LETRODAY 2.5 (Letrozole Tablets 2.5mg)

Valsts: Malaizija

Valoda: angļu

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

Aktīvā sastāvdaļa:

LETROZOLE

Pieejams no:

SYNERRV SDN BHD

SNN (starptautisko nepatentēto nosaukumu):

LETROZOLE

Vienības iepakojumā:

30 Tablets

Ražojis:

Eugia Pharma Specialties Limited

Lietošanas instrukcija

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
LETRODAY 2.5 (LETROZOLE TABLETS 2.5MG)
Letrozole 2.5mg
1
WHAT IS IN THIS LEAFLET
1.
What LETRODAY 2.5 is used
for
2.
How LETRODAY 2.5 works
3.
Before you use LETRODAY 2.5
4.
How to use LETRODAY 2.5
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
LETRODAY 2.5
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT IS LETRODAY 2.5 USED FOR
Letrozole is used to treat breast
cancer in women who have gone
through menopause (i.e., cessation of
periods).
It is also used to prevent cancer from
recurring. It can be used as first
treatment before breast cancer
surgery in case immediate surgery is
not suitable or it can be used as first
treatment after breast cancer surgery
or following five years treatment
with a medicine called Tamoxifen.
Letrozole can be used to prevent the
spread of breast tumour to other parts
of the body in patients with advanced
breast cancer.
If you have any questions about how
Letrozole works or why this
medicine has been prescribed for
you, please ask your doctor.
HOW LETRODAY 2.5 WORKS
LETRODAY 2.5 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. Growth of breast cancer is
frequently stimulated by oestrogens
which are female sex hormones.
Letrozole reduces the amount of
oestrogen by blocking an enzyme
called aromatase that is involved in
the production of oestrogens and
therefore may block the growth of
breast cancer that requires oestrogens
to grow. This results in slowed down
or stopped tumour growth and/or
spreading to other parts of the body.
BEFORE YOU USE LETRODAY 2.5
_-When you must not use it _
Do not take this medicine if you are
unsure about your menopausal status
or if you are still having your period
regularly. Please check with your
doctor.
If you are allergic to any of the
ingredients of this product as listed at
the end of this le

Produkta apraksts

NAME OF THE PRODUCT:
Letrozole Tablets 2.5 mg
(TRADE) NAME OF PRODUCT:
LETRODAY 2.5
STRENGTH:
2.5 mg
PHARMACEUTICAL DOSAGE FORM:
Film Coated Tablet
QUALITATIVE AND QUANTITATIVE COMPOSITIONS:
Each film-coated tablet contains:
Letrozole Ph.Eur ……… 2.5 mg
PHARMACEUTICAL FORM
Letrozole Tablets 2.5 mg
Dark yellow, film coated, round, slightly biconvex, with beveled edges
tablet
debossed with ‘L2.5’ on one side and plain on the other side.
CLINICAL PARTICULARS
THERAPEUTIC 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.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
General target population
_Adults_
The recommended dose of LETRODAY is 2.5 mg once daily. In the adjuvant
and extended adjuvant setting, treatment with LETRODAY should continue
for
5 years or until disease relapse/recurrence occurs, whichever comes
first. In
the large pivotal study of letrozole versus 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 with LETRODAY should
continue
until tumor progression is evident. In the pre-ope