Amidex 1 mg film-coated tablets

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Anastrozole

Mevcut itibaren:

Clonmel Healthcare Ltd

ATC kodu:

L02BG; L02BG03

INN (International Adı):

Anastrozole

Doz:

1 milligram(s)

Farmasötik formu:

Film-coated tablet

Reçete türü:

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

Terapötik alanı:

Aromatase inhibitors; anastrozole

Yetkilendirme durumu:

Marketed

Yetkilendirme tarihi:

2009-07-24

Bilgilendirme broşürü

Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE USER
AMIDEX 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.
IN THIS LEAFLET
1.
What Amidex is and what it is used for
2.
What you need to know before you take Amidex
3.
How to take Amidex
4.
Possible side effects
5.
How to store Amidex
6.
Contents of the pack and other information
1. WHAT AMIDEX IS AND WHAT IT IS USED FOR
Amidex contains a substance called anastrozole. This belongs to a
group of medicines called
‘aromatase inhibitors’. Amidex is used to treat breast cancer in
women who have gone through the
menopause.
Amidex 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 AMIDEX
DO NOT TAKE AMIDEX
•
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 Amidex if any of the above applies to you. If you are not
sure, talk to your doctor or
pharmacist before taking Amidex.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Amidex
•
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 ‘Other medicines and Amidex’)
•
if you have

Ürün özellikleri

Health Products Regulatory Authority
30 September 2021
CRN00CJJW
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amidex 1 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 1 mg of anastrozole.
Excipient(s) with known effect
Each tablet contains 92.75 mg lactose monohydrate.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, round, biconvex tablet with imprint A1 on one side and strength
on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Amidex 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 Amidex 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 _
Amidex 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 Amidex 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
Amidex should be taken orally.
Health Products Regulatory Authority
30 September 2021
CRN00CJJW
Page 2 of 11
4.3 CONTRAINDICATIONS
Anastrozole is contraindi