Prescribing Information
Dymista Prescribing Information
Dymista® Nasal Spray, Suspension (azelastine hydrochloride/ fluticasone propionate)
Prescribing Information
Please refer to Summary of Product Characteristics (SmPC) before prescribing.
Dymista 137 micrograms/50 micrograms per Actuation Nasal Spray. Contains azelastine hydrochloride and fluticasone propionate.
Indication: Relief of symptoms of moderate to severe seasonal and perennial allergic rhinitis if treatment with intranasal antihistamine or glucocorticoid alone is not considered sufficient.
Dosage and administration: Adults and adolescents ≥12 years: One actuation in each nostril twice daily (morning and evening). Children <12 years: Not recommended; safety and efficacy not established.
Method: For nasal use only.
Contraindications: Hypersensitivity to azelastine hydrochloride, fluticasone, or any other ingredients including benzalkonium chloride.
Warnings and precautions: Systemic corticosteroid effects may occur, especially at high doses or prolonged use (e.g., adrenal suppression, Cushingoid features, growth retardation, cataract, glaucoma).
Visual disturbance may occur; consider ophthalmology referral if symptoms such as blurred vision arise.
Growth monitoring is recommended in adolescents receiving prolonged treatment.
Use with caution in patients with severe liver disease, tuberculosis, untreated infections, recent nasal surgery, or trauma.
Contains benzalkonium chloride, which may cause nasal mucosal oedema with long-term use.
Interaction with other medicinal products: Avoid concomitant use with ritonavir or potent CYP3A4 inhibitors unless benefit outweighs risk due to risk of systemic corticosteroid effects.
Pregnancy and lactation: Experience of use in pregnancy and lactation is limited. Dymista should only be used if the potential benefit justifies the potential risk.
Effects on ability to drive and use machines: Dymista has minor influence on ability to drive and use machines.
Undesirable effects: Very common: Epistaxis. Common: Headache, Dysgeusia (unpleasant taste), unpleasant smell. Uncommon: Nasal discomfort (including nasal irritation, stinging, itching), sneezing, nasal dryness, cough, dry throat, throat irritation. Rare: Dry mouth. Very rare: Hypersensitivity reactions including anaphylaxis and angioedema (oedema of the face or tongue and skin rash), bronchospasm, dizziness, somnolence (drowsiness, sleepiness), glaucoma, increased intraocular pressure, cataract, nasal septal perforation, mucosal erosion, nausea, rash, pruritus, urticaria, fatigue (weariness, exhaustion), weakness. Frequency not known: Blurred vision, nasal ulcers.
Package Quantities and Basic Price (UK):
£14.80 for 23g bottle. Each spray (0.14 g) contains 137 mcg of azelastine hydrochloride and 50 mcg of fluticasone propionate. Legal category: POM. Product Licence Holder: Viatris Products Ltd, Station Close, Potters Bar, EN6 1TL, United Kingdom. Tel 0845460 0000. Marketing Authorisation Number: PL 46302/0162. Document number: UK-DYM-2026-00002. Date last revised: June 2026
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 pv.uk@viatris.com.