MEDICATION GUIDE
Pioglitazone and Glimepiride Tablets

Read this Medication Guide carefully before you start taking pioglitazone and glimepiride tablets 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 pioglitazone and glimepiride tablets, ask your doctor or pharmacist.

What is the most important information I should know about pioglitazone and glimepiride tablets?

Pioglitazone and glimepiride tablets can cause serious side effects, including new or worse heart failure.

• Pioglitazone, one of the medicines in pioglitazone and glimepiride tablets, 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 pioglitazone and glimepiride tablets 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, pioglitazone and glimepiride tablets 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

Pioglitazone and glimepiride tablets can have other serious side effects. See "What are the possible side effects of pioglitazone and glimepiride tablets?"

What are pioglitazone and glimepiride tablets?

Pioglitazone and glimepiride tablets are a prescription medicine used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes.

Pioglitazone and glimepiride tablets contain 2 prescription diabetes medicines called pioglitazone (ACTOS) and glimepiride, a sulfonylurea.

Pioglitazone and glimepiride tablets are not for people with type 1 diabetes.

Pioglitazone and glimepiride tablets are not for people with diabetic ketoacidosis (increased ketones in your blood or urine).

It is not known if pioglitazone and glimepiride tablets are safe and effective in children under the age of 18. Pioglitazone and glimepiride tablets are not recommended for use in children.

Who should not take pioglitazone and glimepiride tablets?

See "What is the most important information I should know about pioglitazone and glimepiride tablets?"

Do not take pioglitazone and glimepiride tablets if you:

• have severe heart failure
• are allergic to any of the ingredients in pioglitazone and glimepiride tablets. See the end of this Medication Guide for a complete list of ingredients in pioglitazone and glimepiride tablets
• have a condition called diabetic ketoacidosis. Diabetic ketoacidosis should be treated with insulin

Talk to your doctor before taking pioglitazone and glimepiride tablets if you have any of these conditions.

What should I tell my doctor before taking pioglitazone and glimepiride tablets?

Before you take pioglitazone and glimepiride tablets, 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 pioglitazone and glimepiride tablets 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. Pioglitazone and glimepiride tablets may increase your chance of becoming pregnant. Talk to your doctor about birth control choices while taking pioglitazone and glimepiride tablets. Tell your doctor right away if you become pregnant while taking pioglitazone and glimepiride tablets
• are breastfeeding or plan to breastfeed. It is not known if pioglitazone and glimepiride tablets pass 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 pioglitazone and glimepiride tablets, with this condition may cause your red blood cells to be destroyed too quickly (hemolytic anemia)

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

Pioglitazone and glimepiride tablets and some of your other medicines can affect each other. You may need to have your dose of pioglitazone and glimepiride tablets 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 pioglitazone and glimepiride tablets with other medicines.

How should I take pioglitazone and glimepiride tablets?

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

What are the possible side effects of pioglitazone and glimepiride tablets?

Pioglitazone and glimepiride tablets may cause serious side effects including:

• See "What is the most important information I should know about pioglitazone and glimepiride tablets?"
• low blood sugar (hypoglycemia). This can happen if you skip meals, if you also use another medicine that lowers blood sugar, or if you have certain medical problems. Lightheadedness, dizziness, shakiness, or hunger may happen if your blood sugar is too low. Severe low blood sugar can cause unconsciousness (passing out), seizures, and death. Call your doctor if low blood sugar levels are a problem for you
• liver problems. Call your doctor right away if you have:
  • nausea or vomiting
  • stomach pain
  • unusual or unexplained tiredness
  • loss of appetite
  • dark urine
  • yellowing of your skin or the whites of your eyes
• bladder cancer. There may be an increased chance of having bladder cancer when you take pioglitazone and glimepiride tablets. You should not take pioglitazone and glimepiride tablets if you are receiving treatment for bladder cancer. Tell your doctor right away if you have any of the following symptoms of bladder cancer:
  • blood or a red color in your urine
  • an increased need to urinate
  • pain while you urinate
• broken bones (fractures). Usually in the hand, upper arm, or foot in women. Talk to your doctor for advice on how to keep your bones healthy.
• diabetic eye disease with swelling in the back of the eye (macular edema). Tell your doctor right away if you have any changes in your vision. Your doctor should check your eyes regularly
• release of an egg from an ovary in a woman (ovulation) leading to pregnancy. Ovulation may happen when premenopausal women who do not have regular monthly periods take pioglitazone and glimepiride tablets. This can increase your chance of getting pregnant

The most common side effects of pioglitazone and glimepiride tablets include:

• cold-like symptoms (upper respiratory tract infection)
• headache
• sinus infection
• diarrhea
• nausea
• muscle pain
• sore throat

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 pioglitazone and glimepiride tablets. 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 pioglitazone and glimepiride tablets?

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

General information about the safe and effective use of pioglitazone and glimepiride tablets

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

What are the ingredients in pioglitazone and glimepiride tablets?

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:
Prasco Laboratories
Mason, OH 45040 USA

Revised: December 2016

ACTOS is a registered trademark of Takeda Pharmaceutical Company Limited and used under license by Takeda Pharmaceuticals America, Inc.

PGL329 R3