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- GP-BETAHISTINE TABLETS 24MG [SIN16812P]
GP-BETAHISTINE TABLETS 24MG [SIN16812P]
Active ingredients: GP-BETAHISTINE TABLETS 24MG
Product Info
GP-BETAHISTINE TABLETS 24MG
[SIN16812P]
Product information
Active Ingredient and Strength | BETAHISTINE DIHYDROCHLORIDE - 24 MG |
Dosage Form | TABLET |
Manufacturer and Country | GPAX PHARMACEUTICALS PRIVATE LTD - INDIA |
Registration Number | SIN16812P |
Licence Holder | GOLDPLUS UNIVERSAL PTE LTD |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | N07CA01 |
4.1 Therapeutic indications
Vertigo, tinnitus and hearing loss associated with Ménière's syndrome.
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.
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.
