Rosiglitazone (roe-zi-GLI-ta-zone)

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

Brand Name(s):

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

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.
• You may take this medicine with or without food.
• 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.
• 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. Your doctor might ask you to sign some forms to show that you understand this information.

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 leftover medicine after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.
• 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. Tell your doctor if you are using gemfibrozil (Lopid®), or rifampin (Rifadin®, Rimactane®).

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 liver disease, edema (fluid retention or swelling), macular edema (swelling of the back of the eye), or fragile bones (especially women).
• 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. If you have severe vomiting, diarrhea, or fever, call your doctor for instructions.
• 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.
• If your blood sugar gets too low, you may feel weak, drowsy, confused, anxious, or very hungry. You may also sweat, shake, or have blurred vision, a fast heartbeat, or a headache that will not go away. If you have symptoms of low blood sugar (hypoglycemia), check your blood sugar. If your blood sugar is 70 mg/dL (milligrams per deciliter) or below, do one of the following: Drink 4 ounces (one-half cup) of fruit juice, or eat 5 to 6 pieces of hard candy, or take 2 to 3 glucose tablets. Recheck your blood sugar 15 minutes later. If your blood sugar goes above 70 mg/dL, eat a snack or a meal. If your blood sugar is still below 70 mg/dL, drink one-half cup juice, or eat 5 to 6 pieces of candy, or take 2 to 3 glucose tablets. Carry candy or some type of sugar with you at all times, especially if you are away from home. You can take this if you feel that your blood sugar is too low, even if you do not have a blood glucose meter. Always carefully follow your doctor's instructions about how to treat your low blood sugar. Learn what to do if your blood sugar gets too low. Teach friends, coworkers, and family members what they can do to help if you have low blood sugar. 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.
• Fast, pounding, or uneven heartbeat.
• Fever, chills, cough, runny or stuffy nose, sore throat, and body aches.
• Lightheadedness, dizziness, shakiness, or hunger.
• Nausea, vomiting, diarrhea, loss of appetite, or pain in your upper stomach.
• Rapid weight gain.
• Shortness of breath, cold sweats, and bluish-colored skin.
• Swelling in your hands, ankles, or feet.
• Unusual bleeding or bruising.
• Unusual tiredness or weakness.
• 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.
• Headache.
• Mild skin rash.

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