Anastrozole 1 mg Film-coated Tablets

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Anastrozole

Disponível em:

WPR Healthcare Limited

Código ATC:

L02BG; L02BG03

DCI (Denominação Comum Internacional):

Anastrozole

Dosagem:

1 milligram(s)

Forma farmacêutica:

Film-coated tablet

Via de administração:

Oral use

Unidades em pacote:

Blisters of 28 film-coated tablets

Tipo de prescrição:

Product subject to prescription which may be renewed (B)

Fabricado por:

TEVA UK Limited

Grupo terapêutico:

Enzyme inhibitors

Área terapêutica:

Aromatase inhibitors; anastrozole

Indicações terapêuticas:

It is indicated for the treatment of hormone receptor-positive advanced breast cancer in postmenopausal women

Status de autorização:

Authorised

Data de autorização:

2015-05-01

Folheto informativo - Bula

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 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 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
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT ANASTROZOLE IS AND WHAT IT IS USED FOR

Anastrozole 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.

Anastrozole works by cutting down the amount of the hormone called
oestrogen 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 (hypersensitive) to anastrozole or any of the
other ingredients of Anastrozole (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 PRECAUTIONS
Talk to your doctor or pharmacist 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
con

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Anastrozole 1 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg of anastrozole.
Excipient(s) with known effect
Each tablet contains lactose monohydrate (see section 4.4)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from the UK:_
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
As per PA0749/028/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0749/028/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Core_
Lactose monohydrate
Magnesium stearate (E572)
Povidone K-30
Sodium starch glycolate type A
_Coating_
Hypromellose (E464)
Macrogol 400 and macrogol 6000
Titanium dioxide (E171)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer package of the product on the
market in the country of origin.
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6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special storage
conditions.
6.5 NATURE AND CONTENTS OF CONTAINER
Blisters of 28 film-coated tablets in a cardboard carton.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirem