Azelastine Hydrochloride/Fluticasone Propionate Azelastine Hydrochloride/Fluticasone Propionate
“can be considered “can beof considered the drug choice” 1 the drug of choice” 1 For moderate / severe Forallergic moderate / severe rhinitis allergic rhinitis
Indications: Dymista is indicated for the reliefIndications: of symptoms of moderate to severe Dymista is indicated for the relief of symptoms of moderate to severe seasonal and perennial allergic rhinitis seasonal and with perennial rhinitis if monotherapy eitherallergic intranasal if monotherapy with either intranasal antihistamine or glucocorticoid is not antihistamine or glucocorticoid is not considered sufficient. 2 considered sufficient. 2 ABBREVIATED PRESCRIBING INFORMATION: DYMISTA (AZELASTINE HYDROCHLORIDE / FLUTICASONE PROPIONATE) 137 MICROGRAMS / 50 MICROGRAMS PER ACTUATION, NASAL SPRAY, SUSPENSION. Please refer to Summary of Product Characteristics (SmPC)INFORMATION: before prescribing. DYMISTA (AZELASTINE HYDROCHLORIDE / FLUTICASONE PROPIONATE) 137 MICROGRAMS / 50 MICROGRAMS PER ACTUATION, NASAL SPRAY, SUSPENSION. ABBREVIATED PRESCRIBING
Indications: Relief of symptoms of moderate to severe seasonal and perennial rhinitis if monotherapy with either intranasal antihistamine or glucocorticoid is not considered sufficient. Presentation: Nasal Spray, suspension. Dosage and administration: Posology For full therapeutic Please refer to Summary of Product Characteristics (SmPC) beforeallergic prescribing. benefit regular usage is essential. Contact with theofeyes shouldto be avoided. Adults adolescents yearsifand older) Onewith actuation in each nostril twice daily (morning and is evening). Childrensufficient. below 12Presentation: years DymistaNasal NasalSpray, Spraysuspension. is not recommended for administration: use in children below 12 years of therapeutic age as Indications: Relief of symptoms moderate severe seasonal andand perennial allergic(12rhinitis monotherapy either intranasal antihistamine or glucocorticoid not considered Dosage and Posology For full safety and efficacy has not beenusage established in this age group. Elderly dosebeadjustment is required in this population. and hepatic impairment no data patientsand with renal and hepatic impairment. DurationNasal of treatment Dymista Nasal Spray is suitable forbelow long-term use.ofThe benefit regular is essential. Contact with the eyes No should avoided. Adults and adolescents (12 yearsRenal and older) One actuation in eachThere nostrilare twice daily in (morning evening). Children below 12 years Dymista Spray is not recommended for use in children 12 years age as 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 safety and efficacy has not been established in this age group. Elderly No dose adjustment is required in this population. 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 protective capduration be removed afterwards. Prior to first use Dymista Spray must be primed by of pressing down andDymista releasing theSpray pumpis6fortimes. Dymista Nasal Sprayfor has notPreparing been used moreThe than 7 days it must be reprimed once by and releasing pump. Using the spray: and of treatment should correspond to the periodNasal of allergenic exposure. Method administration Nasal nasalIfuse only. Instruction use thefor spray: bottle should be shaken gently before usepressing for aboutdown 5 seconds by tiltingthe it upwards and downwards The bottle shouldthe be protective shaken gently before use afterwards. for about 5Prior seconds tilting it upwards and downwards and the protective capand be removed After blowing theNasal noseSpray the suspension is to be for sprayed once7into nostril keeping the tilted downward figurethe in pump. sectionUsing 4.2 ofthethe cap be removed to firstbyuse Dymista Nasal Spray must be primed by pressing down releasing afterwards. the pump 6 times. If Dymista has not been used more than dayseach it must be reprimed oncehead by pressing down and(see releasing spray: SmPC). After use The the spray is to be be shaken wiped and thebefore protective capabout to be5replaced. Contraindications: Hypersensitivity to the the protective active substances or to anyafterwards. of the excipients listed in 6.1suspension of the SmPC. precautions: During post-marketing use,downward there have been reports of clinically bottle tip should gently use for seconds by tilting it upwards and downwards and cap be removed After blowing thesection nose the is toWarnings be sprayedand once into each nostril keeping the head tilted (see figure in section 4.2 of the significant drug interactions patients receiving propionate and ritonavir, systemic corticosteroid effects including Cushing’s syndrome