RISKS & SIDE EFFECTS
Please review this safety information
Below you can learn about the risks and side effects of ANORO ELLIPTA. This, however, is not all the safety information for ANORO ELLIPTA and does not replace talking with your healthcare professional about your medical condition or treatment. Please see the full Patient Information for ANORO ELLIPTA, or ask your healthcare provider or pharmacist for more information.
Important information about ANORO ELLIPTA
- ANORO ELLIPTA is used as 1 inhalation 1 time 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).
- ANORO ELLIPTA is not used to treat sudden symptoms of COPD. Always have a rescue inhaler (an inhaled, short-acting bronchodilator) with you to treat sudden symptoms of COPD. If you do not have a rescue inhaler, contact your healthcare provider to have one prescribed for you.
- ANORO ELLIPTA is not for the treatment of asthma. It is not known if ANORO ELLIPTA is safe and effective in people with asthma.
- ANORO ELLIPTA should not be used in children. It is not known if ANORO ELLIPTA is safe and effective in children.
Do not use ANORO ELLIPTA if you:
- have a severe allergy to milk proteins. Ask your healthcare provider if you are not sure.
- are allergic to umeclidinium, vilanterol, or any of the ingredients in ANORO ELLIPTA. See "What are the ingredients in ANORO ELLIPTA?" below for a complete list of ingredients.
- have asthma.
Before using ANORO ELLIPTA, tell your healthcare provider about all of your medical conditions, including if you:
- have heart problems.
- have high blood pressure.
- have seizures.
- have thyroid problems.
- have diabetes.
- have liver problems.
- have eye problems such as glaucoma. ANORO ELLIPTA may make your glaucoma worse.
- have prostate or bladder problems, or problems passing urine. ANORO ELLIPTA may make these problems worse.
- are allergic to milk proteins.
- are pregnant or plan to become pregnant. It is not known if ANORO ELLIPTA may harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if the medicines, umeclidinium and vilanterol, in ANORO ELLIPTA pass into your breast 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. ANORO ELLIPTA and certain other medicines may interact with each other. This may cause serious side effects.
Especially tell your healthcare provider if you take:
- anticholinergics (including tiotropium, ipratropium, aclidinium)
- 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 ANORO ELLIPTA?
Read the step-by-step instructions for using ANORO ELLIPTA at the end of the Patient Information.
- Do not use ANORO ELLIPTA unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly. Ask your healthcare provider or pharmacist if you have any questions.
- Use ANORO ELLIPTA exactly as prescribed. Do not use ANORO ELLIPTA more often than prescribed.
- Use 1 inhalation of ANORO ELLIPTA 1 time each day. Use ANORO ELLIPTA at the same time each day.
- If you miss a dose of ANORO ELLIPTA, take it as soon as you remember. Do not take more than 1 inhalation per day. Take your next dose at your usual time. Do not take 2 doses at 1 time.
- If you take too much ANORO ELLIPTA, 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 or an anticholinergic for any reason. Ask your healthcare provider or pharmacist if any of your other medicines are LABA or anticholinergic medicines.
- Do not stop using ANORO ELLIPTA unless told to do so by your healthcare provider because your symptoms might get worse. Your healthcare provider will change your medicines as needed.
- ANORO ELLIPTA 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.
- 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, or your rescue inhaler does not work as well to relieve your symptoms.
What are the possible side effects of ANORO ELLIPTA?
ANORO ELLIPTA can cause serious side effects, including:
- serious problems in people with asthma. People with asthma who take LABA medicines, such as vilanterol (one of the medicines in ANORO ELLIPTA), without also using a medicine called an inhaled corticosteroid, have an increased risk of serious problems from asthma, including death.
- Call your healthcare provider if breathing problems worsen over time while using ANORO ELLIPTA. You may need a different treatment.
- Get emergency medical care if:
- your breathing problems worsen quickly.
- you use your rescue inhaler medicine, but it does not relieve your breathing problems.
- COPD symptoms that get worse over time. If your COPD symptoms worsen over time, do not increase your dose of ANORO ELLIPTA; instead call your healthcare provider.
- symptoms of using too much of a LABA medicine, including:
- chest pain
- increased blood pressure
- fast or irregular heartbeat
- sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using ANORO ELLIPTA and call your healthcare provider right away.
- 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:
- swelling of your face, mouth, and tongue
- breathing problems
- effects on heart:
- increased blood pressure
- chest pain
- a fast or irregular heartbeat, awareness of heartbeat
- effects on nervous system
- new or worsened eye problems, including acute narrow-angle glaucoma. Acute narrow-angle glaucoma can cause permanent loss of vision if not treated. Symptoms of acute narrow-angle glaucoma may include:
- eye pain or discomfort
- nausea or vomiting
- blurred vision
- seeing halos or bright colors around lights
- red eyes
If you have these symptoms, call your healthcare provider right away before taking another dose.
- urinary retention. People who take ANORO ELLIPTA may develop new or worse urinary retention. Symptoms of urinary retention may include:
- difficulty urinating
- painful urination
- urinating frequently
- urination in a weak stream or drips
If you have these symptoms of urinary retention, stop taking ANORO ELLIPTA and call your healthcare provider right away before taking another dose.
- changes in laboratory blood levels, including high levels of blood sugar (hyperglycemia) and low levels of potassium (hypokalemia)
- Common side effects of ANORO ELLIPTA include:
- sore throat
- sinus infection
- lower respiratory infection
- common cold symptoms
- pain in your arms or legs
- muscle spasms
- neck pain
- chest pain
These are not all the possible side effects of ANORO ELLIPTA. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What are the ingredients in ANORO ELLIPTA?
|INACTIVE INGREDIENTS:||lactose monohydrate (contains milk proteins)||magnesium stearate|