FLUTICASONE/UMECLIDINIUM/VILANTEROL POWDER INHALER - ORAL

FLUTICASONE/UMECLIDINIUM/VILANTEROL POWDER INHALER - ORAL

PHONETIC PRONUNCIATION: (floo-TIK-a-sone/ue-ME-kli-DIN-ee-um/vye-LAN-ter-ol)

COMMON BRAND NAME(S): Trelegy Ellipta

GENERIC NAME(S): fluticasone furoate/umeclidinium bromide/vilanterol trifenat

Uses

USES: This product is used to control and prevent symptoms (such as wheezing and shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchitis and emphysema). Controlling symptoms of breathing problems helps you stay active. This inhaler contains 3 medications: fluticasone, umeclidinium, and vilanterol. Fluticasone belongs to a class of drugs known as corticosteroids. It works by reducing swelling of the airways in the lungs to make breathing easier. Umeclidinium belongs to a class of drugs known as anticholinergics and vilanterol is a LABA medication. Both drugs work by relaxing the muscles around the airways in the lungs so they open up to make breathing easier. Both drugs are also known as bronchodilators. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden shortness of breath. If sudden breathing problems occur, use your quick-relief inhaler as prescribed. This medication is not approved to treat asthma.


How to use FLUTICASONE/UMECLIDINIUM/VILANTEROL POWDER INHALER - ORAL

HOW TO USE: Read the Patient Information Leaflet and Instructions for Use provided by your pharmacist before you start using this medication and each time you get a refill. Follow the illustrated directions for the proper use of this medication. If you have any questions, ask your doctor or pharmacist. Inhale this medication by mouth as directed by your doctor, usually once daily. Do not open the cover of the inhaler until you are ready to use it. Each time you open the cover, you prepare a dose of the medication. If you open and close the cover without inhaling the medication, you will lose the dose. To avoid wasting a dose, do not close the cover until after you have inhaled the medication. You may or may not taste/feel the drug when you inhale. Do not exhale into the device. Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time every day. Do not use it more than one time each day. Do not increase your dose, use this medication more often, or stop using it without first consulting your doctor. Your condition will not improve any faster, and your risk of side effects will increase. To prevent dry mouth, hoarseness, and oral yeast infections from developing, gargle and rinse your mouth with water after each use. Do not swallow the rinse water. If you are using other inhalers at the same time, wait at least 1 minute between the use of each medication. If you have been using a quick-relief inhaler (such as albuterol, also called salbutamol in some countries) on a regular daily schedule (such as 4 times daily), you must stop this schedule and only use the quick-relief inhaler as needed for sudden shortness of breath. Consult your doctor for details. Learn which of your inhalers you should use every day and which you should use if your breathing suddenly worsens (quick-relief drugs). Ask your doctor ahead of time what you should do if you have new or worsening cough or shortness of breath, wheezing, increased sputum, waking up at night with trouble breathing, if you use your quick-relief inhaler more often, or if your quick-relief inhaler does not seem to be working well. Learn when you can treat sudden breathing problems by yourself and when you must get medical help right away. If you are regularly taking corticosteroids by mouth (such as prednisone), continue to follow your doctor's instructions on taking them. Do not stop taking them. Your doctor may want you to reduce your dose gradually. Tell your doctor if your condition does not get better or if it gets worse.

