www.patientedu.org

written byHarvard Medical School

www.patientedu.org

written byHarvard Medical School

Diabetes Goals for Good Health

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Most people think of diabetes as an inherited disease. Indeed, genes do play a role. Still, your risk of getting diabetes depends more

on how you live than on who your parents are. That means diabetes is a preventable disease. And even if you already have diabetes, the combination of good personal and medical care can prevent many of the complications that make diabetes the 6th leading cause of death in the United States.

Your Sugar MetabolismGlucose is the sugar that fuels your metabolism. After you eat, your digestive tract breaks down carbohydrates into sugar that’s absorbed into your bloodstream. Glucose is a vital source of energy for your body’s cells. But to provide that energy, glucose must travel from your blood into your cells.

Insulin is the hormone that unlocks the door to your cells. When your blood glucose level rises after you

eat, your pancreas springs into action, pouring insulin into your blood. If you produce enough insulin and your cells

respond normally, your blood sugar level drops

as glucose enters your cells, where it is burned for

energy or stored away for future use. All in

all, insulin allows your body to turn food into energy and to store up extra energy to keep your engine running if fuel becomes scarce.

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The 3 Types of DiabetesDiabetes is a single name given to 3 different disorders that are all marked by abnormally high blood sugar levels. All forms of diabetes develop when the pancreas is unable to supply enough insulin to meet the body’s demands. In some cases, the problem is a low supply. In others, it’s a high demand. And in some, it’s both a low supply and a high demand.

Diabetes of pregnancy (gestational diabetes) increases the risk of complications for mother and child. Blood sugar levels return to normal after delivery, but the mother has a high risk of developing type 2 diabetes later in her life.

Type 1 diabetes usually begins during childhood and adolescence, frequently around puberty, often with a critical rise in blood sugar levels. The disease is caused by a combination of genetic abnormalities and a viral infection or some other event that triggers the body’s immune system to attack the pancreas, destroying its ability to produce insulin. Type 1 diabetes is the most severe form of the disease, but it accounts for only about 5% to 10% of diabetes cases among adults in the U.S. Lifelong insulin therapy is necessary.

Type 2 diabetes usually begins gradually in adulthood. Alarmingly, however, our current diabetes epidemic features many cases in children. In most patients, the main problem is insulin resistance. The pancreas produces reasonable amounts of the hormone, but the body’s tissues don’t respond properly, so blood sugar levels are abnormally high. Oral medications can help many patients with type 2 diabetes, but over time, the ability of the over-taxed pancreas to produce insulin may run down, producing the need for insulin therapy.

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Does Diabetes Matter?It sure does! Diabetes is a major cause of heart attacks, kidney failure, vision loss, peripheral artery disease, leg amputations, and nerve damage. All in all, diabetes shortens life expectancy by about 7 or 8 years in people aged 50 and older. And diabetes also drains the U.S. economy of about $174 billion a year.

SymptomsMild elevations of blood sugar don’t produce any symptoms, which is why a third of all people with diabetes don’t know they have the disease. When sugar levels get higher, they produce symptoms that may include fatigue, blurred vision, excess urination, and excessive thirst. Increased hunger is another symptom,

About 90% to 95% of America’s 23.6 million people with diabetes

have type 2 disease, and the numbers are increasing every year with the

ongoing diabetes epidemic.

That’s because lifestyle is the major cause of type 2 diabetes, with obesity

heading the list.

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and weight loss may develop despite a hearty appetite. While the blood has too much sugar, the cells don’t get enough. Diabetes is starvation in the midst of plenty.

Over time, the symptoms of diabetes are joined by symptoms of diabetic organ damage. Fortunately, early diagnosis and good treatment can head off many complications.

