Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE
PCO Manufacturing Ltd.
R03AK; R03AK06
SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE
25/50 microgram(s)/dose
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
Authorised
2004-02-06
_ _ _ _ PACKAGE LEAFLET: INFORMATION FOR THE USER SERETIDE ® 50 EVOHALER ® 25 MICROGRAM/50 MICROGRAM PER METERED DOSE, PRESSURISED INHALATION, SUSPENSION SERETIDE ® 125 EVOHALER ® 25 MICROGRAM/125 MICROGRAM PER METERED DOSE, PRESSURISED INHALATION, SUSPENSION SERETIDE ® 250 EVOHALER ® 25 MICROGRAM/250 MICROGRAM PER METERED DOSE, PRESSURISED INHALATION, SUSPENSION 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 symptoms and 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 Seretide is and what it is used for 2. What you need to know before you use Seretide 3. How to use Seretide 4. Possible side effects 5. How to store Seretide 6. Contents of the pack and other information 1. WHAT SERETIDE IS AND WHAT IT IS USED FOR Seretide 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. You must use Seretide every day as directed by your doctor. This will make sure that it works properly in controlling your asthma. SERETIDE HELPS TO STOP BREATHLESSNESS AND WHEEZINESS COMING ON. HOWEVER SERETIDE SHOULD NOT BE USED TO RELIEVE A SUDDEN ATTACK OF BREATHLESSNESS OR WHEEZING. IF THIS HAPPENS YOU NEED TO USE A FAST ACTING ‘R Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Seretide 50 Evohaler 25 microgram/50 microgram/dose pressurised inhalation, suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each single actuation of Seretide provides: 25 micrograms of salmeterol (as salmeterol xinafoate) and 50 micrograms of fluticasone propionate (delivered from the valve). This is equivalent to 21 micrograms of salmeterol and 44 micrograms of fluticasone propionate delivered from the actuator (delivered dose). For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Pressurised inhalation, suspension. _Product imported from Greece and the UK:_ The canister contains a white to off white suspension. 4 CLINICAL PARTICULARS As per PA1077/046/004 5 PHARMACOLOGICAL PROPERTIES As per PA1077/046/004 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Norflurane (HFA 134a) 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf-life expiry date of this product shall be the date shown on the container and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Replace the mouthpiece cover firmly and snap it into position. The canister contains a pressurised liquid. Do not store above 25°C. Do not expose to temperatures higher than 50°C, protect from direct sunlight. The container should not be punctured, broken or burnt even when apparently empty. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _0_ _7_ _/_ _0_ _7_ _/_ _2_ _0_ _1_ _ Read the complete document