BETASERC 24 TABLET 24 mg

Country: Сингапур

Језик: Енглески

Извор: HSA (Health Sciences Authority)

Активни састојак:

BETAHISTINE 2HCl

Доступно од:

ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED

АТЦ код:

N07CA01

Дозирање:

24 mg

Фармацеутски облик:

TABLET

Састав:

BETAHISTINE 2HCl 24 mg

Пут администрације:

ORAL

Тип рецептора:

Prescription Only

Произведен од:

Mylan Laboratories SAS

Статус ауторизације:

ACTIVE

Датум одобрења:

2003-03-24

Карактеристике производа

Updated 04-Sep-17
16mg tablets
24mg tablets
½ - 1 tablet
3 times daily
1 tablet
2 times daily
QUALITATIVE AND QUANTITATIVE COMPOSITION
Betaserc tablets contain 16 mg betahistine
dihydrochloride corresponding to 10.42 mg
betahistine and 24 mg corresponding to
15.63mg betahistine
PHARMACEUTICAL FORM
Betaserc 16 mg is a round,
biconvex,
scored,
almost white to white tablet with
bevelled edges. The diameter is 8.5mm, the
tablet weight is approximately 250mg. The
tablet inscriptions are “267” on either side of
the score line. The tablet can be divided into
equal halves.
Betaserc 24 mg is a round, biconvex,
scored, almost white to white tablet with
beveled edges. The diameter is 10mm, the
tablet weight is approximately 375mg. The
inscriptions are “289” on either side of the
score line.
The purpose of the scoreline is only to
facilitate breaking for ease of swallowing
and not intended to divide the tablet into two
doses.
Excipients (non-medicinal ingredients):
Microcrystalline cellulose, mannitol (E421),
citric acid monohydrate, colloidal anhydrous
silica, talc.
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.
POSOLOGY AND METHOD OF ADMINISTRATION
The dosage for adults is 24-48 mg divided
over the day.
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.
CONTRAINDICATIONS
Hypersensitivity to the active substance or to
any of the excipients.
Phaeochromocytoma.
SPECIAL WAR