Frequently asked questions about ACTOplus met

1. What is ACTOplus met?
2. What is type 2 diabetes?
3. Why is it important to control type 2 diabetes?
4. What should I tell my doctor before taking ACTOplus met?
5. What is the most important information I should know about ACTOplus met?
6. How should I take ACTOplus met?
7. Do I still need to test my blood sugar while using ACTOplus met?
8. What are possible side effects of ACTOplus met?
9. What else can I do to help control type 2 diabetes?
10. Who should not take ACTOplus met?
11. What should I avoid while taking ACTOplus met?
12. How should I store ACTOplus met?

What is ACTOplus met?

ACTOplus met contains 2 prescription antidiabetic medicines, ACTOS and metformin. ACTOplus met is used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes who are already taking ACTOS and metformin together or are taking metformin alone and it is not controlling blood glucose at normal levels.

It is important to eat the right foods, lose weight if needed, and exercise regularly in order to manage your type 2 diabetes. Diet, weight loss, and exercise are an important part of managing type 2 diabetes, and they also help your antidiabetic medicines work better for you.

ACTOplus met has not been studied in children and is not recommended for children.

Back to top

What is type 2 diabetes?

Type 2 diabetes (formerly called non–insulin-dependent diabetes mellitus or adult-onset diabetes) occurs when the body does not produce enough insulin or cannot properly use the insulin it makes to control blood sugar. Insulin allows sugar to enter the cells of your body. Once inside the cells, sugar is used as a source of 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, sugar builds up in the blood (hyperglycemia).

Back to top

Why is it important to control type 2 diabetes?

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

Back to top

What should I tell my doctor before taking ACTOplus met?

Tell your doctor about all of your medical conditions, especially if you:

• Have kidney problems.
• Have liver problems.
• Have heart problems.
• Are older than 80 years. Patients over 80 years should not take ACTOplus met unless their kidney function is checked and it is normal.
• Drink alcohol a lot (all the time or short-term “binge” drinking).
• Are pregnant or planning to become pregnant. It is not known if ACTOplus met can harm your unborn baby. ACTOplus met is not recommended for pregnant women. Talk to your doctor about the best way to control your blood glucose levels while pregnant.
• Are breast-feeding. It is not known if ACTOplus met passes into your milk or whether it can harm your baby. You should not take ACTOplus met if you breast-feed your baby. Talk to your doctor about the best way to control your blood glucose levels while breast-feeding.
• Are a premenopausal woman who is not having periods regularly or at all, or a woman who has gone through the “change of life” (menopause). ACTOplus met can increase your chance of pregnancy. Talk to your doctor about effective birth-control methods.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. ACTOplus met and some of your other medicines can interact with each other. You may need to have your dose of ACTOplus met or certain other medicines adjusted. Certain other medicines can affect your blood glucose control. Know the medicines you take. Keep a list of them to show your doctor and pharmacist. Talk to your doctor before you start any new medicine.

Back to top

What is the most important information I should know about ACTOplus met?

ACTOplus met can cause a rare but serious condition called lactic acidosis (a buildup of an acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital. Stop taking ACTOplus met and call your doctor right away if you get the following symptoms of lactic acidosis:

• You feel very weak or tired.
• You have unusual (not normal) muscle pain.
• You have trouble breathing.
• You have stomach pain with nausea and vomiting or diarrhea.
• You feel cold, especially in your arms and legs.
• You feel dizzy or light-headed.
• You have a slow or irregular heartbeat.
• Your medical condition suddenly changes.

You have an increased risk of lactic acidosis with
ACTOplus met if you:

• Have kidney or liver problems.
• Have congestive heart failure that requires treatment with medicines.
• Drink a lot of alcohol (very often or short-term “binge” drinking).
• Get dehydrated (lose a large amount of body fluids). This can happen if you are sick with a fever, vomiting, or diarrhea. Dehydration can also happen when you sweat a lot with activity or exercise and don’t drink enough fluids.
• Have certain X-ray tests with injectable dye used.
• Have surgery.
• Have a heart attack, severe infection, or stroke.
• Are 80 years of age or older and have not had your kidney function tested.

Back to top

How should I take ACTOplus met?

