Land: Malta
Språk: engelsk
Kilde: Medicines Authority
FORMOTEROL FUMARATE, DIHYDRATE, BUDESONIDE
Orion Corporation Orionintie 1, FI-02200 Espoo, Finland
R03AK07
FORMOTEROL FUMARATE DIHYDRATE 4.5 µg BUDESONIDE 160 µg
INHALATION POWDER
FORMOTEROL FUMARATE DIHYDRATE 4.5 µg BUDESONIDE 160 µg
POM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
Withdrawn
2014-04-16
Page 1 of 10 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BUFAR EASYHALER, 160 MICROGRAMS/4.5 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 Bufar Easyhaler 160/4.5 is and what it is used for 2. What you need to know before you use Bufar Easyhaler 160/4.5 3. How to use Bufar Easyhaler 160/4.5 4. Possible side effects 5. How to store Bufar Easyhaler 160/4.5 6. Contents of the pack and other information 1. WHAT BUFAR EASYHALER 160/4.5 IS AND WHAT IT IS USED FOR Bufar 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE BUFAR EASYHALER 160/4.5 DO NOT USE BUFAR EASYHALER 160/4.5: - if you are allergic to budesonide, formoterol or to the other ingredient of this medicine (listed in section 6) which is lactose (which contains small amounts of milk protei Les hele dokumentet
Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Bufar Easyhaler, 160 micrograms/4.5 micrograms/inhalation, inhalation powder. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each delivered dose (the dose that leaves the mouthpiece) contains: budesonide 160 micrograms/inhalation and formoterol fumarate dihydrate 4.5 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 3800 micrograms per delivered dose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation powder in a device metered inhaler (Easyhaler). White to yellowish powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ASTHMA Bufar Easyhaler 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) Bufar Easyhaler is indicated in adults, aged 18 years and older, for symptomatic treatment of patients with COPD with FEV 1 < 70% predicted normal (post-bronchodilator) and an exacerbation history despite regular bronchodilator therapy (see also section 4.4). Page 2 of 16 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology ASTHMA Bufar Easyhaler is not intended for the initial management of asthma. The dosage of the components of Bufar 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 but also when the maintenance dose is adjusted. If an individual patient should require a combination Les hele dokumentet