País: Malásia
Língua: inglês
Origem: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Mometasone furoate; Indacaterol acetate; Glycopyyronium bromide
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
Mometasone furoate; Indacaterol acetate; Glycopyyronium bromide
30 Capsules and 1 inhaler Units
Siegfried Barbera, S.L.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ ENERZAIR ® BREEZHALER ® INHALATION POWDER HARD CAPSULES Indacaterol Acetate, Glycopyrronium Bromide and Mometasone Furoate (150/50/80 and 150/50/160 micrograms) _________________________________________________________________________________________ 1 WHAT IS IN THIS LEAFLET 1. What Enerzair Breezhaler is used for 2. How Enerzair Breezhaler works 3. Before you use Enerzair Breezhaler 4. How to use Enerzair Breezhaler 5. While you are using it 6. Side effects 7. Storage and Disposal of Enerzair Breezhaler 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Instructions for use of Enerzair Breezhaler Inhaler. WHAT ENERZAIR BREEZHALER IS USED FOR Enerzair Breezhaler is used regularly as treatment for asthma in adults. Asthma is a serious, long-term lung disease where the muscles around the smaller airways become tight (bronchoconstriction) and inflamed. Symptoms come and go and include shortness of breath, wheezing, chest tightness and cough. You should use Enerzair Breezhaler every day and not only when you have breathing problems or other symptoms of asthma. This will ensure that it controls your asthma properly. Do not use this medicine to relieve a sudden attack of breathlessness or wheezing. If you have any questions about how Enerzair Breezhaler works or why this medicine has been prescribed for you, ask your doctor. HOW ENERZAIR BREEZHALER WORKS Enerzair Breezhaler contains three active substances: • indacaterol • glycopyrronium • mometasone furoate Indacaterol and glycopyrronium belong to a group of medicines called bronchodilators. They work in different ways to relax 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 they are taken regularly, they help the small airways to remain open. Mometasone furoate belongs to a group of medicines called corticosteroids (or steroids). Corticosteroids reduce the swelling an Leia o documento completo
Novartis Page 2 Malaysia Package Leaflet 11-Mar-2021 Enerzair Breezhaler 1. NAME OF THE MEDICINAL PRODUCT Enerzair Breezhaler 150/50/80 micrograms inhalation powder, hard capsules Enerzair Breezhaler 150/50/160 micrograms inhalation powder, hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Enerzair Breezhaler 150/50/80 micrograms inhalation powder, hard capsules Enerzair Breezhaler hard capsules are for oral inhalation only. They are also supplied with an Enerzair Breezhaler inhalation device to permit oral inhalation of the contents of the capsule shell. Each capsule contains 173 micrograms of indacaterol acetate equivalent to 150 micrograms of indacaterol, 63 micrograms of glycopyrronium bromide (glycopyrrolate) equivalent to 50 micrograms glycopyrronium and 80 micrograms mometasone furoate. The delivered dose (the dose that leaves the mouthpiece of the inhaler) for 114/46/68 micrograms is equivalent to 114 micrograms indacaterol, 46 micrograms glycopyrronium, and 68 micrograms mometasone furoate. Enerzair Breezhaler 150/50/160 micrograms inhalation powder, hard capsules Enerzair Breezhaler hard capsules are for oral inhalation only. They are also supplied with an Enerzair Breezhaler inhalation device to permit oral inhalation of the contents of the capsule shell. Each capsule contains 173 micrograms of indacaterol acetate equivalent to 150 micrograms of indacaterol, 63 micrograms of glycopyrronium bromide (glycopyrrolate) equivalent to 50 micrograms glycopyrronium and 160 micrograms of mometasone furoate. The delivered dose (the dose that leaves the mouthpiece of the inhaler) for 114/46/136 micrograms is equivalent to 114 micrograms indacaterol, 46 micrograms glycopyrronium and 136 micrograms of mometasone furoate. Excipient(s) with known effect Each capsule contains 25 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation powder, hard capsule (inhalation powder). Enerzair Breezhaler 150 /50/80 micrograms inhalation powder, hard capsules Capsules Leia o documento completo