Aromasin 25 mg coated tablets

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Exemestane

Beschikbaar vanaf:

IMED Healthcare Ltd.

ATC-code:

L02BG; L02BG06

INN (Algemene Internationale Benaming):

Exemestane

Dosering:

25 milligram(s)

farmaceutische vorm:

Coated tablet

Prescription-type:

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

Therapeutisch gebied:

Aromatase inhibitors; exemestane

Autorisatie-status:

Authorised

Autorisatie datum:

2012-08-31

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
AROMASIN 25 MG 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 Aromasin is and what it is used for
2. What you need to know before you take Aromasin
3. How to take Aromasin
4. Possible side effects
5. How to store Aromasin
6. Contents of the pack and other information
1.
WHAT AROMASIN IS AND WHAT IT IS USED FOR
Your medicine is called Aromasin. Aromasin 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.
Aromasin 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.
Aromasin 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 AROMASIN
DO NOT TAKE AROMASIN:
•
if you are or have previously been allergic to exemestane (the
active ingredient in Aromasin) 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 to be pregnant or breast-feeding.
WARNINGS AND PRECAUTION

Productkenmerken

Health Products Regulatory Authority
02 June 2023
CRN00DKYD
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aromasin 25 mg coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains 25 mg exemestane.
Excipients with known effect:
Each tablet contains sucrose and methyl parahydroxybenzoate (E218).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated tablet.
_Product imported from Italy and Bulgaria:_
Round, biconvex, off-white coated tablet marked 7663 on one side.
4 CLINICAL PARTICULARS
As per PA0822/111/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0822/111/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Silica, colloidal hydrated
Crospovidone
Magnesium stearate
Mannitol
Microcrystalline cellulose
Sodium starch glycolate (type A)
Polysorbate
Hypromellose
Polyvinyl alcohol
Simeticone
Macrogol
Sucrose
Magnesium carbonate, light
Titanium dioxide (E171)
Methyl Parahydroxybenzoate (E218)
Cetyl esters wax
Talc
Carnauba wax
Ethyl alcohol
Shellac
Iron oxides (E172)
Health Products Regulatory Authority
02 June 2023
CRN00DKYD
Page 2 of 2
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer carton of the product on the market in
the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
_Product imported from Italy:_
This medicinal product does not require any special temperature
storage conditions.
Store in the original package.
_Product imported from Bulgaria:_
Do not store above 30°C.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister strips of 15 tablets in an over-labelled outer carton.
Pack size: 30 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd.
Unit 625 Kilshane Avenue
Northwest Business Park
Ballycoolin
Dublin 15
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1463/069/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of fir