Exemestane 25mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Exemestane

Available from:

Kent Pharma (UK) 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: 5015201009856

Patient Information leaflet

1 ACCORD LOGO
EXEMESTANE 25MG FILM-COATED TABLETS
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.
-
The full name of this medicine is Exemestane 25mg
Film-coated
Tablets but within the leaflet
it will be referred to as Exemestane tablets.
WHAT IS IN THIS LEAFLET:
1.
What Exemestane tablets are and what they are used for
2.
What you need to know before you take Exemestane tablets
3.
How to take Exemestane tablets4.
Possible side effects
5.
How to store Exemestane tablets
6.
Contents of the pack and other information
1.
WHAT EXEMESTANE TABLETS ARE AND WHAT THEY ARE USED FOR
Exemestane tablets belong to a group of medicines known as aromatase
inhibitors. These drugs
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 tablets are 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 tablets are 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 (hypersensitive) to exemestane
(the active ingredient in
Exemestane tablets) or any of the other ingredients of this medicine
(listed in section 6).
�

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Exemestane 25 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Exemestane
Each film coated tablet contains 25 mg exemestane.
For full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white, round compound cup film coated tablet, with
“25” on one
side and plain on the reverse.
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,
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
Adult and elderly patients
The recommended dose of Exemestane is one film-coated tablet (25mg) to
be
taken orally once a day, after 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).
Children and adolescents
Not recommended for use in children and adolescents
4.3
CONTRAINDICATIONS
Exemestane is contraindicated in:
-
premenopausal women.
-
pregnant or lactating women.
-
patients with hypersensitivity to the active substance or to any of
the
excipients.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Exemestane
should
not
be
administered
to
women
with
pre-menopausal
endocrine
status.
Therefore,
whenever
clinically
appropriate,
the
post-
menopausal status sho