• Take ACTOplus met exactly as prescribed. Your doctor will tell you how many ACTOplus met tablets to take and how often you should take them. Your doctor may need to increase your dose to control your blood glucose. Do not change your dose unless told to do so by your doctor.
• Take ACTOplus met with meals to lower your chance of an upset stomach.
• Stay on your diet and exercise programs and test your blood glucose regularly while taking ACTOplus met.
• Your doctor should monitor your type 2 diabetes through regular blood tests. Your doctor should also do blood tests before starting ACTOplus met and from time to time to check your liver and blood sugar. Your doctor will also do a blood test called a hemoglobin A1C to check how well your blood sugar has been controlled over the past 2–3 months.
• If you miss a dose of ACTOplus met, take your next dose as prescribed unless your doctor tells you differently.
• If you take too much ACTOplus met, call your doctor or a poison control center right away.

You may need to stop ACTOplus met for a short time. Call your doctor for instructions if you:

• Are sick with severe vomiting, diarrhea, or fever.
• Plan to have surgery.
• Are having an X-ray procedure with injection of dye.

Back to top

Do I still need to test my blood sugar while using
ACTOplus met?

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

Back to top

What are possible side effects of ACTOplus met?

ACTOplus met can cause the following side effects:

• Lactic acidosis. See “What is the most important information I should know about ACTOplus met?”
• Hypoglycemia. Call your doctor if you get light-headed, dizzy, shaky, or hungry. These symptoms can occur if you skip meals, use another medicine that lowers blood sugar, or if you have certain medical problems. Your dose of ACTOplus met may need to be lowered if these symptoms are a problem for you.
• Heart failure. ACTOplus met can cause your body to retain fluid and swell. This can lead to heart failure or make heart failure you already have worse. Call your doctor right away if you have:
  • Swelling in your ankles or legs.
  • Shortness of breath or trouble breathing, especially when you lie down.
  • Unusual tiredness.
  • A sudden increase in weight.
• Swelling (edema). ACTOplus met can cause your body to retain fluid and swell. This can be a problem for people who already have edema.
• Weight gain. This may be due to swelling from extra fluid in your body and extra fat gain.
• Liver problems. In rare cases, ACTOplus met may cause serious liver problems. Your doctor should do blood tests to check your liver before you start ACTOplus met and regularly during treatment. 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.

Some common side effects of ACTOplus met are diarrhea, nausea, and upset stomach. Taking ACTOplus met with meals can help reduce these side effects. However, if you have unusual or unexpected stomach problems, talk with your doctor. Stomach problems that occur later during treatment may be a sign of something more serious.

Other common side effects of ACTOplus met are cold-like symptoms and headache. Patients with diabetes should have regular eye exams. If you experience vision problems, consult your doctor immediately. Very rarely, some patients have experienced visual changes while taking pioglitazone, a component of ACTOplus met. These are not all the side effects of ACTOplus met. For more information, talk to your doctor or pharmacist.

Back to top

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

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

Back to top

Who should not take ACTOplus met?

Do not take ACTOplus met if you:

• Have kidney problems.
• Have a condition called metabolic acidosis, including diabetic ketoacidosis. Diabetic ketoacidosis should be treated with insulin.
• Are allergic to pioglitazone hydrochloride (ACTOS) or metformin hydrochloride. See ACTOplus met Complete Prescribing Information for a complete list of ingredients in ACTOplus met.
• Are going to have an X-ray procedure with an injection of dye. Talk to your doctor about when to stop ACTOplus met and when to start it again.

Back to top

What should I avoid while taking ACTOplus met?

Do not drink a lot of alcohol while taking ACTOplus met. This means you should not “binge drink,” and you should not drink a lot of alcohol on a regular basis. Drinking a lot of alcohol can increase your chance of getting lactic acidosis.

Back to top

How should I store ACTOplus met?

Store ACTOplus met at room temperature in its original container.

Keep ACTOplus met and all medicines out of the reach of children.

Back to top

Management of type 2 diabetes should also include nutritional counseling, weight reduction as needed, and exercise.

Please see Important Safety Information, including warnings about heart failure and lactic acidosis, below.