Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
SALMETEROL XINAFOATE ; FLUTICASONE PROPIONATE
Generics (UK) Limited
R03AK06
SALMETEROL XINAFOATE ; FLUTICASONE PROPIONATE
25mcg/125 Microgram
Pressurised Inhalation Suspension
Product subject to prescription which may be renewed (B)
salmeterol and fluticasone
Marketed
2017-02-03
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SIRDUPLA 25 MICROGRAM/125 MICROGRAM PER METERED DOSE PRESSURISED INHALATION, SUSPENSION 25 MICROGRAM/250 MICROGRAM PER METERED DOSE PRESSURISED INHALATION, SUSPENSION Salmeterol (as xinafoate)/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 Sirdupla is and what it is used for 2. What you need to know before you use Sirdupla 3. How to use Sirdupla 4. Possible side effects 5. How to store Sirdupla 6. Contents of the pack and other information 1. WHAT SIRDUPLA IS AND WHAT IT IS USED FOR Sirdupla contains two active substances, 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 glucocorticosteroid which reduces swelling and irritation in the lungs. SIRDUPLA IS INDICATED FOR USE IN ADULTS 18 YEARS OF AGE AND OLDER ONLY. SIRDUPLA IS NOT INDICATED FOR USE IN CHILDREN 12 YEARS OF AGE AND YOUNGER OR ADOLESCENTS 13 TO 17 YEARS OF AGE. The doctor has prescribed this medicine to help prevent breathing problems such as asthma. You must use Sirdupla every day as directed by your doctor. This will make sure that it works properly in controlling your asthma. SIRDUPLA HELPS TO STOP BREATHLESSNESS AND WHEEZINESS COMING ON. HOWEVER SIRDUPLA SHOULD NOT BE USED TO RELIEVE A SUDDEN ATTACK OF BREATHLESSNESS OR WHEEZING. IF THIS HAPPENS YO read_full_document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 25 micrograms of salmeterol (as salmeterol xinafoate) and 125 micrograms of fluticasone propionate. This is equivalent to a delivered dose (ex actuator) of 21 micrograms of salmeterol and 110 micrograms of fluticasone propionate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Pressurised inhalation, suspension. The canister contains a white to off white suspension. The canisters are fitted into white plastic actuators incorporating an atomising orifice and fitted with mauve dustcaps. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sirdupla is indicated in the regular treatment of asthma where use of a combination product (long- 2 2 agonist or 2 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Sirdupla is indicated in adults 18 years of age and older only. Sirdupla is not indicated for use in children, 12 years of age and younger or adolescents, 13 to 17 years of age. Posology Patients should be made aware that salmeterol/fluticasone propionate must be used daily for optimum benefit, even when asymptomatic. Patients should be regularly reassessed by a doctor, so that the strength of salmeterol/fluticasone propionate 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. TO NOTE: SIRDUPLA IS ONLY AVAILABLE IN TWO STRENGTHS; IT IS NOT AVAILABLE IN A LOWER STRENGTH PRODUCT CONTAINING SALMETEROL 25 MICROGRAM AND FLUTICASONE PROPIONATE 50 MICROGRAM, A STRENGTH WHICH IS AVAILABLE FOR OTHER SIMILAR FIXED-DOSE COMBINATION PRODUCTS CONTAINING THESE TWO ACTIVES AND CURRENTLY AVAILABLE ON THE MARKET. Therefore, when it is appropriate to titrate down to a dose of inhaled glucocorticosteroid below 125 micrograms, a change to an alternative fixed-dose combination of salmeterol and fluticasone propionate containing a lower dose of the inhaled glucocorticosteroid is required. Sirdupl read_full_document