Country: Malta
Language: English
Source: Medicines Authority
Viatris Healthcare Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN , Ireland
R01AD58
AZELASTINE HYDROCHLORIDE 137 µg/spray FLUTICASONE PROPIONATE 50 µg/spray
NASAL SPRAY, SUSPENSION
AZELASTINE HYDROCHLORIDE 137 µg/spray FLUTICASONE PROPIONATE 50 µg/spray
POM
NASAL PREPARATIONS
Authorised
2013-02-21
Page 1 of 9 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DYMISTA 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 Dymista Nasal Spray is and what it is used for 2. What you need to know before you use Dymista Nasal Spray 3. How to use Dymista Nasal Spray 4. Possible side effects 5. How to store Dymista Nasal Spray 6. Contents of the pack and other information 1. WHAT DYMISTA NASAL SPRAY IS AND WHAT IT IS USED FOR Dymista 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. Dymista Nasal Spray is used to relieve the symptoms of moderate to severe seasonal and perennial allergic rhinitis if the use of either intranasal antihistamine or corticosteroid alone is not considered sufficient. Seasonal and perennial allergic rhinitis are allergic reactions to substances such as pollen (hayfever), house mites, moulds, dust or pets. Dymista Nasal Spray relieves the symptoms of allergies, for example: runny nose, post nasal drip, sneezing and itchy or blocked nos Read the complete document
Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT DYMISTA 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 Relief of symptoms of moderate to severe seasonal and perennial allergic rhinitis if monotherapy with either intranasal antihistamine or glucocorticoid is not considered sufficient. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _POSOLOGY _ For full therapeutic benefit regular usage is essential. Contact with the eyes should be avoided. _ _ Adults and adolescents (12 years and older) One actuation in each nostril twice daily (morning and evening). Children below 12 years Dymista Nasal Spray is not recommended for use in children below 12 years of age as safety and efficacy has not been established in this age group. Elderly No dose adjustment is required in this population. Page 2 of 9 Renal and hepatic impairment There are no data in patients with renal and hepatic impairment. _ _ _ _ _DURATION OF TREATMENT _ Dymista Nasal Spray is suitable for long-term use. The duration of treatment should correspond to the period of allergenic exposure. _METHOD OF ADMINISTRATION _ Dymista 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 Dymista Nasal Spray must be primed by pressing down and releasing the p Read the complete document