MEDICATION GUIDE ACTOS®
(ak-TOS) (pioglitazone hydrochloride) tablets
Read this Medication Guide carefully before you start taking ACTOS and each time you get a refi ll. 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 fl uid (fl uid retention), which leads to swelling (edema) and weight gain. Extra body fl uid can make some heart problems worse or lead to heart failure. Heart failure means your heart does not pump blood well enough.
• If you have severe heart failure, you cannot start ACTOS. • 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 fl uid 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.
ACTOS 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.
Your doctor will decide if you should take ACTOS.
It is important to eat the right foods, lose weight if needed, and exercise regularly in order to manage your type 2 diabetes. Diet, weight loss, and exercise are the main treatments for type 2 diabetes and they also help your diabetes medicines work better for you.
ACTOS has not been studied in children and is not recommended for children under the age of 18. The risks of giving ACTOS to a child are not known. See “What are some other possible side effects of ACTOS?”
Who should not take ACTOS? Do not take ACTOS if you: • are allergic to any of the ingredients in ACTOS. See the end of this Medication Guide for a complete list of ingredients in ACTOS.
People with severe heart failure should not start taking ACTOS. See “What is the most important information I should know about ACTOS?”
What should I tell my doctor before taking ACTOS? Before starting ACTOS, ask your doctor about what the choices are for diabetes medicines and what the expected benefits and possible risks are for you in particular.
Tell your doctor about all of your medical conditions, especially if you: • have heart failure. • have type 1 (“juvenile”) diabetes or had diabetic ketoacidosis. These conditions should be treated with insulin.
• have a type of diabetic eye disease called macular edema (swelling of the back of the eye).
• have liver problems. Your doctor should do blood tests to check your liver before you start taking ACTOS and during treatment as needed.
• are pregnant or planning to become pregnant. Actos should not be used during pregnancy. It is not known if ACTOS can harm your unborn baby. Talk to your doctor 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 breastfeeding or plan to breastfeed. 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 adjusted. Certain other medicines can affect your blood sugar (glucose) control.
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 prescribed. • Your doctor may need to change your dose of ACTOS to control your blood glucose. Do not change your dose unless told to do so by your doctor.
• ACTOS may be prescribed alone or with other diabetes medicines. This will depend on how well your blood sugar is controlled.
• Take ACTOS one 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 poison control center right away.
• If your body is under stress, for example: due to fever, infection, trauma (such as a car 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.
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68