ALENDRONATE SODIUM - alendronate sodium tablet
Aurobindo Pharma Limited
Alendronate Sodium Tablets, USP
(a len' droe nate soe' dee um)
Read the Medication Guide that comes with alendronate 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 treatment. Talk to your doctor if you have any questions about alendronate sodium tablets.
What is the most important information I should know about alendronate sodium tablets?
Alendronate sodium tablets can cause serious side effects including:
1. Esophagus problems.
Some people who take alendronate 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).
Alendronate sodium tablets may lower the calcium levels in your blood. If you have low blood calcium before you start taking alendronate sodium tablets, they may get worse during treatment. Your low blood calcium must be treated before you take alendronate 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 alendronate
sodium tablets. Take calcium and vitamin D as your doctor tells you to.
3. Bone, joint, or muscle pain.
Some people who take alendronate sodium tablets develop severe bone, joint, or muscle pain.
4. Severe jaw bone problems (osteonecrosis).
Severe jaw bone problems may happen when you take alendronate sodium tablets. Your doctor should examine your mouth before you start alendronate sodium tablets. Your doctor may tell you to see your dentist before you start alendronate sodium tablets. It is important for you to practice good mouth care during treatment with alendronate 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 alendronate sodium tablets?
Alendronate sodium tablets are a prescription medicine used to:
It is not known how long alendronate sodium tablets work for the treatment and prevention of osteoporosis. You should see
your doctor regularly to determine if alendronate sodium tablets are still right for you.
Alendronate sodium tablets are not for use in children.
Who should not take alendronate sodium tablets?
Do not take alendronate sodium tablets if you:
What should I tell my doctor before taking alendronate sodium tablets?
Before you start alendronate 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 alendronate 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 alendronate sodium tablets?
After swallowing alendronate sodium tablet, wait at least 30 minutes:
Do not lie down for at least 30 minutes after you take alendronate sodium tablets and after you eat your first food of the day.
If you miss a dose of alendronate sodium tablets, do not take it later in the day. Take your missed dose on the next morning after you remember and then return to your normal schedule. Do not take 2 doses on the same day.
If you take too much alendronate sodium, call your doctor. Do not try to vomit. Do not lie down.
What are the possible side effects of alendronate sodium tablets?
Alendronate sodium tablets may cause serious side effects.
The most common side effects of alendronate sodium tablets are:
You may get allergic reactions, such as hives or swelling of your face, lips, tongue, or throat.
Worsening of asthma has been reported.
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 alendronate 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 do I store alendronate sodium tablets?
Keep alendronate sodium tablets and all medicines out of the reach of children.
General information about the safe and effective use of alendronate sodium tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use alendronate sodium tablets for a condition for which it was not prescribed. Do not give alendronate 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 alendronate sodium tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about alendronate 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 alendronate sodium tablets?
Active ingredient: alendronate monosodium salt trihydrate
Inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Aurobindo Pharma USA, Inc.
2400 Route 130 North
Dayton, NJ 08810
Aurobindo Pharma Limited
Hyderabad–500 072, India