RISEDRONATE SODIUM - risedronate sodium tablet, film coated
Aurobindo Pharma Limited
Risedronate Sodium Tablets, USP
(ris'' e droe' nate soe' dee um)
Read the Medication Guide that comes with risedronate 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 risedronate sodium tablets, there may be new information about them.
What is the most important information I should know about risedronate sodium tablets?
Risedronate sodium tablets can cause serious side effects including:
1. Esophagus problems
2. Low calcium levels in your blood (hypocalcemia)
3. Severe jaw bone problems (osteonecrosis)
4. Bone, joint, or muscle pain
5. Unusual thigh bone fractures
1. Esophagus problems.
Some people who take risedronate 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).
Risedronate sodium tablets may lower the calcium levels in your blood. If you have low blood calcium before you start taking risedronate sodium tablets, it may get worse during treatment. Your low blood calcium must be treated before you take risedronate 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 risedronate sodium tablets. Take calcium and vitamin D as your doctor tells you to.
3. Severe jaw bone problems (osteonecrosis).
Severe jaw bone problems may happen when you take risedronate sodium tablets. Your doctor should examine your mouth before you start risedronate sodium tablets. Your doctor may tell you to see your dentist before you start risedronate sodium tablets. It is important for you to practice good mouth care during treatment with risedronate sodium tablets.
4. Bone, joint, or muscle pain.
Some people who take risedronate sodium tablets develop severe bone, joint, or muscle pain.
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 risedronate sodium tablets?
Risedronate sodium tablets are a prescription medicine used to:
It is not known how long risedronate sodium tablets work for the treatment and prevention of osteoporosis. You should see your doctor regularly to determine if risedronate sodium tablets are still right for you.
Risedronate sodium tablets are not for use in children.
Who should not take risedronate sodium tablets?
Do not take risedronate sodium tablets if you:
What should I tell my doctor before taking risedronate sodium tablets?
Before you start risedronate sodium tablets, be sure to talk to your doctor if you:
Especially tell your doctor if you take:
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Certain medicines may affect how risedronate sodium tablets work.
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 risedronate sodium tablets?
After swallowing risedronate sodium tablet, wait at least 30 minutes:
Do not lie down for at least 30 minutes after you take risedronate sodium tablets and after you eat your first food of the day.
If you miss a dose of risedronate sodium tablets, do not take it later in the day. Take your missed dose the next morning and then return to your normal schedule. Do not take 2 doses at the same time.
If you miss more than 2 doses of risedronate sodium tablets in a month, call your doctor for instructions.
If you take too much risedronate sodium, call your doctor. Do not try to vomit. Do not lie down.
What are the possible side effects of risedronate sodium tablets?
Risedronate sodium tablets may cause serious side effects:
The most common side effects of risedronate sodium tablets are:
You may get allergic reactions, such as hives, swelling of your face, lips, tongue, or throat.
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 risedronate 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.
How should I store risedronate sodium tablets?
Safely throw away medicine that is out of date or no longer needed.
Keep risedronate sodium tablets and all medicines out of the reach of children.
General information about the safe and effective use of risedronate sodium tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use risedronate sodium tablets for a condition for which it was not prescribed. Do not give risedronate 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 risedronate sodium tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about risedronate sodium tablets that is written for health professionals.
For more information, call Aurobindo Pharma USA, Inc. at 1-866-850-2876.
What are the ingredients in risedronate sodium tablets?
Active ingredient: Risedronate sodium
Inactive ingredients: colloidal silicon dioxide, crospovidone, FD&C Blue#2/Indigo carmine aluminium Lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Aurobindo Pharma Limited
Hyderabad-500 032, India