Uses of Pioglitazone and Metformin Tablets:

• It is used to lower blood sugar in patients with high blood sugar (diabetes).

What do I need to tell my doctor BEFORE I take Pioglitazone and Metformin Tablets?

• If you have an allergy to metformin, pioglitazone, or any other part of this medicine (pioglitazone and metformin tablets).
• If you are allergic to this medicine (pioglitazone and metformin tablets); any part of this medicine (pioglitazone and metformin tablets); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Acidic blood problem, bladder cancer, or type 1 diabetes.
• If you have any of these health problems: Kidney disease or liver disease.
• If you have had a recent heart attack or stroke.
• If you are not able to eat or drink like normal, including before certain procedures or surgery.

This is not a list of all drugs or health problems that interact with this medicine (pioglitazone and metformin tablets).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (pioglitazone and metformin tablets) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Pioglitazone and Metformin Tablets?

• Do not drive if your blood sugar has been low. There is a greater chance of you having a crash.
• The chance of getting bladder cancer may be raised when taking this medicine (pioglitazone and metformin tablets). Talk with the doctor.
• Check your blood sugar as you have been told by your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Follow the diet and workout plan that your doctor told you about.
• It may be harder to control blood sugar during times of stress such as fever, infection, injury, or surgery. A change in physical activity, exercise, or diet may also affect blood sugar.
• Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
• This medicine may raise the chance of broken bones. The chance may be higher in women. Broken bones were seen after people took this medicine (pioglitazone and metformin tablets) for 1 year. Most of the broken bones happened in the upper arm, hand, or foot. Talk with your doctor about how to keep your bones healthy or if you have any questions.
• If you have been taking this medicine (pioglitazone and metformin tablets) for a long time or at high doses, it may not work as well and you may need higher doses to get the same effect. This is known as tolerance. Call your doctor if this medicine (pioglitazone and metformin tablets) stops working well. Do not take more than ordered.
• If you are 65 or older, use this medicine (pioglitazone and metformin tablets) with care. You could have more side effects.
• Do not give to a child. Talk with your doctor.
• There is a chance of pregnancy in women of childbearing age who have not been ovulating. If you want to avoid pregnancy, use birth control while taking this medicine (pioglitazone and metformin tablets).
• Use birth control that you can trust to prevent pregnancy while taking this medicine (pioglitazone and metformin tablets).
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine (pioglitazone and metformin tablets) while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Pioglitazone and Metformin Tablets) best taken?

Use this medicine (pioglitazone and metformin tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with meals.
• Take this medicine (pioglitazone and metformin tablets) at the same time of day.
• Keep taking this medicine (pioglitazone and metformin tablets) as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Bone pain.
• Feeling very tired or weak.
• Change in eyesight.
• Pain when passing urine or blood in urine.
• Passing urine more often.
• Swelling.
• It is common to have stomach problems like upset stomach, throwing up, or diarrhea when you start taking this medicine (pioglitazone and metformin tablets). If you have stomach problems later during treatment, call your doctor right away. This may be a sign of an acid health problem in the blood (lactic acidosis).
• Low blood sugar can happen. The chance may be raised when this medicine (pioglitazone and metformin tablets) is used with other drugs for diabetes. Signs may be dizziness, headache, feeling sleepy or weak, shaking, fast heartbeat, confusion, hunger, or sweating. Call your doctor right away if you have any of these signs. Follow what you have been told to do for low blood sugar. This may include taking glucose tablets, liquid glucose, or some fruit juices.
• Very bad and sometimes deadly liver problems have happened with this medicine (pioglitazone and metformin tablets). Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.

What are some other side effects of Pioglitazone and Metformin Tablets?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.
• Diarrhea.
• Gas.
• Headache.
• Signs of a common cold.
• Weight gain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Pioglitazone and Metformin Tablets?

• Store in the original container at room temperature.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep lid tightly closed.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine (pioglitazone and metformin tablets) is refilled. If you have any questions about this medicine (pioglitazone and metformin tablets), please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.