Screening & DiagnosisAs of January 2010, the American Diabetes Association (ADA) began recommending the A1C test, a simple blood test, to screen people for diabetes. This test, which reflects a person’s average blood sugar level during the preceding 2 to 3 months, has long been used to help people with diabetes monitor their disease. It measures the percent of the oxygen-carrying hemoglobulin molecules in a person’s red blood cells that have glucose attached to them. The advantage of this test is that it doesn’t require overnight fasting, which is necessary for the fasting blood sugar (FBS) test, long considered the gold standard test for diagnosing diabetes. The values used to diagnose diabetes and pre-diabetes with each test are summarized:

Hemoglobin A1C Test

A1C Diagnosis

5.0% or below Normal

5.7% to 6.4% Pre-diabetes

6.5% or higher Diabetes

FBS Test

FBS Diagnosis

Below 100 mg/dL Normal

100–125 mg/dL Pre-diabetes

126 mg/dL or above Diabetes

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Good control of bloodsugar goes a long way toward

preventing complications.

The A1C level reflects a glucose average that corresponds to the numbers in the following table:

* The numbers here show sugar measurements in plasma, blood that has had its cells removed. This is the test that is done by your doctor when blood is drawn into a syringe or tube and tested in a laboratory. Most home glucose-monitor machines, by contrast, measure “whole-blood” glucose.

Source: American Diabetes Association.

A1C

6.0%

7.0%

8.0%

9.0%

10.0%

11.0%

12.0%

Plasma glucose*

126 mg/dL

154 mg/dL

183 mg/dL

212 mg/dL

240 mg/dL

269 mg/dL

298 mg/dL

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People aged 45 and older should be tested (with either the A1C or FBS test) every 3 years. People younger than 45 should also be tested as often as every year if they have a body mass index of 25 kg/m2 or higher and 1 or more of the following additional risk factors:

• Have a mother, father, brother, or sister with diabetes.

• Are physically inactive.

• Are of African American, Asian American, Hispanic American, Native American, or Pacific Islander decent.

• Have given birth to a baby weighing more than 9 lbs or had diabetes during pregnancy.

• Have blood pressure of 140/90 mm Hg or higher.

• Have abnormal blood lipid (fat) levels, such as HDL (“good”) cholesterol levels below 35 mg/dL or triglyceride levels higher than 250 mg/dL.

• Have had impaired glucose tolerance or impaired fasting glucose when previously tested for diabetes.

• Have polycystic ovary syndrome or a history of vascular problems.

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Treating Diabetes: LifestyleHealthy living can prevent many cases of diabetes, and it will help lower blood sugar levels and prevent complications for everyone with the disease. Here are the big 3:

1. Weight control. Shed as much excess fat as you can, especially from around your middle. Every little bit will be a big help.

2. Exercise. It’s crucial for weight loss and lowers blood sugar by making your tissues more responsive to insulin. Walking for 30 minutes nearly every day is a great way to start—and it will also help with your blood pressure and cholesterol.

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3. Diet. Healthy eating is as important as ever. To lose weight, reduce calories. Avoid sugar, sugary drinks, and other sweets.

Limit refined grain products, such as white bread and white rice, as well as white potatoes. Eat lots of high-fiber foods—whole grain products, brown

rice, beans, fruits, and veggies. Choose low-fat dairy products. Get your protein from

fish, poultry, and small portions of lean meat. Avoid processed meats, snack foods, and other high-salt items. Use olive and canola oils, but not animal fat or partially-hydrogenated oils that show up in fried foods, stick margarine, and snack foods. If you chose to drink, use alcohol moderately and responsibly.

Setting Goals & Monitoring Progress

In the past few years, scientists have discovered that good control of blood

sugar goes a long way toward preventing complications. Patients should aim for levels as close to normal as possible. Desirable results

include FBS readings of 110 mg/dL or less, sugar levels below 140 mg/dL when measured 2 hours

after a meal, and A1C levels of 7.0% or less. These are tough standards, but the closer you get, the better.

Patients who take insulin should monitor their own blood sugar levels; and it’s a good idea for other diabetics, too. It’s also important to avoid lowering your sugar too far (a condition called hypoglycemia). Symptoms of low sugar include anxiety, sweating, a

racing heart, and confusion. Without treatment, low blood sugar can even lead to coma, brain damage, and

death. People with diabetes should consider wearing a medical alert bracelet. They should also always carry candy to boost their sugar levels in an emergency.

