Land: Storbritannien
Språk: engelska
Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)
Fluticasone propionate; Salmeterol xinafoate
CST Pharma Ltd
R03AK06
Fluticasone propionate; Salmeterol xinafoate
250microgram/1dose ; 50microgram/1dose
Inhalation powder
Inhalation
No Controlled Drug Status
Caution - AMP level prescribing advised
BNF: 03020000; GTIN: 5055946801162
Page 1 of 2 PACKAGE LEAFLET: INFORMATION FOR THE USER SERETIDE™ 250 ACCUHALER™ (salmeterol xinafoate / fluticasone propionate) Seretide Accuhaler is available in different strengths. Seretide 250 Accuhaler will be referred to as Seretide Accuhaler throughout this leaflet. 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 ACCUHALER IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE SERETIDE ACCUHALER 3. HOW TO USE SERETIDE ACCUHALER 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE SERETIDE ACCUHALER 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT SERETIDE ACCUHALER IS AND WHAT IT IS USED FOR Seretide Accuhaler 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 • Chronic Obstructive Pulmonary Disease (COPD). Seretide Accuhaler, at a dose of 50/500 micrograms, reduces the number of flare ups of COPD symptoms. You must use Seretide Accuhaler every day as directed by your doctor. This will make sure that it works properly in controlling your asthma or COPD. SERETIDE ACCUHALER HELPS TO STOP BREATHLESSNESS AND WHEEZINESS COMING ON. HOWEVER SERETIDE ACCUHALER S Läs hela dokumentet
PRODUCT SUMMARY 1. Trade Name of the Medicinal Product Not applicable. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Not applicable. 3. PHARMACEUTICAL FORM Not applicable. CLINICAL PARTICULARS 4.1. Therapeutic Indications As per UK PL no 00057/0277 4.2. POSOLOGY AND METHOD OF ADMINISTRATION As per UK PL no 00057/0277 4.3. CONTRA-INDICATIONS As per UK PL no 00057/0277 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE As per UK PL no 00057/0277 4.5. INTERACTIONS WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION As per UK PL no 00057/0277 4.6. PREGNANCY AND LACTATION As per UK PL no 00057/0277 4.7. EFFECTS ON ABILITY TO DRIVE AND USE MACHINES As per UK PL no 00057/0277 4.8. UNDESIRABLE EFFECTS As per UK PL no 00057/0277 4.9. OVERDOSE As per UK PL no 00057/0277 PHARMACOLOGICAL PROPERTIES 5.1. Pharmacodynamic Properties As per UK PL no 00057/0277 5.2. PHARMACOKINETIC PROPERTIES As per UK PL no 00057/0277 5.3. PRECLINICAL SAFETY DATA None stated. PHARMACEUTICAL PARTICULARS 6.1. List of Excipients As per ECMA no 026821013 issued by Italy 6.2. INCOMPATIBILITIES As per UK PL no 00057/0277 6.3. SHELF LIFE 36 Months (unopened) 6.4. SPECIAL PRECAUTIONS FOR STORAGE Store below 30°C. 6.5. NATURE AND CONTENTS OF CONTAINER Blister strips in cardboard carton Pack size : 30 6.6. INSTRUCTION FOR USE/HANDLING None stated. ADMINISTRATIVE DATA 7. Marketing Authorisation Holder Waymade Plc Miles Gray Road Basildon Essex SSl4 3FR 8. MARKETING AUTHORIZATION NUMBER PLPI 06464/0315 9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION None stated. 10. DATE OF (PARTIAL) REVISION OF THE TEXT None stated. Läs hela dokumentet