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DUETACT- pioglitazone and glimepiride tablet

  1. Patient Information
  2. Call Your Doctor Right Away If You Have Any Of The Following:
  3. Before You Take Duetact, Tell Your Doctor If You:
  4. How Should I Take Duetact?
  5. Duetact May Cause Serious Side Effects Including:
  6. Active Ingredients:
  7. Inactive Ingredients:
  8. Distributed By:

Patient Information 

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

Pioglitazone, one of the medicines in DUETACT, 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 DUETACT 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, DUETACT 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

DUETACT can have other serious side effects.

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

DUETACT contains 2 prescription diabetes medicines called pioglitazone (ACTOS) and glimepiride, a sulfonylurea.

DUETACT is not for people with type 1 diabetes.

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

It is not known if DUETACT is safe and effective in children under the age of 18. DUETACT is not recommended for use in children.

Before You Take Duetact, Tell Your Doctor If You: 

have heart failure
have kidney problems
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 DUETACT 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.DUETACT may increase your chance of becoming pregnant. Talk to your doctor about birth control choices while taking DUETACT. Tell your doctor right away if you become pregnant while taking DUETACT
are breastfeeding or plan to breastfeed.It is not known if DUETACT 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
have G6PD deficiency (an inherited condition where you don't produce enough of the enzyme (G6PD).Taking glimepiride, one of the medicines in DUETACT, with this condition may cause your red blood cells to be destroyed too quickly (hemolytic anemia)

Tell your doctor about all the medicines you takeincluding prescription and over the counter medicines, vitamins, and herbal supplements.

DUETACT and some of your other medicines can affect each other. You may need to have your dose of DUETACT 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 DUETACT with other medicines.

How Should I Take Duetact? 

Take DUETACT exactly as your doctor tells you to take it
Your doctor may change your dose of DUETACT. Do not change your dose unless your doctor tells you to
DUETACT may be prescribed alone or with other diabetes medicines. This will depend on how well your blood sugar is controlled
Take DUETACT one time each day with the first main meal
If you take colesevelam, a medicine used to lower your cholesterol, take your DUETACT at least 4 hours before you take your colesevelam.
If you miss a dose of DUETACT, 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 DUETACT, 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 DUETACT
Your doctor should do certain blood tests before you start and while you take DUETACT
Your doctor should also do hemoglobin A1C testing to check how well your blood sugar is controlled with DUETACT
Your doctor should check your eyes regularly while you take DUETACT

Duetact May Cause Serious Side Effects Including: 

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

General information about the safe and effective use of DUETACT

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

Active Ingredients: 

pioglitazone and glimepiride

Inactive Ingredients: 

croscarmellose sodium, lactose monohydrate, magnesium stearate, hydroxypropyl cellulose, polysorbate 80, and microcrystalline cellulose

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

DUETACT and ACTOS are registered trademarks of Takeda Pharmaceutical Company Limited and used under license by Takeda Pharmaceuticals America, Inc.

2009 - 2017 Takeda Pharmaceuticals America, Inc.

DTA007 R15

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