Alendronate is in the group of medicines called bisphosphonates (bis FOS fo nayts). It alters the cycle of bone formation and breakdown in the body. Alendronate slows bone loss while increasing bone mass, which may prevent bone fractures.

Cholecalciferol is a form of vitamin D, and is important for the absorption of calcium from the stomach and for the functioning of calcium in the body.

Alendronate and cholecalciferol is used to treat and prevent osteoporosis.

Alendronate and cholecalciferol may also be used for purposes not listed in this medication guide.

Do not take an alendronate and cholecalciferol tablet if you cannot sit upright or stand for at least 30 minutes. This medicine can cause serious problems in the stomach or esophagus (the tube that connects your mouth and stomach). You will need to stay upright for at least 30 minutes after taking the medicine.

Take the alendronate and cholecalciferol tablet first thing in the morning, at least 30 minutes before you eat or drink anything or take any other medicine.

Take each dose with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral water) when taking an alendronate and cholecalciferol tablet.

For at least the first 30 minutes after taking this medicine, do not lie down or recline; do not eat or drink anything other than plain water; and do not take any other medicines including vitamins, calcium, or antacids.

Some people using medicines similar to alendronate have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and a pre-existing dental problem.

If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using alendronate and cholecalciferol. You may need to stop using the medicine for a short time.

Talk with your doctor about the risks and benefits of using this medication.

Do not take an alendronate and cholecalciferol tablet if you cannot sit upright or stand for at least 30 minutes. This medicine can cause serious problems in the stomach or esophagus (the tube that connects your mouth and stomach). You will need to stay upright for at least 30 minutes after taking the medicine.

To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:

• low blood calcium (hypocalcemia);

• a cancer such as sarcoidosis, leukemia, lymphoma;

• a vitamin D deficiency;

• kidney disease; or

• an ulcer in your stomach or esophagus.

Some people using medicines similar to alendronate have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums.

You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and dental surgery or pre-existing dental problems.

Talk with your doctor about the risks and benefits of using this medication.

FDA pregnancy category C. It is not known whether alendronate and cholecalciferol will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether alendronate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.