SENIERE betahistine dihydrochloride 16mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

betahistine dihydrochloride

Available from:

Southern Cross Pharma Pty Ltd

INN (International Name):

betahistine dihydrochloride

Authorization status:

Registered

Patient Information leaflet

SENIERE
1
SENIERE
_ _
_Betahistine dihydrochloride tablets_
_ _
CONSUMER MEDICINE INFORMATION
_ _
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Seniere 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 Seniere 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 SENIERE IS USED
FOR
Seniere 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.
Seniere 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 Seniere for another
reason. Ask your doctor if you
have any questions about why
Seniere has been prescribed for
you.
There is no evidence that
Seniere is addictive.
This medicine is available only
with a doctor’s prescription.
BEFORE YOU TAKE
SENIERE
_WHEN YOU MUST NOT _
_TAKE IT_
_ _
DO NOT TAKE SENIERE IF:
•
you are pregnant or
intend to become
pregnant. Seniere may
affect your developing
baby if taken during
pregnancy.
•
you are breast-feeding or
plan to breast-feed.
Seniere may pass into
breast milk and
therefore there is
possibility that the
breast-fed baby may be
affected.
•
you are allergic to
betahistine
dihydrochloride or any of
the ingredients l

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
SENIERE (BETAHISTINE DIHYDROCHLORIDE) TABLETS
_ _
1. NAME OF THE MEDICINE
Betahistine dihydrochloride.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Seniere tablets contain 16 mg of the active ingredient 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
Seniere tablets are white flat tablets with bevelled edges and a
break-line on one side.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Meniere's syndrome as defined by the following core symptoms: vertigo
(with nausea/ vomiting); hearing
loss (hardness of hearing); tinnitus.
4.2. DOSE AND METHOD OF ADMINISTRATION
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 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.
4.3. CONTRAINDICATIONS
•
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. SPECIAL 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 THE ELDERLY
No data available.
Seniere – AUSTRALIAN PRODUCT INFORMATION
2
PAEDIATRIC USE
Due to lack of clinical experience, betahistine dihydrochloride should
not be used in children less than 18
years (see Section 4.3 CONTRAINDICATIONS).
EFFECTS ON