Metformin and rosiglitazone

You should not use this medicine if you have severe or uncontrolled heart failure, severe kidney problems, or diabetic ketoacidosis.

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 metformin.

This medicine may cause a serious condition called lactic acidosis. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

You should not use this medicine if you are allergic to metformin or rosiglitazone, or if you have:

• severe or uncontrolled heart failure;

• severe kidney problems; or

• diabetic ketoacidosis (call your doctor for treatment).

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 metformin and rosiglitazone.

Some people taking metformin develop a serious condition called lactic acidosis. This may be more likely if you have liver or kidney disease, congestive heart failure, a heart attack or stroke, a severe infection, if you are 65 or older, if you are dehydrated, or if you drink a lot of alcohol. Talk with your doctor about your risk.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• heart disease, congestive heart failure;

• fluid retention;

• kidney disease;

• a problem with your adrenal or pituitary glands;

• liver disease; or

• eye problems caused by diabetes.

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

Follow your doctor's instructions about using this medicine if you are pregnant. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester of pregnancy.

Some women using metformin and rosiglitazone 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.

It is not known whether metformin and rosiglitazone passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Metformin and rosiglitazone is not approved for use by anyone younger than 18 years old.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Get emergency medical help if you have signs of an allergic reaction: hives, itching; difficult breathing; trouble swallowing; swelling of your face, lips, tongue, or throat.

Early symptoms of lactic acidosis may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

Call your doctor at once if you have:

• changes in your vision;

• a light-headed feeling, like you might pass out;

• low red blood cells (anemia)--pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• signs of heart failure--shortness of breath (even while lying down), swelling in your feet or ankles, rapid weight gain;

• liver problems--nausea, vomiting, loss of appetite, upper stomach pain, tiredness, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• nausea, vomiting, upset stomach, diarrhea;

• headache, dizziness; or

• joint pain.

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.

Many other medicines can affect your blood sugar, and some medicines can increase or decrease the effects of metformin and rosiglitazone. Some drugs can also cause you to have fewer symptoms of hypoglycemia, making it harder to tell when your blood sugar is low. Tell your doctor about all your current medicines and any you start or stop using, especially:

• insulin or other oral diabetes medications;

• heart or blood pressure medicine; or

• cholesterol-lowering medicine.

This list is not complete. Other drugs may interact with metformin and rosiglitazone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Commonly reported side effects of metformin/rosiglitazone include: upper respiratory tract infection and diarrhea. Other side effects include: anemia. See below for a comprehensive list of adverse effects.