Pioglitazone Hydrochloride and Metformin Hydrochloride (Page 10 of 11)

16 HOW SUPPLIED/STORAGE AND HANDLING


Pioglitazone and Metformin Hydrochloride Tablets USP, 15 mg/500 mg are white to off-white, oblong, biconvex film-coated tablets, debossed with ‘H’ on one side and ‘92’ on other side.
Bottles of 60 NDC 65862-525-60
Bottles of 180 NDC 65862-525-18
Pioglitazone and Metformin Hydrochloride Tablets USP, 15 mg/850 mg are white to off-white, oblong, biconvex film-coated tablets, debossed with ‘H’ on one side and ‘93’ on other side.
Bottles of 60 NDC 65862-526-60
Bottles of 180 NDC 65862-526-18
Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Keep container tightly closed, and protect from moisture and humidity.

17 PATIENT COUNSELING INFORMATION

See FDA-Approved Patient Labeling (Medication Guide).

  • It is important to instruct patients to adhere to dietary instructions and to have blood glucose and glycosylated hemoglobin tested regularly. During periods of stress such as fever, trauma, infection, or surgery, medication requirements may change and patients should be reminded to seek medical advice promptly.
  • Tell patients to promptly report any sign of macroscopic hematuria or other symptoms such as dysuria or urinary urgency that develop or increase during treatment as these may be due to bladder cancer.
  • Explain to patients the risks of lactic acidosis, its symptoms and conditions that predispose to its development, as noted in the Warnings and Precautions (5.2) section. Advise patients to discontinue pioglitazone and metformin hydrochloride immediately and to promptly notify their healthcare professional if unexplained hyperventilation, myalgia, gastrointestinal symptoms, malaise, unusual somnolence, or other nonspecific symptoms occur. Instruct patients to inform their doctor that they are taking pioglitazone and metformin hydrochloride prior to any surgical or radiological procedure, as temporary discontinuation of pioglitazone and metformin hydrochloride may be required until renal function has been confirmed to be normal.
  • Counsel patients against excessive alcohol intake while receiving pioglitazone and metformin hydrochloride.
  • Inform patients to immediately report symptoms of an unusually rapid increase in weight or edema, shortness of breath, or other symptoms of heart failure while receiving pioglitazone and metformin hydrochloride.
  • Tell patients to promptly stop taking pioglitazone and metformin hydrochloride and seek immediate medical advice if there is unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or dark urine as these symptoms may be due to hepatotoxicity.
  • Inform patients about the importance of regular testing of renal function and hematologic parameters when receiving treatment with pioglitazone and metformin hydrochloride.
  • Inform female patients that treatment with pioglitazone and metformin hydrochloride may result in an unintended pregnancy in some premenopausal anovulatory females due to its effect on ovulation [see Use in Specific Populations (8.3)].
  • Patients should be advised to notify their health practitioner or call the Poison Control Center immediately in case of pioglitazone and metformin hydrochloride overdose.
  • Combination antihyperglycemic therapy may cause hypoglycemia. When initiating pioglitazone and metformin hydrochloride, the risks of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development should be explained to patients and their family members.
  • Patients should be told to take pioglitazone and metformin hydrochloride as prescribed and instructed that any change in dosing should only be done if directed by their physician. If a dose is missed on one day, the dose should not be doubled the following day.

Dispense with Medication Guide available at: www.aurobindousa.com/product-medication-guides

MEDICATION GUIDE

Pioglitazone and Metformin Hydrochloride Tablets, USP

(pye” oh gli’ ta zone and met for’ min hye” droe klor’ ide)

Read this Medication Guide carefully before you start taking pioglitazone 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 and metformin hydrochloride tablets, ask your doctor or pharmacist.

What is the most important information I should know about pioglitazone and metformin hydrochloride tablets?

Pioglitazone and metformin hydrochloride tablets can cause serious side effects, including:

  • new or worse heart failure. Pioglitazone, one of the medicines in pioglitazone and metformin hydrochloride tablets, 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 pioglitazone and metformin hydrochloride tablets 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, pioglitazone and metformin hydrochloride tablets 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 pioglitazone and metformin hydrochloride tablets, 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 pioglitazone and metformin hydrochloride tablets 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 pioglitazone and metformin hydrochloride tablets for a while if you have any of these things.

Pioglitazone and metformin hydrochloride tablets can have other serious side effects. See “What are the possible side effects of pioglitazone and metformin hydrochloride tablets?”

What are pioglitazone and metformin hydrochloride tablets?

Pioglitazone and metformin hydrochloride tablets contain two prescription diabetes medicines called pioglitazone tablets and metformin hydrochloride tablets. Pioglitazone and metformin hydrochloride tablets can be used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes.

