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Umeclidinium powder

Generic Name: umeclidinium (ue-ME-kli-DIN-ee-um)
Brand Name: Incruse Ellipta

Umeclidinium powder is used for:

Treating chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It may also be used for other conditions as determined by your doctor.

Umeclidinium powder is an anticholinergic medicine. It works by relaxing and widening the airways in the lungs, making it easier to breathe.

Do NOT use umeclidinium powder if:

  • you are allergic to any ingredient in umeclidinium powder
  • you have a severe allergy to milk protein
  • you are having severe breathing problems (eg, sudden, severe onset or worsening of COPD symptoms [eg, chest tightness, cough, shortness of breath, wheezing])
  • you are taking aclidinium, atropine, ipratropium, or tiotropium

Contact your doctor or health care provider right away if any of these apply to you.

Before using umeclidinium powder:

Some medical conditions may interact with umeclidinium powder. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances (including milk protein)
  • if you have heart problems, eye problems (eg, glaucoma), prostate problems (eg, enlargement of the prostate), bladder problems, or urinary blockage or trouble urinating

Some MEDICINES MAY INTERACT with umeclidinium powder. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Anticholinergic medicines (eg, aclidinium, ipratropium, tiotropium) or atropine because they may increase the risk of umeclidinium powder's side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if umeclidinium powder may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use umeclidinium powder:

Use umeclidinium powder as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet with detailed instructions for use is available with umeclidinium powder. Talk to your pharmacist if you have questions about this information.
  • A health care provider will teach you how to use umeclidinium powder at home. Be sure you understand how to use umeclidinium powder. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • To prepare a dose of umeclidinium powder, remove the inhaler from the foil tray. Open the cover of the inhaler until you hear a click. The counter will count down by 1 number. Your inhaler is now ready to use.
  • Do not open the cover of the inhaler until you are ready to use it. To avoid wasting doses after the inhaler is ready, do not close the cover until after you have inhaled the medicine.
  • To use a dose of umeclidinium powder, hold the inhaler away from your mouth and breathe out fully. Do not breathe out into the mouthpiece. Place the mouthpiece between your lips, and close your lips firmly around it. Take a long, deep breath through your mouth. Do not block the air vents of the inhaler with your fingers. Remove the inhaler from your mouth and hold your breath for about 3 to 4 seconds, or as long as comfortable for you. Breathe out slowly.
  • Before you close the cover, you may clean the mouthpiece with a dry tissue if needed. Slide the cover up and over the mouthpiece when you are done.
  • You may not taste or feel the medicine, even when you are using the inhaler correctly. Do NOT use another dose if you do not taste or feel the medicine. If you are not sure if you are receiving your dose, contact your doctor or pharmacist.
  • If you are using other inhaled medicines, wait a few minutes between using umeclidinium powder and other inhalers, unless your doctor tells you otherwise.
  • Do not take the device apart. Never wash the mouthpiece or any other part of the inhaler. Keep it dry. Store umeclidinium powder in a dry place.
  • Store umeclidinium powder in the unopened foil tray until right before the first use. Throw umeclidinium powder away 6 weeks after you opening the foil tray or after the dose counter reads "0," whichever comes first.
  • Use umeclidinium powder on a regular schedule to get the most benefit from it. Using umeclidinium powder at the same time each day will help you remember to use it. Do not stop using umeclidinium powder even if you feel better unless your doctor tells you to.
  • If you miss a dose of umeclidinium powder, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once. Do not use umeclidinium powder more often than 1 time every 24 hours.

Ask your health care provider any questions you may have about how to use umeclidinium powder.

Important safety information:

  • Umeclidinium powder will not stop sudden breathing problems once they have already started. Be sure to always carry a rescue inhaler (eg, albuterol) with you to use during sudden breathing problems. If you do not have a rescue inhaler or you have any questions about which medicines should be used during sudden breathing problems, check with your doctor or pharmacist.
  • If you have been regularly using a rescue inhaler, talk with your doctor about how to use it with umeclidinium powder. Rescue inhalers are normally only used with umeclidinium powder to treat breathing problems that may occur between doses.
  • Tell your doctor or dentist that you take umeclidinium powder before you receive any medical or dental care, emergency care, or surgery.
  • If your symptoms become worse, you need to use your rescue inhaler medicine more often than normal, or your rescue inhaler medicine does not work well to treat sudden breathing problems, get medical help right away.
  • Do not stop using umeclidinium powder without checking with your doctor.
  • Umeclidinium powder may sometimes cause severe breathing problems right after you use a dose. If this happens, use your rescue inhaler. Contact your doctor or seek other medical care at once.
  • Lab tests may be performed while you use umeclidinium powder. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Umeclidinium powder should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using umeclidinium powder while you are pregnant. It is not known if this medicine is found in breast milk. Do not breast-feed while taking umeclidinium powder.

Possible side effects of umeclidinium powder:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Cough; mild sore throat; muscle or joint pain; nose or throat irritation; runny or stuffy nose; stomach pain; tooth pain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bruising or dark areas of skin; chest pain; difficult, frequent, or painful urination; eye pain or discomfort; fast or irregular heartbeat; red eyes; shakiness; vision changes (eg, blurred vision, seeing halos or bright colors around lights); weak urine stream or drips; worsening of COPD symptoms (eg, increased wheezing, coughing, chest tightness, shortness of breath).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of umeclidinium powder:

Store umeclidinium powder between at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep umeclidinium powder out of the reach of children and away from pets.

General information:

  • If you have any questions about umeclidinium powder, please talk with your doctor, pharmacist, or other health care provider.
  • Umeclidinium powder is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take umeclidinium powder or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about umeclidinium powder. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to umeclidinium powder. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using umeclidinium powder.

Review Date: August 8, 2016

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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