Letrozole 2.5mg Film-coated tablets film-coated tablets

Land: Armenien

Sprache: Englisch

Quelle: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Wirkstoff:

letrozole

Verfügbar ab:

Accord Healthcare Polska Sp. z o.o.

ATC-Code:

L02BG04

INN (Internationale Bezeichnung):

letrozole

Dosierung:

2,5mg

Darreichungsform:

film-coated tablets

Einheiten im Paket:

(28/2x14/) in blister

Verschreibungstyp:

Prescription

Berechtigungsstatus:

Registered

Berechtigungsdatum:

2021-04-16

Gebrauchsinformation

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, pharmacist or
nurse.
- 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, pharmacist or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Letrozole Tablets are 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 ARE AND WHAT IT IS USED FOR
WHAT LETROZOLE TABLETS ARE 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 ARE USED FOR
Letrozole Tablets are 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 tamoxifen. Letrozo

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Letrozole 2.5 mg 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.
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 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