LETROZOLE GH letrozole 2.5mg 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:

30, 10

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:

2019-03-12

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
LETROZOLE GH
(LETROZOLE) FILM-COATED TABLETS
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Letrozole GH.
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.
Those updates may contain
important information about the
medicine and its use of which
you should be aware.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking
Letrozole GH 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 LETROZOLE GH IS
USED FOR
Letrozole GH 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 GH is available in
tablets containing 2.5 mg of the
active ingredient, letrozole.
Letrozole belongs to a family of
medicines called aromatase
inhibitors. They are also called
"anti-oestrogens" 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 "anti-oestrogen"
such as Letrozole GH or you
may have taken another "anti-
oestrogen" such as tamoxifen in
the past.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
LETROZOLE GH HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have
prescribed Letrozole GH for
another reason.
Letrozole GH is only available
with a doctor's prescription. It is
not addictive
BEFORE YOU TAKE
LETROZOLE GH
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE LETROZOLE GH IF
YOU HAVE AN ALLERGY TO:

letrozole, the active
ingr

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
LETROZOLE GH (LETROZOLE) TABLETS
1
NAME OF THE MEDICINE
Letrozole.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
LETROZOLE GH is available as coated tablets containing 2.5 mg
letrozole.
EXCIPIENTS WITH KNOWN EFFECTS:
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 GH 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 their 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 GH is one 2.5 mg tablet daily.
2
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