Tiludronate is used to treat Paget’s disease of bone (a condition in which the bones are soft and weak and may be deformed, painful, or easily broken). Tiludronate is in a class of medications called bisphosphonates. It works by preventing bone breakdown and increasing bone density (thickness).

Tiludronate comes as a tablet to take by mouth. It is usually taken on an empty stomach once a day for 3 months. This treatment may be repeated if symptoms come back or worsen after some time has passed. Take tiludronate at around the same time every day. Follow the directions on your prescription label carefully and ask your doctor or pharmacist to explain any part you do not understand. Take tiludronate exactly as directed. Do not take it more or less often or for a longer period of time than prescribed by your doctor.

Take tiludronate with a full glass (6 to 8 ounces [180 to 240 milliliters]) of plain water. Do not take tiludronate with any other liquid, including mineral water. Do not eat or drink for 2 hours before or 2 hours after you take tiludronate. Do not lie down for at least 30 minutes after taking this medication.

Tiludronate controls Paget’s disease of bone only when it is taken as prescribed. Do not stop taking tiludronate without talking to your doctor.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Before taking tiludronate,

• Tell your doctor and pharmacist if you are allergic to tiludronate, any other medications, or any of the ingredients in tiludronate tablets. Ask your pharmacist for a list of the ingredients.
• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: chemotherapy medications for cancer and oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone).Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• If you are taking aspirin, indomethacin (Indocin), or calcium or mineral supplements, take them 2 hours before or 2 hours after you take tiludronate. If you are taking antacids containing calcium, magnesium, or aluminum (Maalox, Mylanta, Tums, others), take them at least 2 hours after you take tiludronate.
• Tell your doctor if you are unable to stand or sit upright for at least 30 minutes after taking tiludronate. Your doctor will probably tell you not to take tiludronate.
• Tell your doctor if you are undergoing radiation therapy and if you have or have ever had difficulty or pain when swallowing; heartburn, ulcers, or other problems with your stomach or esophagus (tube connecting the mouth to the stomach); anemia (condition in which the red blood cells do not bring enough oxygen to all the parts of the body); cancer; any type of infection, especially in your mouth; problems with your mouth, teeth, or gums; any condition that stops your blood from clotting normally; or dental or kidney disease.
• Tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. Also tell your doctor if you plan to become pregnant at any time in the future, because tiludronate may remain in your body for years after you stop taking it. Call your doctor if you become pregnant during or after your treatment.
• You should know that tiludronate may cause serious problems with your jaw, especially if you have dental surgery or treatment while you are taking the medication.A dentist should examine your teeth and perform any needed treatments before you start to take tiludronate. Be sure to brush your teeth and clean your mouth properly while you are taking tiludronate. Talk to your doctor before having any dental treatments while you are taking this medication.
• You should know that tiludronate may cause severe bone, muscle, or joint pain. You may begin to feel this pain within days, months, or years after you first take tiludronate. Although this type of pain may begin after you have taken tiludronate for some time, it is important for you and your doctor to realize that it may be caused by tiludronate. Call your doctor right away if you experience severe pain at any time during your treatment with tiludronate. Your doctor may tell you to stop taking tiludronate and your pain may go away after you stop taking the medication.

You should eat and drink plenty of foods and drinks that are rich in calcium and vitamin D while you are taking tiludronate Your doctor will tell you which foods and drinks are good sources of these nutrients and how many servings you need each day. If you find it difficult to eat enough of these foods, tell your doctor. In that case, your doctor may prescribe or recommend a supplement.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Tiludronate may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• Nausea
• Vomiting
• Diarrhea
• Gas
• Swelling of the arms, hands, feet, ankles, or lower legs
• Pain, burning, numbness, or tingling in the hands or feet
• Red or irritated eyes
• Changes in vision
• Rash

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:

• New or worsening heartburn
• Difficulty swallowing
• Pain on swallowing
• Chest pain

Tiludronate may cause other side effects. Call your doctor if you have any unusual problems while you are taking tiludronate.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Do not remove the tablets from the foil strip until you are ready to take them. Store this medication at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain laboratory tests to check your response to tiludronate.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.