Letzo 2.5 mg film-coated tablets

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Letrozole

Dostupné s:

Rowex Ltd

ATC kód:

L02BG; L02BG04

INN (Mezinárodní Name):

Letrozole

Dávkování:

2.5 milligram(s)

Léková forma:

Film-coated tablet

Druh předpisu:

Product subject to prescription which may not be renewed (A)

Terapeutické oblasti:

Aromatase inhibitors; letrozole

Stav Autorizace:

Marketed

Datum autorizace:

2010-11-19

Informace pro uživatele

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LETZO 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. See section 4.
WHAT IS IN THIS LEAFLET
1
What Letzo is and what it is used for
2
What you need to know before you take Letzo
3
How to take Letzo
4
Possible side effects
5
How to store Letzo
6
Contents of the pack and other information
1
WHAT LETZO IS AND WHAT IT IS USED FOR
WHAT LETZO IS AND HOW IT WORKS
Letzo 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.
Letzo 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 LETZO IS USED FOR
Letzo 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 tamoxifen. Letzo is
also used to
prevent breast tumour
spreading to other parts of the body in patients with advanced breast
cancer.
If you have any questions about

Charakteristika produktu

Health Products Regulatory Authority
26 November 2019
CRN009D4D
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Letzo 2.5mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2.5mg letrozole.
Excipients(s) with known effect
Each film-coated tablet contains 58.4 mg of lactose (as lactose
monohydrate) and up to 0.21 mg (0.009 mmol) sodium (as
sodium starch glycolate).
For the fulllist of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablet.
Film-coated tablet, dark yellow, round, slightly biconvex with
bevelled edges. One side bears the imprint “FV”, the other
“CG”.
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 Letzois 2.5mg once daily. No dose adjustment
is required for elderly patients.
In patients with advanced or metastatic breast cancer, treatment with
Letzo should continue until tumour progression is
evident.
In the adjuvant and extended adjuvant setting, treatment with Letzo
should continue for 5 years or until tumour relapse occurs,
whichever is first.
In the adjuvant set