Livial 2.5 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tibolone

Available from:

PCO Manufacturing Ltd.

ATC code:

G03CX; G03CX01

INN (International Name):

Tibolone

Dosage:

2.5 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

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

Therapeutic area:

Other estrogens; tibolone

Authorization status:

Authorised

Authorization date:

2001-09-07

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LIVIAL
® 2.5 MG TABLETS
tibolone
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 risks which need to be considered
when deciding whether to
start taking it, or whether to carry on ta

Summary of Product characteristics

Health Products Regulatory Authority
09 June 2022
CRN00CZ44
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Livial 2.5 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg of tibolone.
Excipients: also includes lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
_Product imported from Greece, Spain, the United Kingdom and Czech
Republic:_
White, circular, flat tablet with bevelled edges, coded ‘MK’ above
‘2’ on one side and ‘Organon’ and a star on the reverse side.
4 CLINICAL PARTICULARS
As per PA23198/021/001
5 PHARMACOLOGICAL PROPERTIES
As per PA23198/021/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Potato starch
Magnesium stearate
Ascorbyl palmitate
Lactose monohydrate
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 25°C.
Store in the original package in order to protect from light and
moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Blisters of 28 or 30 tablets in a carton. Not all pack sizes may be
marketed.
Health Products Regulatory Authority
09 June 2022
CRN00CZ44
Page 2 of 2
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 MARKETING AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 MARKETING AUTHORISATION NUMBER
PPA0465/081/001
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/081/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 07 September 2001
Date of last renewal: 07 September 2006
Last updated: October 2016
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