Avandaryl Medication Guide Information

Read this Medication Guide carefully before you start taking AVANDARYL 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.

Pronunciation: (ah-VAN-duh-ril)
Generic: (rosiglitazone maleate and glimepiride)

Availability: Tablets

What is the most important information I should know about this medication?

This Medication may cause serious side effects, including:
New or worse heart failure

The risk of heart failure may be higher in people who take this medication with insulin. Most people who take insulin should not also take this medication .
Rosiglitazone, one of the two drugs that make up this medication , can cause your body to keep extra fluid (fluid retention), which leads to swelling (edema) and weight gain. Extra body fluid can make some heart problems worse or lead to heart failure. Heart failure means your heart does not pump blood well enough.
If you have severe heart failure, you cannot start this medication .
If you have heart failure with symptoms (such as shortness of breath or swelling), even if these symptoms are not severe, this medication may not be right for you.

Call your doctor right away if you have any of the following:

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

AVANDARYL can have other serious side effects. Be sure to read the section “What are possible side effects of AVANDARYL?”

What is AVANDARYL?

AVANDARYL contains 2 prescription medicines to treat diabetes, rosiglitazone maleate (AVANDIA®) and glimepiride. AVANDARYL is used with diet and exercise to treat adults with 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 and does not cause your body to make more insulin. These medicines can work together to help control your blood sugar. AVANDARYL is not for people with type 1 diabetes mellitus or to treat a condition called diabetic ketoacidosis. It is not known if AVANDARYL is safe and effective in children younger than 18 years old.

Who should not take AVANDARYL?

Many people with heart failure should not start taking AVANDARYL. See “What should I tell my doctor before taking AVANDARYL?”
Do not take AVANDARYL if you are allergic to rosiglitazone or glimepiride or any of the ingredients in AVANDARYL. See the end of this leaflet for a complete list of ingredients in this medication.

Symptoms of a severe allergic reaction with AVANDARYL may include:

Swelling of your face, lips, tongue, or throat
Problems with breathing or swallowing
Skin rash or itching
Raised red areas on your skin (hives)
Blisters on your skin or in your mouth, nose, or eyes
Peeling of your skin
Fainting or feeling dizzy
Very rapid heartbeat

What should I tell my doctor before taking AVANDARYL?

Before starting this medication , ask your doctor about what the choices are for diabetes medicines and what the expected benefits and possible risks are for you in particular.
Before taking this medication, tell your doctor about all of your medical conditions, including if you:

Have heart problems or heart failure.
Have type 1 (“juvenile”) diabetes or had diabetic ketoacidosis. These conditions should be treated with insulin and should not be treated with this medication.
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 this medication and during treatment as needed.
Had liver problems while taking REZULIN™ (troglitazone), another medicine for diabetes.
Have kidney problems. If people with kidney problems use this medication, they may need a lower dose of the medication.
Have glucose 6-phosphate dehydrogenase (G6PD) deficiency. This condition runs in families. People with G6PD deficiency who take glimepiride (one of the medicines in AVANDARYL) may develop hemolytic anemia (fast breakdown of red blood cells).
Are pregnant or plan to become pregnant. It is not known if this medication can harm your unborn baby. You and your doctor should talk about the best way to control your diabetes during pregnancy. If you are a pre-menopausal woman (before the “change of life”) who does not have regular monthly periods, this medication may increase your chances of becoming pregnant. Talk to your doctor about birth control choices while taking this medication. Tell your doctor right away if you become pregnant while taking this medication.
Are breastfeeding or planning to breastfeed. It is not known if this medication passes into breast milk. You and your doctor should decide if you will take this medication or breastfeed. You should not do both.

Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins or herbal supplements. this medication and certain other medicines can affect each other and may lead to serious side effects including high or low blood sugar, or heart problems.

Especially tell your doctor if you take:

Insulin.
Any medicines for high blood pressure, high cholesterol or heart failure, or for prevention of heart disease or stroke.

Know the medicines you take. Keep a list of all your medicines and show it to your doctor and pharmacist before you start a new medicine. They will tell you if it is alright to take AVANDARYL with other medicines.

