País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
Budesonide; Formoterol fumarate dihydrate
Orion Corporation
R03AK; R03AK07
Budesonide; Formoterol fumarate dihydrate
320/9 microgram(s)
Inhalation powder
Product subject to prescription which may be renewed (B)
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and budesonide
Marketed
2014-04-11
1 QR Code to URL: oeh.fi/bfie Scan this code or visit www.oeh.fi/bfie to see instructions on how to use Easyhaler PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BUFOMIX EASYHALER, 320 MICROGRAMS/9 MICROGRAMS/INHALATION, INHALATION POWDER Budesonide/formoterol fumarate dihydrate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 or pharmacist. - 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Bufomix Easyhaler 320/9 is and what it is used for 2. What you need to know before you use Bufomix Easyhaler 320/9 3. How to use Bufomix Easyhaler 320/9 4. Possible side effects 5. How to store Bufomix Easyhaler 320/9 6. Contents of the pack and other information 1. WHAT BUFOMIX EASYHALER 320/9 IS AND WHAT IT IS USED FOR Bufomix Easyhaler is an inhaler that is used to treat asthma in adults and adolescents aged 12 – 17 years. It is also used to treat the symptoms of Chronic Obstructive Pulmonary Disease (COPD) in adults aged 18 years and older. It contains two different medicines: budesonide and formoterol fumarate dihydrate. Budesonide belongs to a group of medicines called ‘corticosteroids’. It works by reducing and preventing swelling and inflammation in your lungs. Formoterol fumarate dihydrate belongs to a group of medicines called ‘long-acting beta 2 adrenoceptor agonists’ or ‘bronchodilators’. It works by relaxing the muscles in your airways. This helps you to breathe more easily. ASTHMA For asthma, your doctor will prescribe two asthma inhalers: Bufomix Easyhaler 320/9 and a separate ‘reliever inhaler’. Use Bufomix Easyhaler every day. Thi Leer el documento completo
Health Products Regulatory Authority 28 October 2022 CRN00D3F7 Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bufomix Easyhaler, 320 micrograms/9 micrograms/inhalation, inhalation powder 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each delivered dose (the dose that leaves the mouthpiece) contains: budesonide 320 micrograms/inhalation and formoterol fumarate dihydrate 9 micrograms/inhalation. With the Easyhaler device the delivered dose (ex-actuator) contains similar quantity of active substance as the metered dose (ex-reservoir). Excipients with a known effect: Lactose monohydrate 7600 micrograms per delivered dose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Inhalation powderin a device metered inhaler (Easyhaler). White to yellowish powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ASTHMA Bufomix Easyhaler is indicated in adults and adolescents (12 years and older) for the regular treatment of asthma where use of a combination (inhaled corticosteroid and long-acting β 2 -adrenoceptor agonist) is appropriate: - patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short‑acting β 2 -adrenoceptor agonists. or - patients already adequately controlled on both inhaled corticosteroids and long‑acting β 2 -adrenoceptor agonists. CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) Bufomix Easyhaler is indicated in adults, aged 18 years and older, for the symptomatic treatment of patients with COPD with forced expiratory volume in 1 second (FEV 1 ) < 70% predicted normal (post-bronchodilator) and an exacerbation history despite regular bronchodilator therapy (see also section 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology ASTHMA Bufomix Easyhaler is not intended for the initial management of asthma. The dosage of the components of Bufomix Easyhaler is individual and should be adjusted to the severity of the disease. This should be considered not only when treatment with combination products is initiated bu Leer el documento completo