Aromasin 25mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Exemestane

Available from:

Pfizer Ltd

ATC code:

L02BG06

INN (International Name):

Exemestane

Dosage:

25mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08030401; GTIN: 5012882005870 5012882005887

Patient Information leaflet

Page 1 of 5
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.
WHAT 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 pregnant or breast-feeding.
WARNINGS AND PRECAU

Summary of Product characteristics

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.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Aromasin should not be administered to women with pre-menopausal
endocrine
status. Therefore, whenever clinically a