BETAHISTINE GH betahistine dihydrochloride 16 mg tablets blister packs

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

betahistine dihydrochloride, Quantity: 16 mg

Available from:

Generic Health Pty Ltd

INN (International Name):

betahistine dihydrochloride

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: citric acid; microcrystalline cellulose; mannitol; colloidal anhydrous silica; purified talc

Administration route:

Oral

Units in package:

60 tablets, 30 tablets, 10 tablets, 25 tablets, 100 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

CONSUMER MEDICINE INFORMATION
BETAHISTINE GH
(BETAHISTINE DIHYDROCHLORIDE) UNCOATED TABLET
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask
about Betahistine GH. It does
not contain all the information
that is known about Betahistine
GH. 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
Betahistine GH 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 BETAHISTINE GH IS
USED FOR
Betahistine GH 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.
Betahistine GH 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
Betahistine GH 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.
Betahistine GH is not addictive.
BEFORE YOU TAKE
BETAHISTINE GH
_WHEN YOU MUST NOT TAKE IT _
DO NOT USE BETAHISTINE GH IF
YOU HAVE AN ALLERGY TO:
•
ANY MEDICINE CONTAINING
BETAHISTINE
DIHYDROCHLORIDE;
•
ANY OF THE INGREDIENTS
LISTED AT THE END OF THIS
LEAFLET.
Some symp

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – BETAHISTINE GH
(BETAHISTINE DIHYDROCHLORIDE) UNCOATED TABLET
1
NAME OF THE MEDICINE
Betahistine dihydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Betahistine GH tablets are available as uncoated tablets containing 16
mg betahistine dihydrochloride.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Betahistine GH 16 mg tablets_:_ Uncoated, round, biconvex, white to
light creamy tablets, with a groove
on one surface.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ménière’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 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.
4.3 CONTRAINDICATIONS
Betahistine GH 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;
Betahistine GH v4.0
Page 2 of 7
(betahistine dihydrochloride) uncoated tablet
•
in patients with hypersensitivity to any component
in 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.
PAEDIATRIC USE
Due to lack of clinical experience, betahistine dihydrochloride should
not be used i