Letrozole 2.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Letrozole

Available from:

Dr Reddy's Laboratories (UK) Ltd

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: 05036072006300 05036072006317

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 adva

Summary of Product characteristics

OBJECT 1
LETROZOLE 2.5 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 21-Jun-2016 | Dr. Reddy's
Laboratories (UK) Ltd
1. Name of the medicinal product
Letrozole 2.5 mg Film-coated tablets
2. Qualitative and quantitative composition
Active substance: Letrozole.
Each film coated tablet contains 2.5 mg letrozole.
Excipients with known effect: Each tablet contains 85.0 mg of lactose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
Dark yellow coloured, round shaped, slightly biconvex bevel edged,
approx. 6mm in diameter film-coated
tablets debossed with '5' on one side and 'H' 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 2.5 mg Film-coated tablets
should continue until tumour progression is evident.
In the adjuvant and extended adjuvant setting, treatment with
Letrozole 2.5 mg Film-coated tablets should
continue for 5 years or until t