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Healthy living can prevent many cases of diabetes.

Blood sugar gets much of the press, but some other things are just as important. Here are 5 additional goals; in many cases, your doctor will have to prescribe medication to help with the first 3:

1. Control your blood pressure: Aim for readings below 130/80 mm Hg.

2. Control your cholesterol: Aim for an LDL (“bad”) cholesterol below 100 mg/dL.

3. Protect your kidneys: Get tested for tiny amounts of protein in your urine (microalbuminuria) and get treatment if you need it.

4. Protect your vision: Seek regular eye care.

5. Protect your feet with good care: Sensible, well-fitted shoes, good nail care, and daily inspection of your feet will get you started.

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Tips for Healthy Eating Away From HomeFor people with diabetes, eating out—whether at a restaurant, a function, or a friend’s home—is always a challenge. Portions can be hefty and packed with calories and saturated fat. When you eat out, it may help to follow these simple guidelines:

• Ask how entrées are prepared, and avoid fried foods or dishes served with heavy sauces or gravies.

• Choose skinless chicken, fish, or lean meat that’s broiled, poached, baked, or grilled.

• Get the server’s advice in selecting healthy, low- fat dishes. Restaurants are used to dealing with specialty diets.

• Don’t feel obligated to clean your plate. Eat a reasonable portion, and take the rest home.

• Choose steamed vegetables and salads to accompany your meals. Request low-calorie dressings and toppings. If they’re not available, ask for all dressings, butter, and sauces to be served on the side so you can use them sparingly.

• If you take insulin and know your meal will be delayed, time your dose appropriately. You may need to eat a roll or piece of fruit to tide you over.

• If you crave a dessert, share it.

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Treating Diabetes: MedicationThe ADA’s 2009 guidelines recommend that people newly diagnosed with type 2 diabetes immediately

take 2 steps to control their blood sugar: 1) make lifestyle changes to lose weight (eating

better and exercising more), and 2) take the medication metformin. Early, aggressive

therapy may prevent blood sugar levels from worsening

with time by saving some of the cells that create insulin (insulin-

secreting beta cells).

Other oral medications, as well as insulin, and other injectable drugs—may be needed to help manage your diabetes. Doctors have a wider range of drugs to choose from and can often use them more effectively in combinations. Be sure to talk with your doctor about how the medications act to treat your condition and whether they address insulin resistance, low insulin production, or are combined to treat both.

Talk with your doctor about what therapies may be appropriate to help you reach the goals set to control your diabetes.

Beating DiabetesScientists are working hard to discover new ways to prevent and treat diabetes. Gene therapy and pancreas transplantation are among the hopes for the future, but they are still a long way off. Still, you can do your part to slow America’s worrisome diabetes epidemic. Type 2 diabetes is a preventable disease. A balanced, healthful diet, regular exercise, and weight control really do work. In fact, a major Harvard study found that simple lifestyle changes can reduce the risk of diabetes by 91%.

These same health habits will lower blood sugar levels, reduce the need for medication, and cut the risk of complications in patients who have diabetes. Many will also need medication. A large number of excellent drugs are now available, and new ones are being developed. Drug treatment requires care and close cooperation between doctors and patients, but it produces major gains.

Tight control of blood sugar levels is the primary goal of diabetes treatment, but blood pressure, cholesterol, kidney function, eye care, and foot care are also very important. Because diabetes is a chronic disease, beating it requires a lifetime commitment. But the benefit justifies the effort.

You can beat diabetes. How sweet it is!

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prescribedbrand-nameoral diabetesmedication#1

Struggling with the numbers game? Ask if ACTOS can help.

Along with a healthy diet and regular exercise, ACTOS, a prescription oral type 2 diabetes medication:

• Helps lower blood sugar by working on 2 common problems in patients with diabetes. (Individual results may vary.)–Helps your body better use the insulin it makes.–Stops your liver from making more sugar when it doesn’t need to.

