ACTAZONE is an effective, convenient way to

treat type 2 diabetes:

Effective. ACTAZONE is clinically proven to lower blood glucose levels.

Convenient. ACTAZONE can always be taken once a day, with or without food.

Management of type 2 diabetes requires nutritional counseling, weight reduction as needed, and exercise. When diet and exercise are not enough, ACTAZONE may be used alone or in combination with sulfonylureas, metformin, or insulin to improve blood glucose control. ACTAZONE should not be used in the treatment of type 1 diabetes.

Patient Information About ACTAZONE
Tablets: 15 mg, 30 mg, and 45 mg.

- What is ACTAZONE?

- What is type 2 diabetes?

- Why is it important to control type 2 diabetes?

- How does ACTAZONE help treat type 2 diabetes?

- What should I discuss with my health professional before taking ACTAZONE?

- How soon will ACTAZONE begin to work?

- How should I take ACTAZONE?

- What should I do if I miss a dose?

- Do I still need to test my blood glucose while using ACTAZONE?

- What other routine laboratory tests are recommended?

- Can I take ACTAZONE with other diabetes medications?

- Will ACTAZONE interfere with other medications?

- What are the possible side effects of ACTAZONE?

- Can ACTAZONE increase my risk for pregnancy?

- What else can I do to help control type 2 diabetes?

- Who should not use ACTAZONE?

- How should I store ACTAZONE?

- Where can I find more information about ACTAZONE?

What is ACTAZONE?

ACTAZONE is a clinically proven, once-a-day medicine that belongs to a type of prescription oral diabetes drugs called thiazolidinediones (THIGH-ah-ZO-li-deen-DYE-owns). Thiazolidinediones are also called insulin sensitizers because they treat type 2 diabetes by helping your body better use the insulin it is already making or the insulin you are taking. ACTAZONE comes in tablets and is always taken once a day, and along with healthy eating and physical activity helps lower blood glucose levels.

What is type 2 diabetes?

Type 2 diabetes (formerly called non-insulin-dependent diabetes, or adult-onset diabetes) occurs when the body does not produce enough insulin and cannot properly use the insulin it makes to control blood glucose. Insulin allows glucose carried in the bloodstream to enter the cells of your body for energy. If your body is resistant to the effects of insulin, a condition known as insulin resistance, and if it cannot make enough insulin to overcome that resistance, glucose builds up in the blood.

Why is it important to control type 2 diabetes?

It is important to control type 2 diabetes because the buildup of glucose in the blood, if not controlled, can lead to serious medical problems such as kidney damage, amputation, heart disease, and blindness.

How does ACTAZONE help treat type 2 diabetes?

ACTAZONE, along with healthy eating and physical activity, works by treating insulin resistance, an important underlying defect in type 2 diabetes, to help your body use insulin more effectively. That is why it is called an insulin sensitizer. It does not cause your body to produce more insulin; instead, it helps your body respond better to its own insulin or the insulin you may take.

What should I discuss with my health professional before taking ACTAZONE?

ACTAZONE is not for everyone. You should talk to your health professional if you have a history of congestive heart failure, liver problems, swelling (edema), or if you are pregnant, intend to become pregnant, or are breast-feeding. ACTAZONE can cause fluid retention or swelling, which may lead to or worsen heart failure. It is also important to tell your health professional if you are taking other prescription medications or over-the-counter products.

How soon will ACTAZONE begin to work?

Your blood glucose levels may be significantly reduced in as quickly as 2 weeks, though the full effect of ACTAZONE may take several more weeks to be seen. If you do not respond adequately to your starting dose of ACTAZONE, your health professional may increase your daily dose to improve your blood glucose control.

How should I take ACTAZONE?

ACTAZONE only needs to be taken once a day. Food does not change how ACTAZONE works, so you can take it with or without meals. To help you remember to take ACTAZONE, it is a good idea to take it at the same time every day.

What should I do if I miss a dose?

If you miss the timing of your daily dose, take ACTAZONE as soon as you remember within the same day. If you miss a day, do not take a double dose the next day to make up for it.

