FEMOLET letrozole 2.5 mg film-coated tablet blister pack

Ülke: Avustralya

Dil: İngilizce

Kaynak: Department of Health (Therapeutic Goods Administration)

Aktif bileşen:

letrozole, Quantity: 2.5 mg

Mevcut itibaren:

Alphapharm Pty Ltd

INN (International Adı):

Letrozole

Farmasötik formu:

Tablet, film coated

Kompozisyon:

Excipient Ingredients: microcrystalline cellulose; colloidal anhydrous silica; sodium starch glycollate; maize starch; magnesium stearate; lactose monohydrate; titanium dioxide; macrogol 8000; hypromellose; triacetin; iron oxide yellow; iron oxide red; quinoline yellow aluminium lake; polydextrose

Uygulama yolu:

Oral

Paketteki üniteler:

30 film-coated tablets, 10 film-coated tablets

Reçete türü:

(S4) Prescription Only Medicine

Terapötik endikasyonlar:

For the treatment of postmenopausal women with hormone receptor positive breast cancer. The safety and efficacy of neoadjuvant use of letrozole has not been established. Letrozole is not indicated in hormone receptor negative disease.

Ürün özeti:

Visual Identification: Dark yellow, capsule-shaped, slightly biconvex film-coated tablets debossed with "LZ 2.5" on one side and "G" on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Yetkilendirme durumu:

Licence status A

Yetkilendirme tarihi:

2011-10-20

Bilgilendirme broşürü

FEMOLET
®
_contains the active ingredient letrozole_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about FEMOLET.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE.
YOU CAN ALSO DOWNLOAD THE MOST UP
TO DATE LEAFLET FROM
WWW.MYLAN.COM.AU.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking FEMOLET
against the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT FEMOLET IS
USED FOR
FEMOLET is used to treat breast
cancer in women who are post-
menopausal, or in other words,
women who no longer have periods,
either naturally due to their age or
after surgery or chemotherapy.
Letrozole, the active ingredient in
FEMOLET, 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 the
cancer from growing.
This may be the first time you are
taking an "antioestrogen" such as
FEMOLET or you may have taken
another "antioestrogen" such as
tamoxifen in the past.
FOLLOW ALL DIRECTIONS GIVEN TO YOU
BY YOUR DOCTOR.
They may differ from the
information contained in this leaflet.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
FEMOLET for another reason.
FEMOLET is only available with a
doctor's prescription.
FEMOLET is not addictive.
BEFORE YOU TAKE
FEMOLET
_WHEN YO

Ürün özellikleri

AUSTRALIAN PRODUCT INFORMATION
FEMOLET
_Letrozole _
1
NAME OF THE MEDICINE
Letrozole
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Femolet is a film-coated tablet containing 2.5 mg letrozole as the
active ingredient.
Letrozole also contains lactose and sulfites.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Femolet tablets are dark yellow, capsule-shaped, slightly biconvex
film-coated tablets debossed with “LZ 2.5”
on one side and “G” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of postmenopausal women with hormone receptor
positive breast cancer (see SECTION 5.1
PHARMCODYNAMIC 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
DOSE AND METHOD OF ADMINISTRATION
ADULTS:
The recommended dose of Femolet 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 in
CLINICAL TRIALS
are based on the Primary Core Analysis with a median
duration of follow up of 26 months).
In patients with metastatic disease, treatment with letrozole should
continue until tumour progression is
evident.
ELDERLY PATIENTS:
No dose adjustmen