• For additional support, Takeda Connection invites you to sign up to receive important tips, useful tools, and potential money-saving discounts. Enroll today at www.actos.com!

ACTOS is not for everyone. Please see the Important Safety Information, including warning about heart failure, on the right.

For more information on ACTOS, talk to your healthcare providers, and visit www.actos.com.

r m Q G W

To receive additional support and potential money-saving discounts for ACTOS:1 Text “diabetes” to 524824† or2 Scan this digital image using

your phone†Messaging and data rates may apply. For terms & conditions, visit www.jagtag.com/t&c.

Indications and UsageACTOS is a prescription medication used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. ACTOS is not for patients with type 1 “juvenile” diabetes or diabetic ketoacidosis.

Important Safety InformationWarning: Heart FailureACTOS is not for everyone. ACTOS can cause or worsen heart failure. Heart failure means your heart does not pump blood well enough. Talk to your doctor immediately if you experience unusually fast weight gain, fluid retention (swelling), shortness of breath, or unusual tiredness. Certain patients with symptoms of heart failure should not start taking ACTOS. Do not take ACTOS if you have severe heart failure.

Do not take ACTOS if you are allergic to any of its ingredients.ACTOS may cause liver problems. Talk to your doctor immediately if you experience unexplained nausea, vomiting, stomach pain, unusual tiredness, loss of appetite, dark urine, or yellowing of the skin or eyes as these could be symptoms of liver damage.Women are at higher risk of having broken bones (fractures) while taking ACTOS.There may be an increased chance of having bladder cancer when you take ACTOS. You should not take ACTOS if you are receiving treatment for bladder cancer. Tell your doctor right away if you have blood or a red color in your urine, have an increased need to urinate, or have pain while you urinate as these may be symptoms of bladder cancer. When taking ACTOS with insulin or other anti-diabetic medications (especially sulfonylureas), hypoglycemia may occur. Lightheadedness, shakiness, dizziness, or hunger may mean that your blood sugar is too low. Talk to your doctor if low blood sugar is a problem for you.Some patients have experienced visual changes while taking ACTOS. If you experience vision problems, consult your doctor immediately. Have your eyes checked regularly.If you are of childbearing age, but do not have regular monthly periods, talk to your doctor before taking ACTOS, as it could increase your chance of becoming pregnant.The most common side effects of ACTOS include cold-like symptoms, headache, sinus infection, muscle pain, and sore throat.Tell your doctor about all the medicines, vitamins, and supplements you take. ACTOS and some other medicines can affect each other. You may need to have your dose of ACTOS or certain other medicines changed.It is not known if ACTOS can harm an unborn, or nursing, baby. Talk to your doctor if you are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed.You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see Brief Summary of the Complete Prescribing Information (Medication Guide), including warning about heart failure, on adjacent page.*IMS Health, NPA™, achieved July 24, 2009.

ACTOS is a trademark of Takeda Pharmaceutical Company Limited registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.

©2011 Takeda Pharmaceuticals North America, Inc. PIO-01210 8/11 Printed in U.S.A.

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prescribedbrand-nameoral diabetesmedication#1

Struggling with the numbers game? Ask if ACTOS can help.

Along with a healthy diet and regular exercise, ACTOS, a prescription oral type 2 diabetes medication:

• Helps lower blood sugar by working on 2 common problems in patients with diabetes. (Individual results may vary.)–Helps your body better use the insulin it makes.–Stops your liver from making more sugar when it doesn’t need to.

• For additional support, Takeda Connection invites you to sign up to receive important tips, useful tools, and potential money-saving discounts. Enroll today at www.actos.com!

ACTOS is not for everyone. Please see the Important Safety Information, including warning about heart failure, on the right.

For more information on ACTOS, talk to your healthcare providers, and visit www.actos.com.

r m Q G W

To receive additional support and potential money-saving discounts for ACTOS:1 Text “diabetes” to 524824† or2 Scan this digital image using

your phone†Messaging and data rates may apply. For terms & conditions, visit www.jagtag.com/t&c.

