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Ryaltris ® is indicated in adults and adolescents 12 years of age and older for the treatment of moderate to severe nasal symptoms associated with allergic rhinitis ( AR ). 1
Ryaltris ® combination intranasal spray can bring rapid relief from allergic rhinitis triggered by perennial factors such as animal dander and dust mites 1-3
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Ryaltris Prescribing Information Ryaltris ( mometasone furoate and olopatadine hydrochloride ) Please refer to the Summary of Product Characteristics ( SmPC ) before prescribing . One delivered dose contains mometasone furoate monohydrate equivalent to 25 microgram mometasone furoate and olopatadine hydrochloride equivalent to 600 micrograms olopatadine . Indication : treatment of moderate to severe nasal symptoms associated with allergic rhinitis in adults and adolescents 12 years of age and older Posology and method of administration : The usual recommended dose is two actuations in each nostril twice daily ( morning and evening ). Children below 12 years : Ryaltris is not recommended . Elderly : No dose adjustment required . Renal and hepatic impairment : there are no data in patients with renal and hepatic impairment , however no dose adjustment is expected to be required . Contraindications : Hypersensitivity to the active substances or to any of the excipients . Ryaltris should not be used in the presence of untreated localised infection involving the nasal mucosa , such as herpes simplex . Patients who have experienced recent nasal surgery or trauma should not use a nasal corticosteroid until healing has occurred . Precautions : Local nasal effects : nasal ulceration and nasal septal perforation have been reported in patients following intranasal antihistamines . Nasal septal perforation has been reported following intranasal corticosteroids . Patients using Ryaltris over several months or longer should be examined periodically for possible changes in the nasal mucosa . Ryaltris is not recommended in cases of nasal septum perforation . In clinical studies with mometasone furoate administered intranasally , the development of localised infections of the nose and pharynx with Candida albicans has occurred ; may require treatment and discontinuation of Ryaltris . Patients using Ryaltris over several months or longer should be examined periodically for evidence of Candida infection or other signs of adverse effects on the nasal mucosa . Visual disturbances may be reported with systemic and topical corticosteroid use . Symptoms such as blurred vision or other visual disturbances should be considered for ophthalmologist referral for evaluation of possible causes including cataract , glaucoma or rare diseases such as central serous chorioretinopathy ( CSCR ). Hypersensitivity Reactions including instances of wheezing , may occur . Discontinue Ryaltris if such reactions occur . Immunosuppression : Chickenpox and measles , for example , can have a more serious or even fatal course in susceptible patients and those using corticosteroids . In children or adults who have not had these diseases or been properly immunized , particular care should be taken to avoid exposure . Corticosteroids should be used with caution , if at all , in patients with active or quiescent tuberculous infections of the respiratory tract , untreated local or systemic fungal or bacterial infections , systemic viral or parasitic infections , or ocular herpes simplex because of the potential for worsening of these infections . Systemic Effects of Corticosteroids : potential systemic effects may include Cushing ’ s syndrome , Cushingoid features , adrenal suppression , growth retardation in children and adolescents , cataract , glaucoma and more rarely , a range of psychological or behavioural effects including psychomotor hyperactivity , sleep disorders , anxiety , depression or aggression ( particularly in children ). When intranasal steroids are used at higher than recommended dosages or in susceptible individuals at recommended dosages , systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear . If such changes occur , the dosage of Ryaltris should be discontinued slowly , consistent with accepted procedures for discontinuing oral corticosteroid therapy . The concomitant use of intranasal corticosteroids with other inhaled corticosteroids could increase the risk of signs or symptoms of hypercorticism and / or suppression of the HPA axis . If there is evidence for higher than recommended doses being used , then additional systemic corticosteroid cover should be considered during periods of stress or elective surgery . The replacement of a systemic corticosteroid with a topical corticosteroid can be accompanied by signs of adrenal insufficiency , and some patients may experience symptoms of withdrawal . Patients previously treated for prolonged periods with systemic corticosteroids and transferred to topical corticosteroids should be carefully monitored for acute adrenal insufficiency in response to stress . In those patients who have asthma or other clinical conditions requiring long term systemic corticosteroid treatment , too rapid a decrease in systemic corticosteroids may cause a severe exacerbation of their symptoms . Somnolence : in isolated cases dizziness , lethargy , fatigue and somnolence may occur when using Ryaltris . In these cases , the ability to drive and use machines may be impaired . Alcohol and other CNS depressants may enhance this effect . Antihistamine effects : concomitant use of other antihistaminic drugs administered may increase the risk of antihistamine adverse effects . Paediatric population : It is recommended that the height of children receiving prolonged treatment with nasal corticosteroids is regularly monitored . If growth is slowed , therapy should be reviewed with the aim of reducing the dose of nasal corticosteroid if possible , to the lowest dose at which effective control of symptoms is maintained . Excipients : Ryaltris contains 0.02 mg benzalkonium chloride in each actuation . Benzalkonium chloride may cause irritation or swelling inside the nose , especially if used for a long time . Adverse reactions : Common ( ≥1 / 100 to < 1 / 10 ): dysgeusia ( unpleasant taste ), epistaxis , nasal discomfort . Uncommon ( ≥1 / 1,000 to < 1 / 100 ): dizziness , headaches , somnolence , nasal dryness , dry mouth , abdominal pain , nausea , fatigue . Rare ( ≥1 / 10,000 to < 1 / 1000 ) bacterial vaginosis , anxiety , depression , insomnia , lethargy , migraine , blurred vision , dry eye , eye discomfort , ear pain , nasal inflammation , nasal mucosal disorder , oropharyngeal pain , sneezing , throat irritation , constipation , sore tongue , laceration . Incidence not known ( reported from use of corticosteroids ): pharyngitis , upper respiratory tract infection , hypersensitivity including anaphylactic reactions , angioedema , bronchospasm , and dyspnoea , cataracts , glaucoma , increased intraocular pressure , nasal septum perforation . Marketing authorisation number : PL 25258 / 0331 Marketing Authorisation Holder and distributer : Glenmark Pharmaceuticals Europe Limited , Laxmi House , 2B Draycott Avenue Kenton , Middlesex , HA3 0BU . United Kingdom Legal classification : POM Cost : £ 13.32 . 1 bottle with 29 g suspension ( 240 actuations ) Date of preparation : June 2021 . Job number : PP-UK-RYAL-0001
Adverse events should be reported . Reporting forms and information can be found at https :// yellowcard . mhra . gov . uk . Adverse events should also be reported to Glenmark Pharmaceuticals Europe Ltd medical _ information @ glenmarkpharma . com or call 0800 458 0383
References : 1 . Ryaltris Summary of Product Characteristics . 2 . Gross GN , et al . Ann Allergy Asthma Immunol 2019 ; 122:630 – 638 . 3 . Segall N , et al . Allergy Asthma Proc 2019 ; 40 ( 5 ): 301-310 .
Ryaltris ® is a registered trademark of Glenmark Speciality S . A .
© 2022 Glenmark Pharmaceuticals Europe Ltd . All rights reserved .
Date of preparation : August 2022 PP-UK-RYAL-0138 V1