Read this Medication Guide carefully before you start taking Actos (Pioglitazone hydrochloride) 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 (Pioglitazone hydrochloride) , ask your doctor or pharmacist.

Actos (Pioglitazone hydrochloride) can cause serious side effects, including

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

Actos (Pioglitazone hydrochloride) can have other serious side effects. See ""

Actos (Pioglitazone hydrochloride) is a prescription medicine used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. Actos (Pioglitazone hydrochloride) 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 (Pioglitazone hydrochloride) .

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 (Pioglitazone hydrochloride) has not been studied in children and is not recommended for children under the age of 18. The risks of giving Actos (Pioglitazone hydrochloride) to a child are not known. See ""

Do not take Actos (Pioglitazone hydrochloride) if you:

People with severe heart failure should not start taking Actos (Pioglitazone hydrochloride) . See ""

Before starting Actos (Pioglitazone hydrochloride) , 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 (Pioglitazone hydrochloride) and some of your other medicines can affect each other. You may need to have your dose of Actos (Pioglitazone hydrochloride) 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 (Pioglitazone hydrochloride) with other medicines.

In studies of pioglitazone (the medicine in Actos (Pioglitazone hydrochloride) ), 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 (Pioglitazone hydrochloride) 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 (Pioglitazone hydrochloride) . 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.

Keep Actos (Pioglitazone hydrochloride) and all medicines out of the reach of children.

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

Active Ingredient: pioglitazone hydrochloride

Inactive Ingredients: lActos (Pioglitazone hydrochloride) e monohydrate, hydroxypropylcellulose, carboxymethylcellulose calcium, and magnesium stearate.

Always check to make sure that the medicine you are taking is the correct one. Actos (Pioglitazone hydrochloride) tablets look like this:

Actos (Pioglitazone hydrochloride) 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.

Distributed by: Deerfield, IL 60015

© 2009 Takeda Pharmaceuticals America, Inc.

September 2009ACT0909-R2/MG

#0011-11

tablets

Each tablet contains :Pioglitazone HCl 15mgCaution : For manufacturing, processing, or repackaging.Rx only.Note : Store at 25°C(77°F);Excursions 15°-30°C(59°-86°F)

Mfg. date :Lot No. :

Takeda Pharmaceutical Company Limited

Made in Japan

#0012-12

tablets

Each tablet contains :Pioglitazone HCl 30mgCaution : For manufacturing, processing, or repackaging.Rx only.Note : Store at 25°C(77°F);Excursions 15°-30°C(59°-86°F)

Mfg. date :Lot No. :

Takeda Pharmaceutical Company Limited

Made in Japan

#0013-13

tablets

Each tablet contains :Pioglitazone HCl 45mgCaution : For manufacturing, processing, or repackaging.Rx only.Note : Store at 25°C(77°F);Excursions 15°-30°C(59°-86°F)

Mfg. date :Lot No. :

Takeda Pharmaceutical Company Limited

Made in Japan