MedPath
HSA Approval

BETASERC TABLETS 16 mg

SIN11365P

BETASERC TABLETS 16 mg

BETASERC TABLETS 16 mg

August 2, 2000

ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED

ABBOTT LABORATORIES (SINGAPORE) PRIVATE LIMITED

Regulatory Information

ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED

ABBOTT LABORATORIES (SINGAPORE) PRIVATE LIMITED

Therapeutic

Prescription Only

Formulation Information

TABLET

**Posology and method of administration** The dosage for adults is 24–48 mg divided over the day. ![Betaserc Dosage Table 1](https://cdn.medpath.com/drug/dosage/20240520/bd20292dcf8acce34b52c6a7d632f020.png) Should be swallowed with water. 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. Pediatric population: Betaserc is not recommended for use in children under the age of 18 years due to insufficient data on safety and efficacy.

ORAL

Medical Information

**Therapeutic Indications** Ménière’s Syndrome as defined by the following core symptoms: - vertigo (with nausea/vomiting) - hearing loss (hardness of hearing) - tinnitus (ringing in the ears) Symptomatic treatment of vestibular vertigo.

**Contraindications** Hypersensitivity to the active substance or to any of the excipients. Phaeochromocytoma.

N07CA01

betahistine

Manufacturer Information

ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED

Mylan Laboratories SAS

Active Ingredients

BETAHISTINE 2HCl

16 mg

Betahistine

Documents

Package Inserts

Betaserc tablets PI.pdf

Approved: January 24, 2018

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