Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET, FILM COATED
**4.2 Posology and method of administration** _Adults and Children 12 years of age and over:_ **CLARITYNE®** Tablet: One tablet (10 mg) once daily; _Children 6 to 12 years of age:_ **CLARITYNE® Tablet:** Body Weight >30 kg -- One tablet (10 mg) once daily Safety and efficacy of CLARITYNE® has not been established in children younger than 2 years of age. Patients with severe liver impairment should be administered a lower initial dose because they may have reduced clearance of loratadine; an initial dose of 5 mg once daily, or 10 mg every other day is recommended.
ORAL
Medical Information
**4.1 Therapeutic indications** **CLARITYNE®** Products are indicated for the relief of symptoms associated with allergic rhinitis, such as sneezing, nasal discharge (rhinorrhea) and itching, as well as ocular itching and burning. Nasal and ocular signs and symptoms are relieved rapidly after oral administration. **CLARITYNE®** Products are also indicated for relief of symptoms and signs of chronic urticaria and other allergic dermatologic disorders.
**4.3 Contraindications** **CLARITYNE®** Products are contraindicated in patients who are hypersensitivity to the active substance or to any of the excipients in these formulations.
R06AX13
loratadine
Manufacturer Information
BAYER (SOUTH EAST ASIA) PTE LTD
Schering-Plough Labo NV
PT. BAYER INDONESIA
Active Ingredients
Documents
Patient Information Leaflets
Clarityne Tablet 10mg PIL.pdf
Approved: January 4, 2023