Rosiglitazone/metformin (By mouth)

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have any kind of heart or blood vessel disease, heart failure, or a history of a heart attack. Tell your doctor if you have kidney disease, liver disease, an adrenal gland disorder, a pituitary gland disorder, edema (fluid retention or swelling), macular edema (swelling of the back of the eye), fragile bones (especially women), or vitamin B12 deficiency.
• Call your doctor right away if you have chest pain or discomfort; nausea; pain or discomfort in the arms, jaw, back, or neck; shortness of breath; sweating; or vomiting. These may be symptoms of a heart attack.
• Check with your doctor right away if you start having chest pain; shortness of breath; excessive swelling of the hands, wrist, ankles, or feet; or if you are rapidly gaining weight. These may be symptoms of a serious heart problem or edema (fluid retention).
• This medicine may not work as well if you have surgery, get hurt, or get sick. Also, avoid getting dehydrated while you are using this medicine, especially if you have a fever, vomiting, or diarrhea. Be sure to drink extra fluids when you exercise or increase your activity level, or if you sweat more than usual.
• This medicine may cause a rare, but serious condition called lactic acidosis in some people. Call your doctor right away if you get sick, or if you have unusual tiredness, weakness, muscle pain, stomach pain, trouble breathing, fever, or nausea.
• Tell your doctor right away if you have a loss of appetite, nausea, vomiting, stomach pain, unusual tiredness or weakness, dark urine, or yellow eyes or skin. These may be symptoms of a serious liver problem.
• Certain women may be at an increased risk for pregnancy while taking this medicine. If you had problems ovulating and had irregular periods in the past, this medicine may cause you to ovulate. This could increase your chance of becoming pregnant. If you are a woman of childbearing potential, you should discuss birth control options with your doctor.
• Check with your doctor if blurred vision, decreased vision, or any other change in vision occurs during your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
• This medicine may increase the risk for bone fractures in women. Ask your doctor about ways to keep your bones strong to help prevent fractures.
• Your doctor will need to check your blood or urine at regular visits while you are using this medicine. Be sure to keep all appointments. You will also need to check your blood sugar on a regular basis at home.
• Some things that can lead to low blood sugar are exercising more than normal or waiting too long to eat. Tell your doctor about any sudden change in your medical condition.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

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, which may spread to your arm, jaw, or back.
• Dark-colored urine or pale stools.
• Extreme weakness, tiredness, or confusion.
• Fast, pounding, or uneven heartbeat.
• Lightheadedness, dizziness, shakiness, or hunger.
• Nausea, vomiting, loss of appetite, or pain in your upper stomach.
• Rapid breathing, trouble breathing, and muscle pain.
• Rapid weight gain.
• Shortness of breath, cold sweats, and bluish-colored skin.
• Swelling in your hands, ankles, or feet.
• Unusual bleeding or bruising.
• Yellowing of your skin or the whites of your eyes.

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

• Back or joint pain.
• Cough, runny nose, sneezing, or sore throat.
• Headache.
• Mild nausea, diarrhea, or upset stomach.
• Mild skin rash or itching.
• Tiredness.

Introduction

Metformin Hydrochloride (met-FOR-min hye-droe-KLOR-ide), Rosiglitazone Maleate (roe-zi-GLI-ta-zone MAL-ee-ate)

Treats type 2 diabetes. Used together with diet and exercise to help control your blood sugar.

Brand Name(s)

Avandamet

There may be other brand names for this medicine.

When This Medicine Should Not Be Used

You should not use this medicine if you have had an allergic reaction to rosiglitazone or metformin, or if you have type 1 diabetes or diabetic ketoacidosis (ketones in the blood). You should not use this medicine if you are having angina-type chest pain or if you recently had a heart attack. You should not use this medicine if you have severe heart failure, severe liver disease, severe kidney disease, or metabolic acidosis (acid in the blood). You should talk with your doctor about temporarily stopping this medicine if you are going to have major surgery or an x-ray procedure with an injection of dyes (contrast agents) into your vein.

How to Use This Medicine

Tablet

• This medicine is only available through a restricted access program. Both you and your doctor must enroll in this program. You might have to sign a consent form in order to receive this medicine and your doctor will closely monitor your progress while you are taking this medicine. Talk to your doctor if you have questions about this.
• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• It is best to take this medicine with food or milk.
• It may take up to 2 weeks for this medicine to start lowering your blood sugar. It may be 2 to 3 months before you get the full effect from the medicine.
• Carefully follow your doctor's instructions about a special diet, exercise, or weight loss. Check your blood sugar on a regular basis at home.
• Drink extra fluids so you will pass more urine while you are using this medicine. This will keep your kidneys working well and help prevent kidney problems.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

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

• Make sure your doctor knows if you are using other medicines to treat your diabetes, such as insulin.
• Make sure your doctor knows if you also use digoxin (Lanoxin®), gemfibrozil (Lopid®), isoniazid (Nydrazid®), morphine, nicotinic acid (Nicobid®, Nicolar®), phenytoin (Dilantin®), procainamide (Procanbid®, Pronestyl®), quinidine (Quinidex®), quinine, ranitidine (Zantac®), rifampin (Rifadin®, Rimactane®), trimethoprim (Bactrim®, Primsol®, Proloprim®, Septra®), or vancomycin (Vancocin®, Vancoled®).
• Tell your doctor if you use asthma medicine, decongestants, diuretics or "water pills" (such as amiloride, furosemide, triamterene, Dyrenium®, Lasix®, or Midamor®), a steroid medicine (such as dexamethasone, prednisolone, prednisone, or Medrol®), a phenothiazine medicine (such as prochlorperazine, Compazine®, Mellaril®, Phenergan®, Thorazine®, or Trilafon®), thyroid replacement (such as levothyroxine, liothyronine, Cytomel®, or Synthroid®), estrogen hormones (such as Premarin®), or birth control pills. Make sure your doctor knows if you use heart or blood pressure medicine (such as amlodipine, metoprolol, nifedipine, propranolol, verapamil, Adalat®, Cardizem®, Inderal®, Lopressor®, Lotrel®, Norvasc®, Procardia®, Tenormin®, or Tiazac®).
• Do not drink alcohol while you are using this medicine.

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