MEDICATION GUIDE

ACTOPLUS MET XR (ak-TŌ-plus-met eX-R)
(pioglitazone and metformin hydrochloride extended-release) tablets

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

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

ACTOPLUS MET XR can cause serious side effects, including:

•

new or worse heart failure. Pioglitazone, one of the medicines in ACTOPLUS MET XR, can cause your body to keep extra fluid (fluid retention), which leads to swelling (edema) and weight gain. Extra body fluid can make some heart problems worse or lead to heart failure. Heart failure means your heart does not pump blood well enough

•

Do not take ACTOPLUS MET XR if you have severe heart failure

•

If you have heart failure with symptoms (such as shortness of breath or swelling), even if these symptoms are not severe, ACTOPLUS MET XR may not be right for you

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

•

swelling or fluid retention, especially in the ankles or legs

•

shortness of breath or trouble breathing, especially when you lie down

•

an unusually fast increase in weight

•

unusual tiredness

•

lactic acidosis. Metformin, one of the medicines in ACTOPLUS MET XR, 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.

 

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

•

you feel cold in your hands or feet

•

you feel dizzy or lightheaded

•

you have a slow or irregular heartbeat

•

you feel very weak or tired

•

you have unusual (not normal) muscle pain

•

you have trouble breathing

•

you feel sleepy or drowsy

•

you have stomach pains, nausea or vomiting

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 XR if you:

•

have severe kidney problems or your kidneys are affected by certain x-ray tests that use injectable dye

•

have liver problems

•

drink alcohol very often, or drink a lot of alcohol in short-term "binge" drinking

•

get dehydrated (lose a large amount of body fluids). This can happen if you are sick with a fever, vomiting, or diarrhea. Dehydration can also happen when you sweat a lot with activity or exercise and do not drink enough fluids

•

have surgery

•

have a heart attack, severe infection, or stroke

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 XR for a while if you have any of these things.

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

What is ACTOPLUS MET XR?

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

ACTOPLUS MET XR is not for people with type 1 diabetes.

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

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

Who should not take ACTOPLUS MET XR?

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

Do not take ACTOPLUS MET XR if you:

•

have severe heart failure

•

are allergic to pioglitazone, metformin or any of the ingredients in ACTOPLUS MET XR. See the end of this Medication Guide for a complete list of ingredients in ACTOPLUS MET XR

•

have severe kidney problems

•

have a condition called metabolic acidosis, including diabetic ketoacidosis. Diabetic ketoacidosis should be treated with insulin

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

What should I tell my doctor before taking ACTOPLUS MET XR?

Before you take ACTOPLUS MET XR, tell your doctor if you:

•

have heart failure

•

have severe kidney problems

•

are going to have dye injected into a vein for an x-ray, CAT scan, heart study, or other type of scanning

•

will be undergoing a surgical procedure

•

drink a lot of alcohol (all the time or short binge drinking)

•

have type 1 ("juvenile") diabetes or had diabetic ketoacidosis

•

have a type of diabetic eye disease that causes swelling in the back of the eye (macular edema)

•

have liver problems

•

have or have had cancer of the bladder

•

are pregnant or plan to become pregnant. It is not known if ACTOPLUS MET XR can harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant about the best way to control your blood glucose levels while pregnant

•

are a premenopausal woman (before the "change of life"), who does not have periods regularly or at all. ACTOPLUS MET XR may increase your chance of becoming pregnant. Talk to your doctor about birth control choices while taking ACTOPLUS MET XR. Tell your doctor right away if you become pregnant while taking ACTOPLUS MET XR

•

are breast-feeding or plan to breast-feed. It is not known if ACTOPLUS MET XR passes into your milk and if it can harm your baby. Talk to your doctor about the best way to control your blood glucose levels while breast-feeding

Tell your doctor about all the medicines you take including prescription and over the counter medicines, vitamins, and herbal supplements.

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

How should I take ACTOPLUS MET XR?

