AVANDAMET contains a combination of metformin and rosiglitazone, two oral diabetes medicines that help control blood sugar levels.

 

AVANDAMET works by decreasing the amount of sugar that the liver produces and the intestines absorb. It also helps to make your body more sensitive to the insulin that you naturally produce.

 

AVANDAMET is for people with type 2 diabetes who do not use daily insulin injections. This medication is not for treating type 1 diabetes.

Some people develop a life-threatening condition called lactic acidosis while taking AVANDAMET. You may be more likely to develop lactic acidosis if you have liver or kidney disease, congestive heart failure, a severe infection, if you are dehydrated, or if you drink large amounts of alcohol. Talk with your doctor about your individual risk.

 

You should not use AVANDAMET if you are allergic to metformin (Glucophage) or rosiglitazone (Avandia), or if you have:

 

severe heart failure; or

kidney disease;

 

if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

 

If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you will need to temporarily stop taking AVANDAMET.

 

AVANDAMET should not be used together with nitrate medication, such as nitroglycerin (Nitro-Dur, Nitrolingual, Nitrostat, Transderm-Nitro, and others), isosorbide dinitrate (Dilatrate, Isordil, Isochron), or isosorbide mononitrate (Imdur, ISMO, Monoket). Tell your doctor if you regularly use this type of medication.

 

To make sure you can safely take AVANDAMET, tell your doctor if you have congestive heart failure or heart disease, a history of heart attack or stroke, liver disease, or eye problems caused by diabetes.

 

Certain oral diabetes medications may increase your risk of serious heart problems. However, not treating your diabetes can damage your heart and other organs. Talk to your doctor about the risks and benefits of treating your diabetes.

 

Some women using AVANDAMET have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need for birth control.

Women may also be more likely than men to have bone fractures in the upper arm, hand, or foot while taking AVANDAMET. Talk with your doctor if you are concerned about this possibility.

 

FDA pregnancy category C. It is not known whether AVANDAMET will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using AVANDAMET. It is not known whether metformin and rosiglitazone passes into breast milk or if it could harm a nursing baby. Do not take AVANDAMET without first talking to your doctor if you are breast-feeding a baby.

 

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

 

AVANDAMET may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or irregular heart rate, dizziness, or feeling very weak or tired.

 

Get emergency medical help if you have any of these signs of an allergic reaction to AVANDAMET: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

 

Call your doctor at once if you have any other serious side effects, such as:

 

- chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

- sudden numbness, weakness, headache, confusion, or problems with vision, speech, or balance;

- swelling or rapid weight gain;

- pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

- severe blistering, peeling, and red skin rash; or

- jaundice (yellowing of the skin or eyes).

 

Less serious AVANDAMET side effects may include:

 

- headache;

- tired feeling;

- diarrhea;

- nausea, vomiting, upset stomach;

- back pain, joint pain; or

- cold symptoms such as stuffy nose, sneezing, sore throat.

 

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

 

Take AVANDAMET exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

 

Take AVANDAMET with meals, especially during the first few weeks of therapy.

 

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office. Visit your doctor regularly.

 

Know the signs of low blood sugar (hypoglycemia) and how to recognize them: headache, hunger, weakness, sweating, tremors, irritability, or trouble concentrating.

 

Check your blood sugar carefully during a time of stress or illness, if you travel, exercise more than usual, drink alcohol, or skip meals. These things can affect your glucose levels and your dose needs may also change.

 

Your doctor may want you to stop taking AVANDAMET for a short time if you become ill, have a fever or infection, or if you have surgery or a medical emergency.

 

Ask your doctor how to adjust your dose if needed. Do not change your medication dose or schedule without your doctor's advice.

Your doctor may have you take extra vitamin B12 while you are taking AVANDAMET. Take only the amount of vitamin B12 that your doctor has prescribed.

 

 

Keep AVANDAMET in the original container and keep the container closed. Store it in a dry place at room temperature.

 

Keep AVANDAMET and all medications out of the reach of children.