Indications and UsageACTOS is a prescription medication used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. ACTOS is not for patients with type 1 “juvenile” diabetes or diabetic ketoacidosis.

Important Safety InformationWarning: Heart FailureACTOS is not for everyone. ACTOS can cause or worsen heart failure. Heart failure means your heart does not pump blood well enough. Talk to your doctor immediately if you experience unusually fast weight gain, fluid retention (swelling), shortness of breath, or unusual tiredness. Certain patients with symptoms of heart failure should not start taking ACTOS. Do not take ACTOS if you have severe heart failure.

Do not take ACTOS if you are allergic to any of its ingredients.ACTOS may cause liver problems. Talk to your doctor immediately if you experience unexplained nausea, vomiting, stomach pain, unusual tiredness, loss of appetite, dark urine, or yellowing of the skin or eyes as these could be symptoms of liver damage.Women are at higher risk of having broken bones (fractures) while taking ACTOS.There may be an increased chance of having bladder cancer when you take ACTOS. You should not take ACTOS if you are receiving treatment for bladder cancer. Tell your doctor right away if you have blood or a red color in your urine, have an increased need to urinate, or have pain while you urinate as these may be symptoms of bladder cancer. When taking ACTOS with insulin or other anti-diabetic medications (especially sulfonylureas), hypoglycemia may occur. Lightheadedness, shakiness, dizziness, or hunger may mean that your blood sugar is too low. Talk to your doctor if low blood sugar is a problem for you.Some patients have experienced visual changes while taking ACTOS. If you experience vision problems, consult your doctor immediately. Have your eyes checked regularly.If you are of childbearing age, but do not have regular monthly periods, talk to your doctor before taking ACTOS, as it could increase your chance of becoming pregnant.The most common side effects of ACTOS include cold-like symptoms, headache, sinus infection, muscle pain, and sore throat.Tell your doctor about all the medicines, vitamins, and supplements you take. ACTOS and some other medicines can affect each other. You may need to have your dose of ACTOS or certain other medicines changed.It is not known if ACTOS can harm an unborn, or nursing, baby. Talk to your doctor if you are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed.You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see Brief Summary of the Complete Prescribing Information (Medication Guide), including warning about heart failure, on adjacent page.*IMS Health, NPA™, achieved July 24, 2009.

ACTOS is a trademark of Takeda Pharmaceutical Company Limited registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.

©2011 Takeda Pharmaceuticals North America, Inc. PIO-01210 8/11 Printed in U.S.A.

16

BRIEF SUMMARY OF PRESCRIBING INFORMATION FOR CONSUMERS – Please see package insert for full prescribing information.

MEDICATION GUIDE ACTOS (ak-TOS)

(pioglitazone hydrochloride) tabletsRead this Medication Guide carefully before you start taking ACTOS 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 ACTOS, ask your doctor or pharmacist. What is the most important information I should know about ACTOS?ACTOS can cause serious side effects, including new or worse heart failure.· ACTOS 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 ACTOS 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, ACTOS 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 tirednessACTOS can have other serious side effects. See “What are the possible side effects of ACTOS?”What is ACTOS?ACTOS is a prescription medicine used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. ACTOS is a diabetes medicine called pioglitazone hydrochloride that may be taken alone or with other diabetes medicines. It is not known if ACTOS is safe and effective in children.Who should not take ACTOS?See “What is the most important information I should know about ACTOS?”Do not take ACTOS if you:· have severe heart failure· are allergic to any of the ingredients in ACTOS. See

the end of this Medication Guide for a complete list of ingredients in ACTOS

Talk to your doctor before taking ACTOS if you have either of these conditions.

