Betaserc 16mg Tablets

দেশ: মাল্টা

ভাষা: ইংরেজি

সূত্র: Malta Medicines Authority

সক্রিয় উপাদান:

BETAHISTINE DIHYDROCHLORIDE

থেকে পাওয়া:

BGP Products BV

এটিসি কোড:

N07CA01

INN (আন্তর্জাতিক নাম):

BETAHISTINE DIHYDROCHLORIDE

ফার্মাসিউটিকাল ফর্ম:

TABLET

রচনা:

BETAHISTINE DIHYDROCHLORIDE 16 mg

প্রেসক্রিপশন টাইপ:

POM

থেরাপিউটিক এলাকা:

OTHER NERVOUS SYSTEM DRUGS

অনুমোদন অবস্থা:

Authorised

পণ্য বৈশিষ্ট্য

Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Betaserc
®
8 mg tablets
Betaserc
®
16 mg tablets
Betaserc
®
24 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Betaserc
®
tablets contain 8, 16 or 24 mg betahistine dihydrochloride.
For a full list of excipients see section 6.1
3.
PHARMACEUTICAL FORM
Betaserc
®
tablet, 8 mg:
A round, flat, white to almost white tablet with bevelled edges. The
diameter is 7 mm; the
tablet weight is about 125 mg. The inscription is 256 on one
tablet-side
Betaserc
®
tablet, 16 mg:
A round, biconvex, scored, white to almost white tablet with bevelled
edges. The diameter
is 8.5 mm; the tablet weight is about 250 mg. The inscription is 267
on either side of the
score on one tablet-side._ _
The tablet can be divided into equal halves
Betaserc
®
tablet, 24 mg:
A round, biconvex, scored, white to almost white tablet with bevelled
edges and relevant
inscriptions. The diameter is 10 mm; the tablet weight is about 375
mg. The inscription is
289 on either side of the score on one tablet-side.
_ _
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide into
equal doses
4.
CLINICAL PARTICULARS
Page 2 of 8
4.1
THERAPEUTIC INDICATIONS
Ménière's Syndrome as defined by the following trias of core
symptoms:
- vertigo (with nausea/vomiting)
- hearing loss (hardness of hearing)
- tinnitus
Symptomatic treatment of vestibular vertigo.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Betaserc
®
tablets 8mg/ Betaserc
®
tablets 16mg:
The dosage for adults is 24-48 mg divided over the day.
_8 mg tablets _
_16 mg tablets _
1-2 tablets
3 times/day
1/2-1 tablet
3 times/day
Betaserc
®
tablets 24mg:
The dosage for adults is 48mg divided over the day.
_24 mg tablets_
1 tablet
2 times/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 after a few months. There are indications that
treatment from the
onse