Anoro Ellipta

The recommended dose of umeclidinium - vilanterol is one inhalation taken once daily. Try to use the inhaler at the same time every day to get the most benefit from it and to help you remember to use it.

Have your doctor or pharmacist explain how to use the inhaler and read the instructions carefully before using the inhaler. If you have any questions about how to use the inhaler, check with your health care professional.

Open the inhaler only when you are going to use the medication immediately. Each time you open and close the cover, a dose is prepared for inhalation. If you do not use the dose, it will be wasted.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important that Anoro Ellipta be used exactly as prescribed by your doctor.

If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Anoro Ellipta at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause dryness of the mouth; it may cause diarrhea; it may cause a cough. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

Umeclidinium - vilanterol is available as a disposable grey and red plastic inhaler containing 2 double-foil strips. One strip contains umeclidinium 62.5 µg per blister and the other strip contains vilanterol 25 µg per blister. Nonmedicinal ingredients: magnesium stearate and lactose monohydrate.

Do not take umeclidinium - vilanterol if you:

• are allergic to umeclidinium, vilanterol or any ingredients of the medication
• are severely allergic to milk proteins
• are using Anoro Ellipta to treat Asthma

Anoro Ellipta should not be used by people under the age of 18.

There may be an interaction between umeclidinium - vilanterol and any of the following:

• aclidinium
• Alfuzosin
• amantadine
• Amiodarone
• amphetamines (e.g., Dextroamphetamine, lisdexamphetamine)
• antihistamines (e.g., cetirizine, doxylamine, Diphenhydramine, Hydroxyzine, Loratadine)
• antipsychotics (e.g., Chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• Atomoxetine
• atropine
• azelastine
• belladonna
• Benztropine
• beta 2 agonists (e.g., salbutamol, formoterol, terbutaline)
• beta-adrenergic blockers (e.g., Atenolol, Propranolol, Sotalol)
• Betahistine
• botulinum toxin
• caffeine
• cannabis
• chloroquine
• cocaine
• Cyclobenzaprine
• Darifenacin
• decongestants (e.g., naphazoline, oxymetazoline, phenylephrine, Pseudoephedrine)
• Degarelix
• Dimenhydrinate
• dipivefrin
• Disopyramide
• diuretics (water pills; e.g., Furosemide, Hydrochlorothiazide, triamterene)
• dobutamine
• dofetilide
• Domperidone
• Donepezil
• dopamine
• Dronedarone
• Epinephrine
• Flavoxate
• Flecainide
• Galantamine
• Glucagon
• glycopyrrolate
• ipratropium
• ketotifen
• Linezolid
• long-acting beta-2 agonists (e.g., formoterol, Indacaterol, salmeterol)
• lopinavir
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• Methadone
• Methylphenidate
• Metoclopramide
• Midodrine
• mifepristone
• Mirabegron
• Modafinil
• monoamine oxidase inhibitors (M.O.S. e.g., Moclobemide, Phenelzine, Rasagiline, Selegiline, Tranylcypromine)
• Nabilone
• narcotic pain relievers (e.g., Codeine, Fentanyl, Morphine, Oxycodone)
• Olopatadine
• orphenadrine
• Oxybutynin
• peginterferon alfa-2b
• Pimozide
• potassium supplements
• pramlintide
• Primaquine
• procainamide
• protein kinase inhibitors (e.g., Bosutinib, Dasatinib, imatinib, Nilotinib)
• quinidine
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin, Ofloxacin)
• rilpivirine
• Rivastigmine
• saquinivir
• scopolamine
• secretin
• serotonin antagonists (anti-emetic medications; e.g., Granisetron, Ondansetron)
• Solifenacin
• sotalol
• Tetrabenazine
• theophyllines (e.g., Aminophylline, Oxtriphylline, Theophylline)
• tiotropium
• Tolterodine
• Topiramate
• Trazodone
• tricyclic antidepressants (e.g., Amitriptyline, Clomipramine, Desipramine)
• Voriconazole

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Anoro Ellipta. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Anoro Ellipta.

Allergy: In rare cases, immediate allergic reactions may occur after using umeclidinium - vilanterol, causing Hives, swelling around the throat and tongue, rash, and worsening of breathing problems. If this occurs, get emergency medical help at once.

