Letrozole 2.5mg tablets

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Letrozole

Verfügbar ab:

Crescent Pharma Ltd

ATC-Code:

L02BG04

INN (Internationale Bezeichnung):

Letrozole

Dosierung:

2.5mg

Darreichungsform:

Oral tablet

Verabreichungsweg:

Oral

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 08030401; GTIN: 5017123063114 5017123063138

Gebrauchsinformation

PACKAGE LEAFLET: INFORMATION FOR THE USER
FEMARA
® 2.5MG 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 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
or pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
See section 4.
The name of your medicine is Femara 2.5mg
tablets but will be referred to as Femara
throughout this leaflet.
WHAT IS IN THIS LEAFLET
1.
What Femara is and what it is used for
2.
What you need to know before you take
Femara
3.
How to take Femara
4.
Possible side effects
5.
How to store Femara
6.
Contents of the pack and other information
1.
WHAT FEMARA IS AND WHAT IT IS USED
FOR
WHAT FEMARA IS AND HOW IT WORKS
Femara 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.
Femara 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 FEMARA IS USED FOR
Femara 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. Femara is also used t

Fachinformation

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 with known effect
Each film-coated tablet contains 61.53 mg lactose monohydrate. For a
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 4.4 an