Exemestane Teva 25 mg film-coated tablets

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Exemestane

Dostupné s:

Teva B.V.

ATC kód:

L02BG; L02BG06

INN (Mezinárodní Name):

Exemestane

Léková forma:

Film-coated tablet

Terapeutické oblasti:

Aromatase inhibitors; exemestane

Stav Autorizace:

Marketed

Datum autorizace:

2010-10-08

Informace pro uživatele

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
EXEMESTANE TEVA 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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Exemestane Teva is and what it is used for
2.
What you need to know before you take Exemestane Teva
3.
How to take Exemestane Teva
4.
Possible side effects
5.
How to store Exemestane Teva
6.
Contents of the pack and other information
1.
WHAT EXEMESTANE TEVA IS AND WHAT IT IS USED FOR
Exemestane Teva 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.
Exemestane Teva 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.
Exemestane Teva 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 EXEMESTANE TEVA
DO NOT TAKE EXEMESTANE TEVA
-
if you are or have previously been allergic to exemestane (the active
ingredient in Exemestane
Teva) 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

Charakteristika produktu

Health Products Regulatory Authority
19 January 2023
CRN00D8FF
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Exemestane Teva 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.
Exemestane Teva 25 mg film-coated tablets are white, round,
lenticular, with uniform appearance and intact edges.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Exemestane Teva 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 Teva 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 Teva is one 25 mg tablet to be
taken once daily, preferably after a meal.
In patients with early breast cancer, treatment with Exemestane Teva
should continue until completion of five years of
combined sequential adjuvant hormonal therapy (tamoxifen followed by
Exemestane Teva), or earlier if tumour relapse occurs.
In patients with advanced breast cancer, treatment with Exemestane
Teva 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_
Exemestane Teva is 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
Exemestane should not be administered to women with pre-meno