IBANDRONATE SODIUM - ibandronate sodium tablet, film coated
Aurobindo Pharma Limited
Ibandronate Sodium Tablets
Read the Medication Guide that comes with ibandronate sodium tablets before you start taking them and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment. Talk to your doctor if you have any questions about ibandronate sodium tablets.
What is the most important information I should know about ibandronate sodium tablets?
Ibandronate sodium tablets may cause serious side effects including:
1. Esophagus problems.
Some people who take ibandronate sodium tablets may develop problems in the esophagus (the tube that connects the mouth and the stomach). These problems include irritation, inflammation, or ulcers of the esophagus which may sometimes bleed.
2. Low calcium levels in your blood (hypocalcemia).
Ibandronate sodium tablets may lower the calcium levels in your blood. If you have low blood calcium before you start taking ibandronate sodium tablets, it may get worse during treatment. Your low blood calcium must be treated before you take ibandronate sodium tablets. Most people with low blood calcium levels do not have symptoms, but some people may have symptoms. Call your doctor right away if you have symptoms of low blood calcium such as:
Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels in your blood, while you take ibandronate sodium tablets. Take calcium and vitamin D as your doctor tells you to.
3. Bone, joint, or muscle pain.
Some people who take ibandronate sodium tablets develop severe bone, joint, or muscle pain.
4. Severe jaw bone problems (osteonecrosis).
Severe jaw bone problems may happen when you take ibandronate sodium tablets. Your doctor may examine your mouth before you start ibandronate sodium tablets. Your doctor may tell you to see your dentist before you start ibandronate sodium tablets. It is important for you to practice good mouth care during treatment with ibandronate sodium tablets.
5. Unusual thigh bone fractures.
Some people have developed unusual fractures in their thigh bone. Symptoms of a fracture may include new or unusual pain in your hip, groin, or thigh.
Call your doctor right away if you have any of these side effects.
What are ibandronate sodium tablets?
Ibandronate sodium tablets are a prescription medicine used to treat or prevent osteoporosis in women after menopause. Ibandronate sodium tablets help increase bone mass and help reduce the chance of having a spinal fracture (break).
It is not known how long ibandronate sodium tablets work for the treatment and prevention of osteoporosis. You should see your doctor regularly to determine if ibandronate sodium tablets are still right for you.
It is not known if ibandronate sodium tablets are safe and effective in children.
Who should not take ibandronate sodium tablets?
Do not take ibandronate sodium tablets if you:
What should I tell my doctor before taking ibandronate sodium tablets?
Before you start ibandronate sodium tablets, be sure to talk to your doctor if you:
Tell your doctor and dentist about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Certain medicines may affect how ibandronate sodium tablets work.
Especially tell your doctor if you take:
Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist each time you get a new medicine.
How should I take ibandronate sodium tablets?
After swallowing ibandronate sodium tablet, wait at least 60 minutes:
Do not lie down for at least 60 minutes after you take ibandronate sodium tablets and do not eat your first food of the day for at least 60 minutes after you take ibandronate sodium tablets.
If you miss a dose of ibandronate sodium tablets, do not take it later in the day. Call your doctor for instructions.
If you take too much ibandronate sodium, call your doctor. Do not try to vomit. Do not lie down.
What are the possible side effects of ibandronate sodium tablets?
Ibandronate sodium tablets may cause serious side effects.
The most common side effects of ibandronate sodium tablets are:
You may get allergic reactions, such as hives, breathing difficulties, swelling of your face, lips, tongue or throat, or feeling faint.
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of ibandronate sodium tablets. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to Aurobindo Pharma USA, Inc. at 1-866-850-2876.
How do I store ibandronate sodium tablets?
Keep ibandronate sodium tablets and all medicines out of the reach of children.
General information about the safe and effective use of ibandronate sodium tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ibandronate sodium tablets for a condition for which it was not prescribed. Do not give ibandronate sodium tablets to other people, even if they have the same symptoms you have. They may harm them.
This Medication Guide summarizes the most important information about ibandronate sodium tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about ibandronate sodium tablets that is written for health professionals.
What are the ingredients in ibandronate sodium tablets?
Active ingredient: ibandronate sodium
Inactive ingredients: colloidal silicon dioxide, crospovidone, microcrystalline cellulose, povidone and sodium stearyl fumarate. The tablet film-coating contains hypromellose, talc, titanium dioxide and triacetin.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Dispense with Medication Guide available at: www.aurobindousa.com/product-medication-guides
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Aurobindo Pharma Limited
Hyderabad-500 038, India