País: Suécia
Língua: sueco
Origem: Läkemedelsverket (Medical Products Agency)
flutikasonpropionat
Viatris Limited
R03BA05
fluticasone propionate
250 mikrogram per puff
Inhalationsspray, suspension
flutikasonpropionat 250 mikrog Aktiv substans
Receptbelagt
Förpacknings: Spraybehållare, 120 doser
Godkänd
2016-03-17
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FLOEBB 50 MICROGRAMS PER ACTUATION PRESSURISED INHALATION, SUSPENSION FLOEBB 125 MICROGRAMS PER ACTUATION PRESSURISED INHALATION, SUSPENSION FLOEBB 250 MICROGRAMS PER ACTUATION PRESSURISED INHALATION, SUSPENSION fluticasone propionate 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, pharmacist or asthma nurse. • 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, pharmacist or asthma nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Floebb is and what it is used for 2. What you need to know before you use Floebb 3. How to use Floebb 4. Possible side effects 5. How to store Floebb 6. Contents of the pack and other information 1. WHAT FLOEBB IS AND WHAT IT IS USED FOR Floebb contains the active substance fluticasone propionate. Fluticasone is a corticosteroid (often just called steroid). It has an anti-inflammatory action which reduces asthma-related swelling and irritation in the lungs. Only a very small dose of steroid is needed because it is inhaled straight into your lungs. Your doctor has prescribed this medicine to help prevent breathing problems such as asthma. Fluticasone propionate is sometimes called a ‘preventer’. Floebb is not used to treat Chronic Obstructive Pulmonary Disease (COPD). You must use Floebb every day as directed by your doctor, even if you are not currently experiencing any breathing problems. This will make sure that it works properly in controlling your asthma. It takes 4-7 days for this medicine to work fully. FLOEBB HELPS TO PREVENT BREATHLESSNESS AND WHEEZING. IT DOES NOT RELIEVE SUDDEN ATTACKS OF BREATHLESSNESS OR WH Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Floebb 50 micrograms per actuation pressurised inhalation, suspension. Floebb 125 micrograms per actuation pressurised inhalation, suspension. Floebb 250 micrograms per actuation pressurised inhalation, suspension. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each metered dose (ex-valve) contains 50 micrograms of fluticasone propionate. This is equivalent to a delivered dose (ex-actuator) of 44 micrograms of fluticasone propionate. Each metered dose (ex-valve) contains 125 micrograms of fluticasone propionate. This is equivalent to a delivered dose (ex-actuator) of 110 micrograms of fluticasone propionate. Each metered dose (ex-valve) contains 250 micrograms fluticasone propionate. This is equivalent to a delivered dose (ex-actuator) of 220 micrograms fluticasone propionate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Pressurised inhalation, suspension. Floebb is supplied in a pressurised aluminium multidose canister, fitted with a metering valve. The canister contains a white to off-white suspension. The canisters are fitted into light orange plastic actuators fitted with white dust caps. The canisters are fitted into orange plastic actuators fitted with white dust caps. The canisters are fitted into dark brown plastic actuators fitted with white dust caps. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fluticasone propionate given by inhalation offers prophylactic treatment for mild, moderate and severe asthma. _Adults and adolescents over 16 years:_ Floebb 50/125/250 micrograms is indicated in adults and adolescents over 16 years of age for the prophylactic treatment of asthma. _Children aged over 4 years up to 12 years and adolescents aged 13 to 16 years:_ Only the lowest strength of this inhaled corticosteroid, Floebb 50 micrograms, is authorised for use in these young age groups. Floebb 50 micrograms is indicated in any child (aged over 4 years up to 12 years) and adolescents (aged 13 to 16 years) with asthm Leia o documento completo