Letrozole 2.5mg Film-coated Tablets tablets film-coated

দেশ: আর্মেনিয়া

ভাষা: ইংরেজি

সূত্র: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

সক্রিয় উপাদান:

letrozole

থেকে পাওয়া:

Wessling BRS Hungary Limited

এটিসি কোড:

L02BG04

INN (আন্তর্জাতিক নাম):

letrozole

ডোজ:

2,5mg

ফার্মাসিউটিকাল ফর্ম:

tablets film-coated

প্যাকেজ ইউনিট:

(28/2x14/), in blister

প্রেসক্রিপশন টাইপ:

Prescription

অনুমোদন অবস্থা:

Registered

অনুমোদন তারিখ:

2015-12-17

তথ্য লিফলেট

PACKAGE LEAFLET:
INFORMATION FOR THE USER
Letrozole 2.5 mg
Film-coated Tablets
Letrozole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it
again.
•
If you have any further questions, ask your
doctor or pharmacist.
•
This medicine has been prescribed for you
only. Do not pass it on to others. It may harm
them, even if their signs of illness are the
same as yours.
•
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET
1. What Letrozole Tablets is and what it is used
for
2. What you need to know Before you take
Letrozole Tablets
3. How to take Letrozole Tablets
4. Possible side effects
5. How to store Letrozole Tablets
6. Contents of the pack and other information 1. WHAT LETROZOLE TABLETS IS AND WHAT IT IS
USED FOR
WHAT LETROZOLE TABLETS IS AND HOW IT WORKS
Letrozole Tablets 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 Tablets reduces the amount of
oestrogen by blocking an enzyme (“aromatase”)
involved in the production of oestrogens and
therefore may block the growth of breast cancer
that needs oestrogens to grow. As a consequence
tumour cells slow or stop growing and/or
spreading to other parts of the body.
WHAT LETROZOLE TABLETS IS USED FOR
Letrozole Tablets is used to treat breast cancer in
women who have gone through menopause i.e.
cessation of periods.
It is used to prevent cancer from happening
again. 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 tamixofen. Letrozole Tablets is
also used to

পণ্য বৈশিষ্ট্য

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Letrozole 2.5mg film-coated Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2.5 mg letrozole.
Excipient(s)
with
known
effect:
Each
tablet
contains
61.500
mg
of
lactose
monohydrate.
For the full list of excipients, see Section 6.1
3
PHARMACEUTICAL FORM
Film-coated tablet
Yellow, round, biconvex, film coated tablets plain on both sides.
4.1
THERAPEUTIC INDICATIONS
•
Adjuvant treatment of postmenopausal women with hormone receptor
positive invasive early breast cancer.
•
Extended
adjuvant
treatment
of
hormone-dependent
invasive
breast
cancer
in
postmenopausal
women
who
have
received
prior
standard
adjuvant tamoxifen therapy for 5 years.
•
First-line treatment in postmenopausal women with hormone-dependent
advanced breast cancer.
•
Advanced breast cancer after relapse or disease progression, in women
with natural or artificially induced postmenopausal endocrine status,
who
have previously been treated with anti-oestrogens.
•
Neo-adjuvant treatment of postmenopausal women with hormone receptor
positive,
HER-2
negative
breast
cancer
where
chemotherapy
is
not
suitable and immediate surgery not indicated.
Efficacy
has
not
been
demonstrated
in
patients
with
hormone
receptor
negative breast cancer.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adult and elderly patients
The
recommended
dose
of
Letrozole
Tablets
is
2.5 mg
once
daily.
No
dose
adjustment is required for elderly patients.
In patients with advanced or metastatic breast cancer, treatment with
Letrozole
Tablets should continue until tumour progression is evident.
In the adjuvant and extended adjuvant setting, treatment with
Letrozole Tablets should
continue for 5 years or until tumour relapse occurs, whichever is
first.
In the adjuvant setting a sequential treatment schedule (letrozole 2
years followed by
tamoxifen 3 years) could also be considered (see sections 4.4 and
5.1).
In the neoadjuvant setting, treatment with Letrozole tablet could be
co