Land: Singapore
Språk: engelska
Källa: HSA (Health Sciences Authority)
BETAHISTINE DIHYDROCHLORIDE
GOLDPLUS UNIVERSAL PTE LTD
N07CA01
TABLET
BETAHISTINE DIHYDROCHLORIDE 24mg
ORAL
Prescription Only
CELOGEN GENERICS PRIVATE LTD
ACTIVE
2023-06-21
- r - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - +----+- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -� GP-BETAHISTINE 1. NAME OF THE MEDICINAL PRODUCT GP-Betahistine Tablets 24mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 24mg betahistine dihydrochloride equivalent to 15.63 mg betahistine. Each tablet contains 24 mg of mannitol. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Tablet White colour, round (approx 10.00mm) & biconvex uncoated tablet scored on one side with the embossing "II" on either sides of the score and plain on other side. : The score line is only to facilitate breaking for ease of swallowing and not to ' divide into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vertigo, tinnitus and hearing loss associated with Meniere'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 o� 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. : Phaeochromocytoma. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE ' ' ' ' ' ' ' Caution is advised in the treatment of patients with a history of Läs hela dokumentet