ACTONEL- risedronate sodium tablet, film coated 
Allergan, Inc.

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Medication Guide

ACTONEL® (AK-toh-nel)

(risedronate sodium)

Tablets 

Read the Medication Guide that comes with ACTONEL® 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 ACTONEL, there may be new information about it. 

What is the most important information I should know about ACTONEL?

ACTONEL 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 ACTONEL 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).

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

4. Bone, joint, or muscle pain.

Some people who take ACTONEL 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 ACTONEL?

ACTONEL is a prescription medicine used to:

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

ACTONEL is not for use in children.

Who should not take ACTONEL?

Do not take ACTONEL if you:

What should I tell my doctor before taking ACTONEL?

Before you start ACTONEL, 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 ACTONEL works.

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 ACTONEL?

After swallowing ACTONEL tablet, wait at least 30 minutes:

Do not lie down for at least 30 minutes after you take ACTONEL and after you eat your first food of the day.

If you miss a dose of ACTONEL, 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 ACTONEL in a month, call your doctor for instructions.

If you take too much ACTONEL, call your doctor. Do not try to vomit. Do not lie down.

What are the possible side effects of ACTONEL?

ACTONEL may cause serious side effects:

The most common side effects of ACTONEL 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 ACTONEL. 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 ACTONEL?

Safely throw away medicine that is out of date or no longer needed.

Keep ACTONEL and all medicines out of the reach of children.

General information about the safe and effective use of ACTONEL.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ACTONEL for a condition for which it was not prescribed. Do not give ACTONEL 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 ACTONEL. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about ACTONEL that is written for health professionals.

For more information, go to www.Actonel.com or call 1-800-678-1605.  

What are the ingredients in ACTONEL?

Active ingredient: risedronate sodium

Inactive ingredients in all dose strengths: crospovidone, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide.  

Inactive ingredients specific to a dose strength: 5 mg—ferric oxide yellow, lactose monohydrate; 30 mg—lactose monohydrate; 35 mg—ferric oxide red, ferric oxide yellow, lactose monohydrate; 75 mg—ferric oxide red; 150 mg—FD&C blue #2 aluminum lake.

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

Distributed by:

Allergan USA, Inc.

Madison, NJ 07940

© 2019 Allergan. All rights reserved.

All trademarks are the property of their respective owners.

Revised: 11/2019

v1.0MG0471

Revised: 11/2019
Allergan, Inc.