Side Effects

SIDE EFFECTS: Dry/irritated throat, hoarseness, or coughing may occur as your body adjusts to the medication. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: white patches in your mouth or on your tongue, signs of infection (such as fever, chills, persistent sore throat), increased thirst/urination, bone pain, difficult/painful urination, shaking (tremor), muscle cramps/weakness, mental/mood changes (such as depression, mood swings, nervousness, agitation), easy bruising/bleeding. This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Infrequently, this medication may cause sudden, severe wheezing/trouble breathing immediately after you use it. If this happens, use your quick-relief inhaler and get medical help right away. Get medical help right away if you have any very serious side effects, including: chest pain, fast/irregular heartbeat, severe dizziness, fainting, eye pain/swelling/redness, vision changes (such as seeing rainbows around lights at night, blurred vision). A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to fluticasone, umeclidinium, or vilanterol, or if you have any other allergies. This product may contain inactive ingredients (such as milk proteins), which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: current/past infections (such as tuberculosis, herpes), heart problems (such as chest pain, irregular heartbeat), high blood pressure, bone loss (osteoporosis), personal or family history of eye problems (such as cataracts, glaucoma), difficulty urinating (such as due to an enlarged prostate), seizures, overactive thyroid, diabetes, liver disease. This product may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using this product, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death). Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using this product safely. This product can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details. If you have switched from a corticosteroid taken by mouth (such as prednisone tablets) to this inhaler within the past 12 months, or if you have been using this product in higher-than-usual doses for a long time, it may be more difficult for your body to respond to physical stress. Before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used a corticosteroid taken by mouth within the past 12 months. Tell your doctor right away if you develop unusual/extreme tiredness or weight loss. Carry a warning card or medical ID bracelet that says you use (or have used) corticosteroid medications. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). This medication may slow down a child's growth if used for a long time. The effect on final adult height is unknown. See the doctor regularly so your child's height can be checked. Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Other medications can affect the removal of fluticasone from your body, which may affect how fluticasone works. Examples include boceprevir, HIV protease inhibitors (such as lopinavir, ritonavir), some azole antifungals (such as ketoconazole), among others. Do not use other anticholinergic drugs (such as ipratropium, tiotropium) or LABA drugs (such as formoterol, salmeterol) while using this medication.

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: shaking (tremor), chest pain, fast/irregular heartbeat, seizures.

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Faq for FLUTICASONE/UMECLIDINIUM/VILANTEROL POWDER INHALER - ORAL

Fluticasone/umeclidinium/vilanterol powder inhaler is used to treat chronic obstructive pulmonary disease (COPD) in adults.

This medication works by reducing inflammation in the airways, relaxing the muscles around the airways, and improving breathing.

Common side effects may include headache, cough, sore throat, sinusitis, and pneumonia. Serious side effects are rare but could include increased heart rate, high blood pressure, or chest pain. It is important to seek medical attention if any severe side effects occur.

Follow the instructions provided by your healthcare professional. Typically, the medication is inhaled once daily. Rinse your mouth after use to prevent any potential thrush infections.

This medication is not approved for use in children. It is only intended for use in adults with COPD.

It is important to discuss all of your current medications with your doctor before starting fluticasone/umeclidinium/vilanterol powder inhaler. Certain medications may interact and cause unwanted side effects or decreased effectiveness.

Individual responses may vary, but some improvement in symptoms can be seen within a few days. It may take several weeks of consistent use for the full benefits of the medication to be realized.

No, it is important to continue using the inhaler as prescribed by your doctor, even if your symptoms improve. Stopping the medication abruptly may cause a relapse or worsening of symptoms.

If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and continue with your regular schedule. Do not take a double dose to make up for the missed one.

- Fluticasone is a corticosteroid that reduces inflammation in the airways. - Umeclidinium is an anticholinergic that helps to relax the muscles around the airways. - Vilanterol is a long-acting beta2-agonist that helps to widen the airways, making it easier to breathe.

- This medication is used in the treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, to improve breathing and reduce symptoms such as coughing, wheezing, and shortness of breath.

- This medication is usually inhaled once daily. Follow the instructions provided by your doctor or pharmacist on how to properly use the inhaler. Generally, you will need to breathe in deeply and exhale fully before inhaling the medication. Rinse your mouth with water after each use to prevent mouth or throat infections.

- Common side effects may include headache, throat irritation, cough, dry mouth, or hoarseness. Inform your doctor if these side effects persist or worsen. Serious side effects may include increased blood pressure, heart problems, or worsening breathing difficulties. Seek immediate medical attention if you experience any chest pain or irregular heartbeats.



Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.