ACTOS- pioglitazone hydrochloride tablet 
Rebel Distributors Corp.



(pioglitazone hydrochloride) tablets

Read this Medication Guide carefully before you start taking ACTOS and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about ACTOS, ask your doctor or pharmacist.

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

ACTOS can cause serious side effects, including new or worse heart failure.

Call your doctor right away if you have any of the following:

ACTOS can have other serious side effects. See "What are the possible side effects of ACTOS?"

What is ACTOS?

ACTOS is a prescription medicine used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. ACTOS is a diabetes medicine called pioglitazone hydrochloride that may be taken alone or with other diabetes medicines.

Your doctor will decide if you should take ACTOS.

It is important to eat the right foods, lose weight if needed, and exercise regularly in order to manage your type 2 diabetes. Diet, weight loss, and exercise are the main treatments for type 2 diabetes and they also help your diabetes medicines work better for you.

ACTOS has not been studied in children and is not recommended for children under the age of 18. The risks of giving ACTOS to a child are not known. See "What are some other possible side effects of ACTOS?"

Who should not take ACTOS?

Do not take ACTOS if you:

People with severe heart failure should not start taking ACTOS. See "What is the most important information I should know about ACTOS?"

What should I tell my doctor before taking ACTOS?

Before starting ACTOS, ask your doctor about what the choices are for diabetes medicines and what the expected benefits and possible risks are for you in particular.

Tell your doctor about all of your medical conditions, especially if you:

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. ACTOS and some of your other medicines can affect each other. You may need to have your dose of ACTOS or certain other medicines adjusted. Certain other medicines can affect your blood sugar (glucose) control.

Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist before you start a new medicine. They will tell you if it is okay to take ACTOS with other medicines.

How should I take ACTOS?

What are other possible side effects of ACTOS?

ACTOS can cause other serious side effects including:

In studies of pioglitazone (the medicine in ACTOS), bladder cancer occurred in a few more people who were taking pioglitazone than in people who were taking other diabetes medicines. There were too few cases to know if the bladder cancer was related to pioglitazone.

Other common side effects of ACTOS are:

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the side effects of ACTOS. 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 ACTOS?

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

General information about ACTOS

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ACTOS for a condition for which it is not prescribed. Do not give ACTOS 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 ACTOS. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about ACTOS that is written for healthcare professionals. For more information, go to or call 1-877-825-3327.

What are the ingredients in ACTOS?

Active Ingredient: pioglitazone hydrochloride

Inactive Ingredients: lactose monohydrate, hydroxypropylcellulose, carboxymethylcellulose calcium, and magnesium stearate.

Always check to make sure that the medicine you are taking is the correct one. ACTOS tablets look like this:

ACTOS® is a registered trademark of Takeda Pharmaceutical Company Limited and used under license by Takeda Pharmaceuticals America, Inc.
All other trademarks are the property of their respective owners.

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

Distributed by:
Takeda Pharmaceuticals America, Inc.
Deerfield, IL 60015

© 2009 Takeda Pharmaceuticals America, Inc.

September 2009

Revised: 9/2010
Rebel Distributors Corp.