Exemestane 25mg tablets

Země: Velká Británie

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivní složka:

Exemestane

Dostupné s:

Viatris UK Healthcare Ltd

ATC kód:

L02BG06

INN (Mezinárodní Name):

Exemestane

Dávkování:

25mg

Léková forma:

Oral tablet

Podání:

Oral

Třída:

No Controlled Drug Status

Druh předpisu:

Valid as a prescribable product

Přehled produktů:

BNF: 08030401; GTIN: 5016695004372

Informace pro uživatele

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Myriad Pro
9 pt
9 pt
Exemestane_25mg_30
Leaflet
1575315
803254
1575315
PL 04569/1276
Remedica Ltd
(Limassol - CY)
P18-0696/09E
1344
N/A
101168520/0170
2
United Kingdom
N/A
N/A
28 Jul 18
01:15
1
157 x 322 mm
Black
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N/A
v3/Jul 2017
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EXEMESTANE 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 _Exemestane 25 mg film-coated tablets_ are
and what they are used for
2.
What you need to know before you take
_Exemestane 25 mg film-coated tablets_
3.
How to take _Exemestane 25 mg film-coated _
_tablets_
4.
Possible side effects
5.
How to store _Exemestane 25 mg film-coated _
_tablets_
6.
Contents of the pack and other information
1. WHAT EXEMESTANE 25 MG FILM-COATED
TABLETS ARE AND WHAT IT IS USED FOR
Your medicine is called _Exemestane 25 mg _
_film-coated tablets. Exemestane 25 mg film-coated _
_tablets_ belongs to a group of medicines known as
aromatase inhibitors. These drugs interfere with
an enzyme called aromatase, which is needed
to make the female sex hormones, oestrogens,
especially in postmenopausal women. Reduct

Charakteristika produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Exemestane 25mg 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
_Adults and elderly patients _
_The recommended dose of exemestane is one 25 mg tablet to be taken
orally once a _
_day, 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.
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.
Method of administration
For oral use.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipient
listed in section 6.1. Pre-
menopausal women and in pregnant or breast-feeding 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, the
post-menopausal status should
be ascertained by assessment