SETEAR betahistine dihydrochloride 24 mg tablet blister pack

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

betahistine dihydrochloride, Quantity: 24 mg

Sẵn có từ:

Southern XP IP Pty Ltd

INN (Tên quốc tế):

betahistine dihydrochloride

Dạng dược phẩm:

Tablet

Thành phần:

Excipient Ingredients: lactose monohydrate; maize starch; microcrystalline cellulose; citric acid; povidone; crospovidone; hydrogenated vegetable oil

Tuyến hành chính:

Oral

Các đơn vị trong gói:

60, 15, 25

Loại thuốc theo toa:

(S4) Prescription Only Medicine

Chỉ dẫn điều trị:

Meniere's syndrome as defined by the following core symptoms: vertigo (with nausea/ vomiting); hearing loss (hardness of hearing); tinnitus.

Tóm tắt sản phẩm:

Visual Identification: White flat tablets with bevelled edges and a break line 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; Container Closure: Neither child resistant closure nor restricted flow insert

Tình trạng ủy quyền:

Licence status A

Ngày ủy quyền:

2017-03-02

Tờ rơi thông tin

Setear
1
SETEAR
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 SETEAR?
Setear contains 24 mg of the active ingredient betahistine
dihydrochloride. Setear 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 Setear? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE SETEAR?
Do not use if you have ever had an allergic reaction to Setear 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
Setear? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Setear 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 SETEAR?
•
The usual adult starting dose is half to one 24 mg tablet taken twice
a day. Your doctor may however prescribe a different
dose. The maximum recommended daily dosage is 48 mg.
•
Swallow Setear 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 Setear? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING SETEAR?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Setear.
•
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 adrenal gland, have or have had any
other medical conditions
including pregnancy or breastfeeding, or have any allergies to any
other medicines or substances.
THINGS YOU
SHOULD NOT DO
•
Do not give Setear to

Đặc tính sản phẩm

AUSTRALIAN PRODUCT INFORMATION
SETEAR 24 MG (BETAHISTINE HYDROCHLORIDE) TABLET
_ _
1. NAME OF THE MEDICINE
Betahistine dihydrochloride
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
SETEAR tablets contain the active ingredient betahistine
dihydrochloride.
Each SETEAR tablet contains 24 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
SETEAR 24 mg 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 24 mg taken two times a
day.
The maximum recommended daily dosage is 48 mg, which may be taken as
16 mg three times daily or
24 mg twice daily. Refer to separate Product Information for
Betahistine 16 mg tablets.
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
.
SETEAR – AUSTRALIAN PRODUCT INFORMATION
2
PAEDI