Eirfem 2.5 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Letrozole

Available from:

Rowa Pharmaceuticals Limited

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:

2009-08-28

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Eirfem 2.5 mg film coated tablets
Rowa®
letrozole
Pharmaceuticals Ltd.
The name of your medicine is Eirfem 2.5 mg film coated tablets,
which will be referred to as Eirfem tablets throughout the rest of
this document.
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, please ask your doctor or your
pharmacist.
• This medicine has been prescribed for you only. Do not pass it on
to others. It may harm them,
even if their symptoms 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 LEAFIET:
1. What Eirfem tablets are and what they are used for
2. What you need to know before you take Eirfem tablets
3. How to take Eirfem tablets
4. Possible side effects
5. How to store Eirfem tablets
6. Contents of the pack and other Information
1. WHAT EIRFEM TABIETS ARE AND WHAT THEY ARE USED FOR
Eirfem tablets contain an active substance called letrozoIe.
Letrozole belongs to a group of medicines called aromatase inhibitors.
It is a hormonal (endocrine)
breast cancer treatment.
Eirfem tablets are used to
- prevent breast cancer recurrences as first treatment after breast
surgery or following five years of
treatment with tamoxifen
- prevent breast tumours spreading to other parts of the body in
patients in advanced stages of the
disease
EIRFEM TABLETS SHOULD BE USED ONLY FOR OESTROGEN RECEPTOR-POSITIVE
BREAST CANCER AND ONLY IN
WOMEN AFTER MENOPAUSE (WHEN YOUR PERIODS HAVE STOPPED COMPLETELY).
Growth of breast cancer is frequently stimulated by oestrogens, which
are female sex hormones.
Eirfem tablets reduce the amount of oestrogen by blocking an enzyme
(aromatase) involved in the
production of oestrogens. As a consequence tumour cells slow or stop
growing and/or spreading to
other parts o

Summary of Product characteristics

Health Products Regulatory Authority
14 November 2019
CRN009D01
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Eirfem 2.5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: 2.5 mg letrozole.
Excipients with known effect:
Also contains sunset yellow FCF (E110).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film coated tablet
Yellow, round, biconvex, film-coated, tablets. Debossed 2.5 on one
side, plain on reverse.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS

Adjuvant treatment of postmenopausal women with hormone receptor
positive early breast cancer.

Extended adjuvant treatment of hormone-dependent 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 in women with natural or artificially induced
postmenopausal status after relapse or
disease progression, who have previously been treated with
anti-oestrogens.
Efficacy has not been demonstrated in patients with hormone receptor
negative breast cancer.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral use
Adult and older people
The recommended dose of Eirfem 2.5 mg film coated tablets is 2.5 mg
once daily. No dose adjustment is required for elderly
patients.
In the adjuvant setting, it is recommended to treat for 5 years or
until tumour relapse occurs. In the adjuvant setting, clinical
experience is available for 2 years (median duration of treatment was
25 months).
In the extended adjuvant setting, clinical experience is available for
4 years (median duration of treatment).
In patients with advanced or metastatic disease, treatment with Eirfem
2.5 mg film coated tablets should continue until tumour
progression is evident.
Paediatric population
Not applicable.
Patients with hepatic and/or renal impairment
No dosage adjustment is required for patients with renal insufficiency
wi