Pioglitazone and metformin hydrochloride tablets are not for people with type 1 diabetes.

Pioglitazone and metformin hydrochloride tablets are not for people with diabetic ketoacidosis (increased ketones in your blood or urine).

It is not known if pioglitazone and metformin hydrochloride tablets are safe and effective in children under the age of 18. Pioglitazone and metformin hydrochloride tablets are not recommended for use in children.

Who should not take pioglitazone and metformin hydrochloride tablets?

See “What is the most important information I should know about pioglitazone and metformin hydrochloride tablets?”

Do not take pioglitazone and metformin hydrochloride tablets if you:

  • have severe heart failure
  • are allergic to pioglitazone, metformin, or any of the ingredients in pioglitazone and metformin hydrochloride tablets. See the end of this Medication Guide for a complete list of ingredients in pioglitazone and metformin hydrochloride tablets
  • 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 pioglitazone and metformin hydrochloride tablets if you have any of these conditions.

What should I tell my doctor before taking pioglitazone and metformin hydrochloride tablets?

Before you take pioglitazone and metformin hydrochloride tablets, 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 pioglitazone and metformin hydrochloride tablets 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. Pioglitazone and metformin hydrochloride tablets may increase your chance of becoming pregnant. Talk to your doctor about birth control choices while taking pioglitazone and metformin hydrochloride tablets. Tell your doctor right away if you become pregnant while taking pioglitazone and metformin hydrochloride tablets
  • are breastfeeding or plan to breastfeed. It is not known if pioglitazone and metformin hydrochloride 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 breastfeeding

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

Pioglitazone and metformin hydrochloride tablets and some of your other medicines can affect each other. You may need to have your dose of pioglitazone 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 and metformin hydrochloride tablets with other medicines.

How should I take pioglitazone and metformin hydrochloride tablets?

  • Take pioglitazone and metformin hydrochloride tablets exactly as your doctor tells you to take them
  • Your doctor may need to change your dose of pioglitazone and metformin hydrochloride tablets. Do not change your pioglitazone and metformin hydrochloride tablets dose unless your doctor tells you to
  • Pioglitazone and metformin hydrochloride tablets may be prescribed alone or with other diabetes medicines. This will depend on how well your blood sugar is controlled
  • Take pioglitazone and metformin hydrochloride tablets with meals to lower your chance of an upset stomach
  • If you miss a dose of pioglitazone and metformin hydrochloride tablets, 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 pioglitazone and metformin hydrochloride, 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 pioglitazone and metformin hydrochloride tablets
  • Your doctor should do certain blood tests before you start and while you take pioglitazone and metformin hydrochloride tablets
  • Your doctor should also do hemoglobin A1C testing to check how well your blood sugar is controlled with pioglitazone and metformin hydrochloride tablets
  • Your doctor should check your eyes regularly while you take pioglitazone and metformin hydrochloride tablets

What are the possible side effects of pioglitazone and metformin hydrochloride tablets?

Pioglitazone and metformin hydrochloride tablets may cause serious side effects, including:

  • See “What is the most important information I should know about pioglitazone and metformin hydrochloride tablets?”
  • 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 pioglitazone and metformin hydrochloride tablets. You should not take pioglitazone and metformin hydrochloride tablets if you are receiving treatment for bladder cancer. Tell your doctor right away if you have any of the following symptoms of bladder cancer:
    • blood or a red color in your urine
    • an increased need to urinate
    • 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 pioglitazone and metformin hydrochloride tablets. This can increase your chance of getting pregnant.
  • low red blood cell count (anemia).

The most common side effects of pioglitazone and metformin hydrochloride tablets 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 pioglitazone 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 and metformin hydrochloride tablets?

  • Store pioglitazone and metformin hydrochloride tablets at 20° to 25°C (68° to 77°F). Keep pioglitazone and metformin hydrochloride tablets in the original container and protect from light.

Keep the pioglitazone and metformin hydrochloride tablets bottle tightly closed and keep tablets dry

Keep pioglitazone and metformin hydrochloride tablets and all medicines out of the reach of children.

General information about the safe and effective use of pioglitazone and metformin hydrochloride tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use pioglitazone and metformin hydrochloride tablets for a condition for which it was not prescribed. Do not give pioglitazone and metformin hydrochloride tablets 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 pioglitazone 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 and metformin hydrochloride tablets that is written for healthcare professionals.

For more information, call 1-866-850-2876.

What are the ingredients in pioglitazone 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.

Dispense with Medication Guide available at: www.aurobindousa.com/product-medication-guides

Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 038, India
Revised: 06/2018

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