Exemestane Actavis 25 mg film-coated tablets

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Exemestane

थमां उपलब्ध:

Actavis Group PTC ehf

ए.टी.सी कोड:

L02BG; L02BG06

INN (इंटरनेशनल नाम):

Exemestane

डोज़:

25 milligram(s)

फार्मास्यूटिकल फॉर्म:

Film-coated tablet

प्रिस्क्रिप्शन प्रकार:

Product subject to prescription which may not be renewed (A)

चिकित्सीय क्षेत्र:

Aromatase inhibitors; exemestane

प्राधिकरण का दर्जा:

Marketed

प्राधिकरण की तारीख:

2010-10-08

सूचना पत्रक

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
EXEMESTANE ACTAVIS 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 Actavis is and what it is used for
2.
What you need to know before you take Exemestane Actavis
3.
How to take Exemestane Actavis
4.
Possible side effects
5.
How to store Exemestane Actavis
6.
Contents of the pack and other information
1.
WHAT EXEMESTANE ACTAVIS IS AND WHAT IT IS USED FOR
Exemestane Actavis 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 Actavis 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 Actavis 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 ACTAVIS
DO NOT TAKE EXEMESTANE ACTAVIS
-
if you are or have previously been allergic to exemestane (the active
ingredient in Exemestane
Actavis) 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
pe

उत्पाद विशेषताएं

Health Products Regulatory Authority
19 June 2020
CRN009MR7
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Exemestane Actavis 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 25 mg film-coated tablets are white, round, lenticular,
with uniform appearance and intact edges.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Exemestane Actavis 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 Actavis 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 Actavis is one 25 mg tablet to be
taken once daily, preferably after a meal.
In patients with early breast cancer, treatment with Exemestane
Actavis should continue until completion of five years of
combined sequential adjuvant hormonal therapy (tamoxifen followed by
Exemestane Actavis), or earlier if tumour relapse
occurs.
In patients with advanced breast cancer, treatment with Exemestane
Actavis 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 Actavis 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 w