Letrozin 2,5 mg, filmomhulde tabletten

Country: Netherlands

Language: Dutch

Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Active ingredient:

LETROZOL 2,5 mg/stuk

Available from:

Meditrina Ltd, Pharmaceutical Company 117 Iraklitou Straat 15238 ATHENE (GRIEKENLAND)

ATC code:

L02BG04

INN (International Name):

LETROZOL 2,5 mg/stuk

Pharmaceutical form:

Filmomhulde tablet

Composition:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMZETMEELGLYCOLAAT ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMZETMEELGLYCOLAAT ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMZETMEELGLYCOLAAT (E468) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Administration route:

Oraal gebruik

Therapeutic area:

Letrozole

Product summary:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); HYPROMELLOSE (E 464); IJZEROXIDE GEEL (E 172); LACTOSE 1-WATER; MACROGOL 8000; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; NATRIUMZETMEELGLYCOLAAT (E468); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);

Authorization date:

1900-01-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
LETROZIN 2,5 MG, FILMOMHULDE TABLETTEN
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. See section 4.
WHAT IS IN THIS LEAFLET
1.
What LETARSIS is and what it is used for
2.
What you need to know before you take LETARSIS
3.
How to take LETARSIS
4.
Possible side effects
5.
How to store LETARSIS
6.
Contents of the pack and other information
1.
WHAT LETARSIS IS AND WHAT IT IS USED FOR
WHAT LETARSIS IS AND HOW IT WORKS
Letarsis 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. Letarsis 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
oestogens to grow. As a consequence
tumour cells slow or stop the growing and/or spreading to other parts
of the body.
WHAT LETARSIS IS USED FOR
Letarsis is used to treat breast cancer in women who have gone through
menopause i.e cessation of
periods.
It is used to prevent breast cancer happening again. It can be used as
a 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 of treatment with tamoxifen.
Letrozole is also used to prevent
breast tumour spreading to other parts of the body in patients

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAAM VAN HET GENEESMIDDEL
Letrozin 2,5 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg letrozole.
Excipient: each tablet contains 61.5 mg lactose monohydrate.
For a 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 early breast
cancer.

Extended adjuvant treatment of hormone-dependent early 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 in women with natural or artificially induced
postmenopausal endocrine
status
after
relapse
or
disease
progression,
who
have
previously
been
treated
with
anti-
oestrogens.
Efficacy has not been demonstrated in patients with hormone-receptor
negative breast cancer.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and elderly patients _
The recommended dose of Letarsisis 2.5 mg once daily. No dose
adjustment is required for elderly
patients.
In patients with advanced or metastatic disease, treatment with
Letarsis should continue until tumour
progression if evident.
In the adjuvant and extended adjuvant setting, treatment with Letarsis
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 section 4.4 and 5.1).
In the neoadjuvant setting, treatment with Letarsis could be continued
for 4 to 8 months in order to
establish optimal tumour reduction. If the response is not adequate,
treatment with Letarsis should be
discontinued and surgery scheduled and/or further treatment options
discu