Tiludronate Disodium Oral tablet

What is this medicine?

TILUDRONATE (tye LOO droe nate) slows calcium loss from bone. It helps to make healthy bone and to slow bone loss in patients with Paget's disease.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• dental disease

• esophagus, stomach, or intestine problems

• kidney disease

• problems sitting or standing

• trouble swallowing

• an unusual or allergic reaction to tiludronate, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

You must take this medicine exactly as directed or you will lower the amount of the medicine you absorb into your body or you may cause yourself harm. Take this medicine by mouth with a full glass (6 to 8 ounces) of plain water. Do not drink anything else, eat, or take any medicine or vitamins within 2 hours, before or after taking your dose. Do not chew or crush this medicine. After taking this medicine, stand or sit up for at least 30 minutes. Take your tablets at the same time each day. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can if you have not already eaten. If you have already eaten, call your doctor of health care professional for advice. Do not take double or extra doses.

What may interact with this medicine?

• aluminum salts

• antacids

• aspirin

• calcium supplements

• iron supplements

• magnesium supplements

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks ups. It may be some time before you see the benefit from this medicine. Do not stop taking your medicine except on your doctor's advice. Your doctor or health care professional may order blood tests and other tests to see how you are doing.

You should make sure you get enough calcium and vitamin D while you are taking this medicine. Discuss the foods you eat and the vitamins you take with your health care professional.

Some people who take this medicine have severe bone, joint, and/or muscle pain. This medicine may also increase your risk for a broken thigh bone. Tell your doctor right away if you have pain in your upper leg or groin. Tell your doctor if you have any pain that does not go away or that gets worse.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions such as skin rash, itching, hives, or swelling of the lips, arms, legs, face, tongue, or throat

• black or tarry stools

• changes in vision

• heartburn or stomach pain

• numbness or tingling in the hands or feet

• pain or trouble swallowing

• redness, blistering, peeling or loosening of the skin, including inside the mouth

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• bone, joint or muscle pain

• diarrhea or constipation

• headache

• nausea or vomiting

• gas

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.