Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
SALMETEROL XINAFOATE; Fluticasone propionate
Rowex Ltd
R03AK; R03AK06
SALMETEROL XINAFOATE; Fluticasone propionate
25 microgram/250 microgram(s)
Pressurised inhalation, suspension
Product subject to prescription which may be renewed (B)
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; salmeterol and fluticasone
Not marketed
2017-05-12
PACKAGE LEAFLET: INFORMATION FOR THE USER AIRFLUSAL ® MDI 25 MICROGRAM/125 MICROGRAM/DOSE PRESSURISED INHALATION, SUSPENSION AIRFLUSAL ® MDI 25 MICROGRAM/250 MICROGRAM/DOSE PRESSURISED INHALATION, SUSPENSION 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 ® MDI is and what it is used for 2. What you need to know before you use AirFluSal ® MDI 3. How to use AirFluSal ® MDI 4. Possible side effects 5. How to store AirFluSal ® MDI 6. Contents of the pack and other information 1. WHAT AIRFLUSAL ® MDI IS AND WHAT IT IS USED FOR AirFluSal ® MDI 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. AirFluSal ® MDI is not recommended for use by children. The doctor has prescribed this medicine to help prevent breathing problems such as asthma. You must use AirFluSal ® MDI every day as directed by your doctor. This will make sure that it works properly in controlling your asthma. AirFluSal ® MDI helps to stop breathlessness and wheeziness coming on. However, AirFluSal ® MDI should not be used to relieve a sudden attack of breathlessness or wheezing. If this happens you need to use a fast-acting ‘reliever’ (‘rescue’) inhaler, su Read the complete document
Health Products Regulatory Authority 22 August 2022 CRN00CW8N Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT AirFluSal MDI 25 microgram/250 microgram/dose pressurised inhalation, suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each metered dose (ex valve) contains 25 micrograms of salmeterol (as salmeterol xinafoate) and 250 micrograms of fluticasone propionate. This is equivalent to a delivered dose (ex actuator) of 21 micrograms of salmeterol and 220 micrograms of fluticasone propionate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Pressurised inhalation, suspension. The container contains a white homogeneous suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS AirFluSal MDI 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 AirFluSal MDI is not recommended for use in children. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Method of administration: Inhalation use. Patients should be made aware that AirFluSal MDI must be used daily for optimum benefit, even when asymptomatic. Patients should be regularly reassessed by a doctor, so that the strength of AirFluSal MDI they are receiving remains optimal and is only changed on medical advice. THE DOSE SHOULD BE TITRATED TO THE LOWEST DOSE AT WHICH EFFECTIVE CONTROL OF SYMPTOMS IS MAINTAINED. WHERE THE CONTROL OF SYMPTOMS IS MAINTAINED WITH THE LOWEST STRENGTH OF AIRFLUSAL MDI (25 MICROGRAMS/125 MICROGRAMS) GIVEN TWICE DAILY THEN THE NEXT STEP WOULD BE TO SWITCH TO A DIFFERENT SALMETEROL/FLUTICASONE INHALED PRODUCT IN A LOWER STRENGTH (25 MICROGRAMS/50 MICROGRAMS). Where the control of symptoms is maintained with the lowest strength of the combination given twice daily then the nex Read the complete document