FEMARA 2.5MG FILM-COATED TABLET

Country: Malasía

Tungumál: enska

Heimild: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Virkt innihaldsefni:

LETROZOLE

Fáanlegur frá:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Alþjóðlegt nafn):

LETROZOLE

Einingar í pakka:

30 Tablets

Framleitt af:

NOVARTIS PHARMA STEIN AG

Upplýsingar fylgiseðill

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
FEMARA
®
FILM-COATED TABLET
Letrozole (2.5mg)
1
WHAT IS IN THIS LEAFLET
1.
What Femara is used for
2.
How Femara works
3.
Before you use Femara
4.
How to use Femara
5.
While you are using Femara
6.
Side effects
7.
Storage and Disposal of Femara
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT FEMARA IS USED FOR
Femara contains an active substance
called letrozole. It belongs to a group of
medicines called aromatase inhibitors.
It is a hormonal (or “endocrine”) breast
cancer treatment.
Femara 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. It is also used
before surgery in postmenopausal
breast cancer women.
HOW FEMARA WORKS
Growth of breast cancer is often
stimulated by estrogens, which are
female sex hormones. Femara reduces
the amount of estrogen by blocking an
enzyme (“aromatase”) involved in the
production of estrogens and therefore,
may block the growth of breast cancers
that need estrogen to grow. As a
consequence tumor cells slow or stop
the progression and/or spreading to
other parts of the body.
BEFORE YOU USE FEMARA
Follow all the doctor’s instructions
carefully. They may differ from the
general information contained in this
leaflet.
_- When you must not use it _

If you are allergic (hypersensitive)
to letrozole or to any of the
ingredients in Femara listed in this
leaflet. If you think you may be
allergic, ask your doctor for advice.

If you still have
periods, i.e. if you
have not yet gone through the
menopause.

If you are pregnant.

If you are
breast-feeding
If any of these conditions apply to you,
tell your doctor before taking Femara.
_PREGNANCY _
You must not take Femara if you are
pregnant as it may harm your unborn
baby. Your doctor will discuss with you
the potential risks of taking Femara
during pregnancy. There are reports of
abnormalities in

Vara einkenni

Novartis
Page 2
Malaysian Package Leaflet
15 Dec 2016
Femara
FEMARA

Non-steroidal aromatase inhibitor (inhibitor of estrogen
biosynthesis); antineoplastic agent.
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
Film-coated tablet
Coated tablet, dark yellow, round, slightly biconvex with bevelled
edges. One side bears the
imprint “FV”, the other “CG”.
ACTIVE SUBSTANCE
:
4,4'-[(1H-1,2,4-triazol-1-yl)-methylene]bis-benzonitrile (INN/USAN=
letrozole).
Each film-coated tablet contains 2.5 mg letrozole.
INDICATIONS
•
Adjuvant treatment of postmenopausal women with hormone receptor
positive early
breast cancer.
•
Adjuvant treatment
of
postmenopausal
women
with
early breast
cancer (positive
or
unknown
oestrogen
or
progesterone
receptor
status)
who
have
received
5
years
of
adjuvant tamoxifen therapy (extended adjuvant therapy).
•
First-line treatment in postmenopausal women with hormone-dependent
advanced breast
cancer.
•
Treatment of advanced
breast
cancer in
women
with natural or artificially induced
postmenopausal status, who have previously been treated with
antioestrogens.
•
Pre-operative therapy in postmenopausal women with localised hormone
receptor positive
breast cancer, to allow subsequent breast-conserving surgery in women
not originally
considered candidates for this type of surgery. Subsequent treatment
after surgery should
be in accordance with standard of care.
DOSAGE AND ADMINISTRATION
DOSAGE
GENERAL TARGET POPULATION
ADULTS
The recommended dose of Femara is 2.5 mg once daily. In the adjuvant
and extended
adjuvant
setting,
treatment
with
Femara
should
continue
for
5
years
or
until
disease
relapse/recurrence occurs, whichever comes first. In the large pivotal
study of letrozole versus
Novartis
Page 3
Malaysian Package Leaflet
15 Dec 2016
Femara
tamoxifen in the adjuvant setting, no benefit in efficacy or safety
was obtained by sequential
administration of these treatments compared with letrozole
administered continuously for 5
years
_. _
In patients with metastatic disease, treatment wi