GP-BETAHISTINE TABLETS 24MG

Country: Singapúr

Tungumál: enska

Heimild: HSA (Health Sciences Authority)

Virkt innihaldsefni:

BETAHISTINE DIHYDROCHLORIDE

Fáanlegur frá:

GOLDPLUS UNIVERSAL PTE LTD

ATC númer:

N07CA01

Lyfjaform:

TABLET

Samsetning:

BETAHISTINE DIHYDROCHLORIDE 24mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

Prescription Only

Framleitt af:

CELOGEN GENERICS PRIVATE LTD

Leyfisstaða:

ACTIVE

Leyfisdagur:

2023-06-21

Vara einkenni

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GP-BETAHISTINE
1. NAME OF THE MEDICINAL PRODUCT
GP-Betahistine Tablets 24mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
tablet
contains
24mg
betahistine
dihydrochloride
equivalent
to
15.63 mg betahistine.
Each tablet contains 24 mg of mannitol.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Tablet
White colour, round (approx 10.00mm) & biconvex uncoated tablet scored
on one side with the embossing "II" on either sides of the score and
plain on
other side.
:
The score line is only to facilitate breaking for ease of swallowing
and not to
'
divide into equal doses.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Vertigo, tinnitus and hearing loss associated with Meniere's syndrome.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adults:
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
o�
treatment.
'
Paediatric population:
not recommended for use in children below 18 years
:
due to insufficient data on safety and efficacy.
:
'
'
Renal impairment: There are no specific clinical trials available in
this patient
:
group.
:
'
Hepatic impairment:
There are no specific clinical trials available in this:
patient group.
:
'
'
_Method of _
_Administration _
The score line is only to facilitate breaking for ease of swallowing
and not to:
divide into equal doses.
:
4.3 CONTRAINDICATIONS
'
'
'
'
Hypersensitivity to the active substance(s) or to any of the
excipients listed in:
section 6.1.
:
Phaeochromocytoma.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
'
'
'
'
'
'
'
Caution is advised in the treatment of patients with a history of