Letrozol Genericon 2,5 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

LETROZOL

Beschikbaar vanaf:

GENERICON PHARMA Gesellschaft m.b.H.

ATC-code:

L02BG04

INN (Algemene Internationale Benaming):

LETROZOL

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

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),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Letrozole

Product samenvatting:

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);

Autorisatie datum:

2009-01-16

Bijsluiter

Common Technical Document
Letrozole
film-coated tablets
CBG-MEB
Module 1 - Section 3.5 Core SPC,
Labelling and Package Leaflet
page 1/9
1.3.5
Package Leaflet - Core
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LETROZOL GENERICON 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 is and what it is used for
2.
What do you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
WHAT IS AND HOW IT WORKS
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.
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 the
growing and/or
spreading to other parts of the body.
WHAT IS USED FOR
Common Technical Document
Letrozole
film-coated tablets
CBG-MEB
Module 1 - Section 3.5 Core SPC,
Labelling and Package Leaflet
page 2/9
is used to treat breast

Productkenmerken

Common Technical Document
Letrozole
film-coated tablets
Module 1 - Section 3.1 Core SPC,
Labelling and Package Leaflet
page 1/24
issue date: 2017-10-18
1.3.1 Summary of Product Characteristics
1
Name of the medicinal product
Letrozol Genericon 2,5 mg, filmomhulde tabletten
2
Qualitative and quantitative composition
Each tablet contains 2.5 mg letrozole.
Excipient
with
known
effect:
each
tablet
contains
61.5
mg
lactose
monohydrate.
For the 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 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.
Common Technical Document
Letrozole
film-coated tablets
Module 1 - Section 3.1 Core SPC,
Labelling and Package Leaflet
page 2/24
issue date: 2017-10-18

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
_Adults 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 se