BESTEDY 24 Betahistine Dihydrochloride Tablets BP 24 mg

Krajina: Malajzia

Jazyk: angličtina

Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktívna zložka:

BETAHISTINE DIHYDROCHLORIDE

Dostupné z:

UNIMED SDN BHD

INN (Medzinárodný Name):

BETAHISTINE DIHYDROCHLORIDE

Počet v balení:

10X10 Tablets

Výrobca:

Aurobindo Pharma Limited (Unit III),

Príbalový leták

BESTEDY 24
BETAHISTINE DIHYDROCHLORIDE TABLETS BP 24MG
Betahistine Dihydrochloride (24mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What BESTEDY is used for
2.
How BESTEDY works
3.
Before you use BESTEDY
4.
How to use BESTEDY
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of BESTEDY
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT BESTEDY IS USED FOR
BESTEDY is used for:
Ménière’s
d i s e a s e
–
the
signs
of
this
include:
• feeling dizzy (vertigo)
• ringing in the ears (tinnitus)
• hearing loss or hearing difficulty
Symptomatic
treatment
of
vestibular
vertigo (an inner ear disorder)
HOW BESTEDY WORKS
Betahistine dihydrochloride is thought to
work by improving blood flow in the
inner ear, which reduces the build-up of
pressure.
BEFORE YOU USE BESTEDY
-
_When you must not use it_
• if you are allergic to betahistine or to
any
of
the
other
ingredients
of
this
medicine.
• if you have a
pheochromocytoma, a
rare tumour of the adrenal gland.
_Pregnancy and lactation _
Do
not
take
BESTEDY
if
you
are pregnant, trying to get pregnant or
think you may be pregnant.
Do
not
take
BESTEDY
if
you
are
breast-feeding.
Ask
your
doctor
or
pharmacist for advice before taking any
medicine.
-
_Before you start to use it_
If you have any of the below conditions,
consult your doctor about whether you
may
take
Betahistine
tablets.
These
groups of patients should be monitored
by a doctor during treatment.
• stomach ulcer (peptic ulcer)
• asthma
• nettle rash, skin rash or a cold in the
nose caused by an allergy, since these
complaints may be exacerbated.
• low blood pressure
Children
Bestedy
24
Betahistine
Dihydrochloride
Tablets
is
not
recommended for use in children under
the age of 18 years.
-
_Taking other medicines_
Tell your doctor if you are taking any
other
medicines,
including
any
that
you buy without a prescription from a
pharmacy, supermarket or health food
shop.
Tell your doctor if you are particularly

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
BESTEDY 24
BETAHISTINE DIHYDROCHLORIDE TABLETS BP 24 MG
_R_
_x_
_ Only_
NAME OF DRUG PRODUCT: Betahistine Dihydrochloride Tablets BP 24 mg.
(TRADE) NAME OF PRODUCT
:
BESTEDY 24
STRENGTH
:
24 mg.
PHARMACEUTICAL DOSAGE FORM :
Tablet.
QUALITATIVE AND QUANTITATIVE COMPOSITIONS:
_Betahistine Dihydrochloride Tablets BP 24 mg:_
Each un-coated tablet contains Betahistine Dihydrochloride Ph.Eur. 24
mg.
PHARMACEUTICAL FORM:
_Betahistine Dihydrochloride Tablets BP 24 mg:_
White to off-white round uncoated tablets debossed with ‘X’ and a
break line on
one side and ‘89’on the other side.
The tablet can be divided into two equal halves
CLINICAL PARTICULARS:
THERAPEUTIC INDICATIONS
Meniere ’s syndrome as defined by the following triad of 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 48mg divided over the day.
24 mg tablets
1 tablet
2 times/day
Method of administration:
BESTEDY 24 Betahistine Dihydrochloride Tablets: 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 after a few months.
There
are indications that treatment from the onset of the disease prevents
the
progression of the disease and/or the loss of hearing in later phases
of the
disease.
Paediatric population:
BESTEDY 24 Betahistine Dihydrochloride Tablets is not recommended for
use
in Children under the age of 18 years due to insufficient data on
safety and
efficacy.
Geriatric population:
Although there are limited data from clinical studies in this patient
group,
extensive post marketing experience suggests that no dose adjustment
is
necessary in this Patient population.
Renal impairment:
There are no specific clinical trials available in this patient group,
but according
to po