AREMED 1 FILM-COATED TABLET 1MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

ANASTROZOLE

Available from:

GOLDPLUS UNIVERSAL PTE LTD

ATC code:

L02BG03

Dosage:

1.00mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

ANASTROZOLE 1.00mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

REMEDICA LTD

Authorization status:

ACTIVE

Authorization date:

2011-08-18

Patient Information leaflet

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PATIENT INFORMATION LEAFLET
AREMED
PRODUCT NAME
Aremed 1 film coated tablets 1mg
NAME AND STRENGTH OF ACTIVE SUBSTANCE
Each film-coated tablet contains 1 mg anastozole.
PRODUCT DESCRIPTION
White, round, film-coated tablets with diameter of 6,6 mm
approximately.
WHAT IS THE MEDICINE 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.
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’.
HOW MUCH AND HOW OFTEN SHOULD YOU USE THIS MEDICINE?
Always take this medicine exactly as your doctor has told you. Check
with your doctor
or pharmacist if you are not sure.

the recommended dose is one tablet once a day.

try to take your tablet at the same time each day.

swallow the tablet whole with a drink of water.

it does not matter if you take Aremed before, with or after food.
Keep taking Aremed for as long as your doctor or pharmacist tells you
to. It is a long-
term treatment and you may need to take it for several years. Check
with your doctor
or pharmacist if you are not sure.
USE IN CHILDREN AND ADOLESCENTS
Anastrozole should not be given to children and adolescents.
WHAT TO DO WHEN YOU HAVE TAKEN MORE THAN THE RECOMMENDED DOSAGE?
If you take more Aremed than you should, talk to a doctor straight
away.
WHAT SHOULD YOU DO IF YOU MISS A DOSE?
If you forget to take a dose, just take your next dose as normal.
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Do not take a double dose (two doses at the same time) to make up for
a forgotten dose.
WHEN YOU SHOULD NOT TAKE THIS MEDICINE?
Do not take Aremed

if you are allergic to anastrozole or any of the other ingredient of
this medicine.

if you are pregnant or breast-feeding.

if you still have menstrual periods and have not gone through

Summary of Product characteristics

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PACKAGE INSERT
AREMED
PRODUCT NAME
Aremed 1 film-coated tablets 1mg
NAME AND STRENGHT OF ACTIVE SUBSTANCE
Each film-coated tablet contains 1 mg anastrozole.
Excipient(s) with known effect
This product contains 65 mg lactose.
PRODUCT DESCRIPTION
Film-coated tablet.
White, round, film-coated tablets with a diameter of 6,6 mm
approximately.
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: Endocrine therapy; Hormone antagonists and
related
agents, Aromatase inhibitors, 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 estrone through the aromatase enzyme complex in
peripheral
tissues. Estrone 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 adrenocorticotrophic
hormone (ACTH)
challenge testing. Corticoid supplements are therefore not needed.
PHARMACOKINETIC PROPERTIES
Absorption
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Absorption of anastrozole is rapid and maximum plasma concentrations
typically occur
within two hours of dosing (under fasted conditions). Food slightly
decreases the rate
but not the extent of absorption. The small change in the rate of
absorption is not
expected
to
result
in
a
clinically
significant
effect
on
the
steady-state
plasma
concentrations during once daily dosing of anastrozole tablets.
Approximately 90 to
95% of plasma anastrozole steady-state concentrations are attained
after 7 d