Letrozole 2.5mg tablets

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Letrozole

Saadav alates:

Viatris UK Healthcare Ltd

ATC kood:

L02BG04

INN (Rahvusvaheline Nimetus):

Letrozole

Annus:

2.5mg

Ravimvorm:

Oral tablet

Manustamisviis:

Oral

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 08030401; GTIN: 5016695003719 5016695003702

Infovoldik

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

Toote omadused

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(s) with known effect
Each film-coated tablet contains 61.5 mg lactose monohydrate.
For the 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.