suppression. concomitant use Warnings of fluticasone andDuring ritonavir should be avoided, unless potential SmPC). Afterinuse the spray tip is tofluticasone be wiped and the protective cap to beresulting replaced.inContraindications: Hypersensitivity to the active substances or toand anyadrenal of the excipients listedTherefore, in section 6.1 of the SmPC. andpropionate precautions: post-marketing use, there havethe been reports benefit of clinically to the patient outweighs thedrug risk interactions of systemic incorticosteroid side-effects (seepropionate section 4.5 the SmPC). Systemic effectscorticosteroid of nasal corticosteroids may occur, particularly when at high doses for prolonged periods. These effectspropionate are much and lessritonavir likely toshould occur be than with oral corticosteroids significant patients receiving fluticasone andofritonavir, resulting in systemic effects including Cushing’s syndrome and prescribed adrenal suppression. Therefore, concomitant use of fluticasone avoided, unless the potentialand benefit to thepatients patient outweighs the risk of systemic corticosteroid side-effects (see section 4.5effects of the SmPC). Systemic effects syndrome, of nasal corticosteroids may occur,adrenal particularly when prescribed at high doses prolonged Thesecataract, effects are much less to rarely, occur than with of oralpsychological corticosteroids may vary in individual and between different corticosteroid preparations. Potential systemic may include Cushing’s Cushingoid features, suppression, growth retardation in for children and periods. adolescents, glaucoma andlikely more a range or and may vary in individual patients and between corticosteroid preparations. Potential systemic effects may include Cushing’s Cushingoid features,first-pass adrenal suppression, retardation in children and ofadolescents, cataract, glaucoma andinmore rarely, a range psychological behavioural effects including psychomotor hyperactivity, sleepdifferent disorders, anxiety, depression or aggression (particularly in children). Dymista Nasalsyndrome, Spray undergoes extensive metabolism, growth therefore the systemic exposure intranasal fluticasone propionate patients with severeofliver disease or behavioural including hyperactivity, sleepadverse disorders, anxiety, depression or aggression (particularly children).Treatment Dymista Nasal Spray undergoes extensive first-pass therefore the intranasal fluticasone propionate in patients with severe disease is likely to be increased. Thiseffects may result in a psychomotor higher frequency of systemic events. Caution is advised when treating theseinpatients. with higher than recommended doses of metabolism, nasal corticosteroids maysystemic result inexposure clinicallyofsignificant adrenal suppression. If there is evidence forliver higher is likely be increased. Thisadditional may resultsystemic in a higher frequency ofcover systemic adverse events. Caution advisedofwhen thesesurgery. patients.InTreatment higher recommended doses of nasal corticosteroids may result clinically significant suppression. there is evidence for higher than recommended dosestobeing used, then corticosteroid should be considered duringisperiods stresstreating or elective general, with the dose of than intranasal fluticasone formulations should be reduced to theinlowest dose at whichadrenal effective control of Ifthe symptoms of rhinitis thandoses recommended being used, systemic cover should be for considered periods of stresscorticosteroids, or elective surgery. In general, theburden dose ofofintranasal fluticasone formulations shouldwhenever be reduced to the lowest dose at whichtreatment effective control of the symptoms of rhinitis is maintained. Higher than the doses recommended onethen (seeadditional section 4.2 of the corticosteroid SmPC) have not been tested Dymista.during As with all intranasal the total systemic corticosteroids should be considered other forms of corticosteroid are prescribed concurrently. is maintained. Higher doses than the recommended one (see sectionat4.2 of the doses. SmPC) have been tested Dymista. As with all intranasal corticosteroids, systemic burden of corticosteroids should treatment be considered other forms ofiscorticosteroid treatmenttoo. areIfprescribed Growth retardation has been reported in children receiving nasal corticosteroids licensed Sincenot Dymista is alsoforgiven to adolescents, it is recommended thatthe thetotal growth of adolescents receiving prolonged withwhenever nasal corticosteroids regularly monitored, growth is concurrently. slowed, retardation reported the in children nasal corticosteroids at licensed doses.dose SinceatDymista is also given to