•

Take ACTOPLUS MET XR exactly as your doctor tells you to take it

•

Your doctor may need to change your dose of ACTOPLUS MET XR. Do not change your ACTOPLUS MET XR dose unless your doctor tells you to

•

ACTOPLUS MET XR may be prescribed alone or with other diabetes medicines. This will depend on how well your blood sugar is controlled

•

Take ACTOPLUS MET XR once a day with meals to lower your chance of an upset stomach

•

Take ACTOPLUS MET XR tablets whole. Do not chew, cut, or crush the tablets. If you cannot swallow ACTOPLUS MET XR whole, tell your doctor. You may need a different medicine.

•

If you take ACTOPLUS MET XR, you may see something that looks like the ACTOPLUS MET XR tablet in your stools. This is normal.

•

If you miss a dose of ACTOPLUS MET XR, take your next dose as prescribed unless your doctor tells you differently. Do not take two doses at one time the next day

•

If you take too much ACTOPLUS MET XR, call your doctor or go to the nearest hospital emergency room right away

•

If your body is under stress, such as from a fever, infection, accident or surgery, the dose of your diabetes medicines may need to be changed. Call your doctor right away

•

Stay on your diet and exercise programs and test your blood sugar regularly while taking ACTOPLUS MET XR

•

Your doctor should do certain blood tests before you start and while you take ACTOPLUS MET XR

•

Your doctor should also do hemoglobin A1C testing to check how well your blood sugar is controlled with ACTOPLUS MET XR

•

Your doctor should check your eyes regularly while you take ACTOPLUS MET XR

What are the possible side effects of ACTOPLUS MET XR?

ACTOPLUS MET XR may cause serious side effects including:

•

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

•

low blood sugar (hypoglycemia). This can happen if you skip meals, if you also use another medicine that lowers blood sugar, or if you have certain medical problems. Lightheadedness, dizziness, shakiness, or hunger may happen if your blood sugar is too low. Call your doctor if low blood sugar levels are a problem for you

•

liver problems. Call your doctor right away if you have:

•

nausea or vomiting

•

stomach pain

•

unusual or unexplained tiredness

•

loss of appetite

•

dark urine

•

yellowing of your skin or the whites of your eyes

•

bladder cancer. There may be an increased chance of having bladder cancer when you take ACTOPLUS MET XR. You should not take ACTOPLUS MET XR if you are receiving treatment for bladder cancer. Tell your doctor right away if you have any of the following symptoms of bladder cancer:

o

blood or a red color in your urine

o

an increased need to urinate

o

pain while you urinate

•

broken bones (fractures). Usually in the hand, upper arm, or foot in women. Talk to your doctor for advice on how to keep your bones healthy

•

diabetic eye disease with swelling in the back of the eye (macular edema). Tell your doctor right away if you have any changes in your vision. Your doctor should check your eyes regularly

•

release of an egg from an ovary in a woman (ovulation) leading to pregnancy. Ovulation may happen when premenopausal women who do not have regular monthly periods take ACTOPLUS MET XR. This can increase your chance of getting pregnant

•

low red blood cell count (anemia)

The most common side effects of ACTOPLUS MET XR include:

•

cold-like symptoms (upper respiratory tract infection)

•

swelling (edema)

•

diarrhea

•

headache

•

increased weight

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 XR. 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 XR?

•

Store ACTOPLUS MET XR at 68°F to 77°F (20°C to 25°C). Keep ACTOPLUS MET XR in the original container to protect from light

•

Keep the ACTOPLUS MET XR bottle tightly closed and keep tablets dry

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

General information about the safe and effective use of ACTOPLUS MET XR

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ACTOPLUS MET XR for a condition for which it was not prescribed. Do not give ACTOPLUS MET XR 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 XR. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about ACTOPLUS MET XR that is written for healthcare professionals. For more information, go to www.actoplusmetxr.com or call 1-877-825-3327.

What are the ingredients in ACTOPLUS MET XR?

Active Ingredients: pioglitazone and metformin hydrochloride.

Inactive Ingredients: candelilla wax, cellulose acetate, povidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycols (PEG 400, PEG 8000), sodium lauryl sulfate, titanium dioxide, and triacetin. Ink contains shellac, iron-oxide red (15 mg/1000 mg tablet strength), FD&C Blue No. 2 Lake (30 mg/1000 mg tablet strength), propylene glycol, and ammonium hydroxide.

ACTOS and ACTOPLUS MET XR 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.

AMX002 R11