Arimidex 1 mg film-coated tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Anastrozole

Tilgjengelig fra:

Originalis B.V.

ATC-kode:

L02BG03

INN (International Name):

Anastrozole

Dosering :

1 milligram(s)

Legemiddelform:

Film-coated tablet

Terapeutisk område:

anastrozole

Autorisasjon dato:

2019-07-19

Informasjon til brukeren

WHAT IS IN THIS LEAFLET:
1.
What Arimidex is and what it is used for
2.
What you need to know before you take Arimidex
3.
How to take Arimidex
4.
Possible side effects
5.
How to store Arimidex
6.
Contents of the pack and other information
1.
WHAT ARIMIDEX IS AND WHAT IT IS USED FOR
Arimidex contains a substance called anastrozole. This belongs to a
group of medicines called ‘aromatase
inhibitors’. Arimidex is used to treat breast cancer in women who
have gone through the menopause.
Arimidex 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 ARIMIDEX
DO NOT TAKE ARIMIDEX
•
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 Arimidex if any of the above apply to you. If you are not
sure, talk to your doctor or
pharmacist before taking Arimidex.
WARNINGS AND PRECAUTIONS
Talk to your doctor, or pharmacist or nurse before taking Arimidex
•
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 ‘Other medicines and Arimidex’).
•
if you have ever had a condition that affects the strength of your
bones (osteoporosis).
•
if you have problems with your liver or kidneys.
If you are not sure if any of the above applies to you, talk to your
doctor or pharmacist before taking
Arimidex.
If you go into the hospital, let the medical staff know you are taking
Arimidex.
OTHER MEDICINES AND ARIMIDEX
Tell your doctor or pharmacist if you are taking or have recently
taken any other medicines. This includes
medicines that you buy without a prescription and herbal medicines.
This is because Arimidex can affect
the way some medicines work and some m

Preparatomtale

Health Products Regulatory Authority
04 October 2021
CRN00CFTV
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Arimidex 1 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 1 mg of anastrozole.
Excipient with known effect
Lactose (as monohydrate)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product imported from the Czech Republic _
White, round, biconvex film-coated tablet approximately 6.1 mm in size
marked 'A' on one side and 'Adx1' on the other side.
4 CLINICAL PARTICULARS
As per PA23154/001/001
5 PHARMACOLOGICAL PROPERTIES
As per PA23154/001/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Lactose monohydrate
Povidone (K29-32)
Sodium starch glycolate
Magnesium stearate
Hypromellose
Macrogol 300
Titanium dioxide
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the blister and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30 °C.
Health Products Regulatory Authority
04 October 2021
CRN00CFTV
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
Blisters of 28 film-coated tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
Any unused medicinal product or waste material should be disposed of
in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
Originalis B.V.
Joop Geesinkweg 901
1114 AB Amsterdam-Duivendrecht
Netherlands
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Originalis B.V.
Joop Geesinkweg 901
1114 AB Amsterdam-Duivendrecht
Netherlands
8 MARKETING AUTHORISATION NUMBER
PPA2306/017/001
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA2306/017/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 19
th
July 2019
10 DATE OF REVISION OF THE TEXT
October 2021