Aremed 1mg Film-coated Tablet

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

ANASTROZOLE

Boleh didapati daripada:

EUCOGEN SDN BHD

INN (Nama Antarabangsa):

ANASTROZOLE

Unit dalam pakej:

14 X 2tablet Tablets

Dikeluarkan oleh:

REMEDICA LTD

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
AREMED 1 MG FILM-COATED TABLETS
_®_
_ _
Anastrozole (1 mg)
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WHAT IS IN THIS LEAFLET
1. What Aremed is used for
2. How Aremed works
3. Before you use Aremed
4. How to use Aremed
5. While you are using it
6. Side effects
7. Storage and Disposal of Aremed
8. Product Description
9. Manufacturer and. Product
Registration Holder
10. Date of revision
WHAT AREMED IS USED FOR
Aremed
contains
a
substance
called
anastrozole. This belongs to a group of
medicines called ‘aromatase inhibitors’.
Aremed is used to treat breast cancer in
women
who
have
gone
through
the
menopause.
HOW AREMED WORKS
Aremed
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’.
BEFORE YOU USE AREMED
_- When you must not use it _
_ _
Do not take this medicine if:
• you are a premenopausal women.
•
you
are
a
pregnant
or
lactating
women.
•
you
are
having
severe
renal
impairment
(creatinine
clearance
less
than 20 ml/min).
• you are having moderate or severe
hepatic disease.
• you have known hypersensitivity to
anastrozole or to any of the excipients.
•
you
are
on
oestrogen-containing
therapies should not be co-administered
with Aremed as they
would
negate
its
pharmacological
action.
Aremed
is
also
contra-indicated
in
patients receiving concurrent tamoxifen
therapy.
Do not take Aremed if any of the above
apply to you. If you are not sure, talk to
your doctor or pharmacist before taking
Aremed.
_- Before you start to use it _
_ _
Talk
to
your
doctor
or
pharmacist
before taking Aremed if:
• you still have menstrual periods and
have not gone through the menopause.
•
you
are
taking
a
medicine
that
contains
tamoxifen
or
medicines
that
contain estrogen (see the section called
‘Taking other medicines’).
• you have ever had a condition that
affects
the
strength
of
your
bones
(osteoporosis).
• you have problems with your live

Ciri produk

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PACKAGE INSERT
1.
PRODUCT NAME
Aremed 1mg film-coated tablet.
2.
NAME AND STRENGTH OF ACTIVE INGREDIENT
Each film-coated tablet contains 1 mg anastrozole.
Excipient(s) with known effect
This product contains 65 mg lactose.
3.
PRODUCT DESCRIPTION
Film-coated tablet.
White, round, film-coated tablets with a diameter of 6,6 mm
approximately
4.
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMICS
Pharmacotherapeutic group: Endocrine therapy; Hormone antagonists and
related
agents, ATC code: L02BG03
Mechanism of action and pharmacodynamics effects
Aremed
is
a
potent
and
highly
selective
non-steroidal
aromatase
inhibitor.
In
postmenopausal women, estradiol is produced primarily from the
conversion of
androstenedione to esterone through the aromatase enzyme complex in
peripheral
tissues. Esterone is subsequently converted to estradiol. Reducing
circulating estradiol
levels has been shown to produce a beneficial effect in women with
breast cancer. In
postmenopausal women, anastrozole at a daily dose of 1 mg produced
estradiol
suppression of greater than 80% using a highly sensitive assay.
Anastrozole does not possess any progestogenic, androgenic or
oestrogenic activity.
Daily doses of anastrozole up to 10 mg do not have any effect on
cortisol or aldosterone
secretion, measured before or after standard ACTH challenge testing.
Corticoid
supplements are therefore not needed.
Clinical efficacy and safety
_ _
_Advanced breast cancer _
_First-line therapy in postmenopausal women with advanced breast
cancer _
Two double-blind, controlled clinical studies of similar design (Study
1033IL/0030 and
Study 1033IL/0027) were conducted to assess the efficacy of
anastrozole compared
with tamoxifen as first-line therapy for hormone receptor-positive or
hormone receptor-
unknown locally advanced or metastatic breast cancer in postmenopausal
women. A
total of 1,021 patients were randomised to receive 1 mg of anastrozole
once daily or 20
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of
10
mg of tamoxifen once daily. The primar