Exemestane 25 mg Film-coated Tablets

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

Exemestane

Доступна з:

LTT Pharma Limited

Код атс:

L02BG; L02BG06

ІПН (Міжнародна Ім'я):

Exemestane

Дозування:

25 milligram(s)

Фармацевтична форма:

Film-coated tablet

Тип рецепту:

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

Терапевтична области:

Aromatase inhibitors; exemestane

Статус Авторизація:

Authorised

Дата Авторизація:

2016-10-07

інформаційний буклет

OTHER MEDICINES AND EXEMESTANE TABLETS
Please tell your doctor if you are taking or have recently taken or
might take
any other medicines, including medicines obtained without
prescription.
Exemestane tablets should not be given at the same time as hormone
replacement therapy (HRT).
Tell your doctor if you are taking any of the following medicines:
*
rifampicin (an antibiotic),
*
drugs used to treat epilepsy (carbamazepine or phenytoin),
*
the herbal remedy St Johns Wort, (Hypericum perforatum), or
preparations
containing it.
EXEMESTANE TABLETS WITH FOOD, DRINK AND ALCOHOL
Exemestane Tablets should be taken after meal at approximately the
same
time each day.
PREGNANCY, BREAST-FEEDING AND FERTILITY
Do not take Exemestane tablets if you are pregnant or breastfeeding.
If you
are pregnant or think you might be, tell your doctor.
Discuss contraception with your doctor if there is any possibility
that you may
become pregnant.
Ask your doctor or pharmacist for advice before taking any medicine.
DRIVING AND USING MACHINES
If you feel drowsy, dizzy or weak whilst taking Exemestane tablets,
you
should not attempt to drive or operate machinery.
HOW TO TAKE EXEMESTANE TABLETS
Adults and the elderly
Always take this medicine exactly as your doctor has told you.
Check with your doctor if you are not sure.
Exemestane tablets should be taken by mouth after meal at
approximately
the same time each day. Your doctor will tell you how to take
Exemestane
and for how long.
The recommended dose is one 25 mg tablet daily.
If you need to go to the hospital whilst taking Exemestane tablets,
let the
medical staff know what medication you are taking.
USE IN CHILDREN
Exemestane tablets is not suitable for use in children.
IF YOU TAKE MORE EXEMESTANE TABLETS THAN YOU SHOULD
If too many tablets are taken by accident, contact your doctor at once
or go
straight to the nearest hospital casualty department. Show them the
pack of
Exemestane tablets.
IF YOU FORGET TO TAKE EXEMESTANE TABLETS
Do not take a double dose to make up for a forgotten tablet

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Exemestane 25 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 25 mg exemestane
Excipients with known effect:
Each film-coated tablet contains mannitol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablets.
Product imported from the United Kingdom.
White to off white, round, biconvex film-coated Tablet with ‘E25’
on one side and plain on the other_._
4 CLINICAL PARTICULARS
As per PA1390/026/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1390/026/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
TABLET CORE
Mannitol
Cellulose Microcrystalline
Crospovidone
Sodium Starch Glycolate (Type A)
Hypromellose E5
Polysorbate 80
Colloidal anhydrous silica
Magnesium Stearate
TABLET COATING
Hypromellose 6cp (E464)
Titanium dioxide (E171)
Macrogol 400
6.2 INCOMPATIBILITIES
Not applicable.
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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 on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This product does not require any special storage conditions.
6.5 NATURE AND CONTENTS OF CONTAINER
Packs contain 30 Film-coated Tablets in White opaque blister packs