Fluticasone/salmeterol (patient information)

Medication Guide

Read the Medication Guide that comes with ADVAIR DISKUS before you start using it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. What is the most important information I should know about ADVAIR DISKUS? ADVAIR DISKUS can cause serious side effects, including:

• People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as salmeterol (one of the medicines in ADVAIR DISKUS), have an increased risk of death from asthma problems. It is not known whether fluticasone propionate, the other medicine in ADVAIR DISKUS, reduces the risk of death from asthma problems seen with LABA medicines.
• It is not known if LABA medicines such as salmeterol increase the risk of death in people with COPD.
• Call your healthcare provider if breathing problems worsen over time while using ADVAIR DISKUS. You may need different treatment.
• Get emergency medical care if:

• Your breathing problems worsen quickly.
• You use your rescue inhaler, but it does not relieve your breathing problems.

• ADVAIR DISKUS should be used only if your healthcare provider decides that your asthma is not well controlled with a long-term asthma control medicine, such as an inhaled corticosteroid. When your asthma is well controlled, your healthcare provider may tell you to stop taking ADVAIR DISKUS. Your healthcare provider will decide if you can stop ADVAIR DISKUS without loss of asthma control. Your healthcare provider may prescribe a different asthma control medicine for you, such as an inhaled corticosteroid.
• Children and adolescents who take LABA medicines may have an increased risk of being hospitalized for asthma problems.

What is ADVAIR DISKUS?

• ADVAIR DISKUS combines the inhaled corticosteroid (ICS) medicine fluticasone propionate and the LABA medicine salmeterol.
• ICS medicines such as fluticasone propionate help to decrease inflammation in the lungs. Inflammation in the lungs can lead to breathing problems.
• LABA medicines such as salmeterol help the muscles around the airways in your lungs stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness, and shortness of breath. These symptoms can happen when the muscles around the airways tighten. This makes it hard to breathe.
• ADVAIR DISKUS is not used to relieve sudden breathing problems.
• It is not known if ADVAIR DISKUS is safe and effective in children younger than 4 years.
• ADVAIR DISKUS is used for asthma and COPD as follows:

• Asthma:

• ADVAIR DISKUS is a prescription medicine used to control symptoms of asthma and to prevent symptoms such as wheezing in adults and children aged 4 years and older.
• ADVAIR DISKUS contains salmeterol [the same medicine found in SEREVENT® DISKUS® (salmeterol xinafoate inhalation powder)]. LABA medicines such as salmeterol increase the risk of death from asthma problems.
• ADVAIR DISKUS is not for adults and children with asthma who are well controlled with an asthma control medicine, such as a low to medium dose of an inhaled corticosteroid medicine.

• COPD:

• ADVAIR DISKUS 250/50 is a prescription medicine used to treat COPD. COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both. ADVAIR DISKUS 250/50 is used long term as 1 inhalation 2 times each day to improve symptoms of COPD for better breathing and to reduce the number of flare-ups (the worsening of your COPD symptoms for several days).

Who should not use ADVAIR DISKUS?

Do not use ADVAIR DISKUS if you:

• Have a severe allergy to milk proteins. Ask your healthcare provider if you are not sure.
• Are allergic to fluticasone propionate, salmeterol, or any of the ingredients in ADVAIR DISKUS. See “What are the ingredients in ADVAIR DISKUS?” below for a complete list of ingredients.

What should I tell my healthcare provider before using ADVAIR DISKUS?

Tell your healthcare provider about all of your health conditions, including if you:

• Have heart problems.
• Have high blood pressure.
• Have seizures.
• Have thyroid problems.
• Have diabetes.
• Have liver problems.
• Have weak bones (osteoporosis).
• Have an immune system problem.
• Have eye problems such as glaucoma or cataracts.
• Are allergic to any of the ingredients in ADVAIR DISKUS, any other medicines, or food products. See “What are the ingredients in ADVAIR DISKUS?” below for a complete list of ingredients.
• Have any type of viral, bacterial, or fungal infection.
• Are exposed to chickenpox or measles.
• Have any other medical conditions.
• Are pregnant or planning to become pregnant. It is not known if ADVAIR DISKUS may harm your unborn baby.
• Are breastfeeding. It is not known if the medicines in ADVAIR DISKUS pass into your milk and if they can harm your baby.

Tell your healthcare provider about all the medicines you take: Including prescription and over-the-counter medicines, vitamins, and herbal supplements. ADVAIR DISKUS and certain other medicines may interact with each other. This may cause serious side effects. Especially, tell your healthcare provider if you take antifungal or anti-HIV medicines.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I use ADVAIR DISKUS?

