국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
FLUTICASONE PROPIONATE
LTT Pharma Limited
R03BA; R03BA05
FLUTICASONE PROPIONATE
125 Mcg/Dose
Pressurised inhalation, suspension
Product subject to prescription which may be renewed (B)
Glucocorticoids; fluticasone
Authorised
2015-02-20
• the way steroids are produced by your body may be affected when using Flixotide (adrenal suppression). This is more likely to happen if you use high doses for a long period of time (e.g. 400 micrograms daily in children). This can cause: - young people to grow more slowly. - something called ‘Cushing’s syndrome’. This happens when you have too much steroid in your body and it can cause thinning of your bones and eye problems (such as cataracts and glaucoma which is high pressure in the eye). Your doctor will help stop this happening by making sure you use the lowest dose of steroid which controls your symptoms. FREQUENCY NOT KNOWN, BUT MAY ALSO OCCUR • depression or aggression. These effects are more likely to occur in children. • nosebleeds • blurred vision (that may be due to cataract or glaucoma). TALK TO YOUR DOCTOR AS SOON AS POSSIBLE IF: • after 7 days of using Flixotide your shortness of breath or wheezing does not get better, or gets worse. • you or your child is on high doses of inhaled steroid and become unwell with vague symptoms such as tummy ache, sickness, diarrhoea, headache or drowsiness. This can happen during an infection such as a viral infection or stomach upset. It is important that your steroid is not stopped suddenly as this could make your asthma worse and could also cause problems with the body’s hormones. REPORTING OF SIDE EFFECTS If you get any side effects, talk to your doctor, pharmacist or nurse. 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 FLIXOTIDE • Keep this medicine out of the sight and reach of children. • Clean you inhaler on a weekly basis and if it becomes blocked as described under ‘Cleaning your Evohaler’, • Do not u 전체 문서 읽기
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Flixotide Evohaler 125 micrograms, per metered dose, Pressurised Inhalation, Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each metered dose contains 125 micrograms of fluticasone propionate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Pressurised Inhalation, Suspension (Pressurised inhalation) _Product imported from Greece._ Pressurised inhalation suspension supplied in an aluminium can with metering valve and an orange (120 dose) actuator. 4 CLINICAL PARTICULARS As per PA1077/044/014 5 PHARMACOLOGICAL PROPERTIES As per PA1077/044/014 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 for this product shall be the date shown on the device 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. Do not refrigerate or freeze. Store in the original package. Avoid storage in direct sunlight or heat. Do not expose to temperatures higher than 50°C. Do not pierce, break or burn the canister 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_ _ _ _1_ _9_ _/_ _1_ _2_ _/_ _2_ _0_ _1_ _6_ _C_ _R_ _N_ _ _ _2_ _1_ _8_ _5_ _8_ _8_ _0_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ Replace the mouthpiece cover firmly and snap it into position. As with most inhaled medications in pressuri 전체 문서 읽기