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What is the most important information I should know about tiludronate?

Take tiludronate on an empty stomach, at least 2 hours before or 2 hours after eating.

Your doctor may ask you to take the medicine first thing in the morning, before you eat or drink anything or take any other medicine.

Take each dose with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral water) when taking a tiludronate tablet.

Wait at least 2 hours after taking tiludronate before you eat or take other medicines including vitamins, calcium, or antacids. Do not take tiludronate if it has been less than 2 hours since your last meal or other medication.

Some people using medicines similar to tiludronate have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and a pre-existing dental problem.

What is tiludronate?

Tiludronate is in the group of medicines called bisphosphonates (bis FOS fo nayts). It alters the cycle of bone formation and breakdown in the body. Tiludronate slows bone loss while increasing bone mass, which may prevent bone fractures.

Tiludronate is used to treat Paget's disease of bone.

Tiludronate may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking tiludronate?

Do not take this medication if you are allergic to tiludronate.

Before using tiludronate, tell your doctor if you have:

• low blood calcium (hypocalcemia);

• a vitamin D deficiency;

• kidney disease; or

• an ulcer in your stomach or esophagus.

If you have any of these conditions, you may not be able to use tiludronate, or you may need a dosage adjustment or special tests during treatment.

Some people using medicines similar to tiludronate have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums.

You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and dental surgery or pre-existing dental problems.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether tiludronate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.