Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET, FILM COATED
**Dosage and Administration** The tablet should be swallowed whole with some liquid, and must not be broken, chewed or crushed. It may be taken with or without food. After consultation with the doctor, duration of treatment should not exceed the period of acute symptoms, and should not exceed 2 to 3 weeks. After improvement of nasal symptoms, treatment should be continued only with cetirizine, where appropriate. **Route of Administration** For oral use. **Adults and Children aged 12 years and older** One tablet twice daily (morning and evening). **Children under 12 years of age** Zyrtec-D is contraindicated in children under 12 years of age (see Sections _Contraindications; Warnings and Precautions_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Elderly** Zyrtec-D should be used with caution in patients over 50 years of age. The dose should be reduced to one tablet daily for patients ≥ 77 years old. **Renal Impairment** The dose should be reduced to one tablet daily in patients with mild to moderate renal insufficiency. Zyrtec-D is contraindicated in severe renal insufficiency (see Section _Contraindications_). **Hepatic Impairment** The dose should be reduced to one tablet daily in patients with mild to moderate hepatic insufficiency.
ORAL
Medical Information
**Indications** Zyrtec-D is indicated for the treatment of symptoms associated with seasonal and perennial allergic rhinitis with nasal congestion, and hypersecretion, nose and/or eye itching and watery eyes. It should be administered when both the anti-allergic properties of cetirizine dihydrochloride and the nasal decongestant activity of pseudoephedrine hydrochloride are desired.
**Contraindications** Zyrtec-D is contraindicated in: - known hypersensitivity to the active substances or excipients, to ephedrine or any other piperazines, - severe hypertension or severe ischaemic heart disease, - severe renal insufficiency, - uncontrolled hyperthyroidism, - severe arrhythmias, - phaeochromocytoma, - elevated intraocular pressure, - urinary retention, - glaucoma, - history of stroke, - high risk of haemorrhagic stroke (see Section _Warnings and Precautions_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_), - concomitant administration of dihydroergotamine (see Section _Interactions_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_), - concomitant treatment with monoamine oxidase (MAO) inhibitor and within 2 weeks after their discontinuation, - children under 12 years of age (see Section _Warnings and Precautions_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
R01BA52
pseudoephedrine, combinations
Manufacturer Information
GLAXOSMITHKLINE PTE LTD
UCB FARCHIM SA
AESICA PHARMACEUTICALS S.R.L