Prenata

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. Keep this product out of reach of children. If overdose does occur, get medical help right away or call a poison control center.

Folic acid may affect certain lab tests for vitamin B12 deficiency (pernicious anemia) without treating this anemia. Folic acid should not be taken alone when treating vitamin B12 deficiency. Consult your doctor or pharmacist for details.

Constipation, diarrhea, or upset stomach may occur. These effects are usually temporary and may disappear as your body adjusts to this medication. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Iron may cause your stools to turn black, which is not harmful.

If your doctor has directed you to use this medication, remember that 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 drug 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 medication, 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 taking this medication, tell your doctor or pharmacist your medical history, especially of: iron overload disorder (such as hemochromatosis, hemosiderosis), use/abuse of alcohol, liver problems, stomach/intestinal problems (such as ulcer, colitis), vitamin B12 deficiency (pernicious anemia).

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

This medication passes into breast milk. Consult your doctor before breast-feeding.

See also How To Use section.

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.

Some products that may interact with this drug include: certain anti-seizure drugs (such as phenytoin).

This product can decrease the absorption of other drugs such as bisphosphonates (for example, alendronate), levodopa, penicillamine, quinolone antibiotics (for example, ciprofloxacin, levofloxacin), thyroid medications (for example, levothyroxine), and tetracycline antibiotics (for example, doxycycline, minocycline). 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 (such as fecal occult blood tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this product.

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.

Do not share this medication with others.

Lab and/or medical tests (such as complete blood count, vitamin B12 levels) may be done while you are taking this product. Keep all medical and lab appointments. Consult your doctor for more details.

This medication 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, and dried fruit. Folic acid and iron are also added to fortified/enriched cereals and bread.

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.