Skelid (Oral)

Tiludronate is used to treat Paget's disease of the bone. This medicine is a bisphosphonate that helps make the bones stronger.

This medicine is available only with your doctor's prescription.

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

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 when swallowing, chest pain, trouble 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.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine compared to the benefits it may provide. Here are some important points to think about for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies have not been done to determine how tiludronate affects children. Its safety and effectiveness have not been established in this age group.

Geriatric

Studies to date have not found specific problems in elderly patients that would limit the usefulness of tiludronate.

Breast Feeding

There are not enough studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the possible benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together. In other cases, two different medicines may be used together even if an interaction might occur. In these situations, your doctor may adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtime or with certain foods due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. The following interactions are highlighted based on their importance, but this list may not include all possible interactions.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical issues, particularly:

• Anemia or
• Blood clotting problems or
• Cancer or use of cancer medicines or
• Dental or tooth problems or
• Infection or
• Poor oral hygiene—Use with caution. This may increase the risk of a serious side effect involving the jaw.

• Barrett's esophagus or
• Bone or joint pain or
• Esophagus problems (e.g., difficulty swallowing or inflammation) or
• Severe muscle pain or
• Stomach or bowel issues (e.g., gastritis, heartburn, or ulcers)—Use with caution. This may worsen these conditions.

• Kidney disease—Use with caution. The effects may be stronger because the body removes the medicine more slowly.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Cough
• Fever
• Head congestion
• Hoarseness or other voice changes
• Nasal congestion
• Runny nose
• Sneezing
• Sore throat

Less common

• Blindness
• Blurred or decreased vision
• Burning, dry, or itching eyes
• Chest pain
• Discharge or excessive tearing
• Eye pain
• Headache
• Redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• Swelling of the face, feet, or lower legs
• Unusual weight gain

Rare

• Bladder pain
• Blistering, peeling, or loosening of the skin
• Bloody or cloudy urine
• Difficult, burning, or painful urination
• Dizziness or lightheadedness
• Fainting
• Feeling of constant movement of self or surroundings
• Frequent urge to urinate
• Headache
• Itching red skin lesions, often with a purple center
• Lower back or side pain
• Nervousness
• Pain or swelling in the arms or legs without any injury
• Pounding in the ears
• Sensation of spinning
• Slow or fast heartbeat
• Sores, ulcers, or white spots in the mouth or on the lips

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Abdominal or stomach cramps
• Confusion
• Convulsions
• Difficulty with breathing
• Irregular heartbeats
• Mood or mental changes
• Muscle cramps in the hands, arms, feet, legs, or face
• Numbness and tingling around the mouth, fingertips, or feet
• Shortness of breath
• Tremor

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Back pain
• Body pain (general)
• Diarrhea
• Nausea
• Upset stomach

Less common

• Bone fractures
• Burning, crawling, itching, numbness, prickling, "pins and needles," or tingling feelings
• Confusion
• Difficulty having a bowel movement (stool)
• Dizziness
• Dry skin
• Hair loss
• Increased thirst
• Increased urination
• Joint pain
• Loss of appetite
• Muscle cramps or spasms
• Muscle pain
• Red or irritated eyes
• Skin rash
• Stomach gas
• Throat pain
• Tooth disorder
• Trouble thinking
• Vomiting

Rare

• Dry mouth
• Fear or nervousness
• Feeling of warmth
• Lack or loss of strength
• Redness of the face, neck, arms, and occasionally, upper chest
• Sleepiness or unusual drowsiness
• Stomach pain
• Sleeplessness
• Trouble sleeping
• Unable to sleep
• Unusual tiredness or weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Skelid

Chemical Class: Bisphosphonate

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance for unwanted effects.

Swallow the tablet whole with a large glass (8 ounces) of plain water. Do not drink mineral water, milk, coffee, juice, or any other liquid when you take the tablet. It is best to take this medicine on an empty stomach, either 2 hours before or 2 hours after eating.

Do not lie down for at least 30 minutes after taking this medicine.

It is important that you eat a well-balanced diet with an adequate amount of calcium and vitamin D while you are taking this medicine. Your doctor can help you choose the best diet for your condition.

If you use calcium supplements, mineral supplements, indomethacin, or aspirin, take them either 2 hours before or 2 hours after you take tiludronate. If you use antacids, wait at least 2 hours after your dose before you take the antacid. If you take these medicines together with tiludronate, it may keep the medicine from working properly.

Tiludronate takes up to 3 months to work. If you feel that the medicine is not working, talk to your doctor. Do not stop taking the medicine without checking with your doctor.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):For treating Paget's disease: Adults—400 milligrams (mg) once a day for at least 3 months. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.