Letrozol Sandoz 2,5 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

LETROZOL 2,5 mg/stuk

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

L02BG04

INN (Algemene Internationale Benaming):

LETROZOL 2,5 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

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

Autorisatie datum:

2010-11-02

Bijsluiter

Sandoz B.V.
Page 1/6
Letrozol Sandoz tablet 2,5 mg tablet 2,5 mg
RVG 106322
1313-v11
1.3.1.3 Bijsluiter
Juli 2020
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LETROZOL SANDOZ
® 2,5 MG, FILMOMHULDE TABLETTEN
letrozol
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 [Nationally completed name] is and what it is used for
2
What you need to know before you take [Nationally completed name]
3
How to take [Nationally completed name]
4
Possible side effects
5
How to store [Nationally completed name]
6
Contents of the pack and other information
1
WHAT [NATIONALLY APPROVED NAME] IS AND WHAT IT IS USED FOR
WHAT [NATIONALLY APPROVED NAME] IS AND HOW IT WORKS
[Nationally approved name] 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.
[Nationally approved name] 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 [NATIONALLY APPROVED NAME] IS USED FOR
[Nationally approved name] 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 treatme

Productkenmerken

Sandoz B.V.
Page 1/24
Letrozol Sandoz
tablet
2,5 mg
RVG 106322
1311-V9
1.3.1.1 Samenvatting van de Productkenmerken
Oktober 2019
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Letrozol Sandoz 2,5 mg, filmomhulde tabletten
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2.5 mg letrozole.
Excipients(s) with known effect
Each film-coated tablet contains 58.4 mg of lactose (as lactose
monohydrate) and up to 0.21 mg (0.009
mmol) sodium (as sodium starch glycolate).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
Film-coated tablet, dark yellow, round, slightly biconvex with
bevelled edges. One side bears the
imprint “FV”, the other “CG”.
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
Sandoz B.V.
Page 2/24
Letrozol Sandoz
tablet
2,5 mg
RVG 106322
1311-V9
1.3.1.1 Samenvatting van de Productkenmerken
Oktober 2019
Posology
_Adult and elderly patients_
The recommended dose of [Nationally approved name] is 2.5 mg once
daily. No dose adjustment is
required for elderly patients.
In patients with advanced or metastatic breast cancer, treatment wi