BETAQUIL 8 (Betahistine Dihydrochloride Tablets BP 8 mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

BETAHISTINE DIHYDROCHLORIDE

Boleh didapati daripada:

HEALOL PHARMACEUTICALS SDN. BHD.

INN (Nama Antarabangsa):

BETAHISTINE DIHYDROCHLORIDE

Unit dalam pakej:

10x10'stablet Tablets

Dikeluarkan oleh:

Aurobindo Pharma Limited

Risalah maklumat

®
BETAQUIL TABLETS
Betahistine Dihydrochloride (8 mg, 16 mg)
_Consumer Medication Information Leaflet (RiMUP) _
1
WHAT IS IN THIS LEAFLET
1.
What BETAQUIL is used for
2.
How BETAQUIL works
3.
Before you use BETAQUIL
4.
How to use BETAQUIL
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
BETAQUIL
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT IS BETAQUIL USED FOR
The active substance of BETAQUIL
is Betahistine Dihydrochloride.
Betahistine is a type of medicine
called a “histamine analogue”.
Betahistine is used for:
Ménière’s disease – the signs of this
include:
•
feeling dizzy (vertigo)
•
ringing in the ears (tinnitus)
•
hearing loss or hearing difficulty
HOW BETAQUIL 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 BETAQUIL
-When you must not use it
Do not take BETAQUIL tablet if
•
you are allergic to betahistine or to
any of the other ingredients of this
medicine.
•
you have a pheochromocytoma, a
rare tumour of the adrenal gland.
_Pregnancy and lactation: _
Do not take BETAQUIL if you are
pregnant, trying to get pregnant or
think you may be pregnant.
Do not take BETAQUIL 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 a stomach ulcer (peptic
ulcer)
•
if you have asthma
•
if you have nettle rash, skin rash or
a
cold
in
the
nose
caused
by
an
allergy, since these complaints may
be exacerbated.
•
if you have low blood pressure
If you suffer from any of the above
conditions, consult your doctor about
whether
you
may
take
Betahistine
tablets.
These groups of patients should be
monitored
by
a
doctor
during
treatment.
CHILDREN
Betahistine is not recommended for
those under 18 years old.
-Taking other medications
Tell your doctor if you are taking any
other medicines, including any that
you buy without a prescription f

Ciri produk

NAME OF DRUG PRODUCT:
Betahistine Dihydrochloride Tablets BP 8 mg
Betahistine Dihydrochloride Tablets BP 16 mg
(TRADE) NAME OF PRODUCT: BETAQUIL 8
BETAQUIL 16
STRENGTH:
8 mg and 16 mg
PHARMACEUTICAL DOSAGE FORM: Tablet.
QUALITATIVE AND QUANTITATIVE COMPOSITIONS:
_Betahistine Dihydrochloride Tablets BP 8 mg:_
Each un-coated tablet contains Betahistine Dihydrochloride Ph.Eur. 8
mg.
_Betahistine Dihydrochloride Tablets BP 16 mg:_
Each un-coated tablet contains Betahistine Dihydrochloride Ph.Eur. 16
mg.
PHARMACEUTICAL FORM:
_Betahistine Dihydrochloride Tablets BP 8 mg:_
White to off-white round, flat uncoated tablets debossed with ‘X’
on one side and
‘87’ on the other side.
_Betahistine Dihydrochloride Tablets BP 16 mg:_
White to off-white round uncoated tablets debossed with ‘X’ and a
break line on
one side and ‘88’on the other side.
CLINICAL PARTICULARS:
THERAPEUTIC INDICATIONS
Meniere’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
Always take Betahistine dihydrochloride tablets exactly as your doctor
has
prescribed. If you have any questions, contact your doctor or
pharmacist. If you
forget to take your tablet(s), do not take a double dose to compensate
for it. If
you require further information, please ask your doctor or pharmacist
for advice.
The dosage for adults is 8 mg – 16 mg three times daily.
Your doctor will adjust the dosage according to your response to the
medication.
Improvement of symptoms may take up to two weeks and 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.
Paediatric population:
Betahistine dihydrochloride tablets is not recommended for use in
children under
the age of 18 years due to insufficient data on safety and