ARIMIDEX

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

ANASTROZOLE

متاح من:

TARO INTERNATIONAL LTD, ISRAEL

ATC رمز:

L02BG03

الشكل الصيدلاني:

FILM COATED TABLETS

تركيب:

ANASTROZOLE 1.0 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

HAUPT PHARMA MUNSTER GmbH, GERMANY

المجموعة العلاجية:

ANASTROZOLE

المجال العلاجي:

ANASTROZOLE

الخصائص العلاجية:

Treatment of advanced breast cancer in post menopausal women. Efficay has not been demonstrated in estrogen receptor negative patients unless they had a previous positive clinical response to tamoxifen. Adjuvant treatment of postmenopausal women with hormone receptor positive early invasive breast cancer. Adjuvant treatment of early breast cancer in hormone receptor positive postmenopausal women who have received 2 to 3 years of adjuvant tamoxifen.

تاريخ الترخيص:

2022-03-31

نشرة المعلومات

Page 1 of 5
Patient leaflet in accordance with the Pharmacists’ Regulations
(Preparations)- 1986
This medicine is dispensed with a doctor's prescription only
Arimidex
®
Film-coated tablets
Composition:
Each tablet contains: anastrozole 1 mg
Inactive ingredients and allergens: see section 2 under ‘Important
information about some of this
medicine’s ingredients’, and section 6 ‘Additional information'.
Read the entire leaflet carefully before you start using this
medicine. This leaflet contains concise
information about this medicine. If you have any further questions,
consult your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm them,
even if it seems to you that their illness is similar to yours.
This medicine is not intended for children and adolescents.
1. What is this medicine intended for?
Treatment of breast cancer in post-menopausal women.
Therapeutic group:
Aromatase enzyme inhibitors. Arimidex works by cutting down the amount
of the hormone called
estrogen that your body makes. Arimidex does this by blocking a
natural substance (an enzyme) in your
body called aromatase.
2. Before using this medicine
Do not use this medicine if:

You are sensitive (allergic) to the active ingredient anastrozole or
to any of the other ingredients in
this medicine (listed in section 6).

You are pregnant or breast-feeding (see section ‘Pregnancy and
breast-feeding’).
Special warnings about using Arimidex
Before treatment with Arimidex, tell your doctor if you:

Still have menstrual periods and have not yet gone through the
menopause.

Are taking a medicine that contains tamoxifen or medicines that
contain estrogen (see section ‘Drug
interactions’).

Have ever had a condition that affects the strength of your bones
(osteoporosis).

Have problems with your liver or kidneys.
Additional warnings:

If you go into the hospital, let the medical staff know you are taking
Arimidex.
Children and adolescents
Arimidex should no

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
ARIMIDEX
1.
NAME OF THE MEDICINAL PRODUCT
ARIMIDEX
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 tablet with logo on one side and strength on
the other.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications

Treatment of advanced breast cancer in postmenopausal women. Efficacy
has not
been
demonstrated
in
estrogen
receptor
negative
patients
unless
they
had
a
previous positive clinical response to tamoxifen.

Adjuvant treatment of postmenopausal women with hormone receptor
positive early
invasive breast cancer.

Adjuvant treatment of early breast cancer in hormone receptor positive
postmenopausal women who have received 2 to 3 years of adjuvant
tamoxifen.
4.2
Posology and method of administration
Adults including the elderly:
One 1 mg tablet to be taken orally once a day
Children:
Not recommended for use in children (see sections 5.1 and 5.2)
Renal Impairment:
No dose
change
is
recommended
in
patients
with
mild
or
moderate renal impairment
Hepatic Impairment:
No dose change is recommended in patients with mild hepatic
disease.
For early disease, the recommended duration of treatment should be 5
years.
4.3
Contraindications
Arimidex is contraindicated in:

Pregnant or breastfeeding women.

Patients with known hypersensitivity to anastrozole or to any of the
excipients listed
in section 6.1.
4.4
Special warnings and precautions for use
General
Arimidex should not be used in premenopausal women. The menopause
should be defined
biochemically (luteinizing-hormone [LH], follicle stimulating hormone
[FSH], and/or estradiol
levels) in any patient where there is doubt about menopausal status.
There are no data to
support the use of Arimidex with LHRH analogues.
Co-administration of tamoxifen or estrogen-cont