Arimidex 1 mg Film-coated Tablets

Pajjiż: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Anastrozole

Disponibbli minn:

IMED Healthcare Ltd.

Kodiċi ATC:

L02BG; L02BG03

INN (Isem Internazzjonali):

Anastrozole

Dożaġġ:

1 milligram(s)

Għamla farmaċewtika:

Film-coated tablet

Tip ta 'preskrizzjoni:

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

Żona terapewtika:

Aromatase inhibitors; anastrozole

L-istatus ta 'awtorizzazzjoni:

Authorised

Data ta 'l-awtorizzazzjoni:

2012-09-28

Fuljett ta 'informazzjoni

PACKAGE LEAFLET: INFORMATION FOR THE USER
ARIMIDEX
® 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 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, or pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. See section 4.
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 breastfeeding’).
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 ca

Karatteristiċi tal-prodott

Health Products Regulatory Authority
01 February 2022
CRN00CS28
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 anastrozole.
Excipient(s) with known effect:
Each film-coated 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 Poland_
White, round, biconvex tablet with logo on one side and 'adxl' 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
Sodium starch glycollate
Magnesium stearate
Hypromellose
Macrogol
Titanium dioxide
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.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30°C. Store in the original packaging.
6.5 NATURE AND CONTENTS OF CONTAINER
Health Products Regulatory Authority
01 February 2022
CRN00CS28
Page 2 of 2
Blister packs of 28 tablets in an over-labelled cardboard carton.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
Any unused product or waste material should be disposed of in
accordance with local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd.
Unit 625 Kilshane Avenue
Northwest Business Park
Ballycoolin
Dublin 15
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1463/070/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 28
th
September 2012
10 DATE OF REVISION OF THE TEXT
February 2022