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Trelegy Ellipta contains three active substances called fluticasone furoate, umeclidinium bromide and vilanterol. Fluticasone furoate belongs to a group of medicines called corticosteroids, often simply called steroids. Umeclidinium bromide and vilanterol belong to a group of medicines called long-acting beta2-adrenergic agonist (LABA) bronchodilators. ICS medicines such as fluticasone furoate help to decrease inflammation in the lungs. Inflammation in the lungs can lead to breathing problems. Anticholinergic medicines such as umeclidinium and LABA medicines such as vilanterol help the muscles around the airways in your lungs stay relaxed to prevent symptoms such as wheezing, cough, chest tightness, and shortness of breath. These symptoms can happen when the muscles around the airways tighten. This makes it hard to breathe. Trelegy Ellipta should be used every day and not only when you have breathing problems or other symptoms of COPD. It should not be used to relieve a sudden attack of breathlessness or wheezing. If you get this sort of attack you must use a quick-acting inhaler (such as salbutamol). TRELEGY ELLIPTA is a prescription medicine used long term (chronic) to treat people with: How to use Do not use TRELEGY ELLIPTA unless your doctor has taught you how to use the inhaler and you understand how to use it correctly. Use TRELEGY ELLIPTA exactly as your doctor tells you to use it. Do not use TRELEGY ELLIPTA more often than prescribed. Use 1 inhalation of TRELEGY ELLIPTA 1 time each day. Use TRELEGY ELLIPTA at the same time each day. If you miss a dose of TRELEGY ELLIPTA, take it as soon as you remember. Do not take more than 1 inhalation per day. Take your next dose at your usual time. Do not take 2 doses at 1 time. Warnings and precautions Don’t use Trelegy Ellipta: To treat sudden, severe symptoms of COPD or asthma. If you have a severe allergy to milk proteins. Ask your doctor if you are not sure. If you are allergic to fluticasone furoate, umeclidinium, vilanterol, or any of the ingredients in TRELEGY ELLIPTA. See the end of this Patient Information for a complete list of ingredients in TRELEGY ELLIPTA. Warnings and precautions Talk to your doctor before using Trelegy Ellipta if you: have heart problems. have high blood pressure. have seizures. have thyroid problems. have diabetes. have liver problems. have weak bones (osteoporosis). have an immune system problem. have eye problems such as glaucoma, increased pressure in your eye, cataracts, blurred vision, or other changes in vision. TRELEGY ELLIPTA may make your glaucoma worse. are allergic to milk proteins. have prostate or bladder problems, or problems passing urine. TRELEGY ELLIPTA may make these problems worse. have any type of viral, bacterial, parasitic, or fungal infection. are exposed to chickenpox or measles. are pregnant or plan to become pregnant. It is not known if TRELEGY ELLIPTA may harm your unborn baby. Side Effects Like all medicines, this medicine can cause side effects, although not everybody gets them. TRELEGY ELLIPTA can cause serious side effects, including: fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using TRELEGY ELLIPTA to help reduce your chance of getting thrush. pneumonia. People with COPD have a higher chance of getting pneumonia. TRELEGY ELLIPTA may increase the chance of getting pneumonia. Call your doctor if you notice any of the following symptoms: increase in mucus (sputum) production chills change in mucus color increased cough fever increased breathing problems weakened immune system and increased chance of getting infections (immunosuppression). reduced adrenal function (adrenal insufficiency). Adrenal insufficiency is a condition where the adrenal glands do not make enough steroid hormones. This can happen when you stop taking oral corticosteroid medicines (such as prednisone) and start taking a medicine containing an ICS (such as TRELEGY ELLIPTA). During this transition period, when your body is under stress from fever, trauma (such as a car accident), infection, surgery, or worse COPD or asthma symptoms, adrenal insufficiency can get worse and may cause death. Symptoms of adrenal insufficiency include: feeling tired nausea and vomiting lack of energy low blood pressure (hypotension) weakness Storage Information Do not store above 30°C. Keep the inhaler inside the sealed tray in order to protect from moisture and only remove immediately before first use. Once the tray is opened, the inhaler can be used for up to 1 month, starting from the date of opening the tray. If stored in a refrigerator, allow the inhaler to return to room temperature for at least one hour before use. Drug Interactions Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. TRELEGY ELLIPTA and certain other medicines may interact with each other. This may cause serious side effects. Especially tell your doctor if you take: anticholinergics (including tiotropium, ipratropium, aclidinium) atropine other LABA (including salmeterol, formoterol, arformoterol, olodaterol, and indacaterol) antifungal or anti-HIV medicines. Ingredients The active substances are fluticasone furoate, umeclidinium bromide and vilanterol. The other ingredients are lactose monohydrate and magnesium stearate.
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