APO-BETAHISTINE betahistine dihydrochloride 16 mg uncoated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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: colloidal anhydrous silica; crospovidone; stearic acid; povidone; lactose monohydrate; microcrystalline cellulose

Administration route:

Oral

Units in package:

25

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 or almost white, round, flat bevelled edged tablets embossed "B16" on one side and scored on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2014-10-20

Patient Information leaflet

APO-Betahistine Tablet
1
APO-BETAHISTINE
TABLETS
_Betahistine dihydrochloride _
CONSUMER MEDICINE INFORMATION
FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about betahistine. It does
not contain all the available
information. 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 using this medicine
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 want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Betahistine is used to treat Meniere's
Syndrome, a disorder of the inner
ear.
Meniere's Syndrome 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.
_HOW IT WORKS _
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.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
This medicine is not addictive.
There is not enough information to
recommend using this medicine in
children less than 18 years of age.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
betahistine dihydrochloride
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue,
throat or other parts of the body
•
rash,

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – APO-BETAHISTINE
(BETAHISTINE DIHYDROCHLORIDE)
1
NAME OF THE MEDICINE
Betahistine dihydrochloride.
2
AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND
PHARMACEUTICAL FORM
Each tablet contains 16mg of betahistine dihydrochloride as the active
ingredient.
List of excipients with known effect: contains sucrose as lactose
monohydrate. Each tablet
contains
the
following
inactive
ingredients:
povidone,
microcrystalline
cellulose,
lactose
monohydrate, colloidal anhydrous silica, crospovidone and stearic
acid.
16 MG TABLETS:
White or almost white, round, flat bevelled edged tablets embossed B16
on one side and scored
on the other 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 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 is 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 2 AND 3
QUALITATIVE AND QUANTITATIVE COMPOSITION AND PHARMACEUTICAL FORM).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Patients with bronchial asthma need to be carefully monitored during
therapy.
2
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
No