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ACTOS- pioglitazone hydrochloride tablet


  1. What Is The Most Important Information I Should Know About Actos?
  2. Call Your Doctor Right Away If You Have Any Of The Following:
  3. Do Not Take Actos If You:
  4. Tell Your Doctor About All Of Your Medical Conditions, Especially If You:
  5. Actos Can Cause Other Serious Side Effects Including:
  6. Always Check To Make Sure That The Medicine You Are Taking Is The Correct One. Actos Tablets Look Like This:
  7. Patient Information
  8. Before You Start Taking Actos, Tell Your Doctor If You:
  9. How Should I Take Actos?
  10. Actos May Cause Serious Side Effects Including:
  11. What Are The Ingredients In Actos?

What Is The Most Important Information I Should Know About Actos? 

ACTOS can cause serious side effects, includingnew 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.
  • If you have severe heart failure, you cannot start ACTOS.
  • 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 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.

Do Not Take Actos If You: 

  • are allergic to any of the ingredients in 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: 

  • have heart failure.
  • have type 1 ("juvenile") diabetes or had diabetic ketoacidosis.These conditions should be treated with insulin.
  • have a type of diabetic eye disease called macular edema(swelling of the back of the eye).
  • have liver problems.Your doctor should do blood tests to check your liver before you start taking ACTOS and during treatment as needed.
  • are pregnant or planning to become pregnant.Actos should not be used during pregnancy. It is not known if ACTOS can harm your unborn baby. Talk to your doctor 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. You should not take ACTOS if you breastfeed 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 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 takeACTOS?

  • Take ACTOS exactly as prescribed.
  • Your doctor may need to change your dose of ACTOS to control your blood glucose. Do not change your dose unless told to do so by your doctor.
  • 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 poison control center right away.
  • If your body is under stress, for example: due to fever, infection, trauma (such as a car 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 blood tests before starting ACTOS and from time to time to check your liver, kidneys, and blood cells.
  • Your doctor should also do regular blood tests (for example, hemoglobin A1C) to check how well your blood sugar is controlled with ACTOS.
  • Your doctor should check your eyes regularly. Some people have had vision changes due to swelling in the back of the eye, called macular edema, while taking ACTOS.
  • It may take 2-3 months to

Actos Can Cause Other Serious Side Effects Including: 

  • Weight gain.Pioglitazone, the medicine in ACTOS can cause weight gain that may be due to fluid retention or extra body fat. Weight gain due to fluid retention can be a serious problem for people with certain conditions, including heart problems.

    • Store ACTOS at 59 to 86 F (15 to 30 C). Keep ACTOS in the original container to protect from light.
    • Keep the ACTOS bottle tightly closed and protect from getting wet (away from moisture and humidity).

    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 www.actos.com or call 1-877-825-3327.

Always Check To Make Sure That The Medicine You Are Taking Is The Correct One. Actos Tablets Look Like This: 

  • 15 mg strength tablets white to off-white, round, convex, non-scored with "ACTOS" on one side, and "15" on the other.
  • 30 mg strength tablets white to off-white, round, flat, non-scored with "ACTOS" on one side, and "30" on the other.
  • 45 mg strength tablets white to off-white, round, flat, non-scored with "ACTOS" on one side, and "45" on the other.

ACTOSis 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
ACT0909-R2/MG

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

Before You Start Taking 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
  • are pregnant or plan to become pregnant.It is not known if ACTOS will 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 breast-feeding or plan to breast-feed.It is not known if ACTOS passes into your milk and if it can harm your baby. You should not take ACTOS if you breastfeed 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 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 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 1 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
  • It may take 2 to 3 months to

Actos May Cause Serious Side Effects Including: 

    • Store ACTOS at 59 F to 86 F (15 C to 30 C). Keep ACTOS in the original container and protect from light
    • Keep the ACTOS bottle tightly closed and protect from getting wet (away from moisture and humidity)
    • 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 hydrochloride

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

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.

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

Distributed by:
Takeda Pharmaceuticals America, Inc.
Deerfield, IL 60015
2009-2011 Takeda Pharmaceuticals America, Inc.

July 2011
ACT003 R16




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