ARX-LETROZOLE letrozole 2.5 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

letrozole, Quantity: 2.5 mg

Available from:

Cipla Australia Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

10, 30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

Visual Identification: Yellow circular, biconvex, film coated tablet debossed with LT on one side and 2.5 on the other side; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2018-12-17

Patient Information leaflet

LETROZOLE APOTEX
1
LETROZOLE APOTEX
_Letrozole _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. It does
not contain all the available
information. 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 you taking this medicine
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 THIS MEDICINE IS
USED FOR
The name of your medicine is
Letrozole APOTEX. It contains the
active ingredient letrozole.
Letrozole 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.
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-
dependant." Reducing the production
of oestrogen may help keep the
cancer from growing.
This may be the first time you are
taking an "anti-oestrogen”, or you
may have taken another "anti-
oestrogen" such as tamoxifen in the
past.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
This medicine is not addictive.
THERE IS NOT ENOUGH INFORMATION TO
RECOMMEND THE USE OF LETROZOLE IN
CHILDREN.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing letrozole
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
LETROZOLE APOTEX (LETROZOLE) TABLETS
1
NAME OF THE MEDICINE
Letrozole.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
LETROZOLE APOTEX is available as coated tablets containing 2.5 mg
letrozole.
EXCIPIENTS WITH KNOWN EFFECT
Lactose monohydrate
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
Tablet containing 2.5mg letrozole: yellow, circular, biconvex
film-coated tablets debossed with
LT on one side and 2.5 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 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
DOSE AND METHOD OF ADMINISTRATION
METHOD OF ADMINISTRATION
Letrozole tablets should be taken orally. A missed dose should be
taken as soon as the patient
remembers. However, if it is almost time for the next dose, the missed
dose should be skipped,
and the patient should go back to her regular dosage schedule. Doses
should not be doubled
because with daily doses over the 2.5 mg recommended dose,
over-proportionality in systemic
exposure was observed.
DOSAGE
ADULTS
The recommended dose of letrozole tablets is one 2.5 mg 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.
2
In the adjuvant setting the median duration of treatment was 25
mon