Letrozole 2.5mg tablets

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Letrozole

Dostopno od:

Zentiva Pharma UK Ltd

Koda artikla:

L02BG04

INN (mednarodno ime):

Letrozole

Odmerek:

2.5mg

Farmacevtska oblika:

Oral tablet

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 08030401; GTIN: 5000283654582 5000283654599

Navodilo za uporabo

PSUSA update - October 2017
PACKAGE LEAFLET: INFORMATION FOR THE USER
LETROZOLE 2.5 MG FILM-COATED TABLETS
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 2.5 mg is and what it is used for
2. What you need to know before you take Letrozole 2.5 mg
3. How to take Letrozole 2.5 mg
4. Possible side effects
5. How to store Letrozole 2.5 mg
6. Contents of the pack and other information
1.
WHAT LETROZOLE 2.5 MG IS AND WHAT IT IS USED FOR
Letrozole 2.5mg 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 gr
owing and/or spreading to other parts of the body.
Letrozole 2.5mg is used to treat breast cancer in women who have gone
through the
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 cases where
immediate surgery is not suitable;
•
as first treatment after breast cancer surgery;
•
following five years treatment with tamoxifen.
Letrozole 2.5 mg is also used to prevent breast tumour spreading to
other parts of the

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Letrozole 2.5 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5mg letrozole.
Excipient
with
known
effect:
each
tablet
contains
61.5mg
lactose
monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Yellow film-coated round biconvex tablets, debossed with L9OO on one
side
and 2.5 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 2.5mg 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 and
5.1).
In the neoadjuvant setting, treatment with letrozole cou