adolescents, it isisrecommended that the growth of may adolescents receiving nasal corticosteroids is regularly monitored, too. If growth is slowed, therapy should beGrowth reviewed with thehas aimbeen of reducing dose ofreceiving nasal corticosteroid if possible, to the lowest which effective control of symptoms maintained. Visual disturbance be reported withprolonged systemic treatment and topicalwith corticosteroid use. If a patient presents with symptoms such as therapy should be reviewedthe withpatient the aim of reducing the dose for of nasal corticosteroid if possible, to lowest dose at whichcauses effective control of include symptoms is maintained. Visual disturbance beas reported systemic and topical corticosteroid use. If abeen patient presents withuse symptoms such as blurred vision or other visual disturbances, should be considered referral to an ophthalmologist forthe evaluation of possible which may cataract, glaucoma or rare diseasesmay such centralwith serous chorioretinopathy (CSCR) which have reported after of systemic blurred vision or other visual disturbances, patient should considered for or referral an ophthalmologist evaluation of possible causes which may include cataract, rare diseases such as centralisserous chorioretinopathy been reported of systemic and topical corticosteroids. Close monitoring is warranted the in patients with a be change in vision with atohistory of increasedfor ocular pressure, glaucoma and/or cataracts. If there is anyglaucoma reason toorbelieve that adrenal function impaired, care must be(CSCR) taken which when have transferring patientsafter fromusesystemic topical corticosteroids. monitoring is warranted in patients a change ininfection, vision ororwith a history of increased ocular pressure, glaucoma there is any benefits reason toofbelieve that adrenal impaired, mustbebeweighed taken when transferring from systemic steroid treatmentand to Dymista Nasal Spray. InClose patients who have tuberculosis, any typewith of untreated have had a recent surgical operation or injury to theand/or nose cataracts. or mouth,Ifthe possible the treatment with function DymistaisNasal Spraycare should against possiblepatients risk. Infections of steroid treatment to Dymista Nasal Spray. In patients who have tuberculosis, any type of untreated infection, or have had a recent surgical operation or injury to the nose or mouth, the possible benefits of the treatment with Dymista Nasal Spray should be weighed against possible risk. Infections of the nasal airways should be treated with antibacterial or antimycotical therapy, but do not constitute a specific contraindication to treatment with Dymista Nasal Spray. Dymista contains benzalkonium chloride. It may cause irritation of the nasal mucosa and bronchospasm. Interactions with other the nasal airways should be treated with antibacterial or antimycotical therapy, but do not constitute a specific contraindication to treatment with Dymista Nasal Spray. Dymista contains benzalkonium chloride. It may cause irritation of the nasal mucosa and bronchospasm. Interactions with other medicinal products and other forms of interactions: Fluticasone propionate Under normal circumstances, low plasma concentrations of fluticasone propionate are achieved after intranasal dosing, due to extensive first pass metabolism and high systemic clearance mediated by cytochrome medicinal products and other forms of interactions: Fluticasone propionate Under normal circumstances, low plasma concentrations of fluticasone propionate are achieved after intranasal dosing, due to extensive first pass metabolism and high systemic clearance mediated by cytochrome P450 3A4 in the P450 gut and Hence, clinically significant drugsignificant interactions by fluticasone unlikely. are A drug interaction study in healthy subjects shownhasthat ritonavir highly(apotent P450 3A4 can greatly increase fluticasone propionate plasma 3A4liver. in the gut and liver. Hence, clinically drugmediated interactions mediated bypropionate fluticasoneare propionate unlikely. A drug interaction study in healthyhas subjects shown that (a ritonavir highlycytochrome potent cytochrome P450inhibitor) 3A4 inhibitor) can greatly increase fluticasone propionate plasma concentrations, resulting in markedly reduced serum reduced cortisol concentrations. During postmarketing use, there have of clinically drug interactions in patientsinreceiving intranasalintranasal or inhaled propionate and ritonavir, resulting in systemic corticosteroid effects. Co- Coconcentrations, resulting in markedly serum cortisol concentrations. During postmarketing use,been therereports have been reports ofsignificant clinically significant drug