BETAHISTINE VIATRIS 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:

Viatris Pty Ltd

INN (International Name):

betahistine dihydrochloride

Pharmaceutical form:

Tablet, uncoated

Composition:

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

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: Round, biconvex, scored, white to almost white, uncoated tablet with bevelled edges, one side inscribed with "267" on either side of the score.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2017-08-29

Patient Information leaflet

BETAHISTINE MYLAN
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING BETAHISTINE MYLAN?
BETAHISTINE MYLAN contains the active ingredient betahistine
dihydrochloride. BETAHISTINE MYLAN 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 the ears
(tinnitus),
loss of clear hearing and 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.
For more information, see Section 1. Why am I using BETAHISTINE MYLAN?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE BETAHISTINE MYLAN?
Do not use if you have ever had an allergic reaction to betahistine
dihydrochloride or any of the ingredients listed at the end of the
CMI.
DO NOT TAKE THIS MEDICINE IF YOU HAVE PEPTIC ULCER OR A RARE
ABNORMALITY OF THE ADRENAL GLAND KNOWN AS
PHAEOCHROMOCYTOMA.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS (E.G.
PEPTIC ULCER, ASTHMA OR A HISTORY OF SKIN CONDITIONS), TAKE
ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE
BREASTFEEDING.
For more information, see Section 2. What should I know before I use
BETAHISTINE MYLAN? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with BETAHISTINE MYLAN and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE BETAHISTINE MYLAN?
•
The usual adult starting dose is half to one tablet taken three times
a day.
•
Take BETAHISTINE MYLAN at about the same time each day during or
immediately after a meal.
More instructions can be found in Section 4. How do I use BETAHISTINE
MYLAN? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING BETAHISTINE MYLAN?
THINGS YOU
SHOULD DO
•
Remin

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
BETAHISTINE MYLAN
_Betahistine dihydrochloride tablets _
1
NAME OF THE MEDICINE
Betahistine dihydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient is betahistine dihydrochloride.
Each tablet contains 16 mg of betahistine dihydrochloride.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
BETAHISTINE MYLAN (betahistine dihydrochloride) 16 mg tablets: round,
biconvex, scored, white
to almost white uncoated tablet, one side inscribed with ‘267’ on
either side of the score.
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 MYLAN (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 2 QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
AND
SECTION
6
PHARMACEUTICAL
PARTICULARS, 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
).
BETAHISTINE MYLAN – PRODUCT INFORMAT