PIOGLITAZONE- pioglitazone tablet 
Zydus Pharmaceuticals (USA) Inc.

----------

Medication Guide

Pioglitazone (PYE o GLIT a zone) Tablets, USP

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 hydrochloride 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 hydrochloride is not recommended for use in children.

Pioglitazone hydrochloride is not for people with type 1 diabetes.

Pioglitazone hydrochloride is 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:

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. It 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. Please address medical inquiries to, (MedicalAffairs@zydususa.com) Tel.:1-877-993-8779.

What are the ingredients in pioglitazone tablets?

Active Ingredient: pioglitazone hydrochloride, USP

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 by:

Cadila Healthcare Ltd.

Ahmedabad, India

Distributed by:

Zydus Pharmaceuticals (USA) Inc.

Pennington, NJ 08534

Rev.: 01/18

Revised: 12/2019
Zydus Pharmaceuticals (USA) Inc.