Advanced Consumer Information

Skelid

Generic Name: tiludronate (Oral route)

tye-loo-DROE-nate

Commonly used brand name(s):

In the U.S.

Skelid

Available Dosage Forms:

Tablet

Therapeutic Class: Calcium Regulator

Chemical Class: Bisphosphonate

Uses For Skelid

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

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

Before Using Skelid

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of tiludronate in children with use in other age groups.

Geriatric

Tiludronate has been tested in elderly patients and has not been found to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of Skelid

Take tiludronate with a full glass (6 to 8 ounces) of plain water on an empty stomach.

It is important that you eat a well-balanced diet with an adequate amount of calcium and vitamin D (found in milk or other dairy products). However, do not take any beverages (including mineral water), dietary supplements, food, or other medicines at least 2 hours before or after taking the tiludronate. To do so may keep this medicine from working properly.

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 of the bone:
  - Adults and teenagers—400 milligrams (mg) a day for at least three 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.

Precautions While Using Skelid

It is important that your doctor check your progress at regular visits to make sure this medicine is working properly and watch for unwanted effects .

It is important that you tell all of your health care providers that you are taking tiludronate. If you are having dental procedures done while taking tiludronate, you may have an increased chance of getting a severe problem with your jaw. Make sure your doctor knows if you have cancer, anemia, blood clotting problems, infection of any kind, poor oral hygiene, or if you have recently had tooth extraction or dental surgery. Make sure your doctor knows if you are also using chemotherapy, radiation, or corticosteroids (such as prednisone, dexamethasone, methylprednisolone, Decadron®, or Medrol®) .

Make sure you tell your doctor about any new medical problems, especially with your teeth or jaws. Tell your doctor if you have severe bone, joint, or muscle pain .

Skelid Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible 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

Blurred or decreased vision
chest pain
eye pain
headache
swelling of face, feet, or lower legs
unusual weight gain

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. Also, your health care professional may 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 or are bothersome or if you have any questions about them:

More common

Back pain
body pain (general)
diarrhea
nausea
upset stomach

Less common

Dizziness
joint pain
muscle pain
pain in throat
red or irritated eyes
skin rash
stomach gas
vomiting

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

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