Letrozole Mylan 2.5 mg film-coated tablets

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Letrozole

Tillgänglig från:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATC-kod:

L02BG; L02BG04

INN (International namn):

Letrozole

Dos:

2.5 milligram(s)

Läkemedelsform:

Film-coated tablet

Receptbelagda typ:

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

Terapiområde:

Aromatase inhibitors; letrozole

Bemyndigande status:

Not marketed

Tillstånd datum:

2011-05-13

Bipacksedel

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LETROZOLE MYLAN 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.
IN THIS LEAFLET:
1.
What Letrozole Mylan is and what it is used for
2.
What you need to know before you take Letrozole Mylan
3.
How to take Letrozole Mylan
4.
Possible side effects
5.
How to store Letrozole Mylan
6.
Contents of the pack and other information
1.
WHAT LETROZOLE MYLAN IS AND WHAT IT IS USED FOR
WHAT LETROZOLE MYLAN IS AND HOW IT WORKS
Letrozole Mylan Tablets contain 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 MYLAN IS USED FOR
Letrozole is used to treat breast cancer in women who have gone
through menopause i.e. cessation of
periods.
It is used to help prevent the 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 is also use

Produktens egenskaper

Health Products Regulatory Authority
06 January 2020
CRN009DD0
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Letrozole Mylan 2.5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2.5 mg of letrozole.
Excipient(s) with known effect
Each film-coated tablet contains 61.5 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Letrozole Mylan 2.5 mg Film-coated Tablets are dark yellow,
capsule-shaped, slightly biconvex film-coated tablets debossed
with “LZ 2.5” on one side and “G” on the other side.
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 Mylan 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 Mylan should continue until tumour
progression is evident.
In the adjuvant and extended adjuvant setting, treatment with
Letrozole Mylan should continue for 5 years or until tumour
relapse occurs, whichever is first.