Nchi: Uswidi
Lugha: Kiswidi
Chanzo: Läkemedelsverket (Medical Products Agency)
flutikasonpropionat; salmeterolxinafoat
Sandoz A/S
R03AK06
fluticasone propionate; salmeterol
50 mikrogram/500 mikrogram
Inhalationspulver, avdelad dos
laktosmonohydrat Hjälpämne; flutikasonpropionat 500 mikrog Aktiv substans; salmeterolxinafoat 73 mikrog Aktiv substans
Apotek
Receptbelagt
Salmeterol och flutikason
Avregistrerad
2015-03-12
PACKAGE LEAFLET: INFORMATION FOR THE USER Aesalfluca Forspiro, 50 microgram/500 microgram/dose, inhalation powder, predispensed SALMETEROL/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 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 Aesalfluca Forspiro is and what it is used for 2. What you need to know before you use Aesalfluca Forspiro 3. How to use Aesalfluca Forspiro 4. Possible side effects 5. How to store Aesalfluca Forspiro 6. Contents of the pack and other information 1. WHAT AESALFLUCA FORSPIRO IS AND WHAT IT IS USED FOR Aesalfluca Forspiro is used to treat: asthma chronic obstructive pulmonary disease (COPD) This disease is characterized by continuous breathing difficulties caused by narrowed airways, often accompanied with coughing and phlegm. This medicine reduces the number of flare ups of COPD symptoms. This medicine contains two active substances. Salmeterol: a long-acting substance that widens the airways Fluticasone: a corticosteroid which reduces swelling and inflammation in the lungs 2. WHAT YOU NEED TO KNOW BEFORE YOU USE AESALFLUCA FORSPIRO DO NOT USE AESALFLUCA FORSPIRO if you are ALLERGIC to salmeterol, fluticasone or to the other ingredient of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Aesalfluca Forspiro if you have: heart disease, including an irregular or fast heartbeat overactive thyroid gland high blood pressure diabetes mellitus low potassium in your blood tuberculosis now Soma hati kamili
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Aesalfluca Forspiro, 50 microgram/500 microgram/dose, inhalation powder, predispensed 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each metered dose of Aesalfluca Forspiro provides: For 50 microgram/500 microgram/dose, inhalation powder, predispensed: 50 micrograms of salmeterol (as salmeterol xinafoate) and 500 micrograms of fluticasone propionate Corresponding with a delivered dose of: 45 micrograms of Salmeterol (as salmeterol xinafoate) and 465 micrograms of fluticasone propionate Excipient with known effect lactose monohydrate: 11.95 mg per metered dose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation powder, pre-dispensed. White, homogenous powder The pre-dispensed powder, contained in blister, is delivered by a purple plastic dry-powder inhalation device. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _ASTHMA_ Aesalfluca Forspiro is indicated in the regular treatment of asthma where use of a combination product (long-acting β 2 agonist and inhaled corticosteroid) is appropriate: patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short acting β 2 agonist or patients already adequately controlled on both inhaled corticosteroid and long-acting β 2 agonist. _CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)_ Aesalfluca Forspiro 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Method of administration: Aesalfluca Forspiro is for inhalation use only. Patients should be made aware that Aesalfluca Forspiro must be used daily for optimum benefit, even when asymptomatic. Patients should be regularly reassessed by a doctor, so that the strength of Aesalfluca Forspiro they are receiving remains optimal and is only changed on medical advice. THE DOS Soma hati kamili