GYNOTRIL letrozole 2.5 mg tablet blister pack

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

letrozole, Quantity: 2.5 mg

Sẵn có từ:

Strides Pharma Science Pty Ltd

INN (Tên quốc tế):

Letrozole

Dạng dược phẩm:

Tablet, film coated

Thành phần:

Excipient Ingredients: lactose monohydrate; maize starch; sodium starch glycollate; iron oxide yellow; colloidal anhydrous silica; magnesium stearate; microcrystalline cellulose; titanium dioxide; hypromellose; macrogol 400

Tuyến hành chính:

Oral

Các đơn vị trong gói:

30

Loại thuốc theo toa:

(S4) Prescription Only Medicine

Chỉ dẫn điều trị:

Treatment of postmenopausal women with hormone receptor positive breast cancer (see "Clinical Trials"). The safety and efficacy of neoadjuvant use has not been established. Letrozole is not indicated in hormone receptor negative disease.

Tóm tắt sản phẩm:

Visual Identification: Yellow to dark yellow round, film coated, biconvex tablet engraved with ' L' on one face and plain on the other; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Tình trạng ủy quyền:

Licence status A

Ngày ủy quyền:

2013-05-20

Tờ rơi thông tin

GYNOTRIL™
CONSUMER MEDICINE INFORMATION
Letrozole 2.5 mg film-coated tablets
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions about Gynotril. It
does not contain all the
information that is known about Gynotril.
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 taking Gynotril 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 GYNOTRIL IS USED FOR
Gynotril is used to treat breast cancer in women who are
post-menopausal - that is, women who
no longer have periods, either naturally due to their age or after
surgery or chemotherapy.
Gynotril contains 2.5 mg of the active ingredient, letrozole and is
presented in tablets.
Letrozole belongs to a family of medicines called aromatase
inhibitors. They are also called
antioestrogens because they act by reducing the production of
oestrogen in your body.
Oestrogen stimulates the growth of certain types of breast cancer.
These cancers are called
oestrogen-dependent. Reducing the production of oestrogen may help to
keep these types of
cancers from growing.
This might be the first time you are taking an antioestrogen such as
Gynotril or you may have
taken another antioestrogen such as tamoxifen in the past.
YOU MUST FOLLOW ALL THE DIRECTIONS GIVEN TO YOU BY YOUR DOCTOR. THEY
CAN DIFFER FROM THE
INFORMATION IN THIS LEAFLET.
Your doctor can prescribe this medicine for another use.
ALWAYS ASK YOUR DOCTOR IF YOU NEED MORE INFORMATION.
Gynotril is not known to be addictive.
Gynotril is only available with a doctor's prescription.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE GYNOTRIL IF YOU ARE ALLERGIC TO:

letrozole, the active ingredient in this medicine; or

any of the other ingredients of Gynotril, as mentioned at the end of
this leaflet.
If you get an allergic reaction, symptoms m

Đặc tính sản phẩm

1
AUSTRALIAN PRODUCT INFORMATION – GYNOTRIL
TM (LETROZOLE)
FILM-COATED TABLETS
1
NAME OF THE MEDICINE
Letrozole
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Gynotril is a film-coated tablet containing 2.5 mg Letrozole as the
active ingredient.
Excipients with known effect: contains lactose
For the full list of excipients, see Section 6.1 List of Excipients
3
PHARMACEUTICAL FORM
Gynotril 2.5 mg tablets are yellow to dark yellow round, film coated,
biconvex tablet, engraved
with ‘L’ on one face and plain on the other.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
For the treatment of postmenopausal women with hormone receptor
positive breast cancer (see
Section 5.1 Pharmacodynamic Properties Clinical Trials)
The safety and efficacy of neoadjuvant use of letrozole has not been
established. Letrozole is not
indicated in hormone receptor negative disease.
4.2
D
OSE AND METHOD OF ADMINISTRATION
ADULTS:
The recommended dose of letrozole is one tablet daily.
In the adjuvant setting, treatment should continue for 5 years or
until tumour relapse occurs,
whichever comes first.
In the extended adjuvant setting, the optimal treatment duration with
letrozole is not known. The
planned duration of treatment in the pivotal study was 5 years.
However, at the time of the analysis,
the median duration of treatment was 24 months, 25% of patients were
treated for at least three
years and less than 1% of patients were treated for the planned 5
years. The median duration of follow
up was 28 months. Treatment should be discontinued at tumour relapse.
In the adjuvant setting the median duration of treatment was 25
months, 73% of the patients were
treated for more than 2 years, 22% of the patients for more than 4
years. The median duration of
follow up was 30 months (the efficacy data mentioned,
see Section 5.1 Pharmacodynamic
Properties Clinical Trials
, are based on the Primary Core Analysis with a median duration of
follow
up of 26 months).
2
In
patients
with
metastatic
disease,
treatment
with
letrozole
should
continue
until
t