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Anoro Ellipta (Generic Umeclidinium and Vilanterol Oral Inhalation)

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WARNING

Umeclidinium and vilanterol are used in conjunction to treat chronic obstructive pulmonary disease, which causes wheezing, shortness of breath, coughing, and chest tightness (COPD; a group of diseases that affect the lungs and airways, which includes chronic bronchitis and emphysema). Anticholinergics are a group of drugs that includes umeclidinium. Vilanterol belongs to a group of drugs known as long-acting beta-agonists (LABAs). These drugs ease breathing difficulties by relaxing and widening airways in the lungs.

Why is this medication prescribed?

Adults with chronic obstructive pulmonary disease can take umeclidinium and vilanterol together to reduce their symptoms of wheezing, shortness of breath, coughing, and chest tightness (COPD; a group of diseases that affect the lungs and airways, which includes chronic bronchitis and emphysema). Anticholinergics are a group of drugs that includes umeclidinium. Vilanterol belongs to a group of drugs known as long-acting beta-agonists (LABAs). Breathing becomes simpler as a result of the lungs’ opening and relaxation.

How should this medicine be used?

Umeclidinium and vilanterol are available as a powder that must be inhaled by mouth into a specialised inhaler. Typically, it is breathed in once daily. Inhale vilanterol and umeclidinium at roughly the same time each day. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. As recommended, take vilanterol and umeclidinium. Use it only as directed by your doctor, neither more nor less often.

Umeclidinium and vilanterol inhalation should not be used to treat COPD attacks that occur suddenly. For use during attacks, your doctor will prescribe a short-acting beta agonist drug like albuterol (Accuneb, Proair, Proventil, Ventolin). Your doctor will likely advise you to discontinue regularly taking this type of medicine but to keep using it to treat attacks if you were doing so before starting therapy with umeclidinium and vilanterol.

COPD that is rapidly deteriorating should not be treated with umeclidinium and vilanterol inhalation. If your breathing issues worsen, if you need to use your short-acting inhaler more frequently to treat COPD attacks, or if your short-acting inhaler does not improve your symptoms, call your doctor or seek emergency medical attention.

Inhaling umeclidinium with vilanterol manages COPD but does not treat it. Even if you feel well, keep taking umeclidinium and vilanterol. Without consulting your physician, do not discontinue taking umeclidinium with vilanterol. Your symptoms can worsen if you stop using umeclidinium and vilanterol inhalation.

Before using umeclidinium with vilanterol inhalation for the first time, request instructions from your physician, pharmacist, or respiratory therapist. He or she can watch you as you practise using your inhaler.

Follow these steps to use the inhaler:

  1. Remove a new inhaler from the box and the foil tray before using it for the first time. Specify the date you opened the tray and the day six weeks later when you need to replace the inhaler in the “Tray opened” and “Discard” blanks on the inhaler label.
  2. Slide the cover down to expose the mouthpiece when you’re prepared to take your dose and wait until it clicks. You will squander the medication if you repeatedly open and shut the inhaler without taking your prescribed dose.
  3. Each time you open the cover, the counter will decrement by 1 each time. Your inhaler won’t deliver the medication if the counter isn’t counting down. Call your pharmacist or doctor if your inhaler isn’t counting down.
  4. Breathe out as far as is comfortable for you while keeping the inhaler away from your lips. Never exhale into the mouthpiece.
  5. Put the mouthpiece in the middle of your lips, then tightly seal them around it. Inhale deeply and steadily for a long time via your mouth. Never inhale via your nose. Be mindful not to use your fingers to obstruct the air vent.
  6. After taking the inhaler out of your mouth, hold your breath for as long as you can comfortably for 3 to 4 seconds. Exhale gradually.
  7. The medication that the inhaler releases may or may not taste or feel good to you. Do not breathe in another dose, even if you do not. Call your doctor or pharmacist if you are unsure that you are receiving your prescribed dose of umeclidinium with vilanterol.
  8. If necessary, you can use a dry tissue to clean the mouthpiece. To seal the inhaler, raise the cover as high over the mouthpiece as it will go.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before using umeclidinium and vilanterol,

