Aromasin Tablet 25mg

Χώρα: Μαλαισία

Γλώσσα: Αγγλικά

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

Δραστική ουσία:

EXEMESTANE

Διαθέσιμο από:

PFIZER (MALAYSIA) SDN. BHD.

INN (Διεθνής Όνομα):

EXEMESTANE

Μονάδες σε πακέτο:

90Tablet Tablets; 30Tablet Tablets

Κατασκευάζεται από:

Pfizer Italia S.r.l.

Φύλλο οδηγιών χρήσης

Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
AROMASIN
®
TABLET
Exemestane (25 mg)
1
WHAT IS IN THIS LEAFLET
1.
What Aromasin is used for
2.
How Aromasin works
3.
Before you use Aromasin
4.
How to use Aromasin
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of Aromasin
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of Revision
11. Serial Number
WHAT AROMASIN IS USED FOR
Aromasin is used to treat hormone
dependent early breast cancer in post-
menopausal women after they have
completed 2-3 years of treatment with the
medicine tamoxifen.
Aromasin is indicated for the second- and
third-line treatment of advanced breast
cancer (ABC) in women with post-
menopausal status whose disease has
progressed following anti-estrogen
therapy alone or following multiple
hormonal therapies respectively.
HOW AROMASIN WORKS
Aromasin is an irreversible, steroidal
aromatase inhibitor. It interferes with the
normal estrogen production by blocking
the enzyme aromatase, which is used to
convert androgens (hormones produced
by adrenal glands) into estrogen. It
thereby helps lower estrogen production
in postmenopausal women. Estrogen
deprivation hampers the growth of
hormone dependent breast cancer.
BEFORE YOU USE AROMASIN
-
_When you must not use it_
- If you are or have previously been
allergic (hypersensitive) to exemestane
(the active ingredient in Aromasin) or
any of the other ingredients of
Aromasin. See section “Product
description” for full list of other
ingredients.
_Pregnancy and lactation_
Do not take Aromasin if you are
pregnant, trying to get pregnant or think
you may be pregnant because it may
cause harm to the fetus. In animal
reproductive studies, exemestane
demonstrated some toxic effects.
Do not take Aromasin if you are breast-
feeding. Ask your doctor or pharmacist
for advice before taking any medicine.
-
_Before you start to use it_
- Tell your doctor if you have a history
or are suffering from any condition,
which affects the strength of you

Αρχείο Π.Χ.Π.

Pfizer Confidential
CLD Title
: Exemestane
CLD Date
: 17 August 2021
Country
: Malaysia
Reference Document: CDS Version 11.0 dated 03 June 2021; USPI dated
May 2018
(Indication 1.1 only) LAB-0098-20.0
Reason for change
: PfLEET 2021-0068641 (S2): To update section 4.8 addition of
ADR’s.
Pfizer Confidential
1. TRADE NAME OF THE MEDICINAL PRODUCT
Aromasin.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sugar-coated tablet contains 25 mg exemestane.
3. PHARMACEUTICAL FORM
Coated tablets.
3.1 DESCRIPTION
Sugar-coated tablets for oral administration.
Aromasin tablets are round, biconvex, off-white to slightly greyish
sugar-coated tablets,
about 6 mm diameter printed with numbers 7663 on one side in black
ink.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Exemestane is indicated for the adjuvant treatment of post-menopausal
women with
estrogen receptor positive early breast cancer who have received two
to three years of
tamoxifen and are switched to Exemestane for completion of a total of
five consecutive
years of adjuvant hormonal therapy.
Exemestane is indicated for the second-line treatment of advanced
breast cancer (ABC)
in women with natural or induced post-menopausal status whose disease
has progressed
following anti-estrogen therapy alone.
Exemestane is also indicated for the third-line treatment in
post-menopausal woman with
ABC whose disease has progressed following multiple hormonal
therapies. Efficacy has
not been demonstrated in patients with estrogen receptor negative
status.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adult and Elderly Patients
The recommended dose of exemestane is one 25 mg tablet to be taken
once daily,
preferably after a meal.
In patient with early breast cancer, treatment with exemestane should
continue until
completion of five years of adjuvant endocrine therapy, or until local
or distant recurrence
or new contralateral breast cancer.
In patient with advanced breast cancer, treatment with exemestane
should continue until
tumor progression is evident.
Hepatic or Renal Insuffic