What is the most important information I should know about SEREVENT DISKUS?

SEREVENT DISKUS can cause serious side effects, including:

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People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as salmeterol (the medicine in SEREVENT DISKUS), have an increased risk of death from asthma problems if they use SEREVENT DISKUS without also using a medicine called an inhaled corticosteroid (ICS).

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Call your healthcare provider if breathing problems worsen over time while using SEREVENT DISKUS. You may need different treatment.

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Get emergency medical care if:

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your breathing problems worsen quickly.

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you use your rescue inhaler, but it does not relieve your breathing problems.

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Do not use SEREVENT DISKUS as your only asthma medicine. SEREVENT DISKUS must only be used with an ICS.

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SEREVENT DISKUS should be used only if your healthcare provider decides that your asthma is not well controlled with an ICS.

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Children and adolescents who take LABA medicines as their only asthma medicine may have an increased risk of being hospitalized for asthma problems.

What is SEREVENT DISKUS?

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SEREVENT DISKUS is a prescription inhaled LABA medicine. 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.

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SEREVENT DISKUS is not used to relieve sudden breathing problems and will not replace a rescue inhaler.

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It is not known if SEREVENT DISKUS is safe and effective in children younger than 4 years.

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SEREVENT DISKUS is used for asthma, exercise-induced bronchospasm (EIB), and chronic obstructive pulmonary disease (COPD) as follows:

 

Asthma:

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SEREVENT 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.

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SEREVENT DISKUS contains salmeterol. LABA medicines such as salmeterol when used alone increase the risk of death from asthma problems.

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SEREVENT 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 ICS medicine.

 

Exercise-Induced Bronchospasm (EIB):

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SEREVENT DISKUS is used to prevent wheezing caused by exercise in adults and children aged 4 years and older.

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If you only have EIB, your healthcare provider may only prescribe SEREVENT DISKUS for your condition.

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If you have EIB and asthma, your healthcare provider should also prescribe an ICS.

 

Chronic Obstructive Pulmonary Disease (COPD):

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COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both.

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SEREVENT DISKUS is a prescription medicine used long term as 1 inhalation 2 times each day to improve symptoms of COPD for better breathing.

Do not use SEREVENT DISKUS:

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to treat your asthma without an ICS.

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to treat sudden, severe symptoms of asthma or COPD.

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if you have a severe allergy to milk proteins. Ask your healthcare provider if you are not sure.

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if you are allergic to salmeterol xinafoate or any of the ingredients in SEREVENT DISKUS. See the end of this Medication Guide for a complete list of ingredients in SEREVENT DISKUS.

Before using SEREVENT DISKUS, tell your healthcare provider about all of your medical conditions, including if you:

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have heart problems.

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have high blood pressure.

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have seizures.

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have thyroid problems.

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have diabetes.

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have liver problems.

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are allergic to milk proteins.

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are pregnant or plan to become pregnant. It is not known if the medicine salmeterol in SEREVENT DISKUS may harm your unborn baby.

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are breastfeeding or plan to breastfeed. It is not known if the medicine in SEREVENT DISKUS passes into your breast milk and if it 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. SEREVENT 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 SEREVENT DISKUS?

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

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Do not use SEREVENT DISKUS unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly.

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Children should use SEREVENT DISKUS with an adult’s help, as instructed by the child’s healthcare provider.

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Use SEREVENT DISKUS exactly as your healthcare provider tells you to use it. Do not use SEREVENT DISKUS more often than prescribed.

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For asthma and COPD, the usual dose is 1 inhalation of SEREVENT DISKUS 2 times each day. Use SEREVENT DISKUS at the same time each day, about 12 hours apart.

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For preventing exercise-induced bronchospasm, the usual dose is 1 inhalation at least 30 minutes before exercise. Do not use SEREVENT DISKUS more often than every 12 hours. Do not use extra SEREVENT DISKUS before exercise if you already use it 2 times each day.

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If you miss a dose of SEREVENT DISKUS, just skip that dose. Take your next dose at your usual time. Do not take 2 doses at 1 time.

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If you take too much SEREVENT 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.

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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.

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Do not stop using SEREVENT 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.

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SEREVENT DISKUS does not relieve sudden breathing problems. 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.

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Call your healthcare provider or get medical care right away if:

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your breathing problems get worse.

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you need to use your rescue inhaler more often than usual.

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your rescue inhaler does not work as well to relieve your symptoms.

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you need to use 4 or more inhalations of your rescue inhaler in 24 hours for 2 or more days in a row.

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you use 1 whole canister of your rescue inhaler in 8 weeks.

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your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you.

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you have asthma and your symptoms do not improve after using SEREVENT DISKUS regularly for 1 week.

What are the possible side effects of SEREVENT DISKUS?

SEREVENT DISKUS can cause serious side effects, including:

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See “What is the most important information I should know about SEREVENT DISKUS?”

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sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using SEREVENT DISKUS and call your healthcare provider right away.

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effects on heart.

             ο  increased blood pressure                                  ο  chest pain

             ο  a fast or irregular heartbeat, awareness of heartbeat

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effects on nervous system.

             ο  tremor                                                               ο  nervousness

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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:

             ο  rash                                                                    ο  swelling of your face, mouth, and tongue

             ο  hives                                                                  ο  breathing problems

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changes in laboratory blood levels, including high levels of blood sugar (hyperglycemia) and low levels of potassium (hypokalemia)

Common side effects of SEREVENT DISKUS include:

Asthma:

•  headache                                    •  nasal congestion                         •  bronchitis

•  throat irritation                          •  runny nose                                   •  flu

COPD:

•  headache                                    •  musculoskeletal pain                  •  throat irritation

•  cough                                         •  respiratory infection

These are not all the possible side effects of SEREVENT DISKUS.

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 SEREVENT DISKUS?

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Store SEREVENT DISKUS at room temperature between 68°F and 77°F (20°C and 25°C).

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Store SEREVENT DISKUS in a dry place away from heat and sunlight.

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Store SEREVENT DISKUS in the unopened foil pouch and only open when ready for use.

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Safely throw away SEREVENT DISKUS in the trash 6 weeks after you open the foil pouch or when the counter reads “0”, whichever comes first. Write the date you open the pouch on the label on the inhaler.

Keep SEREVENT DISKUS and all medicines out of the reach of children.

General information about the safe and effective use of SEREVENT DISKUS.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SEREVENT DISKUS for a condition for which it was not prescribed. Do not give SEREVENT DISKUS to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your healthcare provider or pharmacist for information about SEREVENT DISKUS that was written for health professionals.

What are the ingredients in SEREVENT DISKUS?

Active ingredient: salmeterol xinafoate

Inactive ingredients: lactose monohydrate (contains milk proteins)

For more information about SEREVENT DISKUS, call 1-888-825-5249.

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