In the U.S.—

In Canada—

• Bone resorption inhibitor

Risedronate ( ris-ED-roe-nate) is used to prevent and treat osteoporosis (thinning of bone) in women after menopause. It may also be used in men and women to prevent and treat osteoporosis caused by long-term use of corticosteroids (cortisone-like medicine). Risedronate is also used to treat Paget's disease of the bone.

This medicine is available only with your doctor's prescription, in the following dosage form:

Oral
• Tablets (U.S.)
• Tablets (Canada)

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 risedronate, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to risedronate. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies have not been done in pregnant women. However, studies in animals given large doses of risedronate have shown that this medicine causes decreased weight gain, cleft palate, and deformed bones in the fetus, and, in some cases, death of the fetus.

Breast-feeding—It is not known whether risedronate passes into milk. However, it does pass into the milk in animals. Discuss with your doctor whether or not to breast-feed while you are being treated with this medicine.

Children—There is no specific information comparing use of risedronate in children with use in other age groups.

Older adults—Risedronate 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.

Other 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. When you are taking risedronate, it is especially important that your health care professional know if you are taking any of the following:

• Antacids containing calcium or
• Mineral supplements containing calcium—These medicines may decrease the amount of risedronate that is absorbed into the body

• Digestive system problems, including trouble swallowing, inflammation of the esophagus, or ulcer—Risedronate may make these conditions worse

• Kidney problems—Effects of risedronate may be increased because of slower removal from the body

Take risedronate with a full glass (6 to 8 ounces) of plain water on an empty stomach. It should be taken in the morning at least 30 minutes before any food, beverage, or other medicines. Food and beverages will decrease the amount of risedronate absorbed by the body. Waiting longer than 30 minutes will allow more of the drug to be absorbed. Medicines such as antacids that contain calcium or calcium supplements also will decrease the absorption of risedronate.

Do not lie down for 30 minutes after taking risedronate . This will help risedronate reach your stomach faster. It also will help prevent irritation to your esophagus.

It is important that you eat a well-balanced diet with adequate amounts of calcium and vitamin D (found in milk or other dairy products). However, do not take any foods, beverages, or calcium supplements within 30 minutes or longer before taking the risedronate. To do so may keep this medicine from working properly.

Dosing—

The dose of risedronate 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 risedronate. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral dosage form (tablets):
  • For prevention and treatment of postmenopausal and corticosteroid-induced osteoporosis:
    • Adults—5 milligrams (mg) daily at least 30 minutes before the first food or drink of the day other than water.
    • Children—Use and dose must be determined by your doctor.
  • For Paget's disease of the bone:
    • Adults—30 mg a day for two months. Your doctor may tell you to repeat this dose.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, do not take it later in the day. Resume your usual schedule the next morning. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

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.

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
  • Abdominal or stomach pain;  skin rash  
  
  

• Less common
  • Abdominal or stomach pain (severe);  belching;  bone pain;  cramping of stomach 
  
  

• Red, sore eyes 

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Diarrhea;  headache;  joint pain 
  
  

• Less common
  • Blurred vision or change in vision;  chest pain;  constipation;  cough;  dizziness;  dry eyes ;  fever;  general feeling of discomfort or illness;  headache;  leg cramps;  nausea;  ringing in the ears;  swelling of feet or lower legs ;  weakness 
  
  

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