Letrozole 2.5mg tablets

Land: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Letrozole

Fáanlegur frá:

Sigma Pharmaceuticals Plc

ATC númer:

L02BG04

INN (Alþjóðlegt nafn):

Letrozole

Skammtar:

2.5mg

Lyfjaform:

Oral tablet

Stjórnsýsluleið:

Oral

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 08030401

Upplýsingar fylgiseðill

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, pharmacist or nurse.
•
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,
pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET
1. What Letrozole Tablets are and what it is used
for
2. What you need to know before you take
Letrozole Tablets
3. How to take Letrozole Tablets
4. Possible side effects
5. How to store Letrozole Tablets
6. Contents of the pack and other information 1. WHAT LETROZOLE TABLETS ARE AND WHAT IT IS
USED FOR
WHAT LETROZOLE TABLETS ARE AND HOW IT WORKS
Letrozole Tablets 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 Tablets 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 TABLETS ARE USED FOR
Letrozole Tablets are 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.

Vara einkenni

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