Exemestane 25mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Exemestane

Available from:

Beacon Pharmaceuticals 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: 5060061160889

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 the 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
Posology
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).
Paediatric population
Not recommended for use in children and adolescents
4.3
CONTRAINDICATIONS
Exemestane tablets are contraindicated in patients with a known
hypersensitivity
to the active substance or to any of the excipients, in pre-menopausal
women and
in pregnant or lactating women.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Exemestane should not be administered to women with pre-menopausal
endocrine status. Therefore, whenever clinically appropriate, t