Do I still need to test my blood glucose while using ACTAZONE?

Yes. You should test your blood glucose as often as your health professional recommends.

What other routine laboratory tests are recommended?

It is important to have your blood glucose and glycated hemoglobin (A1C), a measure of your average blood glucose levels over 2 to 3 months, checked regularly by your health professional. You will also need to have blood tests to check for serious or active liver disease prior to starting ACTAZONE therapy, and periodically thereafter per the clinical judgment of the healthcare professional.

While taking ACTAZONE, call your health professional immediately if:

- You experience an unusually rapid increase in weight or edema or develop shortness of breath or other symptoms of heart failure.

- You experience nausea, vomiting, stomach pain, fatigue, anorexia, dark urine, or yellowing of the skin.

Can I take ACTAZONE with other diabetes medications?

Only your health professional can determine which medications are best for your type 2 diabetes. If healthy eating, physical activity, and a single drug are not enough to control your diabetes, ACTAZONE can be taken in combination with certain other medicines (sulfonylureas, metformin, or insulin). Because ACTAZONE works differently than any of these drugs, combining ACTAZONE with another diabetes medication can provide additional improvements in your blood glucose levels.

ACTAZONE is not likely to cause low blood glucose when taken alone, because it does not cause your body to produce more insulin. However, people taking ACTAZONE with sulfonylureas or insulin may be at increased risk for low blood glucose, and an adjustment in the dose of sulfonylurea or insulin may be needed.

Will ACTAZONE interfere with other medications?

ACTAZONE can be taken by people using other common prescription medications, including certain other diabetes medications such as glipizide (a sulfonylurea) and metformin, as well as other medications such as digoxin (a heart medication) and warfarin (a blood thinner). Always inform your health professional about any other prescription medications or over-the-counter products you may be taking.

What are the possible side effects of ACTAZONE?

ACTAZONE was generally well tolerated in clinical trials. The most common side effects reported by people taking ACTAZONE included symptoms of upper respiratory tract infection, headache, sinusitis, muscle soreness, tooth disorder, and sore throat. Occasionally, blood glucose levels increased during clinical trials. This occurred less frequently with ACTAZONE than with placebo (an inactive comparison pill). As with other insulin sensitizers, weight gain may occur. In addition, mild to moderate swelling (edema) and a decrease in blood count (anemia) may occur. Low blood glucose was observed in a few patients who took ACTAZONE along with insulin or with other oral diabetes medications such as sulfonylureas.

Can ACTAZONE increase my risk for pregnancy?

If you are a premenopausal woman who is not ovulating, you should know that ACTAZONE might increase your risk of pregnancy by causing you to ovulate. Therefore, you may need to consider birth control options. Studies using ACTAZONE in combination with oral contraceptives have not been completed. Therefore, women using oral contraceptives should talk with their health professionals as they may be at increased risk for pregnancy if appropriate contraceptive methods or adjustments are not used.

What else can I do to help control type 2 diabetes?

To help control type 2 diabetes, prescription medications such as ACTAZONE should be used in conjunction with nutritional counseling, weight reduction as needed, and physical activity.

Who should not use ACTAZONE?

Patients with moderate to severe heart failure were not studied during clinical trials; therefore, ACTAZONE is not recommended in these individuals. ACTAZONE should not be taken by: people with active liver disease or jaundice (yellowing of the skin); people with type 1 diabetes; women who are pregnant or breast-feeding; or people who are allergic to ACTAZONE or any of its ingredients. ACTAZONE should not be used for the treatment of diabetic ketoacidosis. ACTAZONE should be used with caution in people with swelling (edema).

How should I store ACTAZONE?

Store ACTAZONE at room temperature, in a childproof container that is tightly closed and out of the reach of children, away from moisture and humidity.

Where can I find more information about ACTAZONE?

This is a summary of some of the most important information about ACTAZONE. If you have any further questions about type 2 diabetes or ACTAZONE, you should talk to your health professional. If you would like more information about ACTAZONE.