Xyvion

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

Tibolone

Disponible desde:

Merck Sharp & Dohme Australia Pty Ltd

clase:

Medicine Registered

Información para el usuario

XYVION
®
 TABLETS

_tibolone 2.5 mg_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Xyvion. 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 Xyvion
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 XYVION IS USED
FOR
Xyvion 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.
Xyvion contains tibolone, a
substance that has favourable effects
on different tissues in the body, such
as brain, vagina and bone. Xyvion is
used in postmenopausal women at
least 12 months since their last
natural period.
Xyvion 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"). Xyvion
alleviates these symptoms after
menopause. You will only be
prescribed Xyvion 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 Xyvion to prevent
osteoporosis after menopause.
Xyvion is not a contraceptive.
Xyvion 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 XYVION
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE XYVION IF:
•
you are pregnant or think you
may be pregnant
•
you are breastfeeding
•
you have or h

Ficha técnica

RA 1850 CCDS 1850 12(12.0) 
PI ref.: D120911 v2 
Page 1 of 12 
PRODUCT INFORMATION  

XYVION


NAME OF THE MEDICINE

XYVION  (tibolone) 2.5 mg tablets 

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

OTHER NAME: 
17α-ethynyl-17-hydroxy-7α-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
0
C. 

LIST OF EXCIPIENTS 
XYVION 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 XYVION. 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 
activities. 
RA 1850 CCDS 1850 12(12.0) 
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Page 2 of 12 

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

XYVION 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, 
XYVION inhibits the sulphatase enzyme in cultured breast
cancer cells thereby reducing the 
levels