Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET
**4.2 Posology and method of administration** Adults and adolescents (12 years of age and above) The recommended dose is 10 mg (one tablet) once a day, with or without food. Elderly Rupatadine should be used with caution in elderly people (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Paediatric patients Rupatadine 10 mg Tablets is not recommended for use in children below age 12 due to a lack of data on safety and efficacy. Patients with renal or hepatic insufficiency As there is no clinical experience in patients with impaired kidney or liver functions, the use of Rupatadine 10 mg Tablets is at present not recommended in these patients.
ORAL
Medical Information
**4.1 Therapeutic indications** Symptomatic treatment of allergic rhinitis and urticaria in adults and adolescents (12 years of age and above).
**4.3 Contraindications** Hypersensitivity to rupatadine or to any of the excipients.
R06AX28
rupatadine
Manufacturer Information
HYPHENS PHARMA PTE. LTD.
Noucor Health S.A.
Active Ingredients
Documents
Package Inserts
Rupafin Tablet PI.pdf
Approved: March 3, 2023