País: Malta
Idioma: anglès
Font: Medicines Authority
BUDESONIDE, FORMOTEROL FUMARATE, DIHYDRATE
Orion Corporation Orionintie 1, FI-02200 Espoo, Finland
R03AK07
BUDESONIDE 80 µg FORMOTEROL FUMARATE DIHYDRATE 4.5 µg
PROLONGED-RELEASE TABLET
BUDESONIDE 80 µg FORMOTEROL FUMARATE DIHYDRATE 4.5 µg
POM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
Withdrawn
2016-07-05
Page 1 of 9 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BUFAR EASYHALER, 80 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 80/4.5 is and what it is used for 2. What you need to know before you use Bufar Easyhaler 80/4.5 3. How to use Bufar Easyhaler 80/4.5 4. Possible side effects 5. How to store Bufar Easyhaler 80/4.5 6. Contents of the pack and other information 1. WHAT BUFAR EASYHALER 80/4.5 IS AND WHAT IT IS USED FOR Bufar Easyhaler is an inhaler that is used to treat asthma in adults, adolescents and children aged 6 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. This medicine is not suitable for people with severe asthma. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE BUFAR EASYHALER 80/4.5 DO NOT USE BUFAR EASYHALER 80/4.5: - 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 protein). WARNINGS AND PRECAUTIONS Talk to your doctor or pha Llegiu el document complet
Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Bufar Easyhaler, 80 micrograms/4.5 micrograms/inhalation, inhalation powder. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each delivered dose (the dose that leaves the mouthpiece) contains: budesonide 80 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 known effect: Lactose monohydrate 4000 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 Bufar Easyhaler 80 micrograms/4.5 micrograms/inhalation is indicated in adults, adolescents and children aged 6 years and older. Bufar Easyhaler 80 micrograms/4.5 micrograms/inhalation is indicated 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. NOTE: Bufar Easyhaler 80 micrograms/4.5 micrograms/inhalation is not appropriate in patients with severe asthma. 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. Page 2 of 15 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 of doses other than those available in the combination inhaler, appropriate doses o Llegiu el document complet