Šalis: Švedija
kalba: švedų
Šaltinis: Läkemedelsverket (Medical Products Agency)
flutikasonpropionat; salmeterolxinafoat
Orion Corporation
R03AK06
fluticasone propionate; salmeterol
50 mikrogram/500 mikrogram/dos
Inhalationspulver
laktosmonohydrat Hjälpämne; flutikasonpropionat 500 mikrog Aktiv substans; salmeterolxinafoat 73 mikrog Aktiv substans
Receptbelagt
Förpacknings: Inhalator, 1 x 60 doser (utan fodral); Inhalator, 2 x 60 doser (utan fodral); Inhalator, 3 x 60 doser (utan fodral); Inhalator, 1 x 60 doser (med fodral); Inhalator, 2 x 60 doser (med fodral); Inhalator, 3 x 60 doser (med fodral)
Godkänd
2018-06-25
1 PACKAGE LEAFLET 2 QR code to www.oeh.fi/ xxxx [to be completed nationally]. Scan this code or visit www.oeh.fi/ xxxx [to be completed nationally] to see instructions on how to use Easyhaler PACKAGE LEAFLET: INFORMATION FOR THE USER Safumide Easyhaler 50 microgram/250 microgram/dose, inhalation powder Safumide Easyhaler 50 microgram/500 microgram/dose, inhalation powder Salmeterol/fluticasone propionate 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 Safumide Easyhaler is and what it is used for 2. What you need to know before you use Safumide Easyhaler 3. How to use Safumide Easyhaler 4. Possible side effects 5. How to store Safumide Easyhaler 6. Contents of the pack and other information 1. WHAT SAFUMIDE EASYHALER IS AND WHAT IT IS USED FOR Safumide Easyhaler contains two medicines, salmeterol and fluticasone propionate: Salmeterol is a long-acting bronchodilator. Bronchodilators help the airways in the lungs to stay open. This makes it easier for air to get in and out. The effects last for at least 12 hours. Fluticasone propionate is a corticosteroid which reduces swelling and irritation in the lungs. The doctor has prescribed this medicine to help prevent breathing problems such as: Asthma Chronic Obstructive Pulmonary Disease (COPD). Safumide Easyhaler, at a dose of 50/500 micrograms, reduces the number of flare ups of COPD symptoms. 3 You must use Safumide Easyhaler every day as directed by your doctor. This will make sure that it works properly in controlling your asthm Perskaitykite visą dokumentą
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Safumide Easyhaler 50 microgram/250 microgram/dose, inhalation powder Safumide Easyhaler 50 microgram/500 microgram/dose, inhalation powder 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Safumide Easyhaler 50 microgram/250 microgram: Each delivered dose (the dose that leaves the mouthpiece) contains salmeterol xinafoate corresponding to 48 micrograms of salmeterol and 238 micrograms fluticasone propionate. This corresponds to a metered dose of salmeterol xinafoate corresponding to 50 micrograms of salmeterol and 250 micrograms fluticasone propionate. Safumide Easyhaler 50 microgram/500 microgram: Each delivered dose (the dose that leaves the mouthpiece) contains salmeterol xinafoate corresponding to 48 micrograms of salmeterol and 476 micrograms fluticasone propionate. This corresponds to a metered dose of salmeterol xinafoate corresponding to 50 micrograms of salmeterol and 500 micrograms fluticasone propionate. Excipient with known effect: Lactose monohydrate 17 mg 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 powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _ASTHMA_ Safumide Easyhaler is indicated in the regular treatment of asthma where use of a combination product _ _ (long-acting 2 agonist _ _ and inhaled corticosteroid) is _ _ appropriate: - patients not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled short- acting 2 agonist or - patients already adequately controlled on both inhaled corticosteroid and long-acting 2 agonist. _CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)_ Safumide Easyhaler is indicated for the symptomatic treatment of patients with COPD, with a FEV 1 <60% predicted normal (pre-bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy. 3 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Patient Perskaitykite visą dokumentą