How should I take AVANDARYL?

Take this medication exactly as prescribed. Your doctor may need to change your dose until your blood sugar is better controlled.
Take this medication by mouth one time each day with your first main meal.
It usually takes a few days for this medication to start lowering your blood sugar. It may take 2 to 3 months to see the full effect on your blood sugar level.
This medication should be taken at least 4 hours before taking colesevelam (WELCHOL).
If you miss a dose of this medication, take it 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 double doses to make up for a missed dose.
If you take too much AVANDARYL, call your doctor or poison control center right away.
Test your blood sugar regularly as your doctor tells you.
Your doctor should do blood tests to check your liver before you start this medication and during treatment as needed. Your doctor should also do regular blood sugar tests (for example, “A1c”) to monitor your response to this medication.
Call your doctor if you get sick, get injured, get an infection, or have surgery. This medication may not control your blood sugar levels during these times. Your doctor may need to stop this medication for a short time and give you insulin to control your blood sugar level.
Diet and exercise can help your body use its blood sugar better. It is important to stay on your recommended diet, lose extra weight, and get regular exercise while taking this medication.

What are possible side effects of this medication?

This medication may cause serious side effects, including:

New or worse heart failure. See “What is the most important information I should know about this medication?”
Heart attack. This medication may increase the risk of a heart attack. Talk to your doctor about what this means to you.
Symptoms of a heart attack can include the following:

Chest discomfort in the center of your chest that lasts for more than a few minutes, or that goes away or comes back
Chest discomfort that feels like uncomfortable pressure, squeezing, fullness, or pain
Pain or discomfort in your arms, back, neck, jaw, or stomach
Shortness of breath with or without chest discomfort
Breaking out in a cold sweat
Nausea or vomiting
Feeling lightheaded

Call your doctor or go to the nearest hospital emergency room right away if you think you are having a heart attack.

Swelling (edema). This medication can cause swelling due to fluid retention. See “What is the most important information I should know about this medication ?”
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 low blood sugar levels are a problem for you.
Weight gain. Rosiglitazone, one of the medicines in this medication , 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. See “What is the most important information I should know about AVANDARYL?”
Liver problems. It is important for your liver to be working normally when you take this medication . Your doctor should do blood tests to check your liver before you start taking this medication 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

Macular edema (a diabetic eye disease with swelling in the back of the eye). Tell your doctor right away if you have any changes in your vision. Your doctor should check your eyes regularly. Very rarely, some people have had vision changes due to swelling in the back of the eye while taking rosiglitazone, one of the medicines in this medication.
Fractures (broken bones), usually in the hand, upper arm, or foot. Talk to your doctor for advice on how to keep your bones healthy.
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. See “What should I tell my doctor before taking AVANDARYL?”

The most common side effects with this medication include cold-like symptoms and headache. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store this medication?

Store this medication at room temperature, 59°F to 86°F (15°C to 30°C). Keep this medication in the container it comes in. Keep the container closed tightly.
Safely, throw away this medication that is out of date or no longer needed.

Keep this medication and all medicines out of the reach of children.

General information about AVANDARYL

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use this medication for a condition for which it was not prescribed. Do not give this medication to other people, even if they have the same symptoms you have. It may harm them. This Medication Guide summarizes important information about this medication. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about this medication that is written for healthcare professionals. You can also find out more about this medication by calling 1-888-8255249.

What are the ingredients in this medication?

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.
AVANDARYL tablets are triangles with rounded corners and look like this:

4 mg/1 mg – yellow with “gsk” on one side and “4/1” on the other.
4 mg/2 mg – orange with “gsk” on one side and “4/2” on the other.
4 mg/4 mg – pink with “gsk” on one side and “4/4” on the other.
8 mg/2 mg – pale pink with “gsk” on one side and “8/2” on the other.
8 mg/4 mg – red with “gsk” on one side and “8/4” on the other.

This medication and AVANDIA are registered trademarks of the GSK group of companies.

REZULIN and WELCHOL are trademarks of their respective owners and are not trademarks of the GSK group of companies. The makers of these brands are not affiliated with and do not endorse the GSK group of companies or its products.

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