AVANDARYL™ (ah-VAN-duh-ril) Rosiglitazone Maleate and Glimepiride Tablets

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AVANDARYL™ (ah-VAN-duh-ril)
Rosiglitazone Maleate and Glimepiride Tablets
fda.gov

Read the Patient Information that comes with AVANDARYL before you start taking the
medication and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about AVANDARYL, ask your doctor or pharmacist.
What is AVANDARYL?
AVANDARYL is a prescription medicine that contains 2 medicines to treat diabetes,
rosiglitazone maleate (AVANDIA) and glimepiride (AMARYL). AVANDARYL is used with
diet and exercise to treat type 2 (“adult-onset” or “non-insulin dependent”) diabetes mellitus (“high blood sugar”).
Glimepiride can help your body release more of its own insulin. Rosiglitazone can help your body respond better to the insulin made in your body. These medicines can work together to help control your blood sugar.
Diet, weight loss, and exercise can help your body use its blood sugar better. In order for AVANDARYL to work best, it is very important to exercise, lose excess weight, and follow the diet recommended for your diabetes.
What is Type 2 Diabetes?
Type 2 diabetes happens when a person does not make enough insulin or does not respond normally to the insulin their body makes. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems including kidney damage, heart disease, loss of limbs, and blindness. The main goal of treating diabetes is to lower your blood sugar to a normal level. Lowering and controlling blood sugar may help prevent or delay complications of diabetes
such as heart disease, kidney disease, or blindness. High blood sugar can be lowered by diet and exercise, by certain medicines taken by mouth, and by insulin shots.
Who should not take AVANDARYL?
Do not take AVANDARYL if you:
• are allergic to any of the ingredients in AVANDARYL. The active ingredients in
AVANDARYL are rosiglitazone maleate and glimepiride. See the end of this leaflet for a list of all ingredients in AVANDARYL.
• have had diabetic ketoacidosis. This condition should be treated with insulin.
AVANDARYL has not been studied in children under 18 years of age and is not recommended for use in children under 18 years of age.

What should I tell my doctor before starting AVANDARYL?

