Negara: Malta
Bahasa: Inggris
Sumber: Medicines Authority
BUDESONIDE, FORMOTEROL FUMARATE, DIHYDRATE
Orion Corporation Orionintie 1, FI-02200 Espoo, Finland
R03AK07
BUDESONIDE 80 µg FORMOTEROL FUMARATE DIHYDRATE 4.5 µg
INHALATION POWDER
BUDESONIDE 80 µg FORMOTEROL FUMARATE DIHYDRATE 4.5 µg
POM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
Withdrawn
2016-07-05
Page 1 of 10 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BUFOMIX 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 Bufomix Easyhaler 80/4.5 is and what it is used for 2. What you need to know before you use Bufomix Easyhaler 80/4.5 3. How to use Bufomix Easyhaler 80/4.5 4. Possible side effects 5. How to store Bufomix Easyhaler 80/4.5 6. Contents of the pack and other information 1. WHAT BUFOMIX EASYHALER 80/4.5 IS AND WHAT IT IS USED FOR Bufomix 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. It can be prescribed for asthma in two different ways. A) SOME PEOPLE ARE PRESCRIBED TWO ASTHMA INHALERS: BUFOMIX EASYHALER 80/4.5 AND A SEPARATE ‘RELIEVER INHALER’ They use Bufomix Easyhaler every day. This helps to prevent asthma symptoms from happening. They use their ‘reliever inhaler’ when t Baca dokumen lengkapnya
Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Bufomix 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 Bufomix Easyhaler 80 micrograms/4.5 micrograms/inhalation is indicated in adults, adolescents and children aged 6 years and older. Bufomix 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: Bufomix Easyhaler 80 micrograms/4.5 micrograms/inhalation is not appropriate in patients with severe asthma. 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 Page 2 of 15 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 of doses other than those available in the combination inhaler, appropr Baca dokumen lengkapnya