Umeclidinium Inhalation powder, Vilanterol Inhalation powder

What is this medicine?

UMECLIDINIUM; VILANTEROL (ue MEK li DIN ee um; vye LAN ter ol) inhalation is a combination of two medicines that decrease inflammation and help to open up the airways of your lungs. It is for chronic obstructive pulmonary disease (COPD), including chronic bronchitis or emphysema. Do NOT use for asthma or an acute asthma attack. Do NOT use for a COPD attack.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• bladder problems or difficulty passing urine

• diabetes

• glaucoma

• heart disease or irregular heartbeat

• high blood pressure

• kidney disease

• pheochromocytoma

• prostate disease

• seizures

• thyroid disease

• an unusual or allergic reaction to umeclidinium, vilanterol, lactose, milk proteins, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is inhaled through the mouth. It is used once per day. Follow the directions on the prescription label. Do not use a spacer device with this inhaler. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice. Make sure that you are using your inhaler correctly. Ask you doctor or health care provider if you have any questions.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose and continue with your regular schedule. Do not use double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• cisapride

• dofetilide

• dronedarone

• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

• pimozide

• thioridazine

• ziprasidone

This medicine may also interact with the following medications:

• antihistamines for allergy

• antiviral medicines for HIV or AIDS

• atropine

• beta-blockers like metoprolol and propranolol

• certain medicines for bladder problems like oxybutynin, tolterodine

• certain medicines for depression, anxiety, or psychotic disturbances

• certain medicines for Parkinson's disease like benztropine, trihexyphenidyl

• certain medicines for stomach problems like dicyclomine, hyoscyamine

• certain medicines for travel sickness like scopolamine

• diuretics

• ipratropium

• medicines for colds

• medicines for fungal infections like ketoconazole and itraconazole

• other medicines for breathing problems

• other medicines that prolong the QT interval (cause an abnormal heart rhythm)

• tiotropium

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checkups. Tell your doctor or health care professional if your symptoms do not get better.

If your symptoms get worse or if you need your short-acting inhalers more often, call your doctor right away. Do not use this medicine more than once every 24 hours.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash or hives, swelling of the face, lips, or tongue

• breathing problems right after inhaling your medicine

• changes in vision

• chest pain

• fast, irregular heartbeat

• feeling faint or lightheaded, falls

• fever or chills

• nausea, vomiting

• trouble passing urine or change in the amount of urine

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• constipation

• cough

• diarrhea

• headache

• muscle cramps

• nervousness

• sore throat

• tremor

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Store in a dry place away from direct heat or sunlight. Throw away 6 weeks after you remove the inhaler from the foil tray, or after the dose indicator reads 0, whichever comes first. Throw away any unopened packages after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.