Pioglitazone

Pioglitazone and other similar medications for diabetes may cause or worsen heart failure (condition in which the heart is unable to pump enough blood to the other parts of the body). Before you start to take pioglitazone, tell your doctor if you have or have ever had heart failure, especially if your heart failure is so severe that you must limit your activity and are only comfortable when you are at rest or you must remain in a chair or bed. Also tell your doctor if you were born with a heart defect, and if you have or have ever had swelling of the arms, hands, feet, ankles, or lower legs; heart disease; high cholesterol or fats in the blood; high blood pressure; coronary artery disease (narrowing of the blood vessels that supply blood to the heart); a heart attack; an irregular heartbeat; or sleep apnea. Your doctor may tell you not to take pioglitazone or may monitor you carefully during your treatment.

If you develop heart failure, you may experience certain symptoms. Tell your doctor immediately if you have any of the following symptoms, especially when you first start taking pioglitazone or after your dose is increased: large weight gain in a short period of time; shortness of breath; swelling of the arms, hands, feet, ankles, or lower legs; swelling or pain in the stomach; waking up short of breath during the night; needing to sleep with extra pillows under your head in order to breathe easier while lying down; frequent dry cough or wheezing; difficulty thinking clearly or confusion; fast or racing heart beat; not able to walk or exercise as well; or increased tiredness.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with pioglitazone and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Talk to your doctor about the risks of taking pioglitazone.

Pioglitazone is used with a diet and exercise program and sometimes with other medications, to treat type 2 diabetes (condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood). Pioglitazone is in a class of medications called thiazolidinediones. It works by increasing the body's sensitivity to insulin, a natural substance that helps control blood sugar levels. Pioglitazone is not used to treat type 1 diabetes (condition in which the body does not produce insulin and, therefore, cannot control the amount of sugar in the blood) or diabetic ketoacidosis (a serious condition that may develop if high blood sugar is not treated).

Over time, people who have diabetes and high blood sugar can develop serious or life-threatening complications, including heart disease, stroke, kidney problems, nerve damage, and eye problems. Taking medication(s), making lifestyle changes (e.g., diet, exercise, quitting smoking), and regularly checking your blood sugar may help to manage your diabetes and improve your health. This therapy may also decrease your chances of having a heart attack, stroke, or other diabetes-related complications such as kidney failure, nerve damage (numb, cold legs or feet; decreased sexual ability in men and women), eye problems, including changes or loss of vision, or gum disease. Your doctor and other healthcare providers will talk to you about the best way to manage your diabetes.

Pioglitazone comes as a tablet to take by mouth. It is usually taken once daily with or without meals. Take pioglitazone at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take pioglitazone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may start you on a low dose of pioglitazone and gradually increase your dose.

Pioglitazone controls type 2 diabetes but does not cure it. It may take 2 weeks for your blood sugar to decrease and 2 to 3 months for you to feel the full effect of pioglitazone. Continue to take pioglitazone even if you feel well. Do not stop taking pioglitazone without talking to your doctor.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking pioglitazone,

• tell your doctor and pharmacist if you are allergic to pioglitazone, any other medications, or any of the ingredients in pioglitazone tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements and herbal products you are taking or plan to take while taking pioglitazone. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• the following nonprescription product may interact with pioglitazone: ranitidine (Zantac^®). Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking pioglitazone. Do not start this medication while taking pioglitazone without discussing with your healthcare provider.
• tell your doctor if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section, or if you have or have ever had bladder cancer, diabetic eye disease, or kidney or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking pioglitazone, call your doctor. Do not breast-feed while you are taking pioglitazone.
• if you have not yet experienced menopause (change of life; end of monthly periods) you should know that pioglitazone may increase the chance that you will become pregnant even if you do not have regular monthly periods or if you have a condition that prevents you from ovulating (releasing an egg from the ovaries). Talk to your doctor about methods of birth control that will work for you.
• if you will be having surgery, including dental surgery, tell the doctor or dentist that you are taking pioglitazone.
• ask your doctor what to do if you get sick, develop an infection or fever, experience unusual stress, or are injured. These conditions can affect your blood sugar and the amount of pioglitazone you may need.

Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. It is important to eat a healthy diet, exercise regularly, and lose weight if necessary. This will help to control your diabetes and help pioglitazone work more effectively.

Alcohol may cause a decrease in blood sugar. Ask your doctor about the safe use of alcoholic beverages while you are taking pioglitazone.

If you remember that same day, take the missed dose as soon as you remember it. However, if you do not remember until the next day, skip the missed dose and continue your regular dosing schedule. Do not take more than one dose in one day and do not take a double dose to make up for a missed one.

This medication may cause changes in your blood sugar. You should know the symptoms of low and high blood sugar and what to do if you have these symptoms.

Pioglitazone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• muscle pain
• pain in the arms or legs
• sore throat
• gas

Some side effects can be serious. If you experience any of the following symptoms or those mentioned in the IMPORTANT WARNING section, call your doctor immediately:

• changes in vision
• vision loss
• frequent, painful, or difficult urination
• cloudy, discolored, or bloody urine
• back or stomach pain

You should know that pioglitazone may cause liver problems. Stop taking pioglitazone and call your doctor right away if you have nausea, vomiting, loss of appetite, pain in the upper right part of the stomach, flu-like symptoms, dark urine, yellowing of the skin or eyes, unusual bleeding or bruising, or lack of energy.

In clinical studies, more people who took pioglitazone for more than one year developed bladder cancer than people who did not take pioglitazone Talk to your doctor about the risk of taking this medication.

In clinical studies, more women who took pioglitazone developed fractures (broken bones), especially of the hands, upper arms, or feet, than women who did not take pioglitazone. Men who took pioglitazone did not have a greater risk of developing fractures than men who did not take the medication. If you are a woman, talk to your doctor about the risk of taking this medication.

Pioglitazone may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat, light, and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor, your eye doctor, and the laboratory. Your doctor will probably order regular eye examinations and certain laboratory tests before and during your treatment to check your body's response to pioglitazone. Your blood sugar and glycosolated hemoglobin should be checked regularly to determine your response to pioglitazone. Your doctor will also tell you how to check your response to pioglitazone by measuring your blood or urine sugar levels at home. Follow these directions carefully.

You should always wear a diabetic identification bracelet to be sure you get proper treatment in an emergency.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Actos^®
• Oseni^® (as a combination product containing Alogliptin, Pioglitazone)

• Actoplus Met^® (containing Metformin, Pioglitazone)
• Actoplus Met^® XR (containing Metformin, Pioglitazone)^¶
• Duetact^® (containing Glimepiride, Pioglitazone)