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|Boniva

Boniva

Boniva is used for:

Preventing and treating osteoporosis (weak bones) in women past menopause. Boniva may also be used for other conditions as determined by your doctor.

Boniva is a bisphosphonate. It works by slowing bone loss and allowing new bone to be formed.

Do NOT use Boniva if:

• you are allergic to any ingredient in Boniva
• you have severe kidney problems or low levels of calcium in your blood
• you cannot stand or sit upright for at least 60 minutes

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

Before using Boniva :

Some medical conditions may interact with Boniva . 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 difficulty swallowing, problems with your esophagus, stomach problems (eg, ulcers), or kidney problems

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

• Aluminum, calcium, iron, or magnesium salts (eg, certain antacids or multivitamins) because the effectiveness of Boniva may be decreased
• Aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) because the risk of stomach irritation, including ulcers, may be increased

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

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

• Boniva comes with an additional patient leaflet. Read it carefully and reread it each time you get Boniva refilled.
• Take Boniva on an empty stomach at least 1 hour before eating. Boniva is only effective when taken on an empty stomach.
• Take Boniva with 6 to 8 ounces (180 to 250 mL) of plain water (not mineral water) first thing in the morning at least 1 hour before you take any other medicines or drink anything other than plain water.
• Swallow whole. Do not break, crush, chew, or suck on the tablet before swallowing.
• Do not lie down for at least 1 hour after taking Boniva .
• Calcium or iron supplements, vitamins, or antacids containing calcium, magnesium, aluminum, or iron may interfere with the absorption of Boniva . Take these products and any other medicines at least 1 hour after taking Boniva .
• If you miss a dose of Boniva and your next scheduled dose is more than 7 days away, take one dose in the morning following the day you remember. Then return to your original schedule. Do not take 2 doses within the same week. If your next scheduled dose is only 1 to 7 days away, wait until your next scheduled day to take your dose. Then return to your original schedule. If you miss a dose of Boniva and you are unsure of what to do, contact your doctor or pharmacist.

Ask your health care provider any questions you may have about how to use Boniva .

Important safety information:

• Boniva may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Boniva . Using Boniva alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Boniva may interfere with certain laboratory or diagnostic tests that use a bone-imaging agent. Be sure all your doctors and lab personnel know that you are taking Boniva .
• Boniva can cause pain or trouble swallowing, heartburn, or, rarely, ulcers in your stomach or esophagus. Taking Boniva with plenty of water and not lying down for at least 1 hour afterward will help to reduce your risk of these problems. Discuss the benefits and risks of Boniva with your doctor.
• Follow all dietary and exercise recommendations made by your doctor. Be sure that you are getting adequate calcium and vitamin D in your diet. Weight-bearing exercise may also be beneficial in the prevention of osteoporosis. Consult your doctor or pharmacist for more information.
• Boniva MAY CAUSE JAWBONE PROBLEMS in some patients, especially those who have cancer or certain other diseases (eg, anemia, blood clotting problems, infection), are using certain medicines (eg, chemotherapy, radiation therapy, corticosteroids), or already have dental disease or poor dental hygiene. Talk to your doctor or dentist about an appropriate dental examination before you begin treatment with Boniva . Ask your doctor any questions you may have about dental treatments while you are using Boniva .
• LAB TESTS, including bone thickness or density tests, may be performed to monitor your progress. Be sure to keep all doctor and lab appointments.
• Boniva is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Boniva may cause harm to the fetus. If you think you may be pregnant, discuss with your doctor the benefits and risks of using Boniva during pregnancy. It is unknown if Boniva is excreted in breast milk. If you are or will be breast-feeding while you are using Boniva , check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Boniva :

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; diarrhea; dizziness; headache; heartburn; mild flu-like symptoms; nausea; pain in the arms, legs, or back; stomach upset; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black, tarry stools; chest pain; eye pain; painful or difficult swallowing; severe bone, joint, or muscle pain; severe or persistent dizziness or headache; severe or persistent heartburn or stomach pain; vision changes; vomiting up blood or a substance that looks like coffee grounds.

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.

Store Boniva at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Boniva out of the reach of children and away from pets.

General information:

• If you have any questions about Boniva , please talk with your doctor, pharmacist, or other health care provider.
• Boniva 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 Boniva . 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.