Ország: Málta
Nyelv: angol
Forrás: Medicines Authority
Rowex Ltd Newtown Bantry, Co. Cork, , Ireland
R03AK07
FORMOTEROL FUMARATE DIHYDRATE 9 µg BUDESONIDE 320 µg
INHALATION POWDER, PRE-DISPENSED
FORMOTEROL FUMARATE DIHYDRATE 9 µg BUDESONIDE 320 µg
POM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
Authorised
2023-08-09
PACKAGE LEAFLET: INFORMATION FOR THE USER AIRBUFO ® FORSPIRO ® 320 MICROGRAM/9 MICROGRAM/DOSE INHALATION POWDER, PRE-DISPENSED budesonide/formoterol fumarate dihydrate 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 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 AirBuFo ® Forspiro ® is and what it is used for 2. What you need to know before you use AirBuFo ® Forspiro ® 3. How to use AirBuFo ® Forspiro ® 4. Possible side effects 5. How to store AirBuFo ® Forspiro ® 6. Contents of the pack and other information 1. WHAT AIRBUFO ® FORSPIRO ® IS AND WHAT IT IS USED FOR AirBuFo ® Forspiro ® is an inhaler that is used to treat asthma in adults and adolescents aged 12 to 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: AirBuFo ® Forspiro ® and a separate ‘reliever inhaler’. • Use AirBuFo ® Forspiro ® every day. This helps to prevent asthma symptoms from happening. • Use your ‘reliever inhaler’ when you g Olvassa el a teljes dokumentumot
Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT AirBuFo ® Forspiro ® 320 microgram/9 microgram/dose inhalation powder, pre-dispensed 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each delivered dose (inhaled dose) contains 320 micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate. Each metered dose (pre-dispensed dose contained in the blister) contains 346.3 micrograms of budesonide and 10.8 micrograms of formoterol fumarate dihydrate. Excipient with known effect Each delivered dose contains 7.9 mg lactose (as monohydrate) and each metered dose contains 9.1 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Inhalation powder, pre-dispensed. White to off-white or slightly yellow powder with no agglomerates. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ASTHMA AirBuFo ® Forspiro ® is indicated in adults, and adolescents aged 12-17 years, 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) AirBuFo ® Forspiro ® 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 Route of administration: For inhalation use Posology ASTHMA AirBuFo ® Forspiro ® is not intended for the initial management of asthma. The required dose of the components of AirBuFo ® Forspiro ® is individual and should be adjusted to the severity of the disease. This should be considered Olvassa el a teljes dokumentumot