国家: 马耳他
语言: 英文
来源: Medicines Authority
AZELASTINE HYDROCHLORIDE, FLUTICASONE PROPIONATE
Mylan IRE Healthcare Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland
R01AD58
AZELASTINE HYDROCHLORIDE 137 µg FLUTICASONE PROPIONATE 50 µg
NASAL SPRAY, SUSPENSION
AZELASTINE HYDROCHLORIDE 137 µg FLUTICASONE PROPIONATE 50 µg
POM
NASAL PREPARATIONS
Authorised
2013-02-21
Page 1 of 9 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AZECORT NASAL SPRAY 137 MICROGRAMS / 50 MICROGRAMS PER ACTUATION NASAL SPRAY, SUSPENSION azelastine hydrochloride/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 Azecort Nasal Spray is and what it is used for 2. What you need to know before you use Azecort Nasal Spray 3. How to use Azecort Nasal Spray 4. Possible side effects 5. How to store Azecort Nasal Spray 6. Contents of the pack and other information 1. WHAT AZECORT NASAL SPRAY IS AND WHAT IT IS USED FOR Azecort Nasal Spray contains two active substances: azelastine hydrochloride and fluticasone propionate. • Azelastine hydrochloride belongs to a group of medicines called antihistamines. Antihistamines work by preventing the effects of substances such as histamine that the body produces as part of an allergic reaction – thus reducing symptoms of allergic rhinitis. • Fluticasone propionate belongs to a group of medicines called corticosteroids which reduces inflammation. Azecort Nasal Spray is used for the symptomatic treatment of severe hay fever (seasonal allergic rhinitis) in adults. Seasonal allergic rhinitis is an allergic reaction to substances such as pollen (hayfever). Azecort Nasal Spray relieves the symptoms of seasonal allergies, for example: runny nose, post nasal drip, sneezing and itchy or blocked nose. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE AZECORT NASAL SPRAY DO NOT USE AZECORT NASAL SPRAY: • if you are allergic to azelastine hydr 阅读完整的文件
Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT AZECORT NASAL SPRAY 137 micrograms / 50 micrograms per actuation Nasal Spray, Suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each g of suspension contains 1000 micrograms azelastine hydrochloride and 365 micrograms fluticasone propionate. One actuation (0.14 g) delivers 137 micrograms azelastine hydrochloride (= 125 micrograms azelastine) and 50 micrograms fluticasone propionate. Excipient with known effect: One actuation (0.14 g) delivers 0.014 mg benzalkonium chloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Nasal spray, suspension. White, homogeneous suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For symptomatic treatment of severe seasonal allergic rhinitis in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology _ For full therapeutic benefit regular usage is essential. Contact with the eyes should be avoided. _ _ _Adults_ One actuation in each nostril twice daily (morning and evening). _Paediatric population_ Azecort Nasal Spray should not be used in children and adolescents under 18 years of age. _Elderly _ No dose adjustment is required in this population. _ _ Page 2 of 10 _Renal and hepatic impairment _ There are no data in patients with renal and hepatic impairment. _ _ _ _ _Duration of treatment _ Azecort Nasal Spray is suitable for long-term use. The duration of treatment should correspond to the period of allergenic exposure. Method of administration Azecort Nasal Spray is for nasal use only. _INSTRUCTION FOR USE _ Preparing the spray: The bottle should be shaken gently before use for about 5 seconds by tilting it upwards and downwards and the protective cap be removed afterwards. Prior to first use Azecort Nasal Spray must be primed by pressing down and releasing the pump 6 times. If Azecort Nasal Spray has not been used for more than 7 days it must be reprimed once by pressing down and releasing the pump. Using the spray: The bottle should be shaken gently 阅读完整的文件