Letrozole Medipha Sante 2.5 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Letrozole

Available from:

Medipha Sante SN

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:

Not marketed

Authorization date:

2011-02-25

Patient Information leaflet

_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
LETROZOLE MEDIPHA SANTÉ 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 Letrozole Medipha Santé is and what it is used for
2.
What you need to know before you take Letrozole Medipha Santé
3.
How to take Letrozole Medipha Santé
4.
Possible side effects
5.
How to store Letrozole Medipha Santé
6.
Contents of the pack and other information
1.
WHAT LETROZOLE MEDIPHA SANTÉ IS AND WHAT IT IS USED FOR
WHAT LETROZOLE MEDIPHA SANTÉ IS AND HOW IT WORKS
Letrozole Medipha Santé contains an active substance called
letrozole. It belongs to a group
of medicines called aromatase inhibitors. It is an hormonal (or
“endocrine”) breast cancer
treatment. Growth of breast cancer is frequently stimulated by
oestrogens which are female
sex hormones. Letrozole Medipha Santé 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 MEDIPHA SANTÉ IS USED FOR
Letrozole Medipha Santé 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 can

Summary of Product characteristics

Health Products Regulatory Authority
14 October 2019
CRN009DDN
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Letrozole Medipha Sante 2.5mg film coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2.5 mg letrozole.
Each tablet contains 61.5 mg of lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Film-coated tablet, yellow, round, biconvex.
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 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 should continue until tumour progression is
evident.
In the adjuvant and extended adjuvant setting, treatment with
Letrozole Medipha Santé 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, tr