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ACTOS- pioglitazone tablet


  1. Patient Information
  2. Call Your Doctor Right Away If You Have Any Of The Following:
  3. Before You Take Actos, Tell Your Doctor If You:
  4. How Should I Take Actos?
  5. Actos May Cause Serious Side Effects Including:
  6. What Are The Ingredients In Actos?

Patient Information 

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

ACTOS can cause your body to keep extra fluid (fluid retention), which leads to swelling (edema) and weight gain. Extra body fluid can make some heart problems worse or lead to heart failure. Heart failure means your heart does not pump blood well enough
Do not take ACTOS if you have severe heart failure
If you have heart failure with symptoms (such as shortness of breath or swelling), even if these symptoms are not severe, ACTOS may not be right for you

Call Your Doctor Right Away If You Have Any Of The Following: 

swelling or fluid retention, especially in the ankles or legs
shortness of breath or trouble breathing, especially when you lie down
an unusually fast increase in weight
unusual tiredness

ACTOS can have other serious side effects.

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 that may be taken alone or with other diabetes medicines.

It is not known if ACTOS is safe and effective in children under the age of 18.

ACTOS is not recommended for use in children.

ACTOS is not for people with type 1 diabetes.

ACTOS is not for people with diabetic ketoacidosis (increased ketones in your blood or urine).

Before You Take Actos, Tell Your Doctor If You: 

have heart failure
have type 1 ("juvenile") diabetes or had diabetic ketoacidosis
have a type of diabetic eye disease that causes swelling in the back of the eye (macular edema)
have liver problems
have or have had cancer of the bladder
are pregnant or plan to become pregnant.It is not known if ACTOS can harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant about the best way to control your blood glucose levels while pregnant
are a premenopausal woman (before the "change of life") who does not have periods regularly or at all.ACTOS may increase your chance of becoming pregnant. Talk to your doctor about birth control choices while taking ACTOS. Tell your doctor right away if you become pregnant while taking ACTOS
are breastfeeding or plan to breastfeed.It is not known if ACTOS passes into your milk and if it can harm your baby. Talk to your doctor about the best way to control your blood glucose levels while breastfeeding

Tell your doctor about all the medicines you takeincluding prescription and over the counter 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 changed.

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? 

Take ACTOS exactly as your doctor tells you to take it
Your doctor may change your dose of ACTOS. Do not change your ACTOS dose unless your doctor tells you to
ACTOS may be prescribed alone or with other diabetes medicines. This will depend on how well your blood sugar is controlled
Take ACTOS one time each day, with or without food
If you miss a dose of ACTOS, take your next dose as prescribed unless your doctor tells you differently. Do not take two doses at one time the next day
If you take too much ACTOS, call your doctor or go to the nearest hospital emergency room right away
If your body is under stress such as from a fever, infection, accident, or surgery the dose of your diabetes medicines may need to be changed. Call your doctor right away
Stay on your diet and exercise programs and test your blood sugar regularly while taking ACTOS
Your doctor should do certain blood tests before you start and while you take ACTOS
Your doctor should also do hemoglobin A1C testing to check how well your blood sugar is controlled with ACTOS
Your doctor should check your eyes regularly while you take ACTOS

Actos May Cause Serious Side Effects Including: 

Store ACTOS at 68 F to 77 F (20 C to 25 C). Keep ACTOS in the original container and protect from light
Keep the ACTOS bottle tightly closed and keep tablets dry
Keep ACTOS and all medicines out of the reach of children

General information about the safe and effective use of 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 was 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 www.actos.com or call 1-877-825-3327.

What Are The Ingredients In Actos? 

Active Ingredient: pioglitazone

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

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

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

Revised: December 2016

ACTOS is a trademark of Takeda Pharmaceutical Company Limited registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.

2009 - 2017 Takeda Pharmaceuticals America, Inc.

ACT003 R22



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