Company: Meda Health Sales.
Legal category: Prescription. GMS. Sport permitted.
Active ingredients: Azelastine hydrochloride/fluticasone propionate 137mcg/50mcg per actuation.
Description: Nasal spray, suspension.
Presentation: 23g, €19.75.
Indications: Relief of symptoms of moderate to severe seasonal and perennial allergic rhinitis if monotherapy with either intranasal antihistamine or glucocorticoid not considered sufficient.
Pharmacology: Fluticasone propionate is a synthetic trifluorinated corticosteroid that possesses a very high affinity for the glucocorticoid receptor and has a potent anti-inflammatory action. Azelastine is a phthalazinone derivative and classified as a potent long-acting anti-allergic compound with selective H1-antagonist, mast cell stabilizing and anti-inflammatory properties. Relief of nasal allergic symptoms is observed within 15 minutes after administration.
Dosage: Adult: One actuation in each nostril twice daily (morning and evening). Elderly: As per adults. Children: Over 12 years, as per adults. Under 12 years, not recommended.
Contraindications: Hypersensitivity to the active substances or to any of the excipients.
Special precautions: Systemic effects may occur (high doses for prolonged usage): Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma and, rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (especially in children). Caution: Severe liver disease. Monitor patients with a change in vision or with a history of increased ocular pressure, glaucoma and/or cataracts closely. Patients with tuberculosis, any untreated infection, or recent surgery or injury to nose or mouth (assess risk/benefit). Avoid contact with eyes. Pregnancy, lactation (assess risk/benefit). Driving/using machines. Contains benzalkonium chloride.
Drug interactions: Caution: Potent CYP3A4 inhibitors (e.g. ketoconazole), sedative or CNS drugs, alcohol. Avoid: Ritonavir.
Adverse drug reactions: Epistaxis, headache, dysgeusia (unpleasant taste), unpleasant smell.
Full prescribing information and references available from Meda Health Sales. Telephone: (01) 8026624.