Aromasin 25 mg coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Exemestane

Available from:

Pfizer Healthcare Ireland

ATC code:

L02BG; L02BG06

INN (International Name):

Exemestane

Dosage:

25 milligram(s)

Pharmaceutical form:

Coated tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Aromatase inhibitors; exemestane

Authorization status:

Marketed

Authorization date:

1999-11-12

Patient Information leaflet

Page 1 of 5 Pfleet
No:
2021-0068642,
2020-
0063571
PACKAGE LEAFLET: INFORMATION FOR THE USER
AROMASIN 25 MG COATED TABLETS
exemestane
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
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 Aromasin is and what it is used for
2.
What you need to know before you take Aromasin
3.
How to take Aromasin
4.
Possible side effects
5.
How to store Aromasin
6.
Contents of the pack and other information
1.
W
HAT AROMASIN IS AND WHAT IT IS USED FOR
Your medicine is called Aromasin. Aromasin 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.
Aromasin 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.
Aromasin 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 AROMASIN
DO NOT TAKE AROMASIN:

if you are or have previously been allergic to exemestane (the active
ingredient in Aromasin) 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 pregnan

Summary of Product characteristics

Health Products Regulatory Authority
10 June 2022
CRN00CJN2
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aromasin 25 mg coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: exemestane
Each coated tablet contains 25 mg exemestane.
Excipients with known effect
Each tablet contains 30.2 mg of sucrose and 0.003 mg of methyl
parahydroxybenzoate (E218).
For the full list of excipients, see section 6.1_._
3 PHARMACEUTICAL FORM
Coated tablet.
Round, biconvex, off-white coated tablet marked 7663 on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Aromasin 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.
Aromasin 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 Aromasin is one 25 mg tablet to be taken once
daily, preferably after a meal.
In patients with early breast cancer, treatment with Aromasin should
continue until completion of five years of combined
sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin),
or earlier if tumour relapse occurs.
In patients with advanced breast cancer, treatment with Aromasin
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
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.
Health Products Regulatory Authority
10 June 2022
CRN00CJN2
Page 2 of 10
4.4 SPECIAL WARNI