Read the step-by-step instructions for using ADVAIR DISKUS at the end of this Medication Guide.

• Do not use ADVAIR DISKUS unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly.
• Children should use ADVAIR DISKUS with an adult’s help, as instructed by the child’s healthcare provider.
• ADVAIR DISKUS comes in 3 different strengths. Your healthcare provider prescribed the strength that is best for you.
• Use ADVAIR DISKUS exactly as your healthcare provider tells you to use it. Do not use ADVAIR DISKUS more often than prescribed.
• Use 1 inhalation of ADVAIR DISKUS 2 times each day. Use ADVAIR DISKUS at the same time each day, about 12 hours apart.
• If you miss a dose of ADVAIR DISKUS, just skip that dose. Take your next dose at your usual time. Do not take 2 doses at 1 time.
• If you take too much ADVAIR DISKUS, call your healthcare provider or go to the nearest hospital emergency room right away if you have any unusual symptoms, such as worsening shortness of breath, chest pain, increased heart rate, or shakiness.
• Do not use other medicines that contain a LABA for any reason. Ask your healthcare provider or pharmacist if any of your other medicines are LABA medicines.
• Do not stop using ADVAIR DISKUS unless told to do so by your healthcare provider because your symptoms might get worse. Your healthcare provider will change your medicines as needed.
• ADVAIR DISKUS does not relieve sudden symptoms. Always have a rescue inhaler with you to treat sudden symptoms. If you do not have a rescue inhaler, call your healthcare provider to have one prescribed for you.
• Call your healthcare provider or get medical care right away if:

• Your breathing problems get worse.
• You need to use your rescue inhaler more often than usual.
• Your rescue inhaler does not work as well to relieve your symptoms.
• You need to use 4 or more inhalations of your rescue inhaler in 24 hours for 2 or more days in a row.
• You use 1 whole canister of your rescue inhaler in 8 weeks.
• Your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you.
• You have asthma and your symptoms do not improve after using ADVAIR DISKUS regularly for 1 week.

What are the possible side effects with ADVAIR DISKUS? ADVAIR DISKUS can cause serious side effects, including:

• See “What is the most important information I should know about ADVAIR DISKUS?”
• Fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using ADVAIR DISKUS to help reduce your chance of getting thrush.

• pneumonia. People with COPD have a higher chance of getting pneumonia. ADVAIR DISKUS may increase the chance of getting pneumonia. Call your healthcare provider if you notice any of the following symptoms:

• Increase in mucus (sputum) production
• Change in mucus color
• Fever
• Chills
• Increased cough
• Increased breathing problems

• Weakened immune system and increased chance of getting infections (immunosuppression)
• Reduced adrenal function (adrenal insufficiency). Adrenal insufficiency is a condition where the adrenal glands do not make enough steroid hormones. This can happen when you stop taking oral corticosteroid medicines (such as prednisone) and start taking a medicine containing an inhaled steroid (such as ADVAIR DISKUS). When your body is under stress such as from fever, trauma (such as a car accident), infection, surgery, or worse COPD symptoms, adrenal insufficiency can get worse and may cause death.

Symptoms of adrenal insufficiency include:

• Feeling tired
• Lack of energy
• Weakness
• Nausea and vomiting
• Low blood pressure

• Sudden breathing problems immediately after inhaling your medicine
• Serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction:

• Rash
• Hives
• Swelling of your face, mouth, and tongue
• Breathing problems

• Effects on heart

• Increased blood pressure
• A fast or irregular heartbeat
• Chest pain

• Effects on nervous system

• Tremor
• Nervousness

• Bone thinning or weakness (osteoporosis)
• Slowed growth in children. A child’s growth should be checked often.
• Eye problems including glaucoma and cataracts. You should have regular eye exams while using ADVAIR DISKUS.
• Changes in laboratory blood values (sugar, potassium, certain types of white blood cells)

Common side effects of ADVAIR DISKUS include

Asthma

• Upper respiratory tract infection
• Throat irritation
• Hoarseness and voice changes
• Thrush in your mouth or throat. Rinse your mouth with water without swallowing after use to help prevent this.
• Bronchitis
• Cough
• Headache
• Nausea and vomiting

In children with asthma, infections in the ear, nose, and throat are common.

COPD

• Thrush in your mouth or throat. Rinse your mouth with water without swallowing after use to help prevent this.
• Throat irritation
• Hoarseness and voice changes
• Viral respiratory infections
• Headache
• Muscle and bone pain

Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all the side effects with ADVAIR DISKUS. Ask your healthcare provider or pharmacist for more information. 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 ADVAIR DISKUS?

