IMPORTANT NOTE The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

TITLE ALENDRONATE - ORAL

HOW TO PRONOUNCE (al-EN-droh-nate)

COMMON BRAND NAMES Fosamax

USES Alendronate is used to prevent and treat certain types of bone loss (osteoporosis). It belongs to a class of medications called bisphosphonates, and they decrease the activity of cells which break down bone. Maintaining strong bones by slowing bone loss helps to reduce the risk of fractures. Your risk of developing osteoporosis is greater as you age, after menopause due to the lack of natural estrogen hormones, and if you are taking corticosteroid medications (e.g., prednisone) for long periods.

HOW TO TAKE Follow these instructions very closely to maximize the amount of drug absorbed and reduce the risk of injury to your esophagus. This medicine comes with a patient information leaflet. Read it carefully. Ask your doctor or pharmacist any questions you may have about this medicine. Take this medication by mouth once a day, after getting up for the day and before taking your first food, beverage or other medication. Take it with a full glass (6-8 oz. or 180-240 ml) of plain water. Swallow the tablet whole. Do not chew or suck on it. Then stay fully upright (sitting, standing or walking) for at least 30 minutes and do not lie down until after your first food of the day. Wait at least 30 minutes after taking the medication before you eat or drink anything other than plain water. Do not take this medication at bedtime or before rising for the day. It may not be absorbed and you may have side effects. Other medications, vitamins, antacids, coffee, tea, soda, mineral water and food can decrease the absorption of alendronate. Do not take these for at least 30 minutes after taking alendronate. Use this medication regularly to get the most benefit from it. Remember to use it at the same time each morning.

SIDE EFFECTS Stomach pain, constipation, gas, or nausea may occur. If these effects persist or worsen, notify your doctor or pharmacist promptly. Tell your doctor immediately if any of these unlikely but serious side effects occur: an increase in muscle or bone pain, black stools, vomit that looks like coffee grounds. This medication may infrequently cause serious irritation and ulcers of the esophagus. If you notice any of the following unlikely but very serious side effects, stop taking alendronate and consult your doctor or pharmacist immediately: new or worsening heartburn, chest pain, trouble or painful swallowing. A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching, swelling, dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS Before taking alendronate, tell your doctor or pharmacist if you are allergic to it; or to other bisphosphonates; or if you have any other allergies. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: disorders of the esophagus (e.g., esophageal stricture or achalasia), inability to stand or sit upright for at least 30 minutes, low calcium levels, severe kidney disease. Before using this medication, tell your doctor or pharmacist your medical history, especially of: trouble swallowing, stomach/intestinal disorders (e.g., ulcers). This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: corticosteroids (e.g., prednisone), hormone replacement (e.g., estrogens, progestins), nonsteroidal anti-inflammatory drugs (NSAIDs such as aspirin, ibuprofen). Do not start or stop any medicine without doctor or pharmacist approval.

OVERDOSE If overdose is suspected, contact your local poison control center 1-800-222-1222 (USA) or emergency room immediately. Symptoms of overdose may include: severe stomach pain, painful heartburn, pain in the esophagus (chest pain), muscle weakness, mental/mood changes.

NOTES Do not share this medication with others. Lifestyle changes that help promote healthy bones include increasing weight-bearing exercise, eating well-balanced meals containing adequate calcium and vitamin D, stopping smoking, and limiting alcohol. Consult your doctor to see if you need to take calcium/vitamin D supplements and discuss lifestyle changes that might benefit you. Laboratory and/or medical tests (bone density tests, x-rays, height measurement, blood mineral levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE If you miss a dose, skip the missed dose. Resume your usual dosing schedule the following day. Do not double the dose to catch up.

STORAGE Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.