Letrozole Pharmacare tablets film-coated

국가: 아르메니아

언어: 영어

출처: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

유효 성분:

letrozole

제공처:

Pharmacare Premium Ltd

ATC 코드:

L02BG04

INN (국제 이름):

letrozole

복용량:

2,5mg

약제 형태:

tablets film-coated

패키지 단위:

(30/3x10/) in blister

처방전 유형:

Prescription

승인 상태:

Registered

승인 날짜:

2022-06-10

환자 정보 전단

Letrozole Pharmacare 2.5mg film-coated tablets
Letrozole 2.5mg
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 Pharmacare is and what it is used for
2.What you need to know before you take Letrozole Pharmacare
3.How to take Letrozole Pharmacare
4.Possible side effects
5.How to store Letrozole Pharmacare
6.Contents of the pack and other information
1.
WHAT LETROZOLE PHARMACARE IS AND WHAT IT IS USED FOR
WHAT LETROZOLE PHARMACARE IS AND HOW IT WORKS
Letrozole Pharmacare 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
Pharmacare
reduces the amount of oestrogen by blocking an enzyme
(“aromatase”) involved
in
the
production
of
oestrogens
and
therefore
may
block
the
growth
of
breastcancer that needs oestrogens to grow. As a consequence tumour
cells
slowor stop growing and/or spreading to other parts of the body.
WHAT LETROZOLE PHARMACAREIS USED FOR
Letrozole Pharmacare is used to treat breast cancer in women who have
gone
through menopause i.e cessation of periods. It is used to prevent
breast 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
tamoxifen.
Letrozole
Pharmacare
is
also

제품 특성 요약

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Letrozole Pharmacare 2.5 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: letrozole
Each film-coated tablet contains 2.5 mg of letrozole.
Excipient with known effect: Each film-coated tablet contains 61.5 mg
of lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Yellow round 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 in women with natural or artificially induced
postmenopausal status
after relapse or disease progression, 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 Pharmacare is 2.5 mg once daily. No
dose adjustment is
required for elderly patients.
2
In patients with advanced or metastatic breast cancer, treatment with
Letrozole Pharmacare
should continue until tumour progression is evident.
In the adjuvant and extended adjuvant setting, treatment with
Letrozole Pharmacare 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 Pharmacare could
be co