Aromasin 25 mg coated tablets

Country: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

Exemestane

থেকে পাওয়া:

Originalis B.V.

এটিসি কোড:

L02BG06

INN (International Name):

Exemestane

ডোজ:

25 milligram(s)

ফার্মাসিউটিকাল ফর্ম:

Coated tablet

Therapeutic area:

exemestane

অনুমোদন তারিখ:

2019-07-19

তথ্য লিফলেট

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 PRECAUTIONS
•
Talk to your doctor, pharmacist or nurse before taking Aromasin.
•
Before treatment with Aromasin, your doctor may want to take
blood samples to make sure you have reached the menopause.
•
Routine checking of your vitamin D level will also be made before
treatment, as your level may be very low in the early stages of
breast cancer. You will be given vitamin D supplement if your
levels are below normal.
•
Before taking Aromasin, tell your doctor if you have problems
with your liver or kidneys.
•
Tell your doctor if you have a history or are suffering from any
condition which affects the strength of your bones. Your

পণ্য বৈশিষ্ট্য

Health Products Regulatory Authority
22 July 2019
CRN008VL3
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 of exemestane.
Excipients with known effect
Sucrose
Methyl parahydroxybenzoate (E218)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated tablet
_Product imported from Lithuania_
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 (E551)
Crospovidone
Hypromellose (E464)
Magnesium stearate (E572)
Mannitol (E421)
Microcrystalline cellulose (E460)
Sodium starch glycolate (type A)
Polysorbate 80 (E433)
Polyvinyl alcohol
Simeticone
Macrogol 6000
Sucrose
Magnesium carbonate, light (E504)
Methyl Parahydroxybenzoate (E218)
Cetyl esters wax
Talc
Carnauba wax
Ethyl alcohol
Shellac
Titanium Dioxide (E171)
Black Iron Oxide (E172)
Health Products Regulatory Authority
22 July 2019
CRN008VL3
Page 2 of 2
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the blister and outer package of the product as marketed
in the country of origin
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special storage
conditions.
6.5 NATURE AND CONTENTS OF CONTAINER
Blisters of 30 coated tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Originalis B.V.
Joop Geesinkweg 901
1114 AB Amsterdam-Duivendrecht
Netherlands
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA2306/015/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 19
th
July 2019
10 DATE OF REVISION OF THE TEXT