Země: Evropská unie
Jazyk: angličtina
Zdroj: EMA (European Medicines Agency)
indacaterol, Glycopyrronium bromide
Novartis Europharm Limited
R03AL04
indacaterol, glycopyrronium bromide
Adrenergics in combinations with anticholinergics incl. triple combinations with corticosteroids
Pulmonary Disease, Chronic Obstructive
Xoterna Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Revision: 16
Authorised
2013-09-18
39 B. PACKAGE LEAFLET 40 PACKAGE LEAFLET: INFORMATION FOR THE USER XOTERNA BREEZHALER 85 MICROGRAMS/43 MICROGRAMS INHALATION POWDER, HARD CAPSULES indacaterol/glycopyrronium 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 Xoterna Breezhaler is and what it is used for 2. What you need to know before you use Xoterna Breezhaler 3. How to use Xoterna Breezhaler 4. Possible side effects 5. How to store Xoterna Breezhaler 6. Contents of the pack and other information Instructions for use of Xoterna Breezhaler inhaler 1. WHAT XOTERNA BREEZHALER IS AND WHAT IT IS USED FOR WHAT XOTERNA BREEZHALER IS This medicine contains two active substances called indacaterol and glycopyrronium. These belong to a group of medicines called bronchodilators. WHAT XOTERNA BREEZHALER IS USED FOR This medicine is used to make breathing easier for adult patients who have breathing difficulties due to a lung disease called chronic obstructive pulmonary disease (COPD). In COPD the muscles around the airways tighten. This makes breathing difficult. This medicine blocks the tightening of these muscles in the lungs, making it easier for air to get in and out of the lungs. If you use this medicine once a day, it will help to reduce the effects of COPD on your everyday life. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE XOTERNA BREEZHALER DO NOT USE XOTERNA BREEZHALER - if you are allergic to indacaterol or glycopyrronium or any of the other ingredients of this medicine (listed in section 6). 41 WARNINGS AND PRECAUTIONS Talk Přečtěte si celý dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Xoterna Breezhaler 85 micrograms/43 micrograms inhalation powder hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 143 micrograms of indacaterol maleate equivalent to 110 micrograms of indacaterol and 63 micrograms of glycopyrronium bromide equivalent to 50 micrograms of glycopyrronium. Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 110 micrograms of indacaterol maleate equivalent to 85 micrograms of indacaterol and 54 micrograms of glycopyrronium bromide equivalent to 43 micrograms of glycopyrronium. Excipient(s) with known effect Each capsule contains 23.5 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation powder, hard capsule (inhalation powder). Capsules with transparent yellow cap and natural transparent body containing a white to almost white powder, with the product code “IGP110.50” printed in blue under two blue bars on the body and the company logo ( ) printed in black on the cap. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Xoterna Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is the inhalation of the content of one capsule once daily using the Xoterna Breezhaler inhaler. Xoterna Breezhaler is recommended to be administered at the same time of the day each day. If a dose is missed, it should be taken as soon as possible on the same day. Patients should be instructed not to take more than one dose in a day. Special populations _Elderly population _ Xoterna Breezhaler can be used at the recommended dose in elderly patients (75 years of age and older). 3 _Renal impairment _ Xoterna Breezhaler can be used at the recommended dose in patients with mild to moderate renal impairment. In patients with severe renal impair Přečtěte si celý dokument