Letrozol Pharmacenter 2,5 mg, filmomhulde tabletten

País: Países Bajos

Idioma: neerlandés

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

Ingredientes activos:

LETROZOL

Disponible desde:

Pharmacenter Europe Ltd.

Código ATC:

L02BG04

Designación común internacional (DCI):

LETROZOL

formulario farmacéutico:

Filmomhulde tablet

Composición:

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),

Vía de administración:

Oraal gebruik

Área terapéutica:

Letrozole

Resumen del producto:

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);

Fecha de autorización:

2009-01-16

Información para el usuario

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LETROZOL PHARMACENTER 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 Letrozol Pharmacenter is and what it is used for
2.
What you need to know before you take Letrozol Pharmacenter
3.
How to take Letrozol Pharmacenter
4.
Possible side effects
5.
How to store Letrozol Pharmacenter
6.
Contents of the pack and other information
1.
WHAT LETROZOL PHARMACENTER IS AND WHAT IT IS USED FOR
WHAT LETROZOL PHARMACENTER IS AND HOW IT WORKS
Letrozol Pharmacenter 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. Letrozol Pharmacenter
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 LETROZOL PHARMACENTER IS USED FOR
Letrozol Pharmacenter 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 followin

Ficha técnica

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Letrozol Pharmacenter 2,5 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: letrozole
Each film-coated 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, 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.

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 Letrozol Pharmacenter is 2.5 mg once daily. No
dose adjustment is
required for elderly patients.
In patients with advanced or metastatic breast cancer, treatment with
Letrozol Pharmacenter should
continue until tumour progression if evident.
In the adjuvant and extended adjuvant setting, treatment with Letrozol
Pharmacenter 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 consi