Mylan Laboratories SAS (FRANCE)🇸🇬 Health Sciences Authority
Approval Date
Aug 2, 2000
Approval ID
58f384f5fdcc5a27
Company
Mylan Laboratories SAS (FRANCE)
Type
Therapeutic
Approval Details
Approval Id
58f384f5fdcc5a27
Drug Name
BETASERC TABLETS 16 mg
Product Name
BETASERC TABLETS 16 mg
Approval Number
SIN11365P
Approval Date
2000-08-02
Registrant
ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
Licence Holder
ABBOTT LABORATORIES (SINGAPORE) PRIVATE LIMITED
Drug Type
Therapeutic
Forensic Classification
Prescription Only
Dosage Form
TABLET
Dosage
<p><strong>Posology and method of administration</strong><br>
The dosage for adults is 24–48 mg divided over the day.</p>
<img src="/TGIF/Betaserc-Table1.png" alt="Betaserc Dosage Table 1" /><br><br>
<p>Should be swallowed with water.</p>
<p>The dosage should be individually adapted according to the response. Improvement can sometimes only be observed after a couple of weeks of treatment. The best results are sometimes obtained only after a few months. There are indications that treatment from the onset of the disease prevents its progression and/or the loss of hearing in later phases of the disease.</p>
<p><u>Pediatric population:</u><br>
Betaserc is not recommended for use in children under the age of 18 years due to insufficient data on safety and efficacy.</p>
Route Of Administration
ORAL
Indication Info
<p><strong>Therapeutic Indications</strong><br>
Ménière’s Syndrome as defined by the following core symptoms:</p>
<ul>
<li>vertigo (with nausea/vomiting)</li>
<li>hearing loss (hardness of hearing)</li>
<li>tinnitus (ringing in the ears)</li>
</ul>
<p>Symptomatic treatment of vestibular vertigo.</p>
Contraindications
<p><strong>Contraindications</strong><br>
Hypersensitivity to the active substance or to any of the excipients.<br>
Phaeochromocytoma.</p>
