BETAHISTINE LUPIN 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

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:

Registered

Authorization date:

2022-10-13

Patient Information leaflet

Betahistine Lupin v1
1
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
1.
WHY AM I USING BETAHISTINE LUPIN?
2.
WHAT SHOULD I KNOW BEFORE I USE BETAHISTINE LUPIN?
3.
WHAT IF I AM TAKING OTHER MEDICINES?
4.
HOW DO I USE BETAHISTINE LUPIN?
5.
WHAT SHOULD I KNOW WHILE USING BETAHISTINE LUPIN?
6.
ARE THERE ANY SIDE EFFECTS?
BETAHISTINE LUPIN
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
Betahistine Lupin contains 16 mg of the active ingredient betahistine
dihydrochloride. Betahistine Lupin is used to treat an inner
ear disorder called Meniere’s syndrome, which may cause ringing in
the ears, hearing loss or balance problems and sometimes
nausea, vomiting and headache.
For more information, see Section 1. Why am I using Betahistine Lupin?
in the full CMI.
Do not use if you have ever had an allergic reaction to Betahistine
Lupin or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL 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 Lupin? in the full CMI.
Some medicines may interfere with Betahistine Lupin 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.
•
The usual adult starting dose is half to one 16 mg tablet taken three
times a day. Your doctor may however prescribe a
different dose. The maximum recommended daily dosage is 48 mg.
•
Swallow Betahistine Lupin with a glass of water following food, and at
about the same time each day.
More instructions can be found in Section 4. How do I use Betahistine
Lupin? in the full CMI.
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Betahistine Lupin.
•
Tell your doctor if you have or have had a peptic ulcer, suffer from
asthma, have a history of allergic
skin conditions or tumours of the adre

Summary of Product characteristics

Betahistine Lupin v1
Page 1 of 6
AUSTRALIAN PRODUCT INFORMATION
BETAHISTINE LUPIN (BETAHISTINE DIHYDROCHLORIDE) TABLETS
1
NAME OF THE MEDICINE
Betahistine dihydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
BETAHISTINE LUPIN 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 LUPIN 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.
Betahistine Lupin v1
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 lack of clinical ex