Aromasin 25 mg coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Exemestane

Available from:

PCO Manufacturing Ltd.

ATC code:

L02BG; L02BG06

INN (International Name):

Exemestane

Dosage:

25 milligram(s)

Pharmaceutical form:

Coated tablet

Prescription type:

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

Therapeutic area:

Aromatase inhibitors; exemestane

Authorization status:

Authorised

Authorization date:

2009-08-14

Patient Information leaflet

_ _
_ _
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 PR

Summary of Product characteristics

Health Products Regulatory Authority
07 June 2022
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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, Lithuania and Bulgaria:_
Round, biconvex, off-white coated tablets 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
Tablet core:
Silica, colloidal hydrated
Crospovidone
Hypromellose
Magnesium stearate
Mannitol
Microcrystalline cellulose
Sodium starch glycolate (type A)
Polysorbate
Sugar-coating:
Hypromellose
Polyvinyl alcohol
Simeticone
Macrogol
Sucrose
Magnesium carbonate, light
Titanium dioxide (E171)
Methyl Parahydroxybenzoate (E218)
Cetyl esters wax
Talc
Carnauba wax
Printing Ink:
Ethyl alcohol
Shellac
Iron oxides (E172)
Health Products Regulatory Authority
07 June 2022
CRN00CZ0G
Page 2 of 2
Titanium oxide (E171)
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 package of the product on the market in
the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30°C.
Store in the original package.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister strips of 15 tablets in an outer carton.
Pack size: 30 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/236/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 14
th
August 2009
10 DATE OF REVISION OF THE TEXT
June 2022