What should I tell my doctor before taking ACTOS? Before you start taking ACTOS, tell your doctor if you:· have heart failure· 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· are pregnant or plan to become pregnant. It is not

known if ACTOS will 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. ACTOS may increase your chance of becoming pregnant. Talk to your doctor about birth control choices while taking ACTOS. Tell your doctor right away if you become pregnant while taking ACTOS

· are breast-feeding or plan to breast-feed.It is not known if ACTOS passes into your milk and if it can harm your baby. You should not take ACTOS if you breastfeed 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 non-prescription medicines, vitamins, and herbal supplements. ACTOS and some of your other medicines can affect each other. You may need to have your dose of ACTOS 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 ACTOS with other medicines.How should I take ACTOS?· Take ACTOS exactly as your doctor tells you to take it· Your doctor may change your dose of ACTOS. Do not

change your ACTOS dose unless your doctor tells you to· ACTOS may be prescribed alone or with other diabetes

medicines. This will depend on how well your blood sugar is controlled

· Take ACTOS 1 time each day, with or without food· If you miss a dose of ACTOS, 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 ACTOS, 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 ACTOS

17

BRIEF SUMMARY OF PRESCRIBING INFORMATION FOR CONSUMERS – Please see package insert for full prescribing information.

MEDICATION GUIDE ACTOS (ak-TOS)

(pioglitazone hydrochloride) tabletsRead this Medication Guide carefully before you start taking ACTOS 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 ACTOS, ask your doctor or pharmacist. What is the most important information I should know about ACTOS?ACTOS can cause serious side effects, including new or worse heart failure.· ACTOS 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 ACTOS 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, ACTOS 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 tirednessACTOS can have other serious side effects. See “What are the possible side effects of ACTOS?”What is ACTOS?ACTOS is a prescription medicine used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. ACTOS is a diabetes medicine called pioglitazone hydrochloride that may be taken alone or with other diabetes medicines. It is not known if ACTOS is safe and effective in children.Who should not take ACTOS?See “What is the most important information I should know about ACTOS?”Do not take ACTOS if you:· have severe heart failure· are allergic to any of the ingredients in ACTOS. See

the end of this Medication Guide for a complete list of ingredients in ACTOS

Talk to your doctor before taking ACTOS if you have either of these conditions.

What should I tell my doctor before taking ACTOS? Before you start taking ACTOS, tell your doctor if you:· have heart failure· 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· are pregnant or plan to become pregnant. It is not

known if ACTOS will 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. ACTOS may increase your chance of becoming pregnant. Talk to your doctor about birth control choices while taking ACTOS. Tell your doctor right away if you become pregnant while taking ACTOS

· are breast-feeding or plan to breast-feed.It is not known if ACTOS passes into your milk and if it can harm your baby. You should not take ACTOS if you breastfeed 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 non-prescription medicines, vitamins, and herbal supplements. ACTOS and some of your other medicines can affect each other. You may need to have your dose of ACTOS 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 ACTOS with other medicines.How should I take ACTOS?· Take ACTOS exactly as your doctor tells you to take it· Your doctor may change your dose of ACTOS. Do not

change your ACTOS dose unless your doctor tells you to· ACTOS may be prescribed alone or with other diabetes

medicines. This will depend on how well your blood sugar is controlled

· Take ACTOS 1 time each day, with or without food· If you miss a dose of ACTOS, 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 ACTOS, 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 ACTOS

18

· Your doctor should do certain blood tests before you start and while you take ACTOS

· Your doctor should also do hemoglobin A1C testing to check how well your blood sugar is controlled with ACTOS

· Your doctor should check your eyes regularly while you take ACTOS

· It may take 2 to 3 months to see the full effect of ACTOS on your blood sugar level.

What are the possible side effects of ACTOS?ACTOS may cause serious side effects including:· See “What is the most important information about

ACTOS.” · 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

· 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.

