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 alendronate or vitamin D, 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

• Take this medicine in the morning on an empty stomach. 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.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose the next morning. Do not take 2 tablets on the same day. Then go back to your regular schedule.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep the medicine in the original package until you are ready to use it.

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 alendronate/cholecalciferol works. Tell your doctor if you are using any of the following:
  
  • Cholestyramine, cimetidine, colestipol, mineral oil, olestra, orlistat
  • Cancer medicines
  • Diuretic (water pill)
  • Medicine to treat seizures
  • NSAID medicine (including aspirin, diclofenac, ibuprofen, naproxen)
  • Steroids (including dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone)
• Take alendronate at least 30 minutes before you take any other oral medicine, including aluminum, magnesium, iron, or calcium supplements, or antacids.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, heartburn, anemia, blood clotting problems, ulcers or other stomach or bowel problems, sarcoidosis, a vitamin D deficiency, or a history of leukemia, lymphoma, or other 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
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may cause jaw problems, especially if you have a tooth pulled or have other dental work.
• Your doctor will check your progress and the effects of this medicine at regular visits. 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
• Chest pain, new or worsening heartburn, or 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