País: União Europeia
Língua: inglês
Origem: EMA (European Medicines Agency)
fluticasone furoate, umeclidinium bromide, vilanterol trifenatate
GlaxoSmithKline Trading Services Limited
R03AL08
fluticasone furoate, umeclidinium, vilanterol
Drugs for obstructive airway diseases,
Pulmonary Disease, Chronic Obstructive
Elebrato Ellipta is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting β2-agonist.
Revision: 12
Authorised
2017-11-15
31 B. PACKAGE LEAFLET 32 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ELEBRATO ELLIPTA 92 MICROGRAMS/55 MICROGRAMS/22 MICROGRAMS INHALATION POWDER, PRE-DISPENSED fluticasone furoate/umeclidinium/vilanterol READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Elebrato Ellipta is and what it is used for 2. What you need to know before you use Elebrato Ellipta 3. How to use Elebrato Ellipta 4. Possible side effects 5. How to store Elebrato Ellipta 6. Contents of the pack and other information Step-by-step instructions 1. WHAT ELEBRATO ELLIPTA IS AND WHAT IT IS USED FOR WHAT ELEBRATO ELLIPTA IS Elebrato 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 bronchodilators. WHAT ELEBRATO ELLIPTA IS USED FOR Elebrato Ellipta is used to treat chronic obstructive pulmonary disease _ _ ( COPD ) in adults. COPD is a long- term condition characterised by breathing difficulties that slowly get worse. In COPD the muscles around the airways tighten, making breathing difficult. This medicine widens these muscles in the lungs, reducing the swelling and irritation in the small air passages and making it easier for air to get in and out of the lungs. When used regularly, it can help to control your breathing difficulties and reduce the effects of COPD on your everyday life. ELE Leia o documento completo
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Elebrato Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 92 micrograms fluticasone furoate, 65 micrograms umeclidinium bromide equivalent to 55 micrograms umeclidinium and 22 micrograms vilanterol (as trifenatate). This corresponds to a pre-dispensed dose of 100 micrograms fluticasone furoate, 74.2 micrograms umeclidinium bromide equivalent to 62.5 micrograms umeclidinium and 25 micrograms vilanterol (as trifenatate). Excipient with known effect Each delivered dose contains approximately 25 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation powder, pre-dispensed (inhalation powder) White powder in a light grey inhaler (Ellipta) with a beige mouthpiece cover and a dose counter. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Elebrato Ellipta is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting β2-agonist or a combination of a long-acting β2-agonist and a long-acting muscarinic antagonist (for effects on symptom control and prevention of exacerbations see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ Posology The recommended and maximum dose is one inhalation once daily, each day at the same time. If a dose is missed the next dose should be inhaled at the usual time the next day. _Special populations _ _Elderly_ No dose adjustment is required in patients 65 years of age or older (see section 5.2). _Renal impairment _ No dose adjustment is required in patients with renal impairment (see section 5.2). _Hepatic impairment _ 3 No dose adjustment is required in patients with mild, moderate or severe hepatic impairment. Elebrato Ellipta Leia o documento completo