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|Ferrous Sulfate Controlled-Release Capsules

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Ferrous Sulfate Controlled-Release Capsules

Generic Name: Ferrous Sulfate Controlled-Release Capsules, Controlled-Release Tablets, and Enteric-Coated Tablets (FER-us SULL-fate)
Brand Name: Examples include Fe Caps and Slow Fe

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children younger than 6 years of age. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

Ferrous Sulfate Controlled-Release Capsules is used for:

Preventing or treating low levels of iron in the blood. It also may be used to treat other conditions as determined by your doctor.

Ferrous Sulfate Controlled-Release Capsules is an essential body mineral. It works by replacing iron in your body if your body does not produce enough on its own.

Do NOT use Ferrous Sulfate Controlled-Release Capsules if:

you are allergic to any ingredient in Ferrous Sulfate Controlled-Release Capsules
you have high levels of iron in your blood

Contact your doctor or health care provider right away if any of these apply to you.

Before using Ferrous Sulfate Controlled-Release Capsules:

Some medical conditions may interact with Ferrous Sulfate Controlled-Release Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have inflammation of the intestines, Crohn disease, digestive problems, ulcers, anemia, or a blood disease (eg, porphyria, thalassemia)
if you have had multiple blood transfusions

Some MEDICINES MAY INTERACT with Ferrous Sulfate Controlled-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

Doxycycline, mycophenolate, penicillamine, or thyroid hormones (eg, levothyroxine) because the effectiveness of these medicines may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ferrous Sulfate Controlled-Release Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Ferrous Sulfate Controlled-Release Capsules:

Use Ferrous Sulfate Controlled-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ferrous Sulfate Controlled-Release Capsules is absorbed better on an empty stomach, but may be taken with food if it upsets your stomach.
If you are also taking a bisphosphonate (eg, alendronate), cephalosporin (eg, cephalexin), methyldopa, penicillamine, quinolone (eg, ciprofloxacin), or tetracycline (eg, minocycline) along with Ferrous Sulfate Controlled-Release Capsules, you may need to space the doses several hours apart. Ask your doctor or pharmacist how much time is needed between doses of Ferrous Sulfate Controlled-Release Capsules and your other medicines.
Do not take Ferrous Sulfate Controlled-Release Capsules within 1 hour before or 2 hours after antacids, eggs, whole grain breads or cereal, milk, milk products, coffee, or tea.
Take Ferrous Sulfate Controlled-Release Capsules with a full glass of water (8 oz/240 mL). Do not lie down for 30 minutes after taking Ferrous Sulfate Controlled-Release Capsules.
Ferrous Sulfate Controlled-Release Capsules must be swallowed whole. Do not break, crush, or chew before swallowing.
If you miss a dose of Ferrous Sulfate Controlled-Release Capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Ferrous Sulfate Controlled-Release Capsules.

Important safety information:

Do not take large doses of vitamins (megadoses or megavitamin therapy) unless otherwise directed by your doctor.
Do not exceed the recommended dosage or take Ferrous Sulfate Controlled-Release Capsules for longer than 6 months without checking with your doctor.
Ferrous Sulfate Controlled-Release Capsules contains iron. Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children younger than 6 years of age. In case of accidental overdose, call a doctor or poison control center immediately.
LAB TESTS, including blood tests and iron levels, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
Use Ferrous Sulfate Controlled-Release Capsules with extreme caution in CHILDREN. Safety and effectiveness in this age group have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Ferrous Sulfate Controlled-Release Capsules during pregnancy. Ferrous Sulfate Controlled-Release Capsules is excreted in breast milk. If you are or will be breast-feeding while you are using Ferrous Sulfate Controlled-Release Capsules, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Ferrous Sulfate Controlled-Release Capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; darkened or green stools; diarrhea; nausea; stomach upset.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood or streaks of blood in the stool; fever; vomiting with continuing sharp stomach pain.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch .

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include loss of consciousness; difficulty breathing; seizures; severe nausea; stomach pain; tarry stools; unusual tiredness; vomiting; weak, fast heartbeat.

Proper storage of Ferrous Sulfate Controlled-Release Capsules:

Store Ferrous Sulfate Controlled-Release Capsules at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ferrous Sulfate Controlled-Release Capsules out of the reach of children and away from pets.

General information:

If you have any questions about Ferrous Sulfate Controlled-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.
Ferrous Sulfate Controlled-Release Capsules is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Ferrous Sulfate Controlled-Release Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006

Database Edition 06.4.1.002

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