ARIMIDEX TABLET 1MG

Negara: Malaysia

Bahasa: Inggris

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

Bahan aktif:

ANASTROZOLE

Tersedia dari:

ASTRAZENECA SDN. BHD.

INN (Nama Internasional):

ANASTROZOLE

Unit dalam paket:

28Tablet Tablets

Diproduksi oleh:

AstraZeneca Pharmaceuticals LP

Selebaran informasi

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
ARIMIDEX
® 1MG TABLET
_ _
Anastrozole 1mg
1
WHAT IS IN THIS LEAFLET
1.
What Arimidex 1mg Tablet is
used for
2.
How Arimidex 1mg Tablet
works
3.
Before you use Arimidex 1mg
Tablet
4.
How to use Arimidex 1mg
Tablet
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Arimidex 1mg Tablet
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT ARIMIDEX 1MG TABLET IS
USED FOR
Arimidex 1mg Tablet is used to
treat breast cancer in post-
menopausal women.
HOW ARIMIDEX 1MG TABLET WORKS
Arimidex 1mg Tablet belongs to a
group of medicines called
aromatase inhibitors. This means
that it interferes with some of the
actions of aromatase, an enzyme
within the body which effects the
level of certain female sex
hormones such as oestrogens.
BEFORE YOU USE ARIMIDEX 1MG
TABLET_ _
-
_When you must not use it _
Do not take Arimidex 1mg Tablet
•
if you are pregnant or breast
feeding your baby.
•
if you are allergic to
anastrozole or any of the other
ingredients of Arimidex 1mg
Tablet listed at the end of this
leaflet
-
_Before you start to use it _
Take special care with Arimidex
1mg Tablet
•
if you are suffering from any
disorder or disease which
affects your heart, liver or
kidneys. Please inform your
doctor.
Arimidex 1mg Tablet is not
recommended if you are pre-
menopausal, and it should not be
given to children.
_ _
-
_Taking other medicines _
Please inform your doctor:
•
if you take tamoxifen or
medicine containing oestrogen
(female sex hormone). It may
lessen the effect of Arimidex
1mg Tablet.
•
if you are taking or have
recently taken any other
medicines, even those not
prescribed.
Please note that these statements
may also apply to medicine used
some time ago.
HOW TO USE ARIMIDEX 1MG TABLET
-
_How much to use and when to use _
_it _
•
Follow your doctor's
instructions about when and
how to take your tablets.
•
The usual dose is one tablet
taken daily.
•
Swallow the tablet whole with
a dri

Karakteristik produk

PACKAGE LEAFLET TEXT
Issued to the Medical Profession Only
ARIMIDEX
®
Trade Mark
PHARMACEUTICAL FORM
ARIMIDEX
is
presented
as
white,
biconvex,
film-coated
tablets
containing
1
mg
of
anastrozole. A logo is impressed on one side and a tablet strength
marking on the other side.
THERAPEUTIC INDICATION
Adjuvant treatment of postmenopausal women with hormone receptor
positive early breast
cancer.
Treatment of advanced breast cancer in post-menopausal women. Efficacy
has not been
demonstrated in oestrogen receptor negative patients unless they had a
previous positive
clinical response to tamoxifen.
DOSAGE AND METHOD OF ADMINISTRATION
Adults including the elderly :
One 1mg tablet to be taken orally once a day.
Children
:
Not
recommended
for
use
in
children
(see
Pharmacodynamic
Properties
and
Pharmacokinetic
Properties).
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.
CONTRAINDICATIONS
ARIMIDEX is contraindicated in:
-
pregnant or lactating women.
-
patients with severe renal impairment (creatinine clearance less than
20 ml/min).
-
patients with moderate or severe hepatic disease.
-
patients with known hypersensitivity to anastrozole or to any of the
excipients as
referenced in the list of excipients.
Oestrogen-containing therapies should not be co-administered with
ARIMIDEX as they
would negate its pharmacological action.
Concurrent tamoxifen therapy (see Interaction With Other Medicinal
Products and Other
Forms of Interaction).
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
ARIMIDEX is not recommended for use in children or in premenopausal
women as safety
and efficacy have not been established in this group of patients (see
Pharmacodynamic
Properties and Pharmacokinetic Properties).
The menopause should be defined biochemically in any patient where
there is doubt about
hormonal status.
There are no da