interactions patients receiving or fluticasone inhaled fluticasone propionate and ritonavir, resulting in systemic corticosteroid effects. treatment with other CYP 3A4 cobicistat-containing products is also expected to increase risk of systemic side-effects. The combination should be should avoidedbeunless benefit the increased risk of systemic corticosteroid side-effects, in which case case patients should treatment withinhibitors, other CYPincluding 3A4 inhibitors, including cobicistat-containing products is also expectedthe to increase the risk of systemic side-effects. The combination avoidedtheunless theoutweighs benefit outweighs the increased risk of systemic corticosteroid side-effects, in which patients should be monitored for be systemic corticosteroid Studies have shown other inhibitors of cytochrome 3A4 produce negligible and minor and (ketoconazole) increasesincreases in systemic exposureexposure to fluticasone propionate withoutwithout notablenotable reductions in serum cortisol concentrations. monitored for systemicside-effects. corticosteroid side-effects. Studiesthat have shown that other inhibitors of P450 cytochrome P450 3A4 produce(erythromycin) negligible (erythromycin) minor (ketoconazole) in systemic to fluticasone propionate reductions in serum cortisol concentrations. Nevertheless, careNevertheless, is advised when potent cytochrome P450 3A4 inhibitors (e.g.inhibitors ketoconazole), as there is potential increased fluticasone propionate. Azelastine hydrochloride No specific interaction studiesstudies with azelastine hydrochloride nasalnasal sprayspray havehave care isco-administering advised when co-administering potent cytochrome P450 3A4 (e.g. ketoconazole), as there for is potential forsystemic increasedexposure systemic to exposure to fluticasone propionate. Azelastine hydrochloride No specific interaction with azelastine hydrochloride been performed. been Interaction studies at high oral doses haveoral been performed. However, theyHowever, bear no relevance to relevance azelastinetonasal spray nasal as given recommended nasal doses result in much systemic exposure. Nevertheless, care should be taken administering azelastine hydrochloride in in performed. Interaction studies at high doses have been performed. they bear no azelastine spray as given recommended nasal doses result lower in much lower systemic exposure. Nevertheless, care should be when taken when administering azelastine hydrochloride patients taking concurrent sedative or central nervous medications because sedative effectsedative may beeffect enhanced. may Alcohol also enhance thisenhance effect (see section(see 4.7section of the 4.7 SmPC). pregnancy and lactation: FertilityFertility There are onlyarelimited data with to fertility (see section 5.3 of patients taking concurrent sedative or central nervous medications because may beAlcohol enhanced. may also this effect of theFertility, SmPC). Fertility, pregnancy and lactation: There only limited dataregard with regard to fertility (see section 5.3the of the SmPC). Pregnancy TherePregnancy are no or limited amount of dataamount from theof use azelastine and fluticasone pregnant inwomen. Therefore, Dymista Nasal Spray should used during only if the benefitbenefit justifiesjustifies the potential risk torisk thetofoetus (see (see section 5.3 5.3 SmPC). There are no or limited dataoffrom the usehydrochloride of azelastine hydrochloride andpropionate fluticasoneinpropionate pregnant women. Therefore, Dymista Nasal Spraybeshould be usedpregnancy during pregnancy onlypotential if the potential the potential the foetus section of the SmPC) Lactation It is unknown whether nasallywhether administered hydrochloride/metabolites or fluticasoneorpropionate/metabolites are excreted human breast milk. Dymista Spray should used be during only if the benefitbenefit justifies the potential risk torisk thetonewborns/ of the SmPC) Lactation It is unknown nasallyazelastine administered azelastine hydrochloride/metabolites fluticasone propionate/metabolites areinexcreted in human breast milk.Nasal Dymista Nasal Spraybeshould usedlactation during lactation onlypotential if the potential justifies the potential the newborns/ infant (see sectioninfant 5.3 of thesection SmPC). on ability to drive and use machines: NasalDymista Spray has minor oninfluence the abilityontothe drive andtouse In isolatedIncases fatigue, exhaustion, dizziness or weakness that may caused by thebydisease itself,itself, may may occuroccur (see 5.3Effects of the SmPC). Effects on ability to drive and useDymista machines: Nasal Sprayinfluence has minor ability drivemachines. and use machines. isolated casesweariness, fatigue, weariness, exhaustion, dizziness