When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to rosiglitazone or metformin, or if you have severe heart failure, severe kidney disease, or metabolic acidosis.

How to Use This Medicine:
Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• It is best to take this medicine with food or milk.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how rosiglitazone/metformin works. Tell your doctor if you are using the following:
  
  • Amiloride, digoxin, gemfibrozil, insulin, isoniazid, morphine, nicotinic acid, phenytoin, procainamide, quinidine, quinine, ranitidine, rifampin, triamterene, trimethoprim, or vancomycin
  • Asthma medicine, blood pressure medicine, decongestants, a diuretic (water pill), a phenothiazine medicine (such as chlorpromazine, perphenazine, promethazine, prochlorperazine, thioridazine), a steroid medicine (such as hydrocortisone, methylprednisolone, prednisone, prednisolone, dexamethasone), thyroid medicine, or birth control pills
• Do not drink a lot of alcohol while you are using this medicine. Heavy alcohol use can increase your risk for lactic acidosis.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have heart failure, heart problems, or you had a heart attack. Tell your doctor if you have kidney disease, liver disease, edema (fluid retention or swelling), macular edema, an adrenal or pituitary gland problem, or a vitamin B12 deficiency.
• This medicine may cause the following problems:
  
  • Lactic acidosis (a buildup of acid in the blood that can be life-threatening, but occurs rarely)
  • An increased risk of heart or blood vessel problems
  • Liver problems
  • Macular edema (swelling in the back of the eye)
  • An increased risk for bone fracture
  • Low blood sugar
• Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using it before you have surgery, an X-ray, a CT scan, or other medical tests.
• Even if you had problems ovulating and had irregular periods in the past, this medicine may cause you to ovulate. If you could become pregnant, you should discuss birth control options with your doctor.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash
• Blurred vision or other changes in vision
• Chest pain that may spread to your arms, jaw, back, or neck, trouble breathing, nausea, unusual sweating, faintness
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Extreme weakness, tiredness, confusion, rapid breathing, trouble breathing, and muscle pain
• Rapid weight gain, swelling in your hands, ankles, or feet
• Shaking, trembling, sweating, fast or pounding heartbeat, lightheadedness, hunger, confusion

If you notice these less serious side effects, talk with your doctor:

• Cough, runny nose, sneezing, sore throat
• Headache
• Mild nausea or vomiting, diarrhea, or upset stomach

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088