  • If you have any allergies to umeclidinium, vilanterol, other drugs, milk protein, or any of the ingredients in umeclidinium and vilanterol inhalation, let your doctor and pharmacist know right away. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
  • Inform your physician if you use any additional LABAs, such as salmeterol, arformoterol (Brovana), formoterol (Perforomist), indacaterol (Arcapta), olodaterol (Striverdi Respimat, in Stiolto Respimat), or formoterol (in Bevespi Aerosphere, Duaklir Pressair, Dulera, or Symbicort) (Serevent, in Advair). Your doctor will advise you on which medications to take and which to quit using.
  • Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Incorporate any of the following: antifungals like voriconazole (Vfend), itraconazole (Onmel, Sporanox), and ketoconazole; antihistamines; atenolol (Tenormin), labetalol (Trandate), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal, Innopran) are examples of beta-blockers. Other medications for COPD include aclidinium (Tudorza Pressair), ipratropium (Atrovent HFA), and tiotropium (Spiriva); drugs for irritable bowel syndrome, motion sickness, Parkinson’s disease, ulcers, or urinary issues; and nefazodone, a dditionally, inform your doctor and pharmacist if you are currently taking any of the following drugs or have stopped taking them within the previous two weeks: antidepressants like amitriptyline, amoxapine, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor, Zonalon), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil),Escitalopram (Lexapro); flecainide (Tambocor); fluconazole (Diflucan); haloperidol (Haldol); ibutilide (Corvert); levofloxacin; methadone (Dolophine, Methadose); moxifloxacin (Avelox); ondansetron (Zuplenz, Zofran); pentamidine (Pentam); pimozide (O (Parnate). Umeclidinium and vilanterol may also interact with a wide range of other medications, so it’s important to let your doctor know about all of your current prescriptions—even ones that aren’t on this list. The dosage of your drugs may need to be adjusted, and your health may need to be closely watched for any negative effects.
  • Identify your asthma to your doctor. Umeclidinium and vilanterol should not be used unless a steroid inhaler is also being used, according to your doctor.
  • Inform your doctor if you have or have ever had high blood pressure, an irregular heartbeat, seizures, QT prolongation (an irregular heart rhythm that can cause fainting, unconsciousness, seizures, or sudden death), diabetes, glaucoma (an eye disease), urinary retention (difficulty urinating), problems with the prostate or bladder, or heart, thyroid, or liver disease.
  • If you are breastfeeding a child or intend to become pregnant, let your doctor know. Call your doctor if you get pregnant while taking umeclidinium and vilanterol.
  • You should be aware that vilanterol and umeclidinium inhalation occasionally results in wheezing and breathing difficulties right away. Make a quick call to your doctor if this occurs. Unless your doctor advises you to, stop using umeclidinium and vilanterol inhalation.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

The missed dose should be taken as soon as you remember. If the next dose is soon due, skip the missed one and carry on with your regular dosing plan. Never use more than one dose per day, and never take two doses at once to make up for missing ones.

What side effects can this medication cause?

Vilanterol with umeclidinium may have negative side effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Shaking of a body part that you are unable to control
  • Nervousness
  • Congestion and a sore throat
  • Constipation
  • Diarrhea
  • Arms or legs hurt
  • Spasms of muscles
  • Sore neck
  • Back ache
  • Aching joints
  • Continent pain
  • Headache
  • Nausea
  • Dizziness
  • Toothache

Some adverse effects can be very harmful. Stop using umeclidinium with vilanterol, call your doctor right away, and seek emergency medical attention if you have any of the following symptoms:

  • Rash
  • Hives
  • Itching
  • Face, mouth, or tongue swelling
  • Rapid, pounding, or erratic heartbeat
  • Chest pain
  • Eye discomfort, redness, or soreness; hazy vision; seeing vivid colours surrounding lights; and, occasionally, nausea and vomiting
  • Having trouble peeing, urinating in a weak stream, or dripping urine
  • Uncomfortable or frequent urination

Other adverse effects from umeclidinium and vilanterol are possible. If you experience any strange issues while taking this drug, call your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication out of children’s reach and tightly closed in the foil tray it was packaged in. Store it away from sunshine, excessive heat, and moisture at room temperature (not in the bathroom). When the dose counter reaches 0 (six weeks after removing the inhaler from the foil tray) or each blister has been utilised, whichever occurs first, dispose of the inhaler.

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medicines website at http://goo.gl/c4Rm4p for additional information.

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Overdose signs could include the following:

  • Seizures
  • Chest pain
  • Breathing difficulties
  • Dizziness
  • A hammering, rapid, or erratic heartbeat
  • Nervousness
  • Headache
  • Shaking of a body part that you are unable to control
  • Muscle weakness or cramps
  • Mouth ache
  • Flushed, hot, and dry skin
  • Nausea
  • Excessive fatigue
  • Having trouble falling or staying asleep
  • Distorted vision
  • Dilated eyes
  • Hearing voices or perceiving nonexistent objects (hallucinating)

What other information should I know?

Keep all of your doctor’s appointments.

Inform the lab staff and your doctor that you are taking umeclidinium and vilanterol prior to any laboratory test (particularly those involving methylene blue).

No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

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