Important Safety Information About ADVAIR DISKUS 250/50 for COPD
Do not use ADVAIR to treat sudden, severe symptoms of asthma or COPD. Always have a rescue inhaler medicine with you to treat sudden symptoms.
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Risks & Side Effects
This is not all the safety information about ADVAIR DISKUS. This information does not replace talking with your healthcare provider about your medical condition or treatment. Please see the complete Prescribing Information and Medication Guide for ADVAIR DISKUS for more information or ask your healthcare provider or pharmacist.
ADVAIR DISKUS 250/50 is approved for adults with COPD, including chronic bronchitis, emphysema, or both. ADVAIR DISKUS is not for, and should not be used to treat, sudden, severe symptoms of COPD. ADVAIR won't replace a rescue inhaler. You should only take 1 inhalation of ADVAIR twice a day. Higher doses will not provide additional benefits.
Overview and Important Information
- 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
- fever
- chills
- increased cough
- increased breathing problems
- Thrush in the mouth and throat may occur. It is important to rinse your mouth with water or brush your teeth after using your ADVAIR DISKUS.
- ADVAIR DISKUS does not relieve sudden symptoms. Always have a rescue inhaler medicine with you to treat sudden symptoms. If you do not have an inhaled, short-acting bronchodilator, 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.
- 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 rescue inhaler medicine, but it does not relieve your breathing problems.
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 high blood pressure
- have seizures
- have thyroid problems
- have diabetes
- have liver problems
- 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. See Medication Guide for ADVAIR DISKUS for a complete list of the ingredients in ADVAIR DISKUS.
- 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.
NORVIR and KALETRA are registered trademarks of Abbott Laboratories.
What are the possible side effects with ADVAIR DISKUS?
- ADVAIR DISKUS can cause serious side effects, including:
- 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 the face, mouth, and tongue
- breathing problems
- sudden breathing problems immediately after inhaling your medicine
- effects on heart
- increased blood pressure
- a fast and irregular heartbeat
- chest pain
- effects on nervous system
- tremor
- nervousness
- reduced adrenal function (may result in loss of energy)
- changes in blood (sugar, potassium, certain types of white blood cells)
- weakened immune system and a higher chance of infections. You should avoid exposure to chickenpox and measles, and, if exposed, consult your healthcare provider without delay. Worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex may occur.
- 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.
- pneumonia. People with COPD have a higher chance of getting pneumonia. ADVAIR may increase the chance of getting pneumonia. Call your doctor if you notice any of the following symptoms:
- increase in mucus (sputum) production
- change in mucus color
- fever
- chills
- increased cough
- increased breathing problems
- 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:
- Common side effects of ADVAIR DISKUS 250/50 for COPD include:
- thrush in the mouth and throat
- 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.
What additional important safety information should I know?
Do not use ADVAIR DISKUS more often than prescribed. You should only take 1 inhalation of ADVAIR twice a day. Higher doses will not provide additional benefits.
While you are using ADVAIR DISKUS twice a day, do not use other medicines that contain a long-acting beta2-agonist or LABA for any reason. Ask your healthcare provider or pharmacist if any of your other medicines are LABA medicines.
Call your healthcare provider or get medical care right away if:
- your breathing problems worsen with ADVAIR DISKUS
- you need to use your rescue inhaler medicine more often than usual
- your rescue inhaler medicine does not work as well for you at relieving symptoms
Tell your healthcare provider about any side effect that bothers you or that does not go away.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Important Safety Information About ADVAIR DISKUS® 250/50 (fluticasone propionate 250 mcg and salmeterol 50 mcg inhalation powder)
- Do not use ADVAIR to treat sudden, severe symptoms of asthma or COPD. Always have a rescue inhaler medicine with you to treat sudden symptoms.
- Do not use ADVAIR DISKUS if you have severe allergy to milk proteins. Ask your doctor if you are not sure.
- Do not use ADVAIR more often than prescribed. Do not take ADVAIR with other medicines that contain long-acting beta2-agonists for any reason. Tell your doctor about medicines you take and about all of your medical conditions.
- ADVAIR DISKUS can cause serious side effects, including:
- 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 the face, mouth, and tongue
- breathing problems
- sudden breathing problems immediately after inhaling your medicine
- effects on heart
- increased blood pressure
- a fast and irregular heartbeat
- chest pain
- effects on nervous system
- tremor
- nervousness
- reduced adrenal function (may result in loss of energy)
- changes in blood (sugar, potassium, certain types of white blood cells)
- weakened immune system and a higher chance of infections. You should avoid exposure to chickenpox and measles, and, if exposed, consult your healthcare provider without delay. Worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex may occur.
- 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.
- pneumonia. People with COPD have a higher chance of getting pneumonia. ADVAIR may increase the chance of getting pneumonia. Call your doctor if you notice any of the following symptoms:
- increase in mucus (sputum) production
- change in mucus color
- fever
- chills
- increased cough
- increased breathing problems
- 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:
- Common side effects of ADVAIR DISKUS 250/50 for COPD include:
- thrush in the mouth and throat
- throat irritation
- hoarseness and voice changes
- viral respiratory infections
- headache
- muscle and bone pain
Complete Prescribing Information and Medication Guide for ADVAIR DISKUS
Next: If You Are Taking ADVAIR
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
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