Alendronate Sodium, Cholecalciferol (koe-le-kal-SIF-er-ol)

Prevents or treats osteoporosis (thinning of the bone) in women after menopause and treats osteoporosis in men.

Brand Name(s):

Fosamax Plus D

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• If any of this medicine stays in your esophagus, it may cause serious damage. To lower the risk of this problem, use this medicine exactly as directed by your doctor.
• Take this medicine as soon as you get out of bed in the morning, before you eat or have anything to drink. Swallow the tablet whole with a full glass (6 to 8 ounces) of plain water only (not mineral water, coffee, juice, or any other liquid). Do not chew or suck on the tablet. Do not take the medicine while you are still in bed, and do not take it at bedtime.
• Wait at least 30 minutes after you take the medicine before you eat or drink anything or take any other medicines. This will help your body absorb the medicine.
• Do not lie down for at least 30 minutes after taking this medicine, and do not lie down until after you have eaten some food.
• Carefully follow your doctor's instructions about diet and exercise. It is especially important that you get enough calcium and vitamin D in your diet.
• Follow your dosing instructions given to you by your doctor closely. It may affect the way this medicine works if you do not.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

If a dose is missed:

• This medicine is usually taken one time per week. If you miss your regularly scheduled dose or you forget to take your medicine, wait until the next morning to take it. Do not use extra medicine to make up for a missed dose. You should never take two tablets in one day.

How to Store and Dispose of This Medicine:

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid:

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

• Make sure your doctor knows if you are also using pain or arthritis medicine (sometimes called "NSAIDs"). This includes aspirin, ibuprofen, Advil®, Aleve®, Celebrex®, Ecotrin®, or Motrin®.
• Tell your doctor if you also use mineral oils, olestra (Olean®), orlistat (Xenical®), or medicines to lower your cholesterol (such as cholestyramine, colestipol, Colestid®, or Questran®). Also tell your doctor if you use medicines to treat seizures (such as phenobarbital, Luminal®), cimetidine (Tagamet®), diuretic or "water pill" (such as hydrochlorothiazide [HCTZ]), or phenothiazine medicine (such as prochlorperazine, Compazine®, Mellaril®, or Phenergan®).
• Make sure your doctor knows if you are also using cancer treatment, radiation, or steroids (such as prednisone, dexamethasone, methylprednisolone, Decadron®, or Medrol®).
• Wait at least 30 minutes after you take alendronate before taking any calcium supplements and antacids.
• Do not drink alcohol or smoke tobacco. Both alcohol and smoking can make your bone problems worse.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney disease, stomach ulcers, heartburn, trouble swallowing, or any other kind of stomach or bowel problems. Also tell your doctor if you have anemia, blood clotting problems, blood or bone marrow problems (such as leukemia, lymphoma, sarcoidosis), cancer, infection of any kind, any type of vitamin or mineral deficiency or imbalance, poor oral hygiene, or dental problems.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. If you are having dental procedures done, you may have an increased chance of getting a severe problem of your jaw.
• This medicine can irritate your esophagus. If you think this medicine has started to damage your esophagus, stop taking the medicine and call your doctor. Symptoms of damage to the esophagus are heartburn (either new or worse than usual), pain when swallowing, pain in the center of your chest, trouble swallowing, or feeling that food gets stuck on the way to your stomach.
• Make sure you tell your doctor about any new medical problems, especially with your teeth or jaws. Tell your doctor if you have severe bone, joint, or muscle pain while using this medicine.
• Tell your doctor if you do weight-bearing exercises, or smoke and/or drink excessively. Your doctor will need to take these into consideration in deciding your dose.

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.
• Bloody, black, or tarry stools.
• Blurred vision, eye problems.
• Chest pain, heartburn, or burning in your throat.
• Difficult or painful swallowing.
• Heavy jaw feeling.
• Loosening of a tooth.
• Pain, swelling, or numbness in the mouth or jaw.
• Severe bone, joint, or muscle pain.
• Severe stomach pain or enlarged abdomen (stomach).
• Swelling in your hands, ankles, or feet.
• Tooth problems.

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

• Headache.
• Mild bone, muscle, or joint pain.
• Mild stomach pain, nausea, indigestion, diarrhea, constipation, or gas.

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