What is the most important information I should know about Actos?

• Usually, liver function is monitored with blood tests at the start of treatment, every two months for the first year of treatment, and periodically thereafter during treatment with Actos. Notify your doctor immediately if you develop nausea, vomiting, abdominal pain, unusual fatigue, loss of appetite, yellow skin or eyes, or dark urine. These symptoms may be early signs of liver problems.
• Notify your doctor immediately if you experience an unusually rapid increase in weight or edema (water retention), shortness of breath, or chest pain during treatment with Actos. These may be early symptoms of heart problems.
• Actos usually does not cause hypoglycemia (low blood sugar). However, hypoglycemia may occur as a result of skipped meals, excessive exercise, or alcohol consumption while taking Actos. Know the signs and symptoms of hypoglycemia, which include headache, drowsiness, weakness, dizziness, fast heartbeat, sweating, tremor, and nausea. Carry non-dietetic hard candy or glucose tablets with you to treat episodes of low blood sugar.
• Actos may decrease the effects of some birth control pills. Additional measures may be necessary to prevent pregnancy while taking Actos. Talk to your doctor about the use of birth control.

What is Actos?

• Actos is an antihyperglycemic agent. It helps the body respond better to insulin and it reduces the amount of sugar produced by the liver. It can help control blood sugar levels.
• Actos is used, along with diet and exercise, in the treatment of type 2 diabetes. Actos may also be used with a sulfonylurea (e.g., Diabeta, Glucotrol, Micronase, others), metformin (Glucophage), or insulin when diet and exercise plus any one of these medicines alone do not result in adequate blood sugar control.
• Actos may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking Actos?

• Do not take Actos without first talking to your doctor if you have liver disease.
• Before taking this medication, tell your doctor if you
  • have heart failure or heart disease;
  • have edema (water retention or swelling);
  • have type 1 diabetes mellitus;
  • have a serious infection, illness, or injury; or
  • need surgery.
• You may not be able to take Actos, or you may need a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
• Contact your doctor if you develop a fever or an infection, require surgery, or if you experience a serious injury. Illness or injury may cause a loss of blood sugar control and insulin (or an adjustment of a current insulin dose) may be required for a period of time.
• Treatment with Actos may cause resumption of fertility by allowing for the return of ovulation (production of eggs) in certain women with insulin resistance who were not ovulating before treatment with Actos. Talk to your doctor about adequate forms of birth control while taking Actos if birth control is desired.
• Actos is in the FDA pregnancy category C. This means that it is not known whether Actos will be harmful to an unborn baby. Generally, insulin is the drug of choice for controlling diabetes during pregnancy. Do not take Actos without first talking to your doctor if you are pregnant or could become pregnant during treatment.
• It is not known whether Actos passes into breast milk. Do not take Actos without first talking to your doctor if you are breast-feeding a baby.
• The safety and effectiveness of Actos have not been established for children.

How should I take Actos?

• Take Actos exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.
• Take each dose with a full glass of water.
• Actos can be taken with or without food or meals.
• It is important to take Actos regularly to get the most benefit.
• Your doctor may want you to have blood or urine tests or other medical evaluations during treatment with Actos to monitor blood sugar levels, liver function, or other factors.
• Usually, liver function is monitored with blood tests at the start of treatment, every two months for the first year of treatment, and periodically thereafter during treatment with Actos. Notify your doctor immediately if you develop nausea, vomiting, abdominal pain, unusual fatigue, loss of appetite, yellow skin or eyes, or dark urine. These symptoms may be early signs of liver problems.
• Although Actos does not usually cause hypoglycemia (low blood sugar), hypoglycemia may result from skipped meals, excessive exercise, or alcohol consumption. Know the signs and symptoms of hypoglycemia, which include headache, drowsiness, weakness, dizziness, fast heartbeat, sweating, tremor, and nausea. Carry a piece of non-dietetic hard candy or glucose tablets with you to treat episodes of low blood sugar.
• Store Actos at room temperature away from moisture and heat.

What happens if I miss a dose?

• Take the missed dose as soon as you remember. If you do not remember until the next day, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose.

What happens if I overdose?

• Seek emergency medical attention if an overdose is suspected.
• Symptoms of a Actos overdose are not known.

What should I avoid while taking Actos?

• Follow any diet, medication, and exercise routines closely. Changing any of these factors can affect blood sugar levels.
• Avoid alcohol. It lowers blood sugar and may interfere with diabetes treatment.
• Tell your doctor and dentist that you are taking this medication before having surgery.
• Do not take over-the-counter or prescription cough, cold, allergy, pain, or weight-loss medications during treatment with Actos without first talking to your doctor.

What are the possible side effects of Actos?

• If you experience any of the following serious side effects, stop taking Actos and seek emergency medical attention or notify your doctor immediately:
  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • nausea, vomiting, abdominal pain, or loss of appetite;
  • unusual fatigue;
  • yellowing of the skin or eyes; or
  • dark urine.
• Notify your doctor immediately if you experience an unusually rapid increase in weight or edema (swelling, water retention), shortness of breath, or chest pain during treatment with Actos. These may be early symptoms of heart problems.
• Although Actos does not usually cause hypoglycemia (low blood sugar), hypoglycemia may result from skipped meals, excessive exercise, or alcohol consumption. Know the signs and symptoms of hypoglycemia, which include headache, drowsiness, weakness, dizziness, fast heartbeat, sweating, tremor, and nausea. Carry a piece of non-dietetic hard candy or glucose tablets with you to treat episodes of low blood sugar.
• Other less serious side effects may also occur. Continue to take Actos and talk to your doctor if you experience:
  • headache;
  • muscle aches; or
  • sore throat, nasal discharge, or cold symptoms.
• Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Actos?

• Actos may decrease the effects of some birth control pills. Additional measures may be necessary to prevent pregnancy while taking Actos. Talk to your doctor about the use of birth control.
• Do not take over-the-counter or prescription cough, cold, allergy, pain, or weight-loss medications during treatment with Actos without first talking to your doctor.
• Drugs other than those listed here may also interact with Actos or affect your condition. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.