Femara 2.5 mg film-coated tablets

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Letrozole

Verfügbar ab:

PCO Manufacturing Ltd.

ATC-Code:

L02BG; L02BG04

INN (Internationale Bezeichnung):

Letrozole

Dosierung:

2.5 milligram(s)

Darreichungsform:

Film-coated tablet

Verschreibungstyp:

Product subject to prescription which may not be renewed (A)

Therapiebereich:

Aromatase inhibitors; letrozole

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2013-01-25

Gebrauchsinformation

_ Pil 465-303-1-4293 _
_Pil 465-303-1-4293_
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.
–
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.
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 w

Fachinformation

Health Products Regulatory Authority
15 June 2020
CRN009SYK
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 of known effect: contains lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product imported from Italy and Czech Republic:_
Film-coated tablet, dark yellow, round, slightly biconvex with
bevelled edges. 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.
Coating:
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 shall be the date shown on
the blister and outer package of the product on the
market in the country of origin.
Health Products Regulatory Authority
15 June 2020
CRN009SYK
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30°C.
Store in the original package in order to protect from moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister strips of 10 tablets in an overlabelled outer carton
Pack size: 30 tablets
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/303/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 25
th
January 2013
10 DATE OF REVISION OF THE TEXT
June 2020