Exemestane 25mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Exemestane

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

L02BG; L02BG06

INN (International Name):

Exemestane

Dosage:

25 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Aromatase inhibitors; exemestane

Authorization status:

Marketed

Authorization date:

2010-06-25

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
EXEMESTANE 25 MG FILM-COATED TABLETS
Exemestane
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINTS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist .
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs
of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist . This
includes any possible side effects not listed in
this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Exemestane tablet is and what it is used for
2.
What you need to know before you take Exemestane tablets
3.
How to take Exemestane tablets
4.
Possible side effects
5.
How to store Exemestane tablets
6.
Contents of the pack and other information
1.
WHAT EXEMESTANE TABLET IS AND WHAT IT IS USED FOR
Exemestane belongs to a group of medicines known as aromatase
inhibitors. These medicines interfere with a
substance
called
aromatase,
which
is
needed
to
make
the
female
sex
hormones,
oestrogens,
especially
in
postmenopausal women. Reduction in oestrogen levels in the body is a
way of treating hormone dependent breast
cancer.
Exemestane is used to treat hormone dependent early breast cancer in
postmenopausal women after they have
completed 2-3 years of treatment with the medicine tamoxifen.
Exemestane is also used to treat hormone dependent advanced breast
cancer in postmenopausal women when a
different hormonal drug treatment has not worked well enough.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EXEMESTANE TABLETS
DO NOT TAKE EXEMESTANE TABLETS
−
if you are or have previously been allergic to exemestane or any of
the other ingredients of this medicine
(listed in section 6).
−
if you have not already been through ‘the menopause’, i.e. you are
still having your monthly period,
−
if you are pregnant, likely to be pregnant or breastfeeding.
WARNINGS

Summary of Product characteristics

Health Products Regulatory Authority
27 April 2023
CRN00D6XF
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Exemestane 25mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 25 mg exemestane
Excipients with known effect:
Each film-coated tablet contains 90.40 mg mannitol
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White to off-white, round, biconvex film coated tablets debossed with
‘E25’ on one side and plain on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Exemestane is indicated for the adjuvant treatment of postmenopausal
women with oestrogen receptor positive invasive early
breast cancer (EBC), following 2 – 3 years of initial adjuvant
tamoxifen therapy.
Exemestane is indicated for the treatment of advanced breast cancer in
women with natural or induced postmenopausal status
whose disease has progressed following anti-oestrogen therapy.
Efficacy has not been demonstrated in patients with
oestrogen receptor negative status.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adult and elderly patients
The recommended dose of Exemestane is one 25 mg tablet to be taken
once a daily, preferablyafter a meal.
In patients with early breast cancer, treatment with Exemestane should
continue until completion of five years of combined
sequential adjuvant hormonal therapy (tamoxifen followed by
Exemestane), or earlier if tumour relapse occurs.
In patients with advanced breast cancer, treatment with Exemestane
should continue until tumour progression is evident.
No dose adjustments are required for patients with hepatic or renal
insufficiency (see section 5.2).
Paediatric population
Not recommended for use in children.
4.3 CONTRAINDICATIONS
Exemestane tablets are contraindicated in patients with a known
hypersensitivity to the active substance or to any of the
excipients listed in section 6.1, in pre-menopausal women and in
pregnant or lactating women.
4.4 SPECIAL WARNINGS AND