Pioglitazone (patient information)

# Why is this medication prescribed
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).

# How should this medicine be used?
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 several weeks longer 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.

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

# What special precautions should I follow
Before taking pioglitazone:
- tell your doctor and pharmacist if you are allergic to pioglitazone or any other medications.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements and herbal products you are taking or plan to take.Be sure to mention any of the following: atorvastatin (Lipitor), gemfibrozil (Lopid), hormonal contraceptives (birth control pills, patches, rings, implants, and injections), ketoconazole (Nizoral), midazolam, montelukast (Singulair), nifedipine (Procardia), and rifampin (Rifadin, Rifater, in Rifamate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have ever had a heart attack or heart surgery and if you have or have ever had heart failure, liver disease, or swelling of the arms, hands, feet, ankles or lower legs.
- 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 breastfeed 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 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.

# What special dietary instructions should I follow
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.

# What should I do if I forget a dose
If you remember that same day, take the missed dose as soon as your 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.

# Side effects
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.
You may experience hypoglycemia (low blood sugar) if you are taking this medication in combination with other medications used to treat diabetes. Your doctor will tell you what you should do if you develop hypoglycemia. He or she may tell you to check your blood sugar, eat or drink a food or beverage that contains sugar, such as hard candy or fruit juice, or get medical care. Follow these directions carefully if you have any of the following symptoms of hypoglycemia:
- shakiness
- dizziness or lightheadedness
- sweating
- nervousness or irritability
- sudden changes in behavior or mood
- headache
- numbness or tingling around the mouth
- weakness
- pale skin
- hunger
- clumsy or jerky movements
If hypoglycemia is not treated, severe symptoms may develop. Be sure that your family, friends, and other people who spend time with you know that if you have any of the following symptoms, they should get medical treatment for you immediately.
- confusion
- seizures
- loss of consciousness
Call your doctor immediately if you have any of the following symptoms of hyperglycemia (high blood sugar):
- extreme thirst
- frequent urination
- extreme hunger
- weakness
- blurred vision
If high blood sugar is not treated, a serious, life-threatening condition called diabetic ketoacidosis could develop. Call your doctor immediately if you have any of these symptoms:
- dry mouth
- upset stomach and vomiting
- shortness of breath
- breath that smells fruity
- decreased consciousness

## Mild side effects
Pioglitazone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- runny nose and other cold symptoms
- headache
- muscle pain
- tooth or mouth pain
- sore throat

## Severe side effects
Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:
- shortness of breath
- weight gain
- swelling of the hands, arms, feet, ankles or lower legs
- stomach pain
- nausea
- vomiting
- loss of appetite
- excessive tiredness
- dark urine
- yellowing of the skin or whites of the eyes
- blurred vision
- vision loss
In clinical studies, more people who took pioglitazone 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, especially of the hands, arms, feet, ankles, and lower legs 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  or by phone .

# What storage conditions are needed for this medicine?
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 and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

# In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

# What other information should I know
Keep all appointments with your doctor, your eye doctor, and the laboratory. Your doctor will probably order regular eye examinations and certain laboratory tests to check your body's response to rosiglitazone. 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.

# Brand names
- Actos
- ActoPLUSMet (as a combination product containing pioglitazone and metformin)
- Duetact (as a combination product containing pioglitazone and glimepiride)