Letrozole Bluefish 2.5 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Letrozole

Available from:

Bluefish Pharmaceuticals AB

ATC code:

L02BG; L02BG04

INN (International Name):

Letrozole

Dosage:

2.5 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

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

Therapeutic area:

Aromatase inhibitors; letrozole

Authorization status:

Marketed

Authorization date:

2010-03-26

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
LETROZOLE BLUEFISH 2.5 MG FILM-COATED TABLETS
LETROZOLE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINEBECAUSE 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 of the side effects, talk to your doctor or pharmacist.
This include any possible
side effects not listed in this leaflet.See section 4.
WHAT IS IN THIS LEAFLET
1.
What Letrozole Bluefish is and what it is used for
2.
What you need to know before you take Letrozole Bluefish
3.
How to take Letrozole Bluefish
4.
Possible side effects
5.
How to store Letrozole Bluefish
6.
Contents of the pack and other information
1.
WHAT LETROZOLE BLUEFISH IS AND WHAT IT IS USED FOR
WHAT LETROZOLE BLUEFISH IS AND HOW IT WORKS
Letrozole Bluefish 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 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 BLUEFISH IS USED FOR
Letrozole Bluefish 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 of treatment with tamoxifen. Letro

Summary of Product characteristics

Health Products Regulatory Authority
14 August 2023
CRN00DMHQ
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Letrozole Bluefish 2.5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2.5 mg letrozole.
Each tablet contains 61.5 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Letrozole Bluefish are yellow round, 6.1 mm (±0.2 mm) in diameter,
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 early
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 Bluefish 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 Bluefish should continue until tumour
progression is evident.
In the adjuvant and extended adjuvant setting, treatment with
Letrozole Bluefish 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
consid