cause your stools to turn black, an effect that is not harmful.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking this product, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: iron overload disorders (such as hemochromatosis), repeated blood transfusions, stomach/intestinal problems (such as ulcer, colitis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant before using this product.

Iron passes into breast milk. Consult your doctor before breast-feeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This product can decrease the absorption of other drugs, including bisphosphonates (such as alendronate), levodopa, penicillamine, quinolone antibiotics (such as ciprofloxacin, levofloxacin), thyroid medications (such as levothyroxine), tetracycline antibiotics (such as doxycycline, minocycline), among others. Separate your doses of these medications as far as possible from your doses of this product. Ask your doctor or pharmacist about how long you should wait between doses and for help finding a dosing schedule that will work with all your medications.

This product may interfere with certain lab tests (including testing for blood in stool), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: stomach pain, nausea, vomiting, diarrhea, weakness.

Do not share this product with others.

This product is not a substitute for a proper diet. It is important to maintain a well-balanced diet. Foods rich in iron include red meats (especially liver), fish, beans, dried fruit, and iron-fortified/enriched cereals and bread.

Lab and/or medical tests (such as iron/ferritin levels, complete blood count) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.