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«Page 42 of 47 MEDICATION GUIDE ACTOPLUS MET XR (ak-TŌ-plus-met eX-R) (pioglitazone and metformin hydrochloride extended-release) tablets Read this ...»

Page 42 of 47

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 very weak or tired

• you have unusual (not normal) muscle pain

• you have stomach pains, nausea or vomiting

• you have trouble breathing

• you feel dizzy or lightheaded

• you have a slow or irregular heartbeat 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 kidney problems or your kidneys are affected by certain x-ray tests that use injectable dye. People whose kidneys are not working properly should not take ACTOPLUS MET XR • 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 • are 80 years of age or older, and have not had your kidneys tested 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.

–  –  –

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.

Reference ID: 3405461 Page 47 of 47 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.

–  –  –





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