• Your doctor should do blood tests before starting ACTOS and from time to time to check your liver, kidneys, and blood cells.
• Your doctor should also do regular blood tests (for example, hemoglobin A1C) to check how well your blood sugar is controlled with ACTOS.
• Your doctor should check your eyes regularly. Some people have had vision changes due to swelling in the back of the eye, called macular edema, while taking ACTOS.
• It may take 2-3 months to see the full effect on your blood sugar level.
What are other possible side effects of ACTOS? ACTOS can cause other serious side effects including: • Weight gain. Pioglitazone, the medicine in ACTOS can cause weight gain that may be due to fl uid retention or extra body fat. Weight gain due to fl uid retention can be a serious problem for people with certain conditions, including heart problems. See “What is the most important information I should know about ACTOS?”.
• Liver problems. It is important for your liver to be working normally when you take ACTOS. Your doctor should do blood tests to check your liver before you start taking ACTOS and during treatment as needed. Call your doctor right away if you have unexplained symptoms such as: nausea or vomiting. stomach pain.
unusual or unexplained tiredness. loss of appetite. dark urine.
yellowing of your skin or the whites of your eyes.
• Macular edema (diabetic eye disease with swelling in the back of the eye). Tell your doctor right away if you have any changes in your vision. Your doctor should check your eyes regularly.
• Fractures (broken bones), usually in the hand, upper arm, or foot in women. Talk to your doctor for advice on how to keep your bones healthy. It is not known if ACTOS can affect the bones of children.
• Low red blood cell count (anemia). • Low blood sugar (hypoglycemia). Lightheadedness, dizziness, shakiness, or hunger may indicate that your blood sugar is too low. This can happen if you skip meals, if you use another medicine that lowers blood sugar, or if you have certain medical problems. Call your doctor if low blood sugar levels are a problem for you.
• Ovulation (release of an egg from an ovary in a woman) leading to pregnancy. Ovulation may happen when premenopausal women who do not have regular monthly periods take ACTOS. This can increase the chance of pregnancy. See “What should I tell my doctor before taking ACTOS?”.
In studies of pioglitazone (the medicine in ACTOS), bladder cancer occurred in a few more people who were taking pioglitazone than in people who were taking other diabetes medicines. There were too few cases to know if the bladder cancer was related to pioglitazone.
Other common side effects of ACTOS are: • cold-like symptoms (respiratory tract infection), • headache, • sinus infection, • muscle pain, • tooth disorder, • 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° to 86°F (15° to 30°C). Keep ACTOS in the original container to 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 children. General information about ACTOS
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ACTOS for a condition for which it is 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 hydrochloride
Inactive Ingredients: lactose monohydrate, hydroxypropylcellulose, carboxymethylcellulose calcium, and magnesium stearate.
Always check to make sure that the medicine you are taking is the correct one. ACTOS tablets look like this:
• 15 mg strength tablets – white to off-white, round, convex, non-scored with “ACTOS” on one side, and “15” on the other.
• 30 mg strength tablets – white to off-white, round, flat, non-scored with “ACTOS” on one side, and “30” on the other.
• 45 mg strength tablets – white to off-white, round, flat, non-scored with “ACTOS” on one side, and “45” on the other.
ACTOS® is a registered trademark of Takeda Pharmaceutical Company
Limited and used under license by Takeda Pharmaceuticals America, Inc. All other trademarks are the property of their respective owners.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Distributed by: Takeda Pharmaceuticals America, Inc. Deerfi eld, IL 60015
© 2009 Takeda Pharmaceuticals America, Inc. ACT0909-R2/MG
M001-01 L-PIO-0909-7 September 2009
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