• Store ADVAIR DISKUS at room temperature between 68°F and 77°F (20°C and 25°C). Keep in a dry place away from heat and sunlight.
• Store ADVAIR DISKUS in the unopened foil pouch and only open when ready for use.
• Safely throw away ADVAIR DISKUS in the trash 1 month after you open the foil pouch or when the counter reads 0, whichever comes first.
• Keep ADVAIR DISKUS and all medicines out of the reach of children.

General information about ADVAIR DISKUS

Medicines are sometimes prescribed for purposes not mentioned in a Medication Guide. Do not use ADVAIR DISKUS for a condition for which it was not prescribed. Do not give your ADVAIR DISKUS to other people, even if they have the same condition that you have. It may harm them. This Medication Guide summarizes the most important information about ADVAIR DISKUS. If you would like more information, talk with your healthcare provider or pharmacist. You can ask your healthcare provider or pharmacist for information about ADVAIR DISKUS that was written for healthcare professionals. For more information about ADVAIR DISKUS, call 1-888-825-5249 or visit our website at www.advair.com.

What are the ingredients in ADVAIR DISKUS?

Active ingredients: fluticasone propionate, salmeterol xinafoate Inactive ingredient: lactose monohydrate (contains milk proteins)

Instructions of Use

For Oral Inhalation Only

Read this information before you start using your ADVAIR DISKUS inhaler:

• Take ADVAIR DISKUS out of the foil pouch just before you use it for the first time. Safely throw away the pouch. The DISKUS will be in the closed position.
• Write the date you opened the foil pouch in the first blank line on the label. See image above.
• Write the “use by” date in the second blank line on the label. See Figure A. That date is 1 month after the date you wrote in the first line.
• The counter should read 60. If you have a sample (with “Sample” on the back label) or institutional (with “INSTITUTIONAL PACK” on the foil pouch) pack, the counter should read 14.

How to use your ADVAIR Diskus inhaler

Follow these steps every time you use ADVAIR Diskus:

• Step 1. Open your ADVAIR DISKUS

Hold the DISKUS in your left hand and place the thumb of your right hand in the thumb grip. Push the thumb grip away from you as far as it will go until the mouthpiece shows and snaps into place.

• Step 2. Slide the lever until you hear it click.

Hold the DISKUS in a level, flat position with the mouthpiece towards you. Slide the lever away from the mouthpiece as far as it will go until it clicks.

• The number on the counter will count down by 1. The DISKUS is now ready to use.

Follow the instructions below so you will not accidentally waste a dose====

• Do not close the DISKUS.
• Do not tilt the DISKUS.
• Do not move the lever on the DISKUS.

• Step 3. Inhale your medicine.

• Before you breathe in your dose from the DISKUS, breathe out (exhale) as long as you can while you hold the DISKUS level and away from your mouth. See figure below. Do not breathe into the mouthpiece.

• Put the mouthpiece to your lips. Breathe in quickly and deeply through the DISKUS. Do not breathe in through your nose.

• Remove the DISKUS from your mouth and hold your breath for about 10 seconds, or for as long as is comfortable for you.
• Breathe out slowly as long as you can.
• The DISKUS delivers your dose of medicine as a very fine powder that you may or may not taste or feel. Do not take an extra dose from the DISKUS even if you do not taste or feel the medicine.

• Step 4. Close the DISKUS.

• Place your thumb in the thumb grip and slide it back towards you as far as it will go. Make sure the DISKUS clicks shut and you cannot see the mouthpiece.

• The DISKUS is now ready for you to take your next scheduled dose in about 12 hours. When you are ready to take your next dose, repeat Steps 1 through 4.

• Step 5. Rinse your mouth.

• Rinse your mouth with water after breathing in the medicine. Spit out the water. Do not swallow it.

When should you get a refill?

The counter on top of the DISKUS shows you how many doses are left. After you have taken 55 doses (9 doses from the sample or institutional pack), the numbers 5 to 0 will show in red. See Figure H. These numbers warn you there are only a few doses left and are a reminder to get a refill.

For correct use of the DISKUS, remember:

• Always use the DISKUS in a level, flat position.
• Make sure the lever firmly clicks into place.
• Hold your breath for about 10 seconds after inhaling. Then breathe out fully.
• After each dose, rinse your mouth with water and spit it out. Do not swallow the water.
• Do not take an extra dose, even if you did not taste or feel the powder.
• Do not take the DISKUS apart.
• Do not wash the DISKUS.
• Always keep the DISKUS in a dry place.
• Do not use the DISKUS with a spacer device.

If you have questions about ADVAIR DISKUS or how to use your inhaler, call GlaxoSmithKline (GSK) at 1-888-825-5249 or visit www.advair.com.