Arimidex 1mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Anastrozole

Available from:

AstraZeneca AB

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:

2000-08-11

Patient Information leaflet

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
•
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 st

Summary of Product characteristics

Health Products Regulatory Authority
16 June 2020
CRN009NX2
Page 1 of 11
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).
Method of administration
Arimidex should be taken orally.
Health Products Regulatory Authority
16 June 2020
CR