Summary of content

Betahistin dihydrocloride

Visa No.: 893110378623

Product: Histigo 16mg

API: Betahistin dihydrocloride

Product Category: Others

Version approved leaflet: 706/QÐ-QLD_08/10/2018_163

 

INDICATIONS

Vertigo, tinnitus, and hearing loss associated with Ménière’s disease.

DOSAGE AND ADMINISTRATION

Adults (including the elderly): The initial dose is 16 mg three times daily, taken with meals.
The usual maintenance dose ranges from 24 to 48 mg per day.
Children: Use in children and adolescents under 18 years of age is not recommended, due to insufficient data on safety and efficacy.
Elderly: Although limited data are available from clinical studies in this population, post-marketing experience indicates that no dose adjustment is necessary.
Renal impairment, hepatic impairment: No specific clinical studies have been conducted in these patient groups; however, based on post-marketing experience, no dose adjustment is required.
 

CONTRAINDICATIONS

Pheochromocytoma.
Hypersensitivity to betahistine or to any of the excipients.
 

WARNINGS AND PRECAUTIONS

Prescription only medicine. Read the instructions before use. Consult a physician or pharmacist if needed. Keep out of reach of children