GPAX PHARMACEUTICALS PRIVATE LTD (INDIA)🇸🇬 Health Sciences Authority
Approval Date
Jun 21, 2023
Approval ID
4a37d44ec8bfcfda
Company
GPAX PHARMACEUTICALS PRIVATE LTD (INDIA)
Type
Therapeutic
Approval Details
Approval Id
4a37d44ec8bfcfda
Drug Name
GP-BETAHISTINE TABLETS 24MG
Product Name
GP-BETAHISTINE TABLETS 24MG
Approval Number
SIN16812P
Approval Date
2023-06-21
Registrant
GOLDPLUS UNIVERSAL PTE LTD
Licence Holder
GOLDPLUS UNIVERSAL PTE LTD
Drug Type
Therapeutic
Forensic Classification
PRESCRIPTION ONLY MEDICINES
Dosage Form
TABLET
Dosage
<p><strong>4.2 Posology and method of administration</strong></p>
<p><strong>Posology</strong></p>
<p><u>Adults:</u><br>
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.</p>
<p><u>Paediatric population:</u> not recommended for use in children below 18 years due to insufficient data on safety and efficacy.</p>
<p><u>Renal impairment:</u> There are no specific clinical trials available in this patient group.</p>
<p><u>Hepatic impairment:</u> There are no specific clinical trials available in this patient group.</p>
<p><em>Method of Administration</em></p>
<p>The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.</p>
Route Of Administration
ORAL
Indication Info
<p><strong>4.1 Therapeutic indications</strong><br>
Vertigo, tinnitus and hearing loss associated with Ménière's syndrome.</p>
Contraindications
<p><strong>4.3 Contraindications</strong><br>
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.<br>
Phaeochromocytoma.</p>
