Pronunciation:

ue-mek-li-DIN-ee-um

Brand Names:

• Incruse Ellipta

Dosage Forms:

• Powder

Classifications:

Therapeutic—

Respiratory Agent

Pharmacologic—

Antimuscarinic

Uses of This Medicine:

Umeclidinium is used as maintenance treatment in patients with chronic obstructive pulmonary disease (COPD).

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Use of umeclidinium is not for use in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of umeclidinium in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Potassium Citrate

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amantadine
• Amifampridine
• Buprenorphine
• Bupropion
• Clozapine
• Codeine
• Donepezil
• Glucagon
• Glycopyrrolate
• Glycopyrronium Tosylate
• Methacholine
• Oxycodone
• Quetiapine
• Revefenacin
• Scopolamine
• Secretin Human
• Tapentadol
• Tiotropium

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to milk proteins—Should not be used in patients with these conditions.

• Bladder blockage or
• Enlarged prostate (BPH, prostatic hyperplasia) or
• Heart disease or
• Narrow-angle glaucoma or
• Problems passing urine—Use with caution. May make these conditions worse.

• Liver disease, severe—Use has not been studied in patients with this condition.

Proper Use of This Medicine:

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop using this medicine without telling your doctor. To do so may increase the chance of side effects.

Inhaled umeclidinium comes with patient information leaflet. Read the directions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the inhaler, ask your doctor to show you what to do. Also, ask your doctor to check regularly how you use the inhaler to make sure you are using it properly.

Use this medicine at the same time each day to prevent COPD attacks.

Do not stop using this medicine or other breathing medicines that your doctor has prescribed for you unless you have discussed this with your doctor.

To use the inhaler:

• This medicine comes in a foil tray. Peel back the lid to open the tray.
• Slide the inhaler cover down until you hear a clicking sound. The inhaler is now ready to use. Do not open the cover of the inhaler until you are ready to use it. If you open and close the inhaler without inhaling the dose, you will lose a dose of the medicine.
• Turn your head away from the inhaler, and breathe out fully. Do not breathe into the inhaler.
• Put the mouthpiece between your lips, and close your lips around the mouthpiece. Do not block the air vent with your fingers.
• Breathe in through your mouth as deeply as you can until you have taken a full deep breath. Do not breathe in through your nose.
• Remove the mouthpiece from your mouth and hold your breath for about 3 to 4 seconds or for as long as you can before breathing out slowly. This gives the medicine time to settle in your airways and lungs.
• When you are finished, you may clean the mouthpiece with a dry tissue, if needed, before closing the inhaler cover.
• The inhaler has a window that shows the number of doses that are left. This tells you when you are getting low on medicine. When the inhaler has less than 10 doses left, the left half of the counter will show up in red to remind you to refill your prescription.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For inhalation dosage form (powder):
  • For maintenance treatment of COPD:
    • Adults—One inhalation once a day. Do not take more than one inhalation every 24 hours.
    • Children—Use is not recommended.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep this medicine in a dry place away from heat and sunlight. Throw it away 6 weeks after opening or when the counter reads "0".

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.

Tell your doctor if you are also using any other medicine for your COPD. Your doctor may want you to use it only during a severe COPD attack. Follow your doctor's instructions on how you should take your medicine.

This medicine should not be used if you are having a severe COPD attack, or if symptoms of a COPD attack has already started. Your doctor may prescribe another medicine for you to use in case of an acute COPD attack. If the other medicine does not work as well, tell your doctor right away.

Talk with your doctor or get medical care right away if:

• Your symptoms do not improve after using this medicine for 1 week or if they become worse.
• Your short-acting inhaler does not seem to work as well as it used to and you need it more often than normal (eg, you use 1 whole canister of the short-acting inhaler in 8 weeks time, or you need to use 4 or more inhalations of the short-acting inhaler for 2 or more days in a row).
• You have a big decrease in your peak flow when measured as directed by your doctor.

This medicine should not be used together with atropine (eg, Atreza®) or similar inhaled medicines, such as aclidinium (eg, Tudorza® Pressair®), ipratropium (eg, Atrovent®, Atrovent® HFA), or tiotropium (eg, Spiriva®).

This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. Paradoxical bronchospasm may be life-threatening. Check with your doctor right away if you have coughing, difficulty breathing, shortness of breath, or wheezing after using this medicine.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

Check with your doctor right away if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Check with your doctor right away if you have decrease in urine volume, decrease in the frequency of urination, difficulty in passing urine, or painful urination.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Bladder pain

bloody or cloudy urine

body aches or pain

chest pain

chills

cough

difficult, burning, or painful urination

difficulty with breathing

dryness or soreness of the throat

ear congestion

fast, pounding, or irregular heartbeat or pulse

fever

frequent urge to urinate

hoarseness

loss of voice

lower back or side pain

sneezing

sore throat

tender, swollen glands in the neck

tightness in the chest

trouble in swallowing

unusual tiredness or weakness

voice changes

Rare

Dizziness

fainting

Incidence not known

Blindness

blurred vision

decreased urination

difficulty in passing urine (dribbling)

eye pain or discomfort

hives, itching, skin rash

hoarseness

irritation

joint pain, stiffness, or swelling

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

nausea

redness of the skin

swelling of the eyelids, face, lips, hands, or feet

tearing

tightness in the chest

troubled swallowing

vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Back, neck, arm, or leg pain

belching

bruise

depression

diarrhea

difficulty in moving

dizziness or lightheadedness

feeling of constant movement of self or surroundings

heartburn

indigestion

muscle cramps or stiffness

sensation of spinning

stomach discomfort, upset, or pain toothache

upper abdominal or stomach pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.