· bladder cancer. There may be an increased chance of having bladder cancer when you take ACTOS. You should not take ACTOS 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

· 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

· 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 ACTOS. This can increase your chance of getting pregnant

The most common side effects of ACTOS include: ° cold-like symptoms (respiratory tract infection)° headache° sinus infection° muscle pain° sore throat

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 ACTOS. 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 ACTOS?· Store ACTOS at 59°F to 86°F (15°C to 30°C). Keep

ACTOS in the original container and protect from light· Keep the ACTOS bottle tightly closed and protect

from getting wet (away from moisture and humidity)· Keep ACTOS and all medicines out of the reach of

childrenGeneral information about the safe and effective use of ACTOSMedicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ACTOS for a condition for which it was not prescribed. Do not give ACTOS 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 ACTOS. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about ACTOS that is written for healthcare professionals. For more information, go to www.actos.com or call 1-877-825-3327. What are the ingredients in ACTOS?Active Ingredient: pioglitazone hydrochlorideInactive Ingredients: lactose monohydrate, hydroxy-propylcellulose, carboxymethylcellulose calcium, and magnesium stearate.

ACTOS is a trademark of Takeda Pharmaceutical Company Limited registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Distributed by:Takeda Pharmaceuticals America, Inc.Deerfield, IL 60015

© 2009-2011 Takeda Pharmaceuticals America, Inc.

For more detailed information, see the full prescribing information for ACTOS at www.actos.com or contact Takeda Pharmaceuticals America, Inc. at 1-877-825-3327.

ACT003 R16_CFBS Rev. Jul 2011 L-PIO-0711-5

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· Your doctor should do certain blood tests before you start and while you take ACTOS

· Your doctor should also do hemoglobin A1C testing to check how well your blood sugar is controlled with ACTOS

· Your doctor should check your eyes regularly while you take ACTOS

· It may take 2 to 3 months to see the full effect of ACTOS on your blood sugar level.

What are the possible side effects of ACTOS?ACTOS may cause serious side effects including:· See “What is the most important information about

ACTOS.” · 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

· 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.

· bladder cancer. There may be an increased chance of having bladder cancer when you take ACTOS. You should not take ACTOS 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

· 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

· 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 ACTOS. This can increase your chance of getting pregnant

The most common side effects of ACTOS include: ° cold-like symptoms (respiratory tract infection)° headache° sinus infection° muscle pain° sore throat

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 ACTOS. 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 ACTOS?· Store ACTOS at 59°F to 86°F (15°C to 30°C). Keep

ACTOS in the original container and protect from light· Keep the ACTOS bottle tightly closed and protect

from getting wet (away from moisture and humidity)· Keep ACTOS and all medicines out of the reach of

childrenGeneral information about the safe and effective use of ACTOSMedicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ACTOS for a condition for which it was not prescribed. Do not give ACTOS 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 ACTOS. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about ACTOS that is written for healthcare professionals. For more information, go to www.actos.com or call 1-877-825-3327. What are the ingredients in ACTOS?Active Ingredient: pioglitazone hydrochlorideInactive Ingredients: lactose monohydrate, hydroxy-propylcellulose, carboxymethylcellulose calcium, and magnesium stearate.

ACTOS is a trademark of Takeda Pharmaceutical Company Limited registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Distributed by:Takeda Pharmaceuticals America, Inc.Deerfield, IL 60015

© 2009-2011 Takeda Pharmaceuticals America, Inc.

For more detailed information, see the full prescribing information for ACTOS at www.actos.com or contact Takeda Pharmaceuticals America, Inc. at 1-877-825-3327.

ACT003 R16_CFBS Rev. Jul 2011 L-PIO-0711-5

About This Brochure: This brochure was written by practicing physicians from Harvard Medical School. It is part of a series developed and distributed by the Patient Education Center.

All the information in this brochure and on the associated Web site (www.patientedu.org) is intended for educational use only; it is not intended to provide, or be a substitute for, professional medical advice, diagnosis, or treatment. Only a physician or other qualified health care professional can provide medical advice, diagnosis, or treatment. Always consult your physician on all matters of your personal health.

Harvard Medical School, the Patient Education Center, and its affiliates do not endorse any products.

Consulting Physician: Anthony L. Komaroff, MD Editorial Director: Keith D’Oria

Creative Director: Jon Nichol

© Copyright Harvard Medical School.

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To learn more about diabetes, visit the Patient Education Center at www.patientedu.org/diabetes.