Betastin tablets

Страна: Армения

Език: английски

Източник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активна съставка:

betahistine (betahistine dihydrochloride)

Предлага се от:

Pharmacare PLC

АТС код:

N07CA01

INN (Международно Name):

betahistine (betahistine dihydrochloride)

дозиране:

24mg

Лекарствена форма:

tablets

Броя в опаковка:

(20/2x10/), (30/3x10/) and (100/10x10/), in blister

Вид предписание :

Prescription

Статус Оторизация:

Registered

Дата Оторизация:

2016-09-15

Данни за продукта

CONtr'IDENTIAL
Betastino
16
mg
Tablets
Document
status:
Final
Date:
10 August
2016
Number
ofpages:
4
Summary
of
Product
Characteristics
L0
August
2016
Betastin@
16
mg
Tablets
Summary
of Product
Characteristics
Property
of,Pharmacare
Int. Co.
/ Pharmacare
PLC
COI\.FIDENTIAL
May not
be used,
divulged
or
otherwise
disclosed
without
the
consent
of
Pharmacare
Int.
Co.
/ Pharmacare
PLC
%{
Page
1
CONFIDENTIAL
Betastin@
16
mg Tablets
1. Name
of the
Medicinal Produet
Betastin@
16
mg
Tablets
2.
Qualitative
and
Quantitative
Composition
n-methyl-2-pyridineethaaamin
dihydrochlorider
2
-
(2
-
Qnethylamino)
ethyl)
dihydrochloride;
Betahistine
HCI
;
Betahistine
Hydrochloride
Each
tablet
contains
16
mg of
Betahistine
Hydrochloride.
3. Pharmaceutical
Form
Tablets
for oral
use:
The
Betastinir
16
tablets
are
round
in shape
and
White
or
almost
white in color
tabiet.
pyridine
4. Clinical
Particulars
4.1 Thcrapeutic
indications:
Troubles
ofthe
micro-circulal
and
vascular
tension
of
the labyrinth.
Symptoms
of Meniere's
disease
such
as
vertigo,
tinnitus
and
hearing
loss'
4,2
Posology
and rnethod
of administration:
Betastin@
is-administered
orally. Recommended
dose
of
Betahistine
HC1
t6 mg
is one
tablet
three
times
daily.
Maximum
dose
is 48
mg/day
in divided
doses.
This is
a long telm medicine
when
used for the
treatrnent
of
Meniere's
disease.
Bffect of
Betahistine
HCI on the symptoms
of
hearing
loss
becomes
evident only
after
2 months.
Therefore,
it must
be
taken
for at
least
a
period
of2 monlhs,
depending
on the
progress
of the
disease.
Advise
patient
against
discontinuation
ofthe
drug
before
consultation.
4.3 Contra-indications
:
-
Gasbo-duodenal
ulcers.
-
Pheochromocytoma.
4.4 Special
warnings
and
precautions
for use
Avoid use
in
patients
with history
of ulcers.
Be very careful
when using
with asthma
patienls.
Use
in
pregnancy
and lactation:
Safety and
efficacy of using
Betasdn in human
during
pregnalcy ancl
breast
feeding
has not
been
established.
It
is not recommended
to administer
Betahisiine
HCI to
pregnant
womell,
though
animal c