Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE
LTT Pharma Limited
R03AK; R03AK06
SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE
50/250 microgram(s)
Powder for Inhalation
Product subject to prescription which may be renewed (B)
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; salmeterol and fluticasone
Authorised
2015-01-23
• Feeling shaky (tremor) and fast or uneven heart beat (palpitations) - these are usually harmless and get less as treatment continues . • Chest pain • Feeling worried (this effect mainly occurs in children). • Disturbed sleep • Allergic skin rash RARE (AFFECTS LESS THAN 1 PERSON IN 1000) • BREATHING DIFFICULTIES OR WHEEZING THAT GET WORSE STRAIGHT AFTER TAKING SERETIDE. If this happens STOP USING YOUR SERETIDE INHALER. Use your fast-acting ‘reliever’ inhaler to help your breathing and TELL YOUR DOCTOR STRAIGHT AWAY. • Seretide may affect the normal production of steroid hormones in the body, particularly if you have taken high doses for long periods of time. The effects include: - Slowing of growth in children and adolescents, - Thinning of the bones - Glaucoma - Weight gain - Rounded (moon shaped) face (Cushing’s Syndrome) Your doctor will check you regularly for any of these side effects and make sure you are taking the lowest dose of Seretide to control your asthma. • Behavioural changes, such as being unusually active and irritable (these effects mainly occur in children). • Uneven heart beat or heart gives an extra beat (arrhythmias). Tell your doctor, but do not stop taking Seretide unless the doctor tells you to stop. • A fungal infection in the oesophagus (gullet), which might cause difficulties in swallowing. FREQUENCY NOT KNOWN, BUT MAY ALSO OCCUR: • Depression or aggression. These effects are more likely to occur in children. • Blurred vision. REPORTING OF SIDE EFFECTS If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie. By reporting side effects you can help provide more information on the safety of this medicine. 5. HOW TO STORE SERETIDE • KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Seretide 250 Diskus 50 microgram/250 microgram/dose inhalation powder, pre-dispensed 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 47 micrograms of salmeterol (as salmeterol xinafoate) 231 micrograms of fluticasone propionate. This corresponds to a pre-dispensed dose of 50 micrograms of salmeterol (as salmeterol xinafoate) and 250 micrograms fluticasone propionate. Excipient with known effect: lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Inhalation powder, pre-dispensed. _Product imported from Hungary_ Moulded plastic device containing a foil strip with 60 regularly placed blisters. 4 CLINICAL PARTICULARS As per PA1077/046/002 5 PHARMACOLOGICAL PROPERTIES As per PA1077/046/002 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Lactose monohydrate 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 Do not store above 30 ° C. 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_ _ _ _1_ _5_ _/_ _0_ _6_ _/_ _2_ _0_ _1_ _8_ _C_ _R_ _N_ _ _ _2_ _2_ _0_ _7_ _2_ _7_ _7_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.5 NATURE AND CONTENTS OF CONTAINER The inhalation powder is contained in blisters held Διαβάστε το πλήρες έγγραφο