Anoro Ellipta

Anoro Ellipta is an inhalation powder containing a combination of umeclidinium and vilanterol. Umeclidinium and vilanterol both work by relaxing muscles in the airways to improve breathing.

Anoro Ellipta is used to prevent airflow obstruction and reduce flare-ups in adults with COPD (chronic obstructive pulmonary disease), including bronchitis and emphysema.

Anoro Ellipta is for use only in people with COPD and should not be used to treat asthma.

Use Anoro exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides.

Anoro Ellipta is not a rescue medicine for bronchospasm attacks. Use only fast-acting inhalation medicine for an attack. Seek medical attention if your breathing problems get worse quickly, or if you think your medications are not working as well.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

The usual dose of this medicine is 1 inhalation per day. Use the medicine at the same time each day, and not more than once in 24 hours.

Anoro is a powder that comes with a special Ellipta inhaler device preloaded with blister packs containing measured doses of the medicine. The Ellipta device opens and loads a blister of Anoro each time you use the inhaler. Follow the patient instructions provided with the inhaler device.

Store at room temperature away from moisture, heat, and light. Keep the inhaler device in the sealed foil tray until ready to start using it.

Throw the inhaler away 6 weeks after opening, or when the dose indicator shows a zero (whichever comes first).

Anoro Ellipta is for use only in people with chronic obstructive pulmonary disease (COPD) and should not be used to treat asthma.

Anoro Ellipta is not a rescue medicine. It will not work fast enough to treat a bronchospasm attack. Tell your doctor if any of your medicines seem to stop working as well in controlling your COPD.

Vilanterol may increase the risk of death in people with asthma, but the risk in people with COPD is not known. Seek medical attention if your breathing problems do not improve or if your symptoms get worse quickly.

Anoro Ellipta will not work fast enough to treat a bronchospasm attack. Use only a fast-acting inhalation medicine for an attack.

Seek medical attention if your breathing problems do not improve or if your symptoms get worse quickly.

You should not use Anoro Ellipta if you are allergic to umeclidinium or vilanterol, or if you have a severe allergy to milk proteins.

To make sure Anoro Ellipta is safe for you, tell your doctor if you have ever had:/p>

• heart disease, high blood pressure;
• a seizure;
• liver disease;
• glaucoma;
• diabetes;
• a thyroid disorder; or
• an enlarged prostate or urination problems.

Tell your doctor if you are pregnant or breastfeeding.

Anoro Ellipta is not approved for use by anyone younger than 18 years old.

Get emergency medical help if you have signs of an allergic reaction to Anoro Ellipta: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• wheezing, choking, or other breathing problems after using this medicine;
• painful or difficult urination, or urinating more often;
• blurred vision, tunnel vision, eye pain or redness, or seeing halos around lights;
• high blood sugar - increased thirst or urination, hunger, dry mouth, fruity breath odor; or
• low potassium level - leg cramps, constipation, irregular heartbeats, fluttering in your chest, numbness or tingling, muscle weakness or limp feeling.

Common Anoro Ellipta side effects may include:

• stuffy nose, sinus pain, sore throat;
• chest pain, cough;
• diarrhea, constipation;
• muscle spasms; or
• pain in your neck, arms, or legs.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Dose of Anoro Ellipta for COPD

• 1 inhalation once daily at the same time every day.
• Do not use more than once in 24 hours.

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time. Do not use more than once in 24 hours.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include headache, chest pain, fast heart rate, tremor, and feeling shaky or nervous.

Do not use a second inhaled bronchodilator that contains formoterol, arformoterol, indacaterol, olodaterol, salmeterol, or vilanterol.

Tell your doctor about all your other medicines, especially:

• atropine;
• antifungal, or antiviral medicine;
• monoamine oxidase inhibitors, tricyclic antidepressants, drugs that prolong QT interval;
• beta-blockers;
• medicine to treat depression, anxiety, mood disorders, or mental illness;
• cold or allergy medicine (Benadryl and others);
• medicine to treat Parkinson's disease;
• medicine to treat stomach problems, motion sickness, or irritable bowel syndrome;
• medicine to treat overactive bladder; or
• another bronchodilator medication.

This list is not complete. Other drugs may interact with umeclidinium and vilanterol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Store Anoro Ellipta 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 in the unopened tray and only open when ready for use.

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

Keep out of the reach of children.

Active ingredients: umeclidinium, vilanterol

Inactive ingredients: lactose monohydrate (contains milk proteins), magnesium stearate.

Anoro Ellipta was developed as a collaboration between GSK and Innoviva. GlaxoSmithKline, Durham, NC 27701.