$36.17

ACTONEL

(Also Known As: RISEDRONATE SODIUM)

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 suck or chew on the tablet because it may cause throat irritation.

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.

Follow your dosing instructions given to you by your doctor closely. It may affect the way this medicine works if you do not.

If you develop symptoms of esophageal problems such as difficulty or pain swallowing, pain behind your sternum, or severe heartburn that is continual and getting worse, tell your doctor before continuing to take this medicine.

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 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.
  • For prevention and treatment of postmenopausal osteoporosis:
    • Adults 5 milligrams (mg) daily or 35 mg weekly 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.

Missed dose

If you are on a daily schedule and 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.

If you are on a weekly schedule and miss a dose of this medicine, take it the next morning after you remember. Resume your usual schedule taking the medicine on your chosen day the next week.

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.

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

• Hypocalcemia (not enough calcium in the blood) Should be treated by your doctor before starting on risedronate

• Inability to stand or sit upright for at least 30 minutes This may effect the medicine getting to your stomach and it could cause your esophagus (digestive tract) to be irritated.

• Severe kidney problems Effects of risedronate may be increased because of slower removal from the body

Tell your doctor if you do weight-bearing exercises, smoke and/or drink excessively. Your doctor will need to take these into consideration in deciding your dose.