Actos Patient, Information, Instructions - Pioglitazone hydrochloride

Actos Patient, Information, Instructions - Pioglitazone hydrochloride

PATIENT INFORMATION

It is important to instruct patients to adhere to dietary instructions and to have blood glucose and glycosylated hemoglobin tested regularly. During periods of stress such as fever, trauma, infection, or surgery, medication requirements may change and patients should be reminded to seek medical advice promptly.

ACTOS is not for everyone. ACTOS can cause fluid retention or edema (swelling), which may lead to or worsen heart failure, so tell your doctor if you have a history of these conditions. Talk to your doctor immediately if you experience rapid weight gain, swelling, or shortness of breath while taking ACTOS.

If you have moderate to severe heart failure, ACTOS is not recommended. Also, your doctor should perform a blood test to check for serious liver problems or active liver disease before you start ACTOS and regularly thereafter. Do not take ACTOS if you have active liver disease. Talk to your doctor immediately if you experience nausea, vomiting, stomach pain, tiredness, loss of appetite, dark urine, or yellowing of the skin. (P) If you are of childbearing age, talk to your doctor before taking ACTOS because it could increase your chance of becoming pregnant.

Some people taking ACTOS may experience cold and flu-like symptoms, mild to moderate swelling of legs and ankles, and anemia. Occasionally, blood glucose levels increased during clinical trials. When taking ACTOS with insulin or sulfonylureas, you may be at risk for low blood glucose.

Patients should be told to take ACTOS once daily. ACTOS can be taken with or without meals. If a dose is missed on one day, the dose should not be doubled the following day.

When using combination therapy with insulin or oral hypoglycemic agents, the risks of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development should be explained to patients and their family members.

Therapy with ACTOS, like other thiazolidinediones, may result in ovulation in some premenopausal anovulatory women. As a result, these patients may be at an increased risk for pregnancy while taking ACTOS. Thus, adequate contraception in premenopausal women should be recommended. This possible effect has not been investigated in clinical studies so the frequency of this occurrence is not known.

Please also refer to the WARNINGS