Uses of Ibandronate Tablets:

• It is used to treat soft, brittle bones (osteoporosis) in women who have been through menopause (change of life).
• It is used to put off soft, brittle bones (osteoporosis) in women after change of life.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Ibandronate Tablets?

• If you have an allergy to ibandronate or any other part of this medicine (ibandronate tablets).
• If you are allergic to this medicine (ibandronate tablets); any part of this medicine (ibandronate tablets); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have low calcium levels.
• If you have kidney problems.
• If you are pregnant or breast-feeding. This medicine is not approved for use in women who are pregnant or breast-feeding.
• If you have a swallowing tube (esophagus) that is not normal.
• If you have trouble swallowing.
• If you are not able to stand or sit up for 1 hour.

This is not a list of all drugs or health problems that interact with this medicine (ibandronate tablets).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (ibandronate tablets) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Ibandronate Tablets?

• Tell all of your health care providers that you take this medicine (ibandronate tablets). This includes your doctors, nurses, pharmacists, and dentists.
• Worsening of asthma has happened in people taking drugs like this one. Talk with the doctor.
• Very bad and sometimes deadly allergic side effects have rarely happened. Talk with your doctor.
• This medicine may raise the chance of a broken leg. Talk with the doctor.
• Have a bone density test as you have been told by your doctor. Talk with your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine (ibandronate tablets).
• Follow the diet and workout plan that your doctor told you about.
• This medicine works best when used with calcium/vitamin D and weight-bearing workouts like walking or PT (physical therapy).
• Have a dental exam before starting this medicine (ibandronate tablets).
• Take good care of your teeth. See a dentist often.
• Talk with your doctor before you drink alcohol.
• If you smoke, talk with your doctor.
• Very bad swallowing tube (esophagus) problems like irritation, swelling, ulcers, and bleeding have happened with this medicine (ibandronate tablets). Talk with the doctor.

How is this medicine (Ibandronate Tablets) best taken?

Use this medicine (ibandronate tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take 150 mg tablet on the same day each month.
• Take with a full glass of water at least 60 minutes before the first food, drink, or drugs of the day.
• Take with plain water only. Avoid taking with mineral water, milk, or other drinks.
• Swallow tablet whole. Do not chew, break, or crush.
• Do not suck on this product.
• Do not lie down for at least 60 minutes after taking this medicine (ibandronate tablets).
• Do not take calcium, iron, vitamins with minerals, or antacids within 1 hour of this medicine (ibandronate tablets).
• Keep taking this medicine (ibandronate tablets) as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Do not take it later in the day.
• Take the missed dose on the next morning after you think about it and then go back to your normal time.
• If it is less than 7 days until your next dose, skip the missed dose and go back to your normal time.
• Do not take two 150 mg tablets within the same week.

What are some side effects that I need to call my doctor about right away?

• WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of low calcium levels like muscle cramps or spasms, numbness and tingling, or seizures.
• Chest pain.
• Heartburn.
• Black, tarry, or bloody stools.
• Coughing up blood.
• Throwing up blood or throw up that looks like coffee grounds.
• Trouble swallowing.
• Very bad pain when swallowing.
• Mouth sores.
• Eye pain.
• Change in eyesight.
• Very bad bone, joint, or muscle pain.
• Any new or strange groin, hip, or thigh pain.
• Very bad dizziness.
• Pain when passing urine.
• Passing urine more often.
• This medicine may cause jawbone problems. The risk may be higher with longer use, cancer, dental problems, ill-fitting dentures, anemia, blood clotting problems, or infection. It may also be higher if you have dental work, chemo, radiation, or take other drugs that may cause jawbone problems. Many drugs can do this. Talk with your doctor if any of these apply to you, or if you have questions. Call your doctor right away if you have jaw swelling or pain.

What are some other side effects of Ibandronate Tablets?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Stomach pain or diarrhea.
• Upset stomach or throwing up.
• Flu-like signs.
• Nose or throat irritation.
• Back pain.
• Pain in arms or legs.
• Headache.
• Muscle or joint pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Ibandronate Tablets?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine (ibandronate tablets) is refilled. If you have any questions about this medicine (ibandronate tablets), please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.