or weakness thatalso maybealso be caused the disease whenNasal usingSpray. Dymista Nasal cases, Spray. In cases, the ability to drive and use may be impaired. may this effect. Undesirable effects: Very (≥1/10): common Epistaxis. (≥1/10): Epistaxis. Headache, dysgeusia (unpleasant unpleasant Uncommon when using Dymista In these thethese ability to drive and use machines maymachines be impaired. Alcohol may Alcohol enhance thisenhance effect. Undesirable effects: Very common CommonCommon (>1/100,(>1/100, <1/10):<1/10): Headache, dysgeusia (unpleasant taste),taste), unpleasant smell.smell. Uncommon (>1/1000, <1/100): Nasal discomfort irritation, stinging, itching), sneezing, dryness, cough,throat dry throat, throatForirritation. details rarerarely and very rarely adverse reported events adversesee events see SmPC. (>1/1000, <1/100): Nasal discomfort (including nasal(including irritation, nasal stinging, itching), sneezing, nasal dryness,nasal cough, dry throat, irritation. details For of rare andofvery reported SmPC. Reportingadverse of suspected adverse reactions: Reporting suspected adverse after authorisation of theproduct medicinal product is important. It allows continued monitoring of the benefit/risk of the medicinal product. Healthcare professionals are asked to report any suspected Reporting of suspected reactions: Reporting suspected adverse reactions afterreactions authorisation of the medicinal is important. It allows continued monitoring of the benefit/risk balance balance of the medicinal product. Healthcare professionals are asked to report any suspected reactions via HPRA Pharmacovigilance, Earlsfort IRLTel: – Dublin Tel: +353 1Fax: 6764971; + 353 1Website: 6762517.www.hpra.ie. Website: www.hpra.ie. E-mail: email@example.com. events also should be reported to Pharmacovigilance, Building 4 – Trident Place, Hatfield adverse reactionsadverse via HPRA Pharmacovigilance, Earlsfort Terrace, IRL –Terrace, Dublin 2; +353 12;6764971; + 353 1Fax: 6762517. E-mail: firstname.lastname@example.org. Adverse Adverse events should be also reported to Pharmacovigilance, Mylan,Mylan, Building 4 – Trident Place, Hatfield Business Way, Park, Hatfield, MosquitoHertfordshire, Way, Hatfield, AL10 Hertfordshire, AL10no: 9BW, phone no: +44 800Email: 121 8267, Email: UKPharmacovigilance@mylan.com. Legal Category: Producttosubject to prescription which be renewed (B) Marketing Authorisation Number: PA2010/059/001 Marketing Business Park, Mosquito 9BW, phone +44 (0) 800 121 (0) 8267, UKPharmacovigilance@mylan.com. Legal Category: Product subject prescription which may be may renewed (B) Marketing Authorisation Number: PA2010/059/001 Marketing Authorisation Holder: Mylan IRE Healthcare Limited, Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland. Full Prescribing Information available on request from: Mylan Dublin, Dublin 17. Phone 01 8322250. Date of revision of Abbreviated Prescribing Information: Authorisation Holder: Mylan IRE Healthcare Limited, Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland. Full Prescribing Information available on request from: Mylan Dublin, Dublin 17. Phone 01 8322250. Date of revision of Abbreviated Prescribing Information: 20 20 Dec 2018 Item Code: IE-PI-Dymista-001. Dec 2018 Item Code: IE-PI-Dymista-001. References: 1. Carr W, Bernstein Lieberman P, Meltzer E, Bachert C, Price D, MunzelJ.U,ABousquet J. A noveltherapy intranasal therapy ofwith azelastine with fluticasone for the treatment allergicJrhinitis. Allergy Clin Immunol. 2012 May;129(5):1282-289.e10. doi: 10.1016/j.jaci.2012.01.077. References: 1. Carr W, Bernstein J, Lieberman P, J, Meltzer E, Bachert C, Price D, Munzel U, Bousquet novel intranasal of azelastine fluticasone for the treatment of allergicofrhinitis. Allergy JClin Immunol. 2012 May;129(5):1282-289.e10. doi: 10.1016/j.jaci.2012.01.077. EpubEpub 20122012 MarNasal 13. 2.Spray Dymista Nasal Spray Summary of Product Characteristics. Mar 13. 2. Dymista Summary of Product Characteristics.
For more information, please refer to Summary of Product Characteristics For more information, please refer to Summary of Product Characteristics Mylan Ireland Limited, Newenham Court, Northern Cross, Malahide Road, Dublin 17, Ireland. Mylan Ireland Limited, Newenham Court, Northern Cross, Malahide Road, Dublin 17, Ireland. Item code: DYM-2019-0356 Item code: DYM-2019-0356 Date of Preparation: May 2019 Date of Preparation: May 2019
Adverse events should also be reported to Mylan on +44(0)8001218267 or UKPharmacovigilance@mylan.com Adverse events should also be reported to Mylan on +44(0)8001218267 or UKPharmacovigilance@mylan.com
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