BETASERC TABLETS 16 mg

Prescription Only

Drug type: Therapeutic

ATC code: N07CA01

Dosage form: TABLET

Route of administration: ORAL

Active ingredient: BETAHISTINE 2HCl; BETAHISTINE 2HCL

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.

Posology and method of administration

The dosage for adults is 24–48 mg divided over the day.

Betaserc Dosage Table 1

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.

Registrant

ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED

Approval Date

2000-08-02

Approval Number

SIN11365P

Manufacturer

Mylan Laboratories SAS

Licence Holder

ABBOTT LABORATORIES (SINGAPORE) PRIVATE LIMITED