PIOGLITAZONE HYDROCHLORIDE - pioglitazone hydrochloride tablet 
Aurobindo Pharma Limited

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Medication Guide


Pioglitazone Tablets, USP

[Pioglitazone (PYE o GLIT a zone)]


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


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


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

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

Pioglitazone tablets can have other serious side effects. See “What are the possible side effects of pioglitazone tablets?”

What are pioglitazone tablets?


Pioglitazone tablets are a prescription medicine used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. Pioglitazone tablets are a diabetes medicine called pioglitazone that may be taken alone or with other diabetes medicines.


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


Pioglitazone tablets are not recommended for use in children.


Pioglitazone tablets are not for people with type 1 diabetes.


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


Who should not take pioglitazone tablets?

See“What is the most important information I should know about pioglitazone tablets?”

Do not take pioglitazone tablets if you:

Talk to your doctor before taking pioglitazone tablets if you have either of these conditions.

What should I tell my doctor before taking pioglitazone tablets?

Before you take pioglitazone tablets, tell your doctor if you:

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

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


How should I take pioglitazone tablets?

What are the possible side effects of pioglitazone tablets?

Pioglitazone tablets may cause serious side effects including:

• See “What is the most important information I should know about pioglitazone tablets?”
low blood suger (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. Call your doctor if low blood sugar levels are a problem for you
liver problems. Call your doctor right away if you have:
o nausea or vomiting
o stomach pain
o unusual or unexplained tiredness
o loss of appetite
o dark urine
o 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 tablets. You should not take pioglitazone 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:
o blood or a red color in your urine
o an increased need to urinate
o 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 tablets. This can increase your chance of getting pregnant

The most common side effects of pioglitazone tablets include:

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 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 tablets?

General information about the safe and effective use of pioglitazone tablets


Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use pioglitazone tablets for a condition for which it was not prescribed. Do not give pioglitazone tablets to other people, even if they have the same symptoms you have. They may harm them.


This Medication Guide summarizes the most important information about pioglitazone tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about pioglitazone tablets that is written for healthcare professionals. For more information, call Aurobindo Pharma USA, Inc. at 1-866-850-2876.


What are the ingredients in pioglitazone tablets?


Active Ingredient: pioglitazone

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


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

Manufactured for:
Aurobindo Pharma USA, Inc.
2400 Route 130 North
Dayton, NJ 08810

Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 072, India

Licensed – United States Patents Nos. 5,965,584, 6,166,043, 6,172,090, 6,211,205, 6,271,243, 6,329,404, and 6,303,640.

Revised: 12/2013

Revised: 12/2013
 
Aurobindo Pharma Limited