Livial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Tibolone

Available from:

Merck Sharp & Dohme Australia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

LIVIAL
®
 TABLETS

_Tibolone 2.5 mg_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Livial. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Livial against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS INFORMATION WITH THE
PACK.
You may wish to read it again.
WHAT LIVIAL IS USED FOR
Livial tablets contain the active
ingredient tibolone, which is a
synthetic steroid medicine used for
hormone replacement therapy (HRT).
It mimics the activity of the female
sex hormones in the body.
Livial contains tibolone, a substance
that has favourable effects on
different tissues in the body, such as
brain, vagina and bone. Livial is used
in postmenopausal women 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
oestrogen 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.
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.
Livial is not a contraceptive.
Livial has no effect on alertness and
concentration as far as is known.
A doctor's prescription is required to
obtain this medicine.
BEFORE YOU USE LIVIAL
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE LIVIAL IF:
•
you are pregnant or think you
may be pregnant
•
you are breastfeeding
•
you have or h

Summary of Product characteristics

RA 1850 CCDS 1850 12(12.0) 
PI ref.: A120612 v2  

Page 1 of 12 

PRODUCT INFORMATION 

LIVIAL


NAME OF THE MEDICINE 

LIVIAL (tibolone) 2.5 mg tablets 

TIBOLONE 

_Molecular formula C_
_21_
_H_
_28_
_O_
_2 _
_Molecular mass 312.45 _
_[CAS No. 5630-53-5] _
_ _
CHEMICAL NAME: 
(7
α
, 17
α
) - 17 - hydroxy-7-methyl-19-norpregn-5 (10)-en-20-yn-3-one. 

OTHER NAME: 
17
α
-ethynyl-17-hydroxy-7
α
-methyl-5(10)-estren-3-one. 

PHARMACEUTICAL FORM 
Tablets, each containing 2.5 mg of the steroid tibolone._ _

DESCRIPTION 

Tibolone exists as white to almost white
crystals or crystalline powder. Tibolone is related to 
and derived
from naturally occurring steroids. It is optically pure and
has the D-configuration. 
It is practically insoluble in water, aqueous acid
or alkali at 20°C. 

LIST OF EXCIPIENTS 
LIVIAL tablets 2.5 mg contain potato
starch, magnesium stearate, ascorbyl palmitate and 
lactose. 

PHARMACOLOGY 

PHARMACODYNAMIC PROPERTIES 
ATC code: G03CX01 
After oral administration tibolone is rapidly metabolised into
three compounds which 
contribute to the pharmacological effects of LIVIAL. Two of these
metabolites (the 3
αOH and 
3
βOH metabolite) have predominantly oestrogenic activity, a third
metabolite (∆
4
-isomer of 
tibolone) and the parent compound have
predominantly progestagenic and androgenic 
RA 1850 CCDS 1850 12(12.0) 
PI ref.: A120612 v2  

Page 2 of 12 

activities. 

LIVIAL substitutes for the loss of oestrogen production in
postmenopausal women and 
alleviates menopausal symptoms. LIVIAL prevents bone
loss following menopause or 
ovariectomy. 

LIVIAL has various tissue-specific effects. It has oestrogenic effects on
the vagina, on bone 
and on the thermoregulatory centres in the brain
(hot flushes). Based on in vitro data, LIVIAL 
inhibits the sulphatase enzyme in cultured