ACTOPLUS MET- pioglitazone and metformin hydrochloride tablet, film coated 
Takeda Pharmaceuticals America, Inc.

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MEDICATION GUIDE
ACTOPLUS MET (ak-TŌ-plus-met)
(pioglitazone and metformin hydrochloride) tablets

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

What is the most important information I should know about ACTOPLUS MET?

ACTOPLUS MET can cause serious side effects, including:

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 ACTOPLUS MET 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 ACTOPLUS MET for a while if you have any of these things.

ACTOPLUS MET can have other serious side effects. See "What are the possible side effects of ACTOPLUS MET?"

What is ACTOPLUS MET?

ACTOPLUS MET contains two prescription diabetes medicines called pioglitazone (ACTOS) and metformin hydrochloride (GLUCOPHAGE). ACTOPLUS MET can be used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes.

ACTOPLUS MET is not for people with type 1 diabetes.

ACTOPLUS MET is not for people with diabetic ketoacidosis (increased ketones in your blood or urine).

It is not known if ACTOPLUS MET is safe and effective in children under the age of 18. ACTOPLUS MET is not recommended for use in children.

Who should not take ACTOPLUS MET?

See "What is the most important information I should know about ACTOPLUS MET?"

Do not take ACTOPLUS MET if you:

Tell your doctor before taking ACTOPLUS MET if you have any of these conditions.

What should I tell my doctor before taking ACTOPLUS MET?

Before you take ACTOPLUS MET, 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.

ACTOPLUS MET and some of your other medicines can affect each other. You may need to have your dose of ACTOPLUS MET 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 ACTOPLUS MET with other medicines.

How should I take ACTOPLUS MET?

What are the possible side effects of ACTOPLUS MET?

ACTOPLUS MET may cause serious side effects, including:

The most common side effects of ACTOPLUS MET 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 ACTOPLUS MET. 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 ACTOPLUS MET?

Keep the ACTOPLUS MET bottle tightly closed and keep tablets dry

Keep ACTOPLUS MET and all medicines out of the reach of children.

General information about the safe and effective use of ACTOPLUS MET

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

For more information, go to www.actoplusmet.com or call 1-877-825-3327.

What are the ingredients in ACTOPLUS MET?

Active Ingredients: pioglitazone hydrochloride and metformin hydrochloride

Inactive Ingredients: povidone, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose 2910, polyethylene glycol 8000, titanium dioxide, and talc

ACTOS and ACTOPLUS MET are trademarks of Takeda Pharmaceutical Company Limited registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.

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

Distributed by:
Takeda Pharmaceuticals America, Inc.
Deerfield, IL 60015

Revised: December 2016

©2009 - 2017 Takeda Pharmaceuticals America, Inc.

APM001 R15

Revised: 8/2019
Takeda Pharmaceuticals America, Inc.