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Fosteum is used for:

Dietary management of osteopenia and osteoporosis (weak bones).

Fosteum is a medical food. It works by slowing down bone breakdown activity and speeding up bone building activity.

Do NOT use Fosteum if:

• you are allergic to any ingredient in Fosteum , or to soy
• you or anyone in your family has or has had cancer of the breast or reproductive organs
• you are taking hormone replacement therapy drugs or other drugs for osteoporosis

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

Before using Fosteum :

Some medical conditions may interact with Fosteum . 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 are allergic to soy products
• if you have kidney, liver, or gallbladder problems
• if you have leukemia, lymphoma, sarcoidosis, low blood vitamin D levels, or problems absorbing nutrients from the stomach or bowel

Some MEDICINES MAY INTERACT with Fosteum . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticonvulsants (eg, phenytoin), cimetidine, or thiazide diuretics (eg, hydrochlorothiazide) because they may decrease Fosteum �'s effectiveness
• Quinolone antibiotics (eg, ciprofloxacin) or tetracycline antibiotics (eg, doxycycline) because their effectiveness may be decreased by Fosteum

This may not be a complete list of all interactions that may occur. Ask your health care provider if Fosteum 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 Fosteum :

Use Fosteum as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Fosteum . Talk to your pharmacist if you have questions about this information.
• Take Fosteum by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Take your doses of Fosteum about 12 hours apart.
• Bile acid sequestrants (eg, cholestyramine), mineral oil, or orlistat may decrease the effectiveness of Fosteum . If you are taking any of these medicines, ask your doctor or pharmacist how to take them with Fosteum .
• Olestra may decrease the effectiveness of Fosteum . Some foods (eg, potato chips) may contain olestra. Check food labels to see if any of your foods contain olestra. If they do, check with your doctor or pharmacist.
• Taking Fosteum at the same times each day will help you remember to take it.
• If you miss a dose of Fosteum , 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 Fosteum .

Important safety information:

• Follow the diet and exercise program given to you by your health care provider.
• Taking a calcium supplement while you are using Fosteum is recommended. Check with your doctor for instructions.
• Fosteum has zinc in it. Before you start any new medicine, check the label to see if it has zinc in it too. If it does or if you are not sure, check with your doctor or pharmacist.
• Fosteum should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fosteum while you are pregnant. It is not known if Fosteum is found in breast milk. Do not breast-feed while taking Fosteum .

Possible side effects of Fosteum :

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.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

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 increased thirst; increased urination; lethargy; loss of appetite; severe or persistent nausea or vomiting; weakness.

Store Fosteum at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Fosteum out of the reach of children and away from pets.

General information:

• If you have any questions about Fosteum , please talk with your doctor, pharmacist, or other health care provider.
• Fosteum 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 summary only. It does not contain all information about Fosteum . 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.