Anastrozol ratiopharm 1 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

ANASTROZOL 1 mg/stuk

Beschikbaar vanaf:

Ratiopharm GmbH Graf-Arco-Strasse 3 89079 ULM (DUITSLAND)

ATC-code:

L02BG03

INN (Algemene Internationale Benaming):

ANASTROZOL 1 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MACROGOL 400 ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POVIDON K 30 (E 1201) ; TITAANDIOXIDE (E 171), HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MACROGOL 400 ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT (E468) ; POVIDON K 30 (E 1201) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Anastrozole

Product samenvatting:

Hulpstoffen: HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); LACTOSE 1-WATER; MACROGOL 400; MACROGOL 6000; MAGNESIUMSTEARAAT (E 470b); NATRIUMZETMEELGLYCOLAAT (E468); POVIDON K 30 (E 1201); TITAANDIOXIDE (E 171);

Autorisatie datum:

1900-01-01

Bijsluiter

Anastrozole, NL/H/0834/001, 30.06.2021
Consolidation IB/023 + IA/024
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Anastrozol ratiopharm 1 mg, filmomhulde tabletten
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. 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 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
/.../ contains a substance called anastrozole. This belongs to a group
of medicines called ‘aromatase
inhibitors’. /.../ 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.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE /.../
DO NOT TAKE /.../
-
if you are allergic to anastrozole or any of the other ingredients of
this medicine (listed in
section 6).
-
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 /.../.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking /.../
-
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

Productkenmerken

Anastrozole, NL/H/0834/001, 30.06.2021
Consolidation IB/023 + IA/024
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Anastrozol ratiopharm 1 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 1 mg anastrozole.
Excipient(s) with known effect:
Each film-coated tablet contains 87 mg lactose monohydrate (see
section 4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white, film-coated round-shaped tablet, debossed with
numbers "93" on one side and
"A10" on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
/.../ 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_
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_
Anastrozole, NL/H/0834/001, 30.06.2021
Consolidation IB/023 + IA/024
2
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 administ