This medication is used to treat certain types of bone loss (osteoporosis) and to increase bone mass. Osteoporosis causes bones to become thinner and break more easily. Your chance of developing osteoporosis increases as you age, after menopause due to the lack of natural estrogen hormone, or if you are taking corticosteroid medications (e.g., prednisone) for long periods.

This product is a combination of two medicines, alendronate and cholecalciferol (vitamin D3). Alendronate works by slowing bone loss to help maintain strong bones and reduce the risk of broken bones. It belongs to a class of medications called bisphosphonates. Vitamin D3 helps your body absorb calcium and is necessary for building healthy bones.

Read the Patient Information Leaflet before starting this medication and each time you get a refill. Follow the instructions very closely to make sure your body absorbs as much drug as possible and to reduce the risk of injury to your esophagus. Consult your doctor or pharmacist if you have any questions.

Take this medication by mouth exactly as directed by your doctor, usually once a week. Choose the day of the week that best fits your schedule. Take this medication after getting up for the day, before taking your first food, beverage or other medication. Do not take it at bedtime or while you are still in bed.

Take this medication with a full glass (6-8 ounces or 180-240 milliliters) of plain water. Do not take it with any other beverages. 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 (preferably 1 to 2 hours) after taking this medication before you eat or drink anything other than plain water.

Some drugs may interfere with the absorption of this medication, such as quinapril, certain forms of didanosine (chewable/dispersible buffered tablets or pediatric oral solution), sucralfate, bismuth subsalicylate, mineral oil, orlistat, cholestyramine, and colestipol. Certain supplements and foods may also interfere with absorption of this medication, such as calcium or iron supplements, vitamins with minerals, antacids containing calcium/magnesium/aluminum, dairy products (e.g., milk, yogurt), mineral water, coffee, tea, and calcium-enriched juice. Do not take these products for at least 30 minutes (preferably 1 to 2 hours) after taking this medication.

Use this medication regularly in order to get the most benefit from it. Remember to take it on the same day each week. It may help to mark your calendar with a reminder.

Continue to take other medications for your condition as directed by your doctor.

Stomach upset, bloating, constipation, headache, nausea, or temporary flu-like symptoms (e.g., tiredness, muscle ache) may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: increased or severe bone/joint/muscle pain, swelling of joints/hands/ankles/feet, jaw pain, vision changes.

This medication may infrequently cause irritation/ulcers in your stomach or esophagus. Seek immediate attention if any of these serious side effects occur: new or worsening heartburn, chest pain, difficult/painful swallowing, severe stomach/abdominal pain, black/tarry stools, vomit that looks like coffee grounds.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other bisphosphonates (e.g., risedronate, etidronate, pamidronate); or to cholecalciferol; 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 the following conditions: certain disorders of the esophagus (e.g., esophageal stricture or achalasia), low blood calcium levels (hypocalcemia), inability to sit upright or stand for 30 minutes, severe kidney disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: cancers (e.g., leukemia, lymphoma), difficult or painful swallowing (e.g., dysphagia), esophagus problems (e.g., esophagitis), kidney problems, stomach/intestinal disorders (e.g., ulcers, gastritis), sarcoidosis, problems absorbing nutrients from food (malabsorption disorder).

Infrequently, serious jawbone problems (osteonecrosis) have occurred in people taking similar medications. Most people were also using other medications or had conditions that have actually caused the jawbone problem. If you have cancer, anemia, blood clotting disorders, infections/other diseases of the mouth, or poor dental hygiene, see your dentist for a full examination/treatment before you start this medication. Make sure your dentist knows your entire medical history, including any cancer radiation treatments. Also tell your dentist of all the medications you are using, especially cancer chemotherapy and corticosteroids such as prednisone. Consult your dentist for more details.

This drug is not recommended for use in children. Studies have shown that many children who took this drug had severe side effects such as vomiting, fever, and flu-like symptoms.

Caution is advised if you are pregnant or planning to become pregnant in the future. Alendronate may stay in your body for many years. Its effects on an unborn baby are not known. Discuss the risks and benefits with your doctor before starting treatment with this medication.

Cholecalciferol (vitamin D3) in this medication passes into breast milk. It is not known if alendronate passes into breast milk. Consult your doctor before breast-feeding.

See also the How to Use section.

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: drugs that affect the removal of vitamin D3 (e.g., cimetidine, thiazide diuretics such as hydrochlorothiazide, certain anti-seizure medications such as phenytoin).

Check all prescription and nonprescription medicine labels carefully since many medications contain pain/fever reducers known as NSAIDs (non-steroidal anti-inflammatory drugs such as ibuprofen, naproxen, or aspirin) that could cause stomach irritation/ulcers. Ask your pharmacist about the safe use of those products. Low-dose aspirin, as prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention (usually at dosages of 81-325 milligrams per day), should be continued. Consult your doctor or pharmacist for more details.

This medication may affect the results of certain lab tests (bone-imaging agents). Be sure to tell your doctor or laboratory personnel that you are taking this medication.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: stomach/abdominal pain, heartburn, pain in the esophagus (chest pain), weakness, mental/mood changes, changes in the amount of urine, vomiting.

Do not share this medication with others.

Lifestyle changes that help promote healthy bones include increasing weight-bearing exercise, stopping smoking, limiting alcohol, and eating well-balanced meals that contain adequate calcium and vitamin D. Since you may also need to take calcium and vitamin D supplements and make lifestyle changes, consult your doctor for specific advice.

Laboratory and/or medical tests (e.g., X-rays, height, bone mineral density test, vitamin D and blood mineral levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

If you miss a dose, do not take it later in the day. Take it the next morning after you remember. Continue taking your weekly dose on your usual scheduled day of the week. Do not take two tablets on the same day. Consult your doctor or pharmacist if you have any questions.

Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised October 2008 Copyright(c) 2008 First DataBank, Inc.