Femara 2.5 mg film-coated tablets

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Letrozole

Disponível em:

IMED Healthcare Ltd.

Código ATC:

L02BG; L02BG04

DCI (Denominação Comum Internacional):

Letrozole

Dosagem:

2.5 milligram(s)

Forma farmacêutica:

Film-coated tablet

Área terapêutica:

Aromatase inhibitors; letrozole

Data de autorização:

2020-09-11

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE USER
FEMARA
®
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 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.
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 to prevent breast tumour spreading to other parts
of the
body in patients with advanced br

Características técnicas

Health Products Regulatory Authority
14 September 2020
CRN009WCV
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Femara 2.5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: letrozole.
Each film-coated tablet contains 2.5 mg letrozole.
Excipient(s) with known effect: lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets
_Product imported from Czech Republic_
Film-coated tablet, dark yellow, round, slightly biconvex. One side
bears the imprint "FV", the other "CG"
4 CLINICAL PARTICULARS
As per PA0896/012/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0896/012/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Lactose monohydrate Cellulose microcrystalline Maize starch
Sodium starch glycolate
Magnesium stearate
Silica colloidal anhydrous
Hypromellose
Talc
Macrogol 8000
Titanium dioxide E171
Iron oxide yellow E172
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product is the date shown on the
blister and outer package of the product as marketed in the
country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30°C.
Health Products Regulatory Authority
14 September 2020
CRN009WCV
Page 2 of 2
Store in the original package in order to protect from moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Blisters packs: 30 tablets per pack, 10 tablets per blister strip.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd.
Unit 625 Kilshane Avenue
Northwest Business Park
Ballycoolin
Dublin 15
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1463/137/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 11
th
September 2020
10 DATE OF REVISION OF THE TEXT