Letrozole Galenicum Health 2.5 mg film-coated tablets

Ülke: Malta

Dil: İngilizce

Kaynak: Medicines Authority

Mevcut itibaren:

Galenicum Health, S.L.U Calle Sant Gabriel, 50 Esplugues de Llobregat 08950 Barcelona, Spain

ATC kodu:

L02BG04

INN (International Adı):

LETROZOLE 2.5 mg

Farmasötik formu:

FILM-COATED TABLET

Kompozisyon:

LETROZOLE 2.5 mg

Reçete türü:

POM

Terapötik alanı:

ENDOCRINE THERAPY

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2023-10-19

Bilgilendirme broşürü

PACKAGE LEAFLET: INFORMATION FOR THE USER
LETROZOLE GALENICUM HEALTH 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 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 or 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 Galenicum Health is and what it is used for
2.
What you need to know before you take Letrozole Galenicum Health
3.
How to take Letrozole Galenicum Health
4.
Possible side effects
5.
How to store Letrozole Galenicum Health
6.
Contents of the pack and other information
1.
WHAT LETROZOLE GALENICUM HEALTH IS AND WHAT IT IS USED FOR
WHAT LETROZOLE GALENICUM HEALTH IS AND HOW IT WORKS
Letrozole Galenicum Health 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
Galenicum Health 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 GALENICUM HEALTH IS USED FOR
Letrozole Galenicum Health 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 use

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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Letrozole Galenicum Health 2.5 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film
-
coated tablet contains 2.5 mg letrozole.
Excipients of known effect:
Each tablet contains:
45mg Lactose monohydrate
0.00065 mg Tartrazine
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablets
Yellow, circular, biconvex, film coated tablets plain on both sides
The approximate length dimensions of
the Letrozole 2.5 mg film coated tablets are: 6.0 ± 0.5 mm
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
havereceived 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
inducedpostmenopausal 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 Galenicum Health 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 Galenicum Health should
continue until tumour progression is evident.
In the adjuvant and extended adjuvant setting, treatment with
Letrozole Galenicum Health should continue
for 5 years or until tumour relapse occurs, whichever is first.
In the adjuvant setting a sequential