Anastrozol Genericon 1 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

ANASTROZOL

Beschikbaar vanaf:

GENERICON PHARMA Gesellschaft m.b.H.

ATC-code:

L02BG03

INN (Algemene Internationale Benaming):

ANASTROZOLE

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POVIDON K 30 (E 1201) ; TITAANDIOXIDE (E 171), HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT (E468) ; POVIDON K 30 (E 1201) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Anastrozole

Product samenvatting:

Hulpstoffen: HYPROMELLOSE (E 464); LACTOSE 1-WATER; MACROGOL 400; MAGNESIUMSTEARAAT (E 470b); NATRIUMZETMEELGLYCOLAAT (E468); POVIDON K 30 (E 1201); TITAANDIOXIDE (E 171);

Autorisatie datum:

2008-02-29

Bijsluiter

Common Technical Document
Anastrozole 1 mg
film-coated tablets
Module 1 - Section 3.5 Core SPC,
Labelling and Package Leaflet
page 1/7
version:Gen01
1.3.5
Package Leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
ANASTROZOL GENERICON 1 MG, FILMOMHULDE TABLETTEN Active substance: anastrozole
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 or
nurse. This
includes any possible side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET:
1.
What Anastrozole 1 mg is and what it is used for
2.
What you need to know before you take Anastrozole 1 mg
3.
How to take Anastrozole 1 mg
4.
Possible side effects
5.
How to store Anastrozole 1 mg
6.
Contents of the pack and other information
1.
WHAT ANASTROZOLE 1 MG IS AND WHAT IT IS USED FOR
Anastrozole belongs to a group of medicines called ‘aromatase
inhibitors’.
Anastrozole is used to treat breast cancer in women who have gone
through the
menopause.
Anastrozole works by cutting down the amount of the hormone called
estrogen
that your body makes. It does this by blocking a natural substance (an
enzyme) in
your body called ‘aromatase’.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ANASTROZOLE 1 MG
DO NOT TAKE ANASTROZOLE 1 MG

if you are ALLERGIC TO ANASTROZOLE OR ANY OF THE OTHER INGREDIENTS of
this
medicine (listed in section 6, Contents of the pack and other
information).
Common Technical Document
Anastrozole 1 mg
film-coated tablets
Module 1 - Section 3.5 Core SPC,
Labelling and Package Leaflet
page 2/7
version:Gen01

if you are PREGNANT or BREAST FEEDING (see the section called
“Pregnancy and
breastfeeding”).
Do not take Anastr

Productkenmerken

Common Technical Document
Anastrozol 1 mg, film-coated tablets.
CBG-MEB
Module 1 - Section 3.5 Core SPC,
Labelling and Package Leaflet
page 1/21
issue date:
version: Gen02
1.3.5
Summary of Product Characteristics
1
NAME OF THE MEDICINAL PRODUCT
Anastrozol Genericon 1 mg, filmomhulde tabletten
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg anastrozole.
Excipient
with
known
effect:
Each
tablet
contains
93
mg
lactose
monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
White film-coated round biconvex tablets, debossed with “ANA” and
“1” on
one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of hormone receptor-positive advanced breast cancer in
postmenopausal women.
Adjuvant
treatment
of
postmenopausal
women
with
hormone
receptor
positive early invasive breast cancer.
Adjuvant treatment of early
breast cancer in hormone receptor positive
postmenopausal
women
who
have
received
2
to
3
years
of
adjuvant
tamoxifen.
Common Technical Document
Anastrozol 1 mg, film-coated tablets.
CBG-MEB
Module 1 - Section 3.5 Core SPC,
Labelling and Package Leaflet
page 2/21
issue date:
version: Gen02
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose for adults including the elderly is one 1 mg
tablet
once a day.
For postmenopausal women with hormone receptor-positive early invasive
breast cancer, the recommended duration of adjuvant endocrine
treatment is 5
years.
Special Populations
Paediatric population
Anastrozole is not recommended_ _for use in children and adolescents
due to
insufficient data on safety and efficacy (see sections 4.4 and 5.1).
Renal impairment
No dose change is recommended in patients with mild or moderate renal
impairment.
In patients with severe
renal impairment, administration
of
Anatrozol should be performed with caution (see section 4.4 and 5.2).
Hepatic impairment
No dose change is recommended in patients with mild hepatic disease.
Caution is advised in patients with moderate to severe he