BETASERT betahistine dihydrochloride 16 mg tablets blister packs
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
10-12-2020
Summary of Product characteristics
(SPC)
10-12-2020
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
betahistine dihydrochloride, Quantity: 16 mg
Available from:
Arrotex Pharmaceuticals Pty Ltd
INN (International Name):
betahistine dihydrochloride
Pharmaceutical form:
Tablet, uncoated
Composition:
Excipient Ingredients: microcrystalline cellulose; citric acid; colloidal anhydrous silica; mannitol; purified talc
Administration route:
Oral
Units in package:
10 tablets, 60 tablets, 100 tablets, 25 tablets, 30 tablets
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Meniere's Syndrome as defined by the following core symptoms: vertigo (with nausea/vomiting), hearing loss (hardness of hearing) and tinnitus.
Product summary:
Visual Identification: Uncoated, round, biconvex, white to light creamy tablets, with a groove on one surface.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Authorization status:
Licence status A
Authorization date:
2014-08-14
Patient Information leaflet
BETASERT
CMI
BETASERT
_Betahistine dihydrochloride _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask
about BETASERT. It does not
contain all the information that is
known about BETASERT. It does
not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking BETASERT
against the benefits they expect it
will have for you.
If you have any concerns about
taking this medicine, ask your
doctor or pharmacist.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT BETASERT IS FOR
BETASERT is used to treat a
disorder of your inner ear. This
disorder may include one or more
of the following symptoms in one
or both ears:
•
Ringing in your ears (tinnitus)
•
Loss of clear hearing
•
Problems with balance (vertigo)
These symptoms may also be
associated with nausea, vomiting
and headache. Often these
symptoms together are referred to
as Meniere’s Syndrome.
BETASERT tablets contain the
active ingredient betahistine
dihydrochloride. Betahistine works
by improving the blood flow of the
inner ear and restoring it to
normal. It also acts on the nerve
endings in the inner ear to
normalise the way in which the
nerves respond to outside
influences.
Your doctor will have explained
why you are being treated with
BETASERT and told you what dose
to take.
FOLLOW ALL DIRECTIONS GIVEN TO YOU
BY YOUR DOCTOR CAREFULLY. They may
differ from the information
contained in this leaflet.
This medicine is only available with
a doctor’s prescription. Your
doctor may prescribe this medicine
for another use. Ask your doctor if
you want more information.
BETASERT is not addictive.
BEFORE YOU TAKE BETASERT
_WHEN YOU MUST NOT TAKE IT _
DO NOT USE BETASERT IF YOU HAVE
AN ALLERGY TO:
•
ANY MEDICINE CONTAINING
BETAHISTINE DIHYDROCHLORIDE
•
ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET
Some symptoms of an allergic
reaction include skin rash, itching,
shortness of breath o
Read the complete document
Summary of Product characteristics
1
AUSTRALIAN PRODUCT INFORMATION BETASERT (BETAHISTINE DIHYDROCHLORIDE) TABLETS
1
NAME OF THE MEDICINE
Betahistine dihydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
BETASERT (betahistine dihydrochloride) tablets are available as
uncoated tablets containing
betahistine dihydrochloride 16 mg.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
BETASERT (betahistine dihydrochloride) 16 mg tablets are Uncoated,
round, biconvex, white
to light creamy tablets, with a groove on one surface.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Ménière’s Syndrome as defined by the following core symptoms:
•
vertigo (with nausea/vomiting)
•
hearing loss (hardness of hearing)
•
tinnitus
4.2
D
OSE AND METHOD OF ADMINISTRATION
The recommended starting dose in adults is 8 to 16 mg three times a
day. The maximum
recommended daily dose is 48 mg.
The tablets may be taken with or without food. However, if
gastrointestinal upset occurs, it is
recommended that the tablets be taken with meals.
The dosage should be individually adapted according to the response.
Improvement in
symptoms may be observed in the first few days to weeks of treatment.
2
4.3
C
ONTRAINDICATIONS
BETASERT (betahistine dihydrochloride) Tablets are contraindicated as
follows:
•
during pregnancy and lactation.
•
in children less than 18 years.
•
in patients suffering from phaeochromocytoma
•
in patients with active peptic ulcer or a history of this condition
•
in patients with hypersensitivity to any component to the product (
see Section 6.1 List
of excipients
)
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
Patients with bronchial asthma need to be carefully monitored during
therapy.
Caution should be taken in the treatment of patients receiving
antihistamines (see
Section 4.5 Interactions with Other Medicines and other forms of
interactions).
USE IN HEPATIC IMPAIRMENT:
Not available
USE IN RENAL IMPAIRMENT:
Not available
USE IN THE ELDERLY:
Not available
PAEDIATRIC USE: Due to lack of clinical ex
Read the complete document
