GRAND Magazine - November/December 2008 - 82

Important Information This brief summary 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? • In patients with asthma, long-acting beta2-agonist (LABA) medicines, such as salmeterol (one of the medicines in ADVAIR DISKUS), may increase the chance of death from asthma problems. In a large asthma study, more patients who used salmeterol died from asthma problems compared with patients who did not use salmeterol. It is not known whether ﬂuticasone propionate, the other medicine in ADVAIR DISKUS, changes your chance of death from asthma problems seen with salmeterol. Talk with your healthcare provider about this risk and the beneﬁts of treating your asthma with ADVAIR DISKUS. • ADVAIR DISKUS does not relieve sudden symptoms. Always have a fast-acting inhaler (short-acting beta2agonist medicine) with you to treat sudden symptoms. If you do not have a fast-acting inhaler, contact your healthcare provider to have one prescribed for you. • Do not stop using ADVAIR DISKUS unless told to do so by your healthcare provider because your symptoms might get worse. • ADVAIR DISKUS should be used only if your healthcare provider decides that another asthmacontroller medicine alone does not control your asthma or that you need 2 asthma-controller medicines. • Call your healthcare provider if breathing problems worsen over time while using ADVAIR DISKUS. You may need different treatment. • Get emergency medical care if: - breathing problems worsen quickly, and - you use your fast-acting inhaler, but it does not relieve your breathing problems. What is ADVAIR DISKUS? • ADVAIR DISKUS contains 2 medicines: - ﬂuticasone propionate (the same medicine found in FLOVENT®), an inhaled corticosteroid medicine. Inhaled corticosteroids help to decrease inﬂammation in the lungs. Inﬂammation in the lungs can lead to asthma symptoms. - salmeterol (the same medicine found in SEREVENT®), a LABA. LABA medicines are used in patients with asthma or chronic obstructive pulmonary disease (COPD). LABA medicines help the muscles around the airways in your lungs stay relaxed to prevent symptoms, such as wheezing and shortness of breath. These symptoms can happen when the muscles around the airways tighten. This makes it hard to breathe. In severe cases, wheezing can stop your breathing and cause death if not treated right away. Asthma ADVAIR DISKUS is used long term, twice a day, to control symptoms of asthma and to prevent symptoms such as wheezing in adults and children ages 4 and older. Chronic Obstructive Pulmonary Disease (COPD) COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both.ADVAIR DISKUS 250/50 is used long term, twice a day, to help improve lung function for better breathing in adults with COPD. ADVAIR DISKUS 250/50 has been shown to decrease the number of ﬂare-ups and worsening of COPD symptoms (exacerbations). Who should not use ADVAIR DISKUS? Do not use ADVAIR DISKUS: • to treat sudden, severe symptoms of asthma or COPD • if you have a severe allergy to milk proteins. Ask your doctor if you are not sure. 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 seizures • have diabetes • have osteoporosis • have an immune system problem • 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 ADVAIR DISKUS passes into your milk and if it can harm your baby • are allergic to any of the ingredients in ADVAIR DISKUS, any other medicines, or food products • are exposed to chickenpox or measles Tell your healthcare provider about all the medicines you take, including prescription and nonprescription 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 ritonavir. The anti-HIV medicines Norvir ® (ritonavir capsules) Soft Gelatin, Norvir® (ritonavir oral solution), and Kaletra® (lopinavir/ritonavir) Tablets contain ritonavir. Know the medicines you take. Keep a list and show it to your healthcare provider and pharmacist each time you get a new medicine. How do I use ADVAIR DISKUS? Do not use ADVAIR DISKUS unless your healthcare provider has taught you and you understand everything. Ask your healthcare provider or pharmacist if you have any questions. • Children should use ADVAIR DISKUS with an adult’s help, as instructed by the child’s healthcare provider. • Use ADVAIR DISKUS exactly as prescribed. Do not use ADVAIR DISKUS more often than prescribed. ADVAIR DISKUS comes in 3 strengths. Your healthcare provider will prescribe the one that is best for your condition. • The usual dosage of ADVAIR DISKUS is 1 inhalation twice a day (morning and evening). The 2 doses should be about 12 hours apart. Rinse your mouth with water after using ADVAIR DISKUS. • If you take more ADVAIR DISKUS than your doctor has prescribed, get medical help right away if you have any unusual symptoms, such as worsening shortness of breath, chest pain, increased heart rate, or shakiness. • 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 one time. • Do not use a spacer device with ADVAIR DISKUS. • Do not breathe into ADVAIR DISKUS. • While you are using ADVAIR DISKUS twice a day, 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 change or stop any of your medicines used to control or treat your breathing problems. Your healthcare provider will adjust your medicines as needed. • Make sure you always have a fast-acting inhaler with you. Use your fast-acting inhaler if you have breathing problems between doses of ADVAIR DISKUS. • have high blood pressure • have thyroid problems • have liver problems Call your healthcare provider or get medical care right away if: • your breathing problems worsen with ADVAIR DISKUS • you need to use your fast-acting inhaler more often than usual • your fast-acting inhaler does not work as well for you at relieving symptoms • you need to use 4 or more inhalations of your fast-acting inhaler for 2 or more days in a row • you use 1 whole canister of your fast-acting inhaler in 8 weeks’ time • 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? • See “What is the most important information I should know about ADVAIR DISKUS?” • Patients 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 - increased breathing problems - fever - increased cough - chills • 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, including: - rash - swelling of the face, mouth, and tongue - hives - breathing problems • increased blood pressure • chest pain • a fast and irregular heartbeat • headache • tremor • nervousness • weakened immune system and a higher chance of infections • lower bone mineral density. This may be a problem for people who already have a higher chance of low bone density (osteoporosis). • eye problems including glaucoma and cataracts. You should have regular eye exams while using ADVAIR DISKUS. • slowed growth in children. A child’s growth should be checked often. Other common side effects include: • hoarseness and voice changes • throat irritation • thrush in the mouth and throat • respiratory tract infections 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 the FDA at 1-800-FDA-1088. Ask your healthcare provider or pharmacist for additional information about ADVAIR DISKUS. You can also contact the company that makes ADVAIR DISKUS (toll free) at 1-888-825-5249 or at www.advair.com. ADVAIR DISKUS, DISKUS, FLOVENT, and SEREVENT are registered trademarks of GlaxoSmithKline. Norvir and Kaletra are registered trademarks of Abbott Laboratories. ©2008 The GlaxoSmithKline Group of Companies All rights reserved. Printed in USA. AD4493R0 August 2008 T:10 in GlaxoSmithKline Research Triangle Park, NC 27709 ADD:3PI June 2008

http://www.advair.com http://www.advair.com

GRAND Magazine - November/December 2008

Table of Contents for the Digital Edition of GRAND Magazine - November/December 2008