Anastrozole 1 mg Film-coated tablets

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Anastrozole

Disponível em:

Rowa Pharmaceuticals Limited

Código ATC:

L02BG; L02BG03

DCI (Denominação Comum Internacional):

Anastrozole

Dosagem:

1 milligram(s)

Forma farmacêutica:

Film-coated tablet

Tipo de prescrição:

Product subject to prescription which may not be renewed (A)

Área terapêutica:

Aromatase inhibitors; anastrozole

Status de autorização:

Marketed

Data de autorização:

2009-11-27

Folheto informativo - Bula

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ANASTROZOLE 1 MG FILM-COATED TABLETS
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, pharmacist or
nurse.
-
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, 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 is and what it is used for
2.
What you need to know before you take Anastrozole
3.
How to take Anastrozole
4.
Possible side effects
5.
How to store Anastrozole tablets
6.
Contents of the pack and other information.
1.
WHAT ANASTROZOLE IS AND WHAT IT IS USED FOR
Anastrozole tablets contain 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.
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
DO NOT TAKE ANASTROZOLE
-
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 Anastrozole if any of the above apply to you. If you are
not sure, talk to your doctor or
pharmacist before taking Anastrozole.
WARNINGS AND PRECUATIONS
Talk to your doctor, pharmacist or nurse before taking Anastrozole.
-
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
co

Características técnicas

Health Products Regulatory Authority
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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Anastrozole 1 mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 1 mg anastrozole.
Excipients with known effect :
Each film-coated tablet contains 90.3 mg lactose (as lactose
monohydrate) (see section 4.4).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, round, biconvex, film-coated tablets. Marked with '1' on one
side and plain on the reverse side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Anastrozole is indicated for the:
Treatment of hormone receptor-positive advanced breast cancer in
postmenopausal women.
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_
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
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
hepatic impairment (see section 4.4).
Method of administration
Anastrozole should be taken orally.
4.3 CONTRAINDICATIONS
Anastrozole is contraindicated in:
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
Pregnant or breast-feeding women

Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
General