Letrozole Teva 2.5 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Letrozole

Available from:

Teva Pharma B.V.

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:

2010-06-04

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LETROZOLE TEVA 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 Teva is and what it is used for
2.
What you need to know before you take Letrozole Teva
3.
How to take Letrozole Teva
4.
Possible side effects
5.
How to store Letrozole Teva
6.
Contents of the pack and other information
1.
WHAT LETROZOLE TEVA IS AND WHAT IT IS USED FOR
_What Letrozole Teva is and how it works _
Letrozole Teva 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 Teva 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 Teva is used for _
Letrozole Teva 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 treatment with tamoxifen. Letrozole
Teva is also used to preve

Summary of Product characteristics

Health Products Regulatory Authority
12 November 2019
CRN009D2W
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Letrozole Teva 2.5 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2.5 mg letrozole.
Excipients with known effect_: _
Each film-coated tablet contains 60.42 mg lactose and 0.02 mg
tartrazine aluminium lake (E102).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Dark yellow, standard convex round, film-coated tablet debossed with
“93” on one side and “B1” 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
_Adults 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 should continue for 5 years or until tumour relapse
occurs, whichever is first.
In the adjuvant setting a sequential treatment sch