Arimidex 1mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Anastrozole

Available from:

AstraZeneca UK Limited

ATC code:

L02BG; L02BG03

INN (International Name):

Anastrozole

Dosage:

1 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

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

Therapeutic area:

Aromatase inhibitors; anastrozole

Authorization status:

Marketed

Authorization date:

1996-01-17

Patient Information leaflet

UIM/PIL/Arimidex/ONC 17 0031a (based on ONC 16 0009) 30/10/2017 AH
Page 1 of 6
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 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
UIM/PIL/Arimidex/ONC 17 0031a (based on ONC 16 0009) 30/10/2017 AH
Page 2 of 6

if you still have menstrual peri

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Arimidex 1mg 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 93 mg of 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 of about 6.1 mm marked with
‘A’ on one side and ‘Adx1’ on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Arimidex 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 Arimidex 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_
Arimidex 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 Arimidex 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).
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