BETAHISTINE SANDOZ betahistine dihydrochloride 16mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

betahistine dihydrochloride, Quantity: 16 mg

Available from:

Southern Cross Pharma Pty Ltd

INN (International Name):

betahistine dihydrochloride

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: lactose monohydrate; maize starch; microcrystalline cellulose; citric acid; povidone; crospovidone; hydrogenated vegetable oil

Administration route:

Oral

Units in package:

25 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), tinnitus.

Product summary:

Visual Identification: White flat tablets with bevelled edges. Breakline on one side; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2015-11-16

Patient Information leaflet

BETAHISTINE SANDOZ
1
BETAHISTINE SANDOZ
_ _
_Betahistine dihydrochloride tablets_
_ _
CONSUMER MEDICINE INFORMATION
_ _
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Betahistine Sandoz tablets. It
does not contain all the
available information. It does not
take the place of talking to your
doctor and pharmacist.
IF YOU HAVE ANY CONCERNS
ABOUT BEING GIVEN THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you being
given Betahistine Sandoz
tablets against the benefits this
medicine is expected to have
for you.
KEEP THIS LEAFLET WITH THE
MEDICINE. YOU MAY NEED TO
READ IT AGAIN.
WHAT BETAHISTINE
SANDOZ IS USED FOR
Betahistine Sandoz is used to
treat a disorder of the working
of your inner ear. This disorder
may include one or more of the
following symptoms, in one or
both ears:
•
Ringing in the 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 Méniere's
Syndrome.
Betahistine Sandoz tablets
contain the active ingredient
betahistine dihydrochloride,
which work 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 normalize the way
in which the nerves respond to
outside influences.
Your doctor may have
prescribed Betahistine Sandoz
for another reason. Ask your
doctor if you have any questions
about why Betahistine Sandoz
has been prescribed for you.
There is no evidence that
Betahistine Sandoz is addictive.
This medicine is available only
with a doctor’s prescription.
BEFORE YOU TAKE
BETAHISTINE SANDOZ
_WHEN YOU MUST NOT _
_TAKE IT_
_ _
DO NOT TAKE BETAHISTINE
SANDOZ IF:
•
you are pregnant or
intend to become
pregnant. Betahistine
Sandoz may affect your
developing baby if taken
during pregnancy.
•
you are breast-feeding or
plan to breast-feed.
Betahistine Sandoz may
pass into breast milk an

Summary of Product characteristics

200203-Betahistine Sandoz-pi
Page 1 of 6
AUSTRALIAN PRODUCT INFORMATION
BETAHISTINE SANDOZ (BETAHISTINE DIHYDROCHLORIDE) TABLETS
1
NAME OF THE MEDICINE
Betahistine dihydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
BETAHISTINE SANDOZ tablets contain 16 mg of betahistine
dihydrochloride.
Excipient with known effect: sugars as lactose.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
BETAHISTINE SANDOZ tablets are white flat tablets with bevelled edges
and a breakline on
one side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Meniere'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
DOSAGE
The recommended starting dose in adults is one-half to one tablet (8
to 16 mg) taken three
times a day. The maximum recommended daily dosage is 48 mg. 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.
Improvement in symptoms may be observed in the first few days to weeks
of treatment.
METHOD OF ADMINISTRATION
The tablets may be taken with or without food. However, if
gastrointestinal upset occurs, it is
recommended that the tablets be taken with meals.
4.3
C
ONTRAINDICATIONS
•
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.
200203-Betahistine Sandoz-pi
Page 2 of 6
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 THE ELDERLY
No data available.
PAEDIATRIC USE
Due to