Livial 2.5mg Tablets

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Tibolone

Disponible desde:

Imbat Limited

Código ATC:

G03CX; G03CX01

Designación común internacional (DCI):

Tibolone

Dosis:

2.5 milligram(s)

formulario farmacéutico:

Tablet

tipo de receta:

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

Área terapéutica:

Other estrogens; tibolone

Estado de Autorización:

Authorised

Fecha de autorización:

2009-06-12

Información para el usuario

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
LIVIAL
® 2.5MG TABLETS
(tibolone)
Your medicine is available using the above name but will be
referred to as Livial throughout this leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE

Keep this leaflet. You may need to read it again.

If you have any further questions or need more advice,
ask your doctor, family planning nurse or pharmacist.

This medicine has been prescribed for you. Do not pass it
on to others. It may harm them.

If any of the side effects gets severe, or if you notice any
not listed in this leaflet, please tell your doctor or
pharmacist.
IN THIS LEAFLET:
1.
What Livial is and what it is used for
2.
What you need to know before you use Livial
3.
How to take Livial
4.
Possible side effects
5.
How to store Livial
6.
Contents of the pack and other information
1.
WHAT LIVIAL IS AND WHAT IT IS USED FOR
Livial is a Hormone Replacement Therapy (HRT). Livial contains
tibolone, and is used in postmenopausal women with at least
12 months since their last natural period.
Livial is used for:
RELIEF OF SYMPTOMS OCCURRING AFTER MENOPAUSE
During the menopause, the amount of estrogen, produced by a
woman’s body, drops. This can cause symptoms such as hot
face, neck and chest (“hot flushes”). Livial alleviates these
symptoms after menopause. You will only be prescribed Livial
if your symptoms seriously hinder your daily life.
If indicated:
PREVENTION OF OSTEOPOROSIS
After the menopause some women may develop fragile bones
(osteoporosis). You should discuss all available options with
your doctor.
If you are at an increased risk of fractures due to osteoporosis,
and other medicines are not suitable for you, you can take
Livial to prevent osteoporosis after menopause.
In section 6 “Contents of the pack and other information” you
can find more information about Livial and what it is used for.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE
LIVIAL
MEDICAL HISTORY AND REGULAR CHECK-UPS
The use of HRT or Livial carries

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Livial 2.5mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5mg of tibolone.
Excipients: lactose
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
_Product imported from the UK and Greece:_
White, round, flat tablets with bevelled edges, coded 'MK'
above '2'
on one side and 'Organon'
and a star on the reverse
side.
4 CLINICAL PARTICULARS
As per PA0964/006/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0964/006/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Potato starch
Magnesium stearate
Ascorbyl palmitate
Lactose
6.2 INCOMPATIBILITIES
Not applicable
6.3 SHELF LIFE
The shelf life expiry date of this product is the date shown on the
blister strips and outer carton of the product as
marked in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25ºC. Keep the blister in the outer carton in
order to protect from light and moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Cardboard outer containing blister strips.
Pack size: 28 or 30 tablets
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6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM
SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements
7 PARALLEL PRODUCT AUTHORISATION HOLDER