Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Salmeterol; Fluticasone propionate
Rowex Ltd
R03AK; R03AK06
Salmeterol; Fluticasone propionate
50 microg/500 microgram(s)/dose
Inhalation powder, pre-dispensed
Product subject to prescription which may be renewed (B)
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; salmeterol and fluticasone
Marketed
2014-11-14
PACKAGE LEAFLET: INFORMATION FOR THE USER AIRFLUSAL ® 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 AirFluSal ® Forspiro ® is and what it is used for 2. What you need to know before you use AirFluSal ® Forspiro ® 3. How to use AirFluSal ® Forspiro ® 4. Possible side effects 5. How to store AirFluSal ® Forspiro ® 6. Contents of the pack and other information 1. WHAT AIRFLUSAL ® FORSPIRO ® IS AND WHAT IT IS USED FOR AirFluSal ® 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 AIRFLUSAL ® FORSPIRO ® DO NOT USE AIRFLUSAL ® 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 AirFluSal ® Forspiro ® if you have: heart disease, including an irregular or fast heartbeat overactive thyroid gland high blood pressure diabetes mellitus Läs hela dokumentet
Health Products Regulatory Authority 13 April 2021 CRN008SSP Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT AirFluSal® Forspiro® 50 microgram/500 microgram/dose, inhalation powder, predispensed 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each metered dose of AirFluSal ® 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_ AirFluSal ® 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)_ AirFluSal ® 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: AirFluSal ® Forspiro ® is for inhalation use only. Patients should be made aware that AirFluSal ® Forspiro ® must be used daily for optimum benefit, even when asymptomatic. Patients should be regularly reassessed by a doctor, so that the strength of Ai Läs hela dokumentet