Letrozole 2.5mg tablets

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Letrozole

Disponibil de la:

Accord-UK Ltd

Codul ATC:

L02BG04

INN (nume internaţional):

Letrozole

Dozare:

2.5mg

Forma farmaceutică:

Oral tablet

Calea de administrare:

Oral

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 08030401; GTIN: 5060149315651 5060149312315

Prospect

PAGE 1 OF 7
PACKAGE LEAFLET
PAGE 2 OF 7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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 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 Tablets contain 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 help prevent the 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 spreadin

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Letrozole 2.5mg film-coated Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2.5 mg letrozole.
Excipient(s)
with
known
effect:
Each
tablet
contains
61.500
mg
of
lactose
monohydrate.
For the full list of excipients, see Section 6.1
3
PHARMACEUTICAL FORM
Film-coated tablet
Yellow, round, biconvex, film coated tablets plain on both sides.
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
Tablets
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
Tablets should continue until tumour progression is evident.
In the adjuvant and extended adjuvant setting, treatment with
Letrozole Tablets 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 tablet could be
co