Land: Sverige
Språk: svenska
Källa: Läkemedelsverket (Medical Products Agency)
flutikasonpropionat; formoterolfumaratdihydrat
Mundipharma AB
R03AK11
fluticasone propionate; formoterol
50 mikrogram/5 mikrogram/puff
Inhalationsspray, suspension
flutikasonpropionat 50 mikrog Aktiv substans; formoterolfumaratdihydrat 5 mikrog Aktiv substans; etanol, vattenfri Hjälpämne
Receptbelagt
Förpacknings: Inhalator, 120 puffar; Inhalator, 3 x 120 puffar
Avregistrerad
2018-07-06
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER FLUTIFORM K-HALER 50 MICROGRAM /5 MICROGRAM PER ACTUATION PRESSURISED INHALATION, SUSPENSION FLUTIFORM K-HALER 125 MICROGRAM /5 MICROGRAM PER ACTUATION PRESSURISED INHALATION, SUSPENSION fluticasone propionate/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 Läs hela dokumentet. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What FLUTIFORM K-HALER is and what it is used for 2. What you need to know before you use FLUTIFORM K-HALER 3. How to use FLUTIFORM K-HALER 4. Possible side effects 5. How to store FLUTIFORM K-HALER 6. Contents of the pack and other information 1. WHAT FLUTIFORM K-HALER IS AND WHAT IT IS USED FOR Please note:- FLUTIFORM K-HALER pressurised inhalation, suspension is the full name of the product, however throughout this leaflet it is referred to as FLUTIFORM K-HALER or simply as an inhaler, sometimes together with a reference to a specific strength. FLUTIFORM K-HALER is an inhaler (a pressurised inhalation suspension) which contains two active ingredients: Fluticasone propionate which belongs to a group of medicines called steroids. Steroids help to reduce swelling and inflammation in the lungs. Formoterol fumarate dihydrate which belongs to a group of medicines called long-acting beta 2 agonists. Long-acting beta 2 agonists are long-acting bronchodilators which help the airways in your lungs to stay open, making it easier for you to breathe. Together these two active ingredients help to improve your breathing. It
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Flutiform K-haler 50 microgram/5 microgram per actuation pressurised inhalation, suspension. Flutiform K-haler 125 microgram/5 microgram per actuation pressurised inhalation, suspension. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each metered dose (ex-valve) contains: • 50 micrograms of fluticasone propionate and 5 micrograms of formoterol fumarate dihydrate. This is equivalent to a delivered dose (ex-actuator) of approximately 46 micrograms of fluticasone propionate and 4.5 micrograms of formoterol fumarate dihydrate. • 125 micrograms of fluticasone propionate and 5 micrograms of formoterol fumarate dihydrate. This is equivalent to a delivered dose (ex-actuator) of approximately 115 micrograms of fluticasone propionate and 4.5 micrograms of formoterol fumarate dihydrate. Excipient with known effect _Each actuation contains 1 mg ethanol._ For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Pressurised inhalation, suspension The canister contains white to off-white liquid suspension. The canister is sealed inside a pale grey breath- triggered actuator with an integrated dose indicator and an orange mouthpiece cover. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This fixed-dose combination of fluticasone propionate and formoterol fumarate (Flutiform K-haler) is indicated in the regular treatment of asthma where the use of a combination product (an inhaled corticosteroid and a long -acting β 2 agonist) is appropriate: • For patients not adequately controlled with inhaled corticosteroids and ‘as required’ inhaled short-acting β 2 agonist. Or • For patients already adequately controlled on both an inhaled corticosteroid and a long-acting β 2 agonist. Flutiform K-haler is indicated in adults and adolescents aged 12 years and above. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Patients will need to be trained on the use of the inhaler and their asthma should be regularly reassessed by a doctor, so tha Läs hela dokumentet