Tablets Chemical Name:
PIOGLITAZONE (pye-oh-GLI-ta-zone)
Common uses Actos 15mg is used to treat type 2 diabetes by
reducing the resistance your body has to insulin. It is used either alone or in combination with other
anti-diabetes medicines, including metformin or insulin, as part of a diet and exercise program.
Before using WARNING: THIAZOLIDINEDIONE ANTIDIABETICS SUCH
AS ACTOS 15mg MAY CAUSE OR WORSEN HEART FAILURE IN SOME PATIENTS. Tell your doctor if you have a history of heart
failure. Actos 15mg should not be used to treat patients with moderate to severe heart failure. You will be
monitored for signs of heart failure when you start Actos 15mg and when your dose increases. CONTACT YOUR DOCTOR AT
ONCE if you develop swelling of the hands, ankles, or feet; shortness of breath; or sudden, unexplained weight
gain. Your doctor may need to stop your medicine or change your dose. Some medicines or medical conditions may
interact with Actos 15mg. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that
you are taking. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking gemfibrozil,
insulin, oral antidiabetic medicines (such as glipizide), rifampin, or anticoagulants (such as warfarin). USE OF
ACTOS 15mg IS NOT RECOMMENDED if you have newly diagnosed or worsening heart failure (acute congestive heart
failure), type 1 diabetes, diabetic ketoacidosis, active liver disease, or experienced jaundice with troglitazone.
Tell your doctor if you have a history of liver problems, abnormal liver function tests, heart problems (eg,
congestive heart failure), or eye or vision problems. Inform your doctor of any other medical conditions including
diabetic ketoacidosis (a severe problem associated with diabetes), swelling problems (edema), allergies, pregnancy,
or breast-feeding. USE OF ACTOS 15mg in children under age 18 is not recommended. Discuss with your doctor the
risks and benefits of giving Actos 15mg to your child. Contact your doctor or pharmacist if you have any questions
or concerns about taking Actos 15mg.
Directions Follow the directions for using Actos 15mg
provided by your doctor. An additional patient information leaflet is available with Actos 15mg. Ask your doctor,
nurse, or pharmacist any questions that you may have about this information. Actos 15mg may be taken on an empty
stomach or with food. STORE ACTOS 15mg at room temperature at 77 degrees F (25 degrees C) in a tightly-closed
container, away from heat, moisture, and light. Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is
permitted. Taking Actos 15mg at the same times each day will help you to remember. CONTINUE TO TAKE ACTOS 15mg even
if you feel well. Do not miss any doses. IF YOU MISS A DOSE OF ACTOS 15mg, take it as soon as possible. If it is
almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do NOT take 2
doses at once.
Cautions DO NOT STOP USING ACTOS 15mg or other diabetes
medicine without first checking with your doctor. CHECK WITH YOUR DOCTOR before adjusting the dose of your diabetes
medicine or changing your diet. IF YOU ARE TAKING ACTOS 15mg WITH OTHER DIABETES MEDICINE, you are at an increased
risk of becoming hypoglycemic (low blood sugar). Signs of hypoglycemia include an increased heartbeat, headache,
sweating, tremor, increased hunger, changes in vision, nervousness, or tiredness. Discuss with your doctor or nurse
how to handle hypoglycemic reactions. ACTOS 15mg MAY BE ASSOCIATED WITH AN INCREASED RISK OF BONE FRACTURE IN SOME
WOMEN. Inform your doctor if you have a history of bone fracture, low calcium intake, osteoporosis, or weakened
bones. Actos 15mg may be associated with an increased risk of bladder cancer. Discuss any questions or concerns
with your doctor. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while you are using Actos 15mg. Laboratory and/or
medical tests such as fasting blood sugar, hemoglobin A1C, eye examinations, and liver function may be done to
monitor your progress or to check for side effects. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY
CARE, OR SURGERY, tell the doctor or dentist that you are using Actos 15mg. BEFORE YOU BEGIN TAKING ANY NEW
MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. FOR WOMEN TAKING BIRTH
CONTROL PILLS: Actos 15mg may decrease the effectiveness of your birth control pill. To prevent pregnancy, use an
additional form of birth control. FOR WOMEN: Actos 15mg may increase your chance of pregnancy by causing ovulation
to resume in premenopausal women who have not been ovulating. IF YOU PLAN ON BECOMING PREGNANT, discuss with your
doctor the benefits and risks of using Actos 15mg during pregnancy. IT IS UNKNOWN IF ACTOS 15mg IS EXCRETED in
breast milk. DO NOT BREAST-FEED while taking Actos 15mg.
Possible side effects A SIDE EFFECT that may occur while
taking Actos 15mg is sore throat. If it continues or is bothersome, check with your doctor. CONTACT YOUR DOCTOR
IMMEDIATELY if you experience the following side effects: bloating or swelling of ankles, feet, or hands; blurred
vision or other vision changes; chest pain; rapid weight gain; shortness of breath; fatigue; unexplained nausea or
vomiting; stomach pain; loss of appetite; unusual thirst; unusual amount of urine; dark urine; or yellowing of the
skin or eyes. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist. This is not
a complete list of all side effects that may occur. If you have questions about side effects, contact your
healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at
1-800-FDA-1088.
Drug interactions Drug interactions can result in unwanted
side effects or prevent a medicine from doing its job. Use our drug interaction checker to find out if your
medicines interact with each other.
If you take too
much If overdose is suspected, contact your local poison control center or emergency room
immediately.
Additional information FOLLOW THE DIETARY AND EXERCISE
PLAN provided by your doctor. Carry an identification card at all times that says you are diabetic. Monitor your
blood sugar levels regularly according to your doctor's directions. If your blood sugar level is often higher or
lower than it should be and you are taking Actos 15mg according to directions, check with your doctor. IT MAY BE
HARDER TO CONTROL YOUR BLOOD SUGAR DURING TIMES OF STRESS such as fever, infection, injury, or surgery. Talk to
your doctor about how to control your blood sugar if any of these occur. DO NOT SHARE ACTOS 15mg with others for
whom it was not prescribed. DO NOT USE ACTOS 15mg for other health conditions. KEEP THIS PRODUCT out of the reach
of children. IF USING ACTOS 15mg FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out.