Letrozole Denk 2.5 tablets film-coated

Ország: Örményország

Nyelv: angol

Forrás: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktív összetevők:

letrozole

Beszerezhető a:

Haupt Pharma Muenster GmbH

ATC-kód:

L02BG04

INN (nemzetközi neve):

letrozole

Adagolás:

2,5mg

Gyógyszerészeti forma:

tablets film-coated

db csomag:

(30/3x10/) in blister

Recept típusa:

Prescription

Engedélyezési státusz:

Registered

Engedély dátuma:

2021-07-05

Betegtájékoztató

_Letrozole Denk 2.5_
Film-coated tablet – oral use
Aromatase inhibitor
Active substance: letrozole
Package leaflet: Information for the
patient
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.
See section 4.
What is in this leaflet
1.
WHAT LETROZOLE DENK 2.5 IS
AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE
YOU TAKE LETROZOLE DENK 2.5
3.
HOW TO TAKE LETROZOLE DENK 2.5
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE LETROZOLE DENK 2.5
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
What Letrozole Denk 2.5 is and what
it is used for
What Letrozole Denk 2.5 is and how it
works
Letrozole Denk 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 oestro
-
gens which are female sex hormones. Letrozole
Denk 2.5 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 Denk 2.5 is used for
Letrozole Denk 2.5 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 surger

Termékjellemzők

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Letrozole Denk 2.5
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: letrozole
Each film-coated tablet contains 2.5 mg letrozole.
Excipient with known effect:
Each film-coated tablet contains 61.5 mg of lactose monohydrate and
less than 1 mmol sodium (23 mg).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FROM
Film-coated tablet
Yellow to dark yellow, round, biconvex, film-coated tablets.
4.
CLINICAL PARTICULARS
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 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 should continue until
tumour progression is evident.
In the adjuvant and extended adjuvant setting, treatment with
letrozole 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).
2
In the neoadjuvant setting, treat