PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE - pioglitazone hydrochloride and metformin hydrochloride tablet, film coated 
Aurobindo Pharma Limited

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MEDICATION GUIDE

Pioglitazone and Metformin Hydrochloride Tablets, USP

(pye'' oh gli' ta zone and met for' min hye'' droe klor' ide)


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


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

Pioglitazone and metformin hydrochloride tablets can cause serious side effects, including:


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



Call your doctor right away if you have any of the following symptoms, which could be signs of lactic acidosis:


Most people who have had lactic acidosis with metformin have other things that, combined with the metformin, led to the lactic acidosis. Tell your doctor if you have any of the following, because you have a higher chance for getting lactic acidosis with pioglitazone and metformin hydrochloride tablets if you:



The best way to keep from having a problem with lactic acidosis from metformin is to tell your doctor if you have any of the problems in the list above. Your doctor may decide to stop your pioglitazone and metformin hydrochloride tablets for a while if you have any of these things.


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


What are pioglitazone and metformin hydrochloride tablets?

Pioglitazone and metformin hydrochloride tablets contain two prescription diabetes medicines called pioglitazone tablets and metformin hydrochloride tablets. Pioglitazone and metformin hydrochloride tablets can be used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes.


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


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


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


Who should not take pioglitazone and metformin hydrochloride tablets?

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


Do not take pioglitazone and metformin hydrochloride tablets if you:


Tell your doctor before taking pioglitazone and metformin hydrochloride tablets if you have any of these conditions.


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

 

Before you take pioglitazone and metformin hydrochloride 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 and metformin hydrochloride tablets and some of your other medicines can affect each other. You may need to have your dose of pioglitazone and metformin hydrochloride 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 metformin hydrochloride tablets with other medicines.


How should I take pioglitazone and metformin hydrochloride tablets?


What are the possible side effects of pioglitazone and metformin hydrochloride tablets? 

Pioglitazone and metformin hydrochloride tablets may cause serious side effects, including:


The most common side effects of pioglitazone and metformin hydrochloride 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 and metformin hydrochloride 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 metformin hydrochloride tablets?



Keep the pioglitazone and metformin hydrochloride tablets bottle tightly closed and keep tablets dry


Keep pioglitazone and metformin hydrochloride tablets and all medicines out of the reach of children.


General information about the safe and effective use of pioglitazone and metformin hydrochloride tablets

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


For more information, call 1-866-850-2876.


What are the ingredients in pioglitazone and metformin hydrochloride tablets?

Active Ingredients: pioglitazone hydrochloride and metformin hydrochloride


Inactive Ingredients: carboxymethylcellulose calcium, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol 6000, talc, and titanium dioxide.


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

Dispense with Medication Guide available at: www.aurobindousa.com/product-medication-guides

Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 038, India
 
Revised: 06/2018

Revised: 6/2024
Aurobindo Pharma Limited