Alendronate is a bisphosphonate (bis FOS fo nayt) medicine that alters bone formation and breakdown in the body. This can slow bone loss and may help 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.

You should not take alendronate and cholecalciferol if you have low levels of calcium in your blood (hypocalcemia), or a problem with the movement of muscles in your esophagus.

Do not take this medicine tablet if you cannot sit upright or stand for at least 30 minutes. Alendronate 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 this medication.

Follow all directions on your prescription label. Do not take alendronate and cholecalciferol in larger or smaller amounts or for longer than recommended.

Alendronate and cholecalciferol tablets are taken once each week. Choose the day of the week that best fits your schedule. Every week, take one alendronate and cholecalciferol tablet on your chosen day.

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 the tablet with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral water) when taking this medicine.

Do not crush, chew, or suck the tablet. Swallow the pill whole.

After taking an alendronate and cholecalciferol tablet, carefully follow these instructions:

• Do not lie down or recline for at least 30 minutes after taking alendronate and cholecalciferol.

• Do not eat or drink anything other than plain water.

• Do not take any other medicines including vitamins, calcium, or antacids for at least 30 minutes after taking alendronate and cholecalciferol. It may be best to take your other medicines at a different time of the day. Talk with your doctor about the best dosing schedule for your other medicines.

To be sure this medication is helping your condition, your bone mineral density will need to be tested on a regular basis. You may not need to take alendronate and cholecalciferol for longer than 3 to 5 years if you take it for osteoporosis.

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.

Alendronate and cholecalciferol is only part of a complete program of treatment that may also include diet changes, exercise, and taking calcium and vitamin supplements. Follow your diet, medication, and exercise routines very closely.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Osteoporosis:

-70 mg alendronate-2800 IU cholecalciferol orally once a week or
-70 mg alendronate-5600 IU cholecalciferol orally once a week

Comments:
-Refer to administration advice for details on how to take this drug.
-Reevaluate bisphosphonate therapy periodically.

Uses:
-Treatment to increase bone mass and reduce the incidence of fractures, including those of the hip and spine (vertebral compression fractures) in postmenopausal women
-Treatment to increase bone mass in men with osteoporosis

You should not take this medicine if you have low levels of calcium in your blood (hypocalcemia), or a problem with the movement of muscles in your esophagus.

Do not take this medicine tablet if you cannot sit upright or stand for at least 30 minutes. Alendronate 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 this medication.

To make sure alendronate and cholecalciferol is safe for you, tell your doctor if you have:

• 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.

In rare cases, this medicine may cause bone loss (osteonecrosis) in the jaw. Symptoms include jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work. The longer you use alendronate and cholecalciferol, the more likely you are to develop this condition.

Osteonecrosis of the jaw may be more likely if you have cancer or received chemotherapy, radiation, or steroids. Other risk factors include blood clotting disorders, anemia (low red blood cells), and a pre existing dental problem.

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

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 and cholecalciferol passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

If you forget to take alendronate and cholecalciferol on your scheduled day, take it first thing in the morning on the day after you remember the missed dose. Then return to your regular weekly schedule on your chosen dose day. Do not take two (2) tablets in one day.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Drink a full glass of milk and call your local poison control center or emergency room right away. Do not make yourself vomit and do not lie down.

Overdose symptoms may include muscle cramps, numbness or tingling, tight muscles in your face, seizure (convulsions), irritability, and unusual thoughts or behavior.

Do not take any other medicines including vitamins, calcium, or antacids for at least 30 minutes after taking alendronate and cholecalciferol.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Alendronate and cholecalciferol may cause serious side effects. Stop using alendronate and cholecalciferol and call your doctor at once if you have:

• chest pain, new or worsening heartburn;

• difficulty or pain when swallowing;

• pain or burning under the ribs or in the back;

• new or worsening heartburn;

• severe joint, bone, or muscle pain;

• new or unusual pain in your thigh or hip; or

• jaw pain, numbness, or swelling.

Common side effects of alendronate and cholecalciferol may include:

• mild heartburn, stomach upset;

• diarrhea, gas, constipation;

• mild joint or back pain; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• aspirin or other NSAIDs (nonsteroidal anti-inflammatory drugs)--ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may interact with alendronate and cholecalciferol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.