Asthma related death: The safety and effectiveness of using Anoro Ellipta to treat asthma symptoms have not been determined. Studies have shown an increase in deaths caused by severe asthma symptoms when LABA medications have been used without a corticosteroid. Anoro Ellipta should not be used by people with asthma.

Diabetes: Umeclidinium - vilanterol may cause an increase in blood sugar levels and glucose tolerance may change. If you have diabetes or are at risk for developing diabetes, discuss with your doctor how Anoro Ellipta may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Anoro Ellipta, and whether any special monitoring is needed. People with diabetes may find it necessary to monitor their blood sugar more frequently while using Anoro Ellipta.

Glaucoma: Umeclidinium may cause symptoms of glaucoma (increased pressure in the eyes), such as blurred vision or eye pain or pressure to become worse. If you have glaucoma, discuss with your doctor how Anoro Ellipta may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Anoro Ellipta, and whether any special monitoring is needed.

Heart conditions: Anoro Ellipta can cause an increase in blood pressure or heart rate in addition to changes to the heart rhythm. If you have any heart conditions, discuss with your doctor how Anoro Ellipta may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Anoro Ellipta, and whether any special monitoring is needed.

Heart rhythm: Beta-2 agonists, such as vilanterol, can cause changes to the normal rhythm of the heart, including an irregular heartbeat called QT prolongation. QT prolongation is a serious life-threatening condition that can cause fainting, seizures, and sudden death. If you are at risk for heart rhythm problems (e.g., people with heart failure, Angina, low potassium or magnesium levels), discuss with your doctor how Anoro Ellipta may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Anoro Ellipta, and whether any special monitoring is needed.

Inhalation-induced bronchospasm: Inhaled forms of medications may cause spasms of the airways, which make breathing difficult. If you experience this problem when using umeclidinium - vilanterol stop using Anoro Ellipta immediately. Speak to your doctor if you experience any problems with breathing while taking this or other inhaled medication.

Seizures: There have been occasional reports of seizures occurring with umeclidinium - vilanterol. Seizures are more likely to occur when higher doses of Anoro Ellipta are taken. If you have a history of Epilepsy or medical conditions that increase the risk of seizures, discuss with your doctor how Anoro Ellipta may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Anoro Ellipta, and whether any special monitoring is needed.

Smoking: If you smoke, discuss with your doctor or pharmacist the benefits of stopping smoking. Smoking contributes to the symptoms of COPD. People who stop smoking often see a significant improvement in their breathing symptoms.

Thyroid disease: Anoro Ellipta may increase the symptoms of an overactive thyroid gland. If you have a history of thyroid disease, discuss with your doctor how Anoro Ellipta may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Anoro Ellipta, and whether any special monitoring is needed.

Urinary tract problems: Anoro Ellipta can cause the symptoms of some urinary tract problems to become worse. If you have an enlarged prostate or other condition that causes urination to be difficult, discuss with your doctor how Anoro Ellipta may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Anoro Ellipta, and whether any special monitoring is needed.

Worsening symptoms: If you find you need to use your short-acting ("rescue") inhaler more often or if your condition seems to worsen, call your doctor. It is very important that you have your "rescue" medication with you at all times. If you have not been given instructions beforehand, contact your doctor immediately about what to do if any of the following situations occur (they may be signs of seriously worsening COPD):

• decreased effectiveness of short-acting, inhaled bronchodilators such as salbutamol, terbutaline, or fenoterol (less than 4 hours of relief)
• need for more inhalations than usual of short-acting, inhaled bronchodilators

Pregnancy: Anoro Ellipta should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Anoro Ellipta, contact your doctor immediately.

Breast-feeding: It is not known if either umeclidinium or vilanterol pass into breast milk. If you are a breast-feeding mother and are using Anoro Ellipta, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Anoro Ellipta have not been established for children or people under the age of 18.

This product must be inhaled by mouth. Carefully follow the package's instructions. If needed, ask your pharmacist for additional information or for a demonstration. This medication is typically used only once a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Use it regularly and continuously to maintain its beneficial effects. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. If you forget a dose, simply skip it and then take the next dose at the regularly scheduled time.