RISEDRONATE SODIUM- risedronate sodium tablet, delayed release 
Greenstone LLC

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Medication Guide

Risedronate sodium

delayed-release tablets

Read this Medication Guide that comes with Risedronate sodium before you start taking it 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, there may be new information about it. 

What is the most important information I should know about Risedronate sodium?

Risedronate sodium 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 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 may lower the calcium levels in your blood. If you have low blood calcium before you start taking Risedronate sodium, it may get worse during treatment. Your low blood calcium must be treated before you take Risedronate sodium. 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 are taking Risedronate sodium. 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. Your doctor should examine your mouth before you start Risedronate sodium. Your doctor may tell you to see your dentist before you start Risedronate sodium. It is important for you to practice good mouth care during treatment with Risedronate sodium.

4. Bone, joint, or muscle pain.

Some people who take Risedronate sodium 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 is Risedronate sodium?

Risedronate sodium is a prescription medicine used to treat osteoporosis in women after menopause.

It is not known how long Risedronate sodium works for the treatment and prevention of osteoporosis. You should see your doctor regularly to determine if Risedronate sodium is still right for you.

Risedronate sodium is not for use in children.

Who should not take Risedronate sodium?

Do not take Risedronate sodium if you:

What should I tell my healthcare provider before taking Risedronate sodium?

Before you take Risedronate sodium, tell your healthcare provider if you:

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 works.

Especially tell your doctor if you take:

Ask your doctor or pharmacist for a list of these medications, if you are not sure.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I take Risedronate sodium?

After swallowing Risedronate sodium wait at least 30 minutes:

Do not lie down for at least 30 minutes after you take Risedronate sodium.

If you miss your weekly Risedronate sodium dose, take Risedronate sodium the morning after you remember then return to your normal schedule. Do not take 2 doses at the same time.

You should take calcium and vitamin D as directed by your doctor.

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?

Risedronate sodium may cause serious side effects:

The most common side effects of Risedronate sodium include:

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. 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?

Keep Risedronate sodium and all medicines out of the reach of children.

General information about the safe and effective use of Risedronate sodium  

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use Risedronate sodium for a condition for which it was not prescribed. Do not give Risedronate sodium to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about Risedronate sodium. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Risedronate sodium that is written for health professionals.

For more information, go to www.greenstonellc.com or call 1-800-438-1985.  

What are the ingredients in Risedronate sodium?

Active ingredient: risedronate sodium

Inactive ingredients: Edetate disodium, ferric oxide yellow, magnesium stearate, methacrylic acid copolymer, polysorbate 80, silicified microcrystalline cellulose (ProSolv SMCC90), simethicone, sodium starch glycolate, stearic acid, talc, and triethyl citrate.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

For all medical inquiries contact:
Greenstone LLC Medical Communications
1-800-438-1985
Rev. March 2017

Distributed by:
Greenstone LLC
Peapack, NJ 07977

© 2017 Allergan. All rights reserved.
Patented. See www.allergan.com/patents.

73353H10

Revised: 3/2017
Greenstone LLC