You and your doctor will decide what treatment is best for you. Tell your doctor about all your medical conditions, including if you:
• have heart problems or heart failure. AVANDARYL can cause your body to keep extra
fluid (fluid retention) which leads to swelling and weight gain. Extra body fluid can make some heart problems worse or lead to heart failure.
• have type 1 (“juvenile”) diabetes. You should not take AVANDARYL if you have type 1 diabetes.
• have a type of diabetic eye disease called macular edema (swelling of the back of the eye).
• have liver problems. Your doctor should do blood tests to check your liver before you start taking AVANDARYL and during treatment as needed.
• had liver problems while taking REZULIN® (troglitazone), another medicine for
diabetes.
• have kidney problems. If patients with kidney problems use AVANDARYL, they may need a lower dose of the medication.
• are pregnant or trying to become pregnant. It is not known if AVANDARYL can harm
your unborn baby. You and your doctor should talk about the best way to control your high blood sugar during pregnancy. You should not use AVANDARYL if you are pregnant or trying to get pregnant.
• are a premenopausal woman (before the “change of life”) who does not have regular
monthly periods. AVANDARYL may increase your chances of becoming pregnant. Talk to
your doctor about birth control choices while taking AVANDARYL.
• are breastfeeding. It is not known if AVANDARYL passes into breast milk. You should not use AVANDARYL while breastfeeding.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. AVANDARYL and certain other medicines can affect each other and lead to serious side effects including high blood sugar or low blood sugar.
Keep a list of all the medicines you take. Show this list to your doctor and pharmacist before you start a new medicine. They will tell you if it is okay to take AVANDARYL with other medicines.
How should I take AVANDARYL?
• Take AVANDARYL by mouth once a day with your first main meal. Your doctor may need to adjust your dose until your blood sugar is better controlled.
• It usually takes a few days for AVANDARYL to start lowering your blood sugar. It may take 2 to 3 months to see the full effect on your blood sugar level.
• If you miss a dose of AVANDARYL, take your pill as soon as you remember unless it is time to take your next dose. Take your next dose at the usual time. Do not take a double dose to make up for a missed dose.
• If you take too much AVANDARYL, call your doctor or poison control center right away. Too much AVANDARYL can make your blood sugar level too low.
• Test your blood sugar regularly as your doctor tells you.
• Diet and exercise can help your body use its blood sugar better. It is important to stay on your recommended diet, lose excess weight, and get regular exercise while taking AVANDARYL.
• Your doctor should do blood tests to check your liver before you start AVANDARYL and during treatment as needed. Your doctor should also do regular blood testing [for example, blood glucose (“sugar”) or glycosylated HbA1c (“A1c” or HbA1c)] to monitor your response to AVANDARYL.
• Call your doctor if you get sick, injured, or have surgery. AVANDARYL may not control your blood sugar levels during these times. Your doctor may need to stop AVANDARYL for a short time and give you insulin to control your blood sugar level.
• Your doctor should check your eyes regularly. Very rarely, some patients have experienced vision changes due to swelling in the back of the eye while taking rosiglitazone, one of the drugs in AVANDARYL.
What are possible serious side effects of AVANDARYL?
Talk to your doctor about these side effects:
• heart failure. AVANDARYL can cause your body to keep extra fluid (fluid retention), which leads to swelling and weight gain. Extra body fluid can make some heart problems worse or lead to heart failure. See “swelling (edema) from fluid retention” section below.
• low blood sugar (hypoglycemia). Lightheadedness, dizziness, shakiness or hunger may mean that your blood sugar is too low. This can happen if you skip meals, drink alcohol, use another medicine that lowers blood sugar, exercise (particularly hard or long), or if you have certain medical problems. Call your doctor if you have low blood sugar.
• high blood sugar or loss of control of blood sugar (hyperglycemia). If you have fever, an infection, trauma, or surgery, your doctor may temporarily stop the AVANDARYL and treat the high blood sugar with insulin.
• swelling (edema) from fluid retention. See “heart failure” section above. Call your doctor right away if you have symptoms such as:
-swelling or fluid retention, especially in the ankles or legs
-shortness of breath or trouble breathing, especially when you lie down
-an unusually fast increase in weight
-unusual tiredness
• weight gain. AVANDARYL can cause weight gain that may be due to fluid retention or extra body fat. Weight gain can be a serious problem for people with certain conditions including heart problems. Call your doctor if you have an unusually fast increase in weight.
• low red blood cell count (anemia).
• ovulation (release of egg from an ovary in women) leading to pregnancy. Ovulation may happen in premenopausal women who do not have regular monthly periods. This can increase the chance of pregnancy.
• liver problems. It is important for your liver to be working normally when you take AVANDARYL. Your doctor should do blood tests to check your liver before you start taking AVANDARYL and during treatment as needed.
Call your doctor right away if you have unexplained symptoms such as:
-nausea or vomiting
-stomach pain
-unusual or unexplained tiredness
-loss of appetite
-dark urine
-yellowing of your skin or the whites of your eyes
The most common side effects with AVANDARYL include cold-like symptoms, injury, and
dizziness.
How should I store AVANDARYL?
• Store AVANDARYL at room temperature, 59° to 86° F (15° to 30° C). Keep
AVANDARYL in the container it comes in.
• Safely throw away AVANDARYL that is out of date or no longer needed.
• Keep AVANDARYL and all medicines out of the reach of children.
General information about AVANDARYL
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use AVANDARYL for a condition for which it was not prescribed. Do not give AVANDARYL to other people, even if they have the same symptoms you have. It may harm them.
This leaflet summarizes the most important information about AVANDARYL. If you would like more information , talk with your doctor. You can ask your doctor or pharmacist for information about AVANDARYL that is written for healthcare professionals. You can also find out more about AVANDARYL by calling 1-888-825-5249 or visiting the website www.AVANDARYL.com.

What are the ingredients in AVANDARYL?
Active Ingredients: rosiglitazone maleate and glimepiride.
Inactive Ingredients: Hypromellose 2910, lactose monohydrate, macrogol (polyethylene glycol) magnesium stearate, microcrystalline cellulose, sodium starch glycolate, titanium dioxide, triacetin, and 1 or more of the following: Yellow, red, or black iron oxides.

Always check to make sure that the medicine you are taking is the correct one. The dosage strength and appearance of each tablet of AVANDARYL (rosiglitazone maleate and glimepiride) are as follows:
4 mg/1 mg – yellow, rounded triangular tablet, “gsk” on one side and “4/1” on the other.
4 mg/2 mg – orange, rounded triangular tablet, “gsk” on one side and “4/2” on the other.
4 mg/4 mg – pink, rounded triangular tablet, “gsk” on one side and “4/4” on the other.
8 mg/2 mg – pale pink, rounded triangular tablet, “gsk” on one side and “8/2” on the other.
8 mg/4 mg – red, rounded triangular tablet, “gsk” on one side and “8/4” on the other.

AVANDARYL is a trademark and AVANDIA is a registered trademark of GlaxoSmithKline.
AMARYL is a registered trademark of AVENTIS Pharmaceuticals Inc.
REZULIN is a registered trademark of Parke-Davis Pharmaceuticals Ltd.

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