Anastrozol-CT 1 mg, filmomhulde tabletten

País: Países Bajos

Idioma: neerlandés

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

Ingredientes activos:

ANASTROZOL

Disponible desde:

Teva Pharma B.V.

Código ATC:

L02BG03

Designación común internacional (DCI):

ANASTROZOLE

formulario farmacéutico:

Filmomhulde tablet

Composición:

HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POLYETHYLEENGLYCOL (E 1521) ; POVIDON (E 1201) ; TITAANDIOXIDE (E 171), HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT (E468) ; POLYETHYLEENGLYCOL (E 1521) ; POVIDON (E 1201) ; TITAANDIOXIDE (E 171),

Vía de administración:

Oraal gebruik

Área terapéutica:

Anastrozole

Resumen del producto:

Hulpstoffen: HYPROMELLOSE (E 464); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); NATRIUMZETMEELGLYCOLAAT (E468); POLYETHYLEENGLYCOL (E 1521); POVIDON (E 1201); TITAANDIOXIDE (E 171);

Fecha de autorización:

2007-10-03

Información para el usuario

common-pl NL H 834-836
05.08.2014
1
PACKAGE LEAFLET:
INFORMATION FOR THE USER
ANASTROZOL-CT 1 MG, FILMOMHULDE TABLETTEN
Active substance: anastrozole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
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. Do not pass it on to
others. It may harm them, even if
their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist. See section 4.
In this leaflet:
1. What /.../ is and what it is used for
2. Before you take /.../
3. How to take /.../
4. Possible side effects
5. How to store /.../
6. Further information
1. WHAT /.../ IS AND WHAT IT IS USED FOR
/.../ contains a substance called anastrozole. This belongs to a group
of medicines called ‘aromatase
inhibitors’. Anastrozole is used to treat breast cancer in women who
have gone through the
menopause.
/.../ 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. BEFORE YOU TAKE /.../
Do not take /.../
-
if you are allergic (hypersensitive) to anastrozole or any of the
other ingredients of /.../ (see section
6: Further information).
-
if you are pregnant or breast-feeding (see the section called
‘Pregnancy and breast-feeding’).
Do not take /.../ if any of the above apply to you. If you are not
sure, talk to your doctor or pharmacist
before taking /.../.
Take special care with /.../
Before treatment with /.../ check with your doctor or pharmacist
-
if you still have menstrual periods and have not yet gone through the
menopause.
-
if you are taking a medicine that contains tamoxifen or medicines that
contain estrogen (see the
section called ‘Taking other medicines’).
-
if you have ever had a condition that affects the strength of your
bo

Ficha técnica

common-spc NL H 0834-836
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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
_ANASTROZOL-CT 1 MG, FILMOMHULDE TABLETTEN _
2.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 1 mg anastrozole.
Excipients
Each film-coated tablet contains 93 mg of lactose monohydrate (see
section 4.4).
For a 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
_Anastrozole 1mg, film-coated tablets_
is indicated for the:

Treatment of hormone receptor-positive advanced breast cancer in
postmenopausal women.

Adjuvant treatment of hormone receptor-positive early invasive breast
cancer in
postmenopausal women.

Adjuvant treatment of hormone receptor-positive early invasive breast
cancer in
postmenopausal women who have received 2 to 3 years of adjuvant
tamoxifen.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of anastrozole 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_
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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 anastrozole should be
performed with caution
(see sections 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 hepatic impairment (see section 4.4).
Method of administration
Anastrozole 1 mg, film coated tablets should be taken orally.
4.3
CONTRAIND