Ország: Európai Unió
Nyelv: angol
Forrás: EMA (European Medicines Agency)
indacaterol, Mometasone furoate
Novartis Europharm Limited
R03AK
indacaterol, mometasone
Drugs for obstructive airway diseases,
Asthma
Bemrist Breezhaler is indicated as a maintenance treatment of asthma in adults and adolescents 12 years of age and older not adequately controlled with inhaled corticosteroids and inhaled short acting beta2-agonists.
Revision: 6
Authorised
2020-05-30
51 B. PACKAGE LEAFLET 52 PACKAGE LEAFLET: INFORMATION FOR THE USER BEMRIST BREEZHALER 125 MICROGRAMS/62.5 MICROGRAMS INHALATION POWDER, HARD CAPSULES BEMRIST BREEZHALER 125 MICROGRAMS/127.5 MICROGRAMS INHALATION POWDER, HARD CAPSULES BEMRIST BREEZHALER 125 MICROGRAMS/260 MICROGRAMS INHALATION POWDER, HARD CAPSULES indacaterol/mometasone furoate 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 Bemrist Breezhaler is and what it is used for 2. What you need to know before you use Bemrist Breezhaler 3. How to use Bemrist Breezhaler 4. Possible side effects 5. How to store Bemrist Breezhaler 6. Contents of the pack and other information Instructions for use of Bemrist Breezhaler inhaler 1. WHAT BEMRIST BREEZHALER_ _IS AND WHAT IT IS USED FOR WHAT BEMRIST BREEZHALER_ _IS AND HOW IT WORKS Bemrist Breezhaler _ _ contains two active substances called indacaterol and mometasone furoate. Indacaterol belongs to a group of medicines called bronchodilators. It relaxes the muscles of the small airways in the lungs. This helps to open the airways and makes it easier for air to get in and out of the lungs. When it is taken regularly, it helps the small airways to remain open. Mometasone furoate belongs to a group of medicines called corticosteroids (or steroids). Corticosteroids reduce the swelling and irritation (inflammation) in the small airways in the lungs and so gradually ease breathing problems. Corticosteroids also help to prevent attacks of asthma. WHAT BEMRIST BREEZHALER IS USED FOR Bemris Olvassa el a teljes dokumentumot
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Bemrist Breezhaler 125 micrograms/62.5 micrograms inhalation powder, hard capsules Bemrist Breezhaler 125 micrograms/127.5 micrograms inhalation powder, hard capsules Bemrist Breezhaler 125 micrograms/260 micrograms inhalation powder, hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Bemrist Breezhaler 125 micrograms/62.5 micrograms inhalation powder, hard capsules Each capsule contains 150 mcg of indacaterol (as acetate) and 80 mcg of mometasone furoate. Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 125 mcg of indacaterol (as acetate) and 62.5 mcg of mometasone furoate. Bemrist Breezhaler 125 micrograms/127.5 micrograms inhalation powder, hard capsules Each capsule contains 150 mcg of indacaterol (as acetate) and 160 mcg of mometasone furoate. Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 125 mcg of indacaterol (as acetate) and 127.5 mcg of mometasone furoate. Bemrist Breezhaler 125 micrograms/260 micrograms inhalation powder, hard capsules Each capsule contains 150 mcg of indacaterol (as acetate) and 320 mcg of mometasone furoate. Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 125 mcg of indacaterol (as acetate) and 260 mcg of mometasone furoate. Excipient(s) with known effect Each capsule contains approximately 25 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation powder, hard capsule (inhalation powder). Bemrist Breezhaler 125 micrograms/62.5 micrograms inhalation powder, hard capsules Transparent (uncoloured) capsules containing a white powder, with the product code “IM150-80” printed in blue above one blue bar on the body and with the product logo printed in blue and surrounded by two blue bars on the cap. Bemrist Breezhaler 125 micrograms/127.5 micrograms inhalation powder, hard capsules Transparent (uncoloured) capsules containing a white powder, with Olvassa el a teljes dokumentumot