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|Ferrous Fumarate/Docusate Controlled-Release Tablets

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Ferrous Fumarate/Docusate Controlled-Release Tablets

Generic Name: Ferrous Fumarate/Docusate Controlled-Release Tablets (FER-us FYOO-ma-rate/DOK-yoo-sate)
Brand Name: Ferro-Sequels

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

Ferrous Fumarate/Docusate Controlled-Release Tablets is used for:

Treating and preventing low levels of iron in the blood. It also may be used for other conditions as determined by your doctor.

Ferrous Fumarate/Docusate Controlled-Release Tablets is a combination essential body mineral and stool softener. It works by replacing iron in your body if your body does not produce enough on its own. The stool softener helps to decrease the constipation associated with iron products.

Do NOT use Ferrous Fumarate/Docusate Controlled-Release Tablets if:

you are allergic to any ingredient in Ferrous Fumarate/Docusate Controlled-Release Tablets
you have high levels of iron in your blood
you have appendicitis

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

Before using Ferrous Fumarate/Docusate Controlled-Release Tablets:

Some medical conditions may interact with Ferrous Fumarate/Docusate Controlled-Release Tablets. 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 colon, Crohn disease, digestive problems, ulcers, certain types of anemia or any blood disease such as porphyria, or a history of bowel blockage
if you have had multiple blood transfusions
if you currently have stomach pain, nausea, or vomiting

Some MEDICINES MAY INTERACT with Ferrous Fumarate/Docusate Controlled-Release Tablets. 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 their effectiveness may be decreased by Ferrous Fumarate/Docusate Controlled-Release Tablets
Mineral oil because its absorption may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ferrous Fumarate/Docusate Controlled-Release Tablets 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 Fumarate/Docusate Controlled-Release Tablets:

Use Ferrous Fumarate/Docusate Controlled-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Ferrous Fumarate/Docusate Controlled-Release Tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
Swallow Ferrous Fumarate/Docusate Controlled-Release Tablets whole. Do not break, crush, or chew before swallowing.
If you take a bisphosphonate (eg, alendronate), cephalosporin (eg, cephalexin), penicillamine, quinolone (eg, ciprofloxacin), or tetracycline (eg, minocycline), ask your doctor or pharmacist how to take it with Ferrous Fumarate/Docusate Controlled-Release Tablets.
Do not take an antacid within 1 hour before or 2 hours after you take Ferrous Fumarate/Docusate Controlled-Release Tablets.
Avoid eggs, whole grain breads or cereal, milk, milk products, coffee, or tea within 2 hours before or after taking Ferrous Fumarate/Docusate Controlled-Release Tablets. These foods may reduce absorption of Ferrous Fumarate/Docusate Controlled-Release Tablets.
Take Ferrous Fumarate/Docusate Controlled-Release Tablets with a full glass of water (8 oz/240 mL). Do not lie down for 30 minutes after taking Ferrous Fumarate/Docusate Controlled-Release Tablets.
If you miss a dose of Ferrous Fumarate/Docusate Controlled-Release Tablets, 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 Fumarate/Docusate Controlled-Release Tablets.

Important safety information:

Do not take large doses of vitamins while you use Ferrous Fumarate/Docusate Controlled-Release Tablets unless your doctor tells you to.
Do NOT take more than the recommended dose or use for longer than 6 months without checking with your doctor.
Ferrous Fumarate/Docusate Controlled-Release Tablets may darken the stools. This is normal and not a cause for concern.
Ferrous Fumarate/Docusate Controlled-Release Tablets contains a stool softener. Do not take any other laxative or stool softener products without first checking with your doctor or pharmacist.
Lab tests, including blood cell counts and iron levels, may be performed while you use Ferrous Fumarate/Docusate Controlled-Release Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Ferrous Fumarate/Docusate Controlled-Release Tablets should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Ferrous Fumarate/Docusate Controlled-Release Tablets while you are pregnant. Ferrous Fumarate/Docusate Controlled-Release Tablets is found in breast milk. If you are or will be breast-feeding while you use Ferrous Fumarate/Docusate Controlled-Release Tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Ferrous Fumarate/Docusate Controlled-Release Tablets:

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:

Bitter taste; constipation; diarrhea; green stools; nausea; stomach upset; throat irritation.

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

Severe allergic reactions (rash; hives; itching; 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 Fumarate/Docusate Controlled-Release Tablets:

Store Ferrous Fumarate/Docusate Controlled-Release Tablets 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 Fumarate/Docusate Controlled-Release Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Ferrous Fumarate/Docusate Controlled-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
Ferrous Fumarate/Docusate Controlled-Release Tablets 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 Fumarate/Docusate Controlled-Release Tablets. 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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