DYMISTA CONTROL LONG FORM PRODUCT INFORMATION

Dymista Control 137 micrograms / 50 micrograms per Actuation Nasal Spray. Contains azelastine hydrochloride and fluticasone propionate. Indication: Relief of symptoms of moderate to severe seasonal allergic rhinitis in adults if monotherapy with either intranasal antihistamine or glucocorticoid is not considered sufficient. Dosage and method of use: 18 years of age or over: one actuation in each nostril twice daily (morning and evening). The maximum daily dose: 2 sprays per nostril per day. Children and adolescents under 18 years of age: Not recommended. Dymista Control Nasal Spray is for nasal use only. Contraindications: Hypersensitivity to azelastine, fluticasone, or any excipients including benzalkonium chloride. Warnings and Precautions: Seek medical advice if symptoms do not improve within 7 days, or if improved but not adequately controlled. Do not use for >3 months without consulting a doctor.

Caution in patients using other corticosteroid products (oral, inhaled, topical, ocular). Avoid use in patients with fever, nasal/sinus infection, recent nasal surgery, injury, or ulceration. Systemic corticosteroid effects may occur, especially at high doses or prolonged use (e.g., adrenal suppression, Cushingoid features, growth retardation, cataract, glaucoma). Ritonavir and potent CYP3A4 inhibitors may greatly increase fluticasone plasma concentration. Co-treatment with ritonavir and potent CPY3A4 should be avoided unless benefit outweighs the risk. Visual disturbance may occur; consider ophthalmology referral if blurred vision develops. 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. Dymista Control has minor influence on ability to drive and use machines. Interactions: Ritonavir and other potent CYP3A4 inhibitors (e.g., cobicistat, ketoconazole) may greatly increase fluticasone levels and the risk of systemic corticosteroid effects. Sedatives, CNS depressants, and alcohol may enhance azelastine‑related drowsiness. Pregnancy and lactation: Experience of use in pregnancy and lactation is limited. Dymista Control should only be used if the potential benefit justifies the potential risk. Side-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. Product licence number: PL 46302/0094 MAH: Viatris Products Ltd, Station Close, Potters Bar, EN6 1TL, United Kingdom. Supply classification: P. Cost (excl VAT): £13.72 (Trade price) Document number: UK-DTC-2026-00002. Date last revised: June 2026