ACTOPLUS MET- pioglitazone hydrochloride and metformin hydrochloride tablet, film coated 
Cardinal Health

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MEDICATION GUIDE

ACTOPLUS MET® (ak-TŌ-plus-met)
(pioglitazone hydrochloride 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 new or worse heart failure.

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

Metformin, one of the medicines in ACTOPLUS MET, can cause a rare but serious condition called lactic acidosis (a buildup of an acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital.

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.

Lactic acidosis can be hard to diagnose early, because the early symptoms could seem like the symptoms of many other health problems besides lactic acidosis. You should call your doctor right away if you get the following symptoms, which could be signs of lactic acidosis:

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

What is ACTOPLUS MET?

ACTOPLUS MET is a prescription medicine used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes.

ACTOPLUS MET contains 2 prescription diabetes medicines called pioglitazone hydrochloride (ACTOS) and metformin hydrochloride (GLUCOPHAGE).

Your doctor will decide if you should take ACTOPLUS MET.

ACTOPLUS MET can be used for adults with type 2 diabetes who:

If you are taking pioglitazone or metformin, check with your healthcare provider and make sure you understand exactly how your healthcare provider wants you to switch over to ACTOPLUS MET.

It is important to eat the right foods, lose weight if needed, and exercise regularly in order to manage your type 2 diabetes. Diet, weight loss, and exercise are the main treatments for type 2 diabetes and they also help your diabetes medicines work better for you.

ACTOPLUS MET has not been studied in children and is not recommended for children under the age of 18. The risks of giving ACTOPLUS MET to a child are not known. See "What are some other possible side effects of ACTOPLUS MET?"

Who should not take ACTOPLUS MET?

Do not take ACTOPLUS MET if you:

People with severe heart failure should not start taking ACTOPLUS MET. See "What is the most important information I should know about ACTOPLUS MET?".

What should I tell my doctor before taking ACTOPLUS MET?

Before starting ACTOPLUS MET, ask your doctor about what the choices are for diabetes medicines and what the expected benefits and possible risks are for you in particular.

Tell your doctor about all of your medical conditions, especially if you:

Tell your doctor about all the medicines you take including prescription and non-prescription 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 adjusted. Certain other medicines can affect your blood sugar (glucose) control.

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?

You may need to stop ACTOPLUS MET for a short time. Call your doctor for instructions if you:

What are other possible side effects of ACTOPLUS MET?

ACTOPLUS MET can cause other serious side effects including:

The most common side effects of ACTOPLUS MET reported in clinical trials included diarrhea, nausea, and upset stomach. These side effects usually happen during the first few weeks of treatment. Taking ACTOPLUS MET with meals can help lessen these side effects. However, if you have unusual or unexpected stomach problems, talk with your doctor. Stomach problems that start up later during treatment may be a sign of something more serious.

Other common side effects of ACTOPLUS MET are:

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

General information about 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 is 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.

Always check to make sure that the medicine you are taking is the correct one. ACTOPLUS MET tablets look like this:

ACTOS® and ACTOPLUS MET® are registered trademarks of Takeda Pharmaceutical Company Limited and used under license by Takeda Pharmaceuticals America, Inc.

All other trademarks are the property of their respective owners.

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

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

© 2009, 2011 Takeda Pharmaceuticals America, Inc.

July 2011
APM001 R9

Revised: 08/2012
 
Cardinal Health