Exedral 25, 25 mg film-coated tablets

Valsts: Malta

Valoda: angļu

Klimata pārmaiņas: Medicines Authority

Aktīvā sastāvdaļa:

EXEMESTANE

Pieejams no:

Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus

ATĶ kods:

L02BG06

SNN (starptautisko nepatentēto nosaukumu):

EXEMESTANE 25 mg

Zāļu forma:

FILM-COATED TABLET

Kompozīcija:

EXEMESTANE 25 mg

Receptes veids:

POM

Ārstniecības joma:

ENDOCRINE THERAPY

Autorizācija statuss:

Authorised

Autorizācija datums:

2014-09-23

Lietošanas instrukcija

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EXEDRAL_ _25, 25 MG FILM-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 Exedral 25 is and what it is used for
2.
What you need to know before you take Exedral 25
3.
How to take Exedral 25
4.
Possible side effects
5.
How to store Exedral 25
6.
Contents of the pack and other information
1.
WHAT EXEDRAL 25 IS AND WHAT IT IS USED FOR
Your medicine is called Exedral 25. Exedral 25 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.
Exedral 25 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.
Exedral
25
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 EXEDRAL 25
DO NOT TAKE EXEDRAL 25:
•
if you are or have previously been allergic to exemestane (the active
ingredient in
Exedral 25) or any of the other ingredients of this medicine (listed
in section 6).
mt-pl-exedral-25mg-fc-tabs- a4
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•
if you have
NOT
already been through ‘the menopause’, i.e. you are still

Produkta apraksts

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SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Exedral 25, 25 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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, round, biconvex film-coated tablets.
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 daily,
preferably 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.
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No dose adjustments are required for patients with hepatic or renal
insufficiency (see
section 5.2).
_Paediatric population _
Not recommended for use in children.
Method of administration
Oral use.
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 breastfeeding women.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Exemestane should not be administered to women with pre-menopausal
endocrine
status. Therefore, whenever clin