Agerdex 1 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Anastrozole

Available from:

McDermott Laboratories Ltd., T/A Gerard Laboratories

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:

2007-11-09

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
AGERDEX 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 Agerdex is and what it is used for
2.
What you need to know before you take Agerdex
3.
How to take Agerdex
4.
Possible side effects
5.
How to store Agerdex
6.
Contents of the pack and other information
1.
WHAT AGERDEX IS AND WHAT IT IS USED FOR
Agerdex 1 mg film-coated tablets contain a substance called
anastrozole. This belongs to a group of
medicines called ‘aromatase inhibitors’. Agerdex is used to treat
breast cancer in women who have gone
through the menopause.
Agerdex 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 AGERDEX
DO NOT TAKE AGERDEX:
•
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 Agerdex if any of the above apply to you. If you are not
sure, talk to your doctor or pharmacist
before taking Agerdex.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Agerdex
- 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 oestrogen (see the section
called

Summary of Product characteristics

Health Products Regulatory Authority
19 July 2021
CRN00C933
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Agerdex 1 mg 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 lactose monohydrate (see
section 4.4).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White film-coated round biconvex tablets, debossed with "ANA" and "1"
on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Agerdex 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 Agerdex 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 _
Agerdex 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 Agerdex 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
Agerdex should be taken orally.
4.3 CONTRAINDICATIONS
Agerdex is contraindicated in:
Health Products Regulatory Authority
19 J