Anoro Ellipta

Generic Name: umeclidinium and vilanterol (ue ME kli DIN ee um and vye LAN ter ol)
Brand Name: Anoro Ellipta

What is Anoro Ellipta?

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

Anoro Ellipta is used to prevent airflow obstruction or bronchospasm in people with COPD (chronic obstructive pulmonary disease).

Anoro Ellipta may also be used for purposes not listed in this medication guide.

Important information

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

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.

Before taking this medicine

You should not use this medicine if you are allergic to umeclidinium, vilanterol, or milk proteins. Anoro Ellipta is for use only in people with COPD and should not be used to treat asthma.

To make sure Anoro Ellipta is safe for you, tell your doctor if you have:

• heart disease, high blood pressure;

• epilepsy or other seizure disorder;

• liver disease;

• narrow-angle glaucoma;

• diabetes (or ketoacidosis);

• thyroid disorder; or

• an enlarged prostate, bladder obstruction or other urination problems.

Vilanterol may increase the risk of death in people with asthma, but the risk in people with COPD is not known. Talk with your doctor about your individual risks and benefits of using this medicine. Follow all patient instructions for safe use.

It is not known whether Anoro Ellipta will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether umeclidinium and vilanterol passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

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

How should I use Anoro Ellipta?

Use Anoro Ellipta exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Using this medicine improperly can cause death or serious side effects on the heart.

You may need to stop using other COPD medications you have been using in the past on a regular basis. Carefully follow your doctor's dosing 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 a 24-hour period.

Anoro Ellipta will not work fast enough to treat a bronchospasm attack. Use only a fast-acting inhalation medicine for an attack. Tell your doctor if any of your medicines seem to stop working as well in controlling your COPD.

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

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

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 device away 6 weeks after you have taken it out of the foil pouch, or if the dose indicator shows a zero, whichever comes first.

Anoro Ellipta dosing information

Usual Adult Dose for Chronic Obstructive Pulmonary Disease - Maintenance:

1 inhalation once daily by the oral inhalation route only
Maximum dose: Do not use more than one time in 24 hours

Comments: Use at same time each day

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose. Do not use more than 1 inhalation in a single day.

What happens if I overdose?

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

Overdose symptoms may include fast heart rate, and feeling shaky or short of breath.

What should I avoid while using Anoro Ellipta?

Do not use a second inhaled bronchodilator similar to vilanterol, such as salmeterol (Advair, Serevent), formoterol or arformoterol (Foradil, Perforomist, Symbicort, Brovana) unless your doctor has told you to.

Anoro Ellipta side effects

Get emergency medical help if you have any 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 medication;

• chest pain;

• fast or pounding heartbeats;

• tremors, nervousness;

• blurred vision, tunnel vision, eye pain or redness, or seeing halos around lights;

• painful or difficult urination, urinating more or less than usual;

• increased blood pressure - severe headache, blurred vision, pounding in your neck or ears, anxiety, confusion, chest pain;

• high blood sugar - increased thirst or urination, hunger, dry mouth, fruity breath odor; or

• low potassium - leg cramps, constipation, irregular heartbeats, numbness or tingling, muscle weakness or limp feeling.

Common Anoro Ellipta side effects may include:

• stuffy nose, sinus pain, sore throat;

• mild chest pain, cough with mucus;

• 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 FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Anoro Ellipta?

Tell your doctor about all your current medicines and any you start or stop using during your treatment with Anoro Ellipta, especially:

• atropine;

• an antibiotic, antifungal medicine, or antiviral medicine (to treat hepatitis C or HIV/AIDS);

• bladder or urinary medicines;

• other bronchodilators;

• cold or allergy medicine that contains an antihistamine;

• medication for Parkinson's disease; or

• medication to treat excess stomach acid, stomach ulcer, motion sickness, or irritable bowel syndrome.

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

Where can I get more information?

• Your pharmacist can provide more information about Anoro Ellipta.

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• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Anoro Ellipta only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2017 Cerner Multum, Inc. Version: 2.01. Revision Date: 2017-03-27, 10:00:16 AM.