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

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17.2 FDA-Approved Medication Guide


See attached leaflet.
 
Manufactured for:
Aurobindo Pharma USA, Inc.
2400 Route 130 North
Dayton, NJ 08810
 
Manufactured by:
Aurobindo Pharma Limited
Unit-VII (SEZ)
Mahaboob Nagar (Dt)
AP-509302, INDIA
 
Licensed ­- United States Patents Nos. 5,965,584, 6,166,042, 6,166,043, and 6,172,090.
 
Issued: June 2012
 
MEDICATION GUIDE
Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets
 
Read this Medication Guide carefully before you start taking pioglitazone hydrochloride 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 hydrochloride and metformin hydrochloride tablets, ask your doctor or pharmacist.
 
What is the most important information I should know about pioglitazone hydrochloride and metformin hydrochloride tablets? 
 
Pioglitazone hydrochloride 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 hydrochloride 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 hydrochloride and metformin hydrochloride tablets for a while if you have any of these things.
 
Pioglitazone hydrochloride and metformin hydrochloride tablets can have other serious side effects. See “What are the possible side effects of pioglitazone hydrochloride and metformin hydrochloride tablets?”
 
What are pioglitazone hydrochloride and metformin hydrochloride tablets?
 
Pioglitazone hydrochloride and metformin hydrochloride tablets contain 2 prescription diabetes medicines called pioglitazone tablets and metformin hydrochloride tablets. Pioglitazone hydrochloride and metformin hydrochloride tablets can be used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes.
 
Pioglitazone hydrochloride and metformin hydrochloride tablets are not for people with type 1 diabetes
 
Pioglitazone hydrochloride and metformin hydrochloride tablets are not for people with diabetic ketoacidosis (increased ketones in your blood or urine).
 
It is not known if pioglitazone hydrochloride and metformin hydrochloride tablets are safe and effective in children.
 
Who should not take pioglitazone hydrochloride and metformin hydrochloride tablets?
 
See “What is the most important information I should know about pioglitazone hydrochloride and metformin hydrochloride tablets?”
 
Do not take pioglitazone hydrochloride and metformin hydrochloride tablets if you:
 
Tell your doctor before taking pioglitazone hydrochloride and metformin hydrochloride tablets if you have any of these conditions.
 
What should I tell my doctor before taking pioglitazone hydrochloride and metformin hydrochloride tablets?
 
Before you start taking pioglitazone hydrochloride and metformin hydrochloride tablets, tell your doctor if you: 
Tell your doctor about all the medicines you take including prescription and non-­prescription medicines, vitamins, and herbal supplements.
 
Pioglitazone hydrochloride and metformin hydrochloride tablets and some of your other medicines can affect each other. You may need to have your dose of pioglitazone hydrochloride 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 hydrochloride and metformin hydrochloride tablets with other medicines.
 
How should I take pioglitazone hydrochloride and metformin hydrochloride tablets?
 
What are the possible side effects of pioglitazone hydrochloride and metformin hydrochloride tablets?
 
Pioglitazone hydrochloride and metformin hydrochloride tablets may cause serious side effects including:
 

 
The most common side effects of pioglitazone hydrochloride 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 hydrochloride 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 hydrochloride and metformin hydrochloride tablets?
 
Keep pioglitazone hydrochloride and metformin hydrochloride tablets and all medicines out of the reach of children. 

General information about the safe and effective use of pioglitazone hydrochloride and metformin hydrochloride tablets
 
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use pioglitazone hydrochloride and metformin hydrochloride tablets for a condition for which it was not prescribed. Do not give pioglitazone hydrochloride and metformin hydrochloride 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 hydrochloride 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 hydrochloride and metformin hydrochloride tablets that is written for healthcare professionals.
 
For more information, call 1-866-850-2876.
 
What are the ingredients in pioglitazone hydrochloride 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.
 
Manufactured for:
Aurobindo Pharma USA, Inc.
2400 Route 130 North
Dayton, NJ 08810
 
Manufactured by:
Aurobindo Pharma Limited
Unit-VII (SEZ)
Mahaboob Nagar (Dt)
AP-509302, INDIA
 
Licensed ­- United States Patents Nos. 5,965,584, 6,166,042, 6,166,043, and 6,172,090. 

Issued: June 2012

Revised: 02/2013
 
Aurobindo Pharma Limited