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, or if you are taking corticosteroid medications (such as prednisone) for a long time.

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 (fractures). 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 Medication Guide provided by your pharmacist before you start taking 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. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually once a week. Choose the day of the week that best fits your schedule and take it on that day each week.

Take this medication after getting up for the day and before taking your first food, beverage, or other medication. Take it with a full glass (6-8 ounces or 180-240 milliliters) 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. This product works only if taken on an empty stomach. Wait at least 30 minutes (preferably 1 to 2 hours) after taking the medication before you eat or drink anything other than plain water.

Do not take this medication at bedtime or while you are still in bed. It may not be absorbed and you may have side effects.

Calcium or iron supplements, vitamins, antacids, coffee, tea, soda, mineral water, calcium-enriched juices, and food can decrease the absorption of alendronate. Do not take these for at least 30 minutes (preferably 1 to 2 hours) after taking this medication.

Take this medication regularly to get the most benefit from it. To help you remember, take it on the same day each week. Mark your calendar with a reminder. Talk to your doctor about the risks and benefits of long-term use of this medication.

Stomach pain, constipation, diarrhea, gas, or nausea may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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 right away if you have any serious side effects, including:

• jaw/ear pain
• swelling of joints/hands/ankles/feet
• increased or severe bone/joint/muscle pain
• new or unusual hip/thigh/groin pain
• black/tarry stools
• vomit that looks like coffee grounds

This medication may rarely 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 talk to your doctor or pharmacist right away:

• new or worsening heartburn
• chest pain
• pain or difficulty when swallowing

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• 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 or at www.fda.gov/medwatch.

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 alendronate/vitamin D3, tell your doctor or pharmacist if you are allergic to it; or to other bisphosphonates; or to other vitamin D products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• disorders of the esophagus (such as esophageal stricture or achalasia)
• trouble swallowing
• trouble standing or sitting upright for at least 30 minutes
• low calcium levels
• kidney problems
• stomach/intestinal disorders (such as ulcers)

Some people taking alendronate/vitamin D3 may have serious jawbone problems. Your doctor should check your mouth before you start this medication. Tell your dentist that you are taking this medication before you have any dental work done. To help prevent jawbone problems, have regular dental exams and learn how to keep your teeth and gums healthy. If you have jaw pain, tell your doctor and dentist right away.

Before having any surgery (especially dental procedures), tell your doctor and dentist about this medication and all other products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor or dentist may tell you to stop taking alendronate before your surgery. Follow all instructions about stopping or starting this medication.

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.

Tell your doctor if you are pregnant or plan to become pregnant. Alendronate may stay in your body for many years. You should not become pregnant while using this medication. Discuss the risks and benefits with your doctor.

Cholecalciferol (vitamin D3) in this medication passes into breast milk. It is unknown if alendronate passes into breast milk. Consult your doctor before breastfeeding.

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Vitamin D3 is very similar to calcitriol. Do not use medications containing calcitriol while using vitamin D3.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: severe stomach pain, painful heartburn, pain in the esophagus (chest pain), muscle weakness/cramps, 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. You may also need to take calcium and additional vitamin D supplements. Consult your doctor for specific advice.

Lab and/or medical tests (X-rays, height measurement, blood mineral levels) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it the next morning after you remember. Then go back to your weekly dosing schedule on your usual day of the week. Do not take two doses on the same day.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications 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.