When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to risedronate or calcium, or if you have esophagus problems or trouble swallowing. Do not use it if you cannot stand or sit upright for at least 30 minutes after you take the medicine.

How to Use This Medicine:
Tablet, Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed. The usual dose is to take the risedronate tablet on day 1 and then the calcium tablet on each of the next 6 days.
• Risedronate tablet:
  
  • Take this medicine once a week in the morning on an empty stomach. Choose a day of the week that best fits your activity schedule and will be easy to remember. Follow the directions exactly to lower the risk of esophagus problems.
  • Sit or stand while you take this medicine. Do not lie down for at least 30 minutes after you take the medicine, and do not lie down until after you have eaten.
  • Use plain water to take your medicine. The medicine may not work as well if you use other liquids.
  • Swallow the tablet whole with 6 to 8 ounces of water. Do not chew or suck on the tablet.
  • Wait at least 30 minutes after you take this medicine before you eat or drink or take any other medicine. This will help your body absorb the medicine.
• Calcium tablet: Take with food to help your body absorb the calcium.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose:
  
  • Risedronate: Take a dose the next morning after you remember. Do not take 2 tablets on the same day. Return to your regular schedule the following week.
  • Calcium: Take a dose as soon as you remember. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how risedronate/calcium works. Tell your doctor if you are using any of the following:
  
  • Thyroid medicine
  • Diuretic (water pill)
  • Antibiotic (including ciprofloxacin, moxifloxacin, ofloxacin, doxycycline, minocycline, tetracycline)
  • Cancer medicines
  • NSAID pain or arthritis medicine (including aspirin, celecoxib, diclofenac, ibuprofen, naproxen)
  • Steroids (including dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone)
  • Supplements or antacids that contain aluminum, magnesium, iron, or calcium

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, anemia, blood clotting problems, heartburn, ulcers or other stomach or bowel problems, or a history of cancer. Tell your doctor if you have dental problems or if you wear dentures. Also tell your doctor if you smoke or drink alcohol.
• This medicine may cause the following problems:
  
  • Damage to your esophagus
  • Low calcium levels
  • Increased risk for a thigh bone fracture
  • Increased risk for kidney stones
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine could cause jaw problems, especially if you have a tooth pulled or have other dental work.
• This medicine may interact with the dye used for bone scans.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Blood in the urine, lower back pain, side pain, sharp back pain just below the ribs
• Chest pain, new or worsening heartburn, or a burning feeling in your throat
• Muscle spasms or twitching, tingling or numbness in your fingers, toes, or around your mouth
• Pain or difficulty when swallowing
• Pain, swelling, numbness, or a heavy feeling in your mouth or jaw, loose teeth, or other tooth problems
• Severe bone, joint, or muscle pain
• Unusual pain in your thigh, groin, or hip

If you notice these less serious side effects, talk with your doctor:

• Mild stomach pain or upset

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088