IBANDRONATE MONTHLY - ORAL

Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Uses

Ibandronate is used to prevent and treat certain types of bone loss (osteoporosis). Osteoporosis causes bones to become thinner and break more easily. Your chance of developing osteoporosis increases after menopause, as you age, or if you take corticosteroid medications (such as prednisone) for long periods. This medication works by slowing bone loss to help maintain strong bones and reduce the risk of broken bones (fractures). Ibandronate belongs to a class of medications called bisphosphonates.

How to Use

Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking ibandronate and each time you get a refill.

Follow the instructions very closely to make sure you absorb as much of the drug as possible and 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 month on the same date each month.

Choose the day of the month that best fits your schedule.

Take this medication after getting up for the day, and at least 60 minutes 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 to 8 ounces/180 to 240 milliliters) of plain water.

Do not take it with any other beverages.

Do not chew or suck the tablet or keep it in your mouth to melt.

Swallow the tablet whole.

Then stay fully upright (sitting, standing, or walking) for at least 60 minutes and do not lie down until after your first food of the day.

Wait at least 60 minutes after taking ibandronate before you eat or drink anything other than plain water and before taking any other medication by mouth.

Medications such as quinapril, sucralfate, and bismuth subsalicylate may interfere with the absorption of ibandronate.

Calcium or iron supplements, vitamins with minerals, and antacids containing calcium, magnesium or aluminum, as well as foods such as dairy products (such as milk, yogurt), mineral water, and calcium-enriched juice, may also interfere with absorption.

Do not take these products for at least 60 minutes after taking ibandronate.

Take this medication regularly to get the most benefit from it.

Remember to take it on the same day each month.

It may help to mark your calendar with a reminder.

Talk to your doctor about the risks and benefits of long-term use of this medication.

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

Side Effects

Stomach upset, diarrhea, pain in arms/legs, or mild flu-like symptoms (such as tiredness, muscle ache) 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: increased or severe bone/joint/muscle pain, new or unusual hip/thigh/groin pain, jaw pain, vision changes.

This medication may rarely cause irritation and ulcers in your stomach or esophagus.

Get medical help right away if any of these serious side effects occur: new/severe/worsening heartburn, chest pain, difficult or painful swallowing, severe stomach/abdominal pain, black/tarry stools, vomit that looks like coffee grounds.

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.

Precautions

Before taking ibandronate, tell your doctor or pharmacist if you are allergic to it; or to other bisphosphonates (such as alendronate, etidronate, pamidronate, risedronate); 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: esophagus problems (such as heartburn, narrowing of the esophagus, achalasia), low blood calcium levels (hypocalcemia), inability to sit upright or stand for 60 minutes, difficult or painful swallowing, stomach/intestinal disorders (such as ulcers), kidney disease.

Some people taking ibandronate 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 surgery (especially dental procedures), tell your doctor and dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Your doctor or dentist may tell you to stop taking ibandronate before your surgery.

Ask for specific instructions about stopping or starting this medication.

Tell your doctor if you are pregnant or plan to become pregnant.

Ibandronate may stay in your body for many years.

You should not become pregnant while using ibandronate.

Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk.

Consult your doctor before breastfeeding.

Drug Interactions

See also the 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.

This medication may interfere with certain lab tests (such as bone-imaging tests), possibly causing false test results.

Make sure lab personnel and all your doctors know you use this drug.