Letrozole 2.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Letrozole

Available from:

Sun Pharmaceutical Industries Europe B.V.

ATC code:

L02BG04

INN (International Name):

Letrozole

Dosage:

2.5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08030401; GTIN: 8718309121525

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
LETROZOLE 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 is and what it is used for
2. What you need to know before you take Letrozole
3. How to take Letrozole
4. Possible side effects
5. How to store Letrozole
6. Contents of the pack and other information
1. WHAT LETROZOLE IS AND WHAT IT IS USED FOR
WHAT LETROZOLE IS AND HOW IT WORKS
Letrozole 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 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 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 is also used to prevent breast
tumour spreading to other parts of the body in patients
with advan

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Letrozole 2.5 mg Film-coated Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2.5 mg of letrozole.
Excipient with known effect
Each film-coated tablet contains 61.53 mg lactose monohydrate. For a
full list of
excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated Tablet
Letrozole 2.5 mg Film-coated Tablets are dark yellow, capsule-shaped,
slightly
biconvex, 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 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 schedule (letrozole 2
years followed by
tamoxifen 3 years) could also be considered (see sections 4.4 an