When This Medicine Should Not Be Used:
You should not use this medicine if you have had an allergic reaction to tiludronate, or if you cannot stand or sit upright for at least 30 minutes.

How to Use This Medicine:
Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Swallow the tablet whole with a large glass (8 ounces) of plain water only (not mineral water, coffee, juice, or any other liquid). It is best to take this medicine on an empty stomach, 2 hours before or 2 hours after eating.
• Do not lie down for at least 30 minutes after taking this medicine.
• Carefully follow your doctor's instructions about any special diet. It is especially important that you get enough calcium and vitamin D in your diet.
• This medicine works slowly, so you may not feel better until you have been taking it for awhile. Talk to your doctor if you have questions, and do not stop taking the medicine without talking to your doctor first.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not take any other medicine within 2 hours before or 2 hours after taking tiludronate. This is especially important if you are taking aspirin, indomethacin (Indocin®), or calcium or mineral supplements.
• Make sure your doctor knows if you are using medicines that weaken your immune system such as cancer treatment, radiation, or steroids (such as prednisone, dexamethasone, methylprednisolone, Decadron®, or Medrol®).
• Wait at least 2 hours after you take tiludronate before taking antacids that contain aluminum, magnesium, or calcium (such as Maalox®, Mylanta®, or Tums®).

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney disease, esophagus problems (Barrett's esophagus), trouble with swallowing, heartburn, ulcers, stomach or bowel problems, or bone, joint or muscle pains.
• Tell your doctor if you have anemia, blood clotting problems, cancer, an infection, poor oral hygiene, or dental problems.
• This medicine can irritate your esophagus. Stop taking this medicine and call your doctor right away if you have severe heartburn (new or worse than usual), pain with swallowing, chest pain, trouble with swallowing, or feel like food is getting stuck in your esophagus.
• It is important that you tell all of your doctors or dentist that you are taking tiludronate. Make sure you tell your doctor about any new medical problems, especially with your teeth or jaw. If you have dental procedures while using this medicine, you may have an increased chance for serious jaw problems. Tell your doctor right away if you have any jaw tightness, swelling, numbness, or pain while using this medicine.
• This medicine can cause muscle or joint pain that in some cases is very severe. Tell your doctor right away if you have bone, joint, or muscle pain while using this medicine.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash.
• Blurred vision, eye problems.
• Change in how much or how often you urinate, painful urination.
• Chest pain.
• Fever, chills, cough, sore throat, and body aches.
• Headache or dizziness.
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet.
• Rapid weight gain.
• Severe bone, joint, or muscle pain.
• Swelling in your hands, ankles, or feet.
• Trouble swallowing, stomach pain, or new or increased heartburn.
• Unusual tiredness or weakness.

If you notice these less serious side effects, talk with your doctor:

• Dry mouth or tooth problems.
• Mild constipation, nausea, vomiting, diarrhea, or upset stomach.
• Runny or stuffy nose.
• Skin rash or itching.

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088