Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET
**4.2 Posology and method of administration** **Posology** Adults: The dosage for adults is 24–48mg divided over the day. The 24mg strength can be taken 2 times daily. Daily dose should not exceed 48mg. The dosage should be individually adapted according to the response. Improvement can sometimes only be observed after a couple of weeks of treatment. Paediatric population: not recommended for use in children below 18 years due to insufficient data on safety and efficacy. Renal impairment: There are no specific clinical trials available in this patient group. Hepatic impairment: There are no specific clinical trials available in this patient group. _Method of Administration_ The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
ORAL
Medical Information
**4.1 Therapeutic indications** Vertigo, tinnitus and hearing loss associated with Ménière's syndrome.
**4.3 Contraindications** Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. Phaeochromocytoma.
N07CA01
betahistine
Manufacturer Information
GOLDPLUS UNIVERSAL PTE LTD
CELOGEN GENERICS PRIVATE LTD
Active Ingredients
Documents
Package Inserts
GP Betahitine Tablets Package Insert.pdf
Approved: June 21, 2023