tibolone 2.5mg tablets
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common
questions about Tibogen. 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 Tibogen
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 leaflet with the medicine.
You may need to read it again.
What is Tibogen used
Tibogen contains tibolone, a
substance that can replace the
natural sex hormones after
The production of sex hormones by
the body decreases during and after
menopause. Women may then suffer
from complaints such as hot flushes,
night sweats, vaginal irritation,
depression and loss of sexual desire.
In addition, menopause may cause
thinning of the bones (osteoporosis).
Tibogen is used in postmenopausal
women at least 12 months since
their last natural period.
Tibogen is used for:
Relief of symptoms occurring
During 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"). Tibogen
alleviates these symptoms after
You will only be prescribed
Tibogen 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
If you are at an increased risk of
fractures due to osteoporosis and
other medicines are not suitable for
you, you can take Tibogen to
prevent osteoporosis after
Tibogen is not a contraceptive.
Tibogen has no effect on alertness
and concentration as far as is known.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you.
This medicine is available only with
a doctor’s prescription.
Before you use Tibogen
When you must not take it
Do not take Tibogen if:
you are pregnant or think you
may be pregnant. It may affect
your developing baby if you
take it during pregnancy.
you are breastfeeding
you have or have ever had
breast cancer, or if you are
suspected of having it
you have cancer which is
growth sensitive to oestrogens,
such as cancer of the womb
lining (endometrium), or if
you are suspected of having it
you have any unexplained
you have excessive thickening
of the womb lining
(endometrial hyperplasia) that
is not being treated
you have or have ever had a
blood clot in a vein
(thrombosis), such as in the
legs (deep venous thrombosis)
or the lungs (pulmonary
you have a blood clotting
disorder (such as protein C,
protein S, or antithrombin
you have or recently have had
a disease caused by blood
clots in the arteries, such as a
heart attack, stroke or angina
you have or have ever had
liver disease and your liver
function tests have not
returned to normal
you have a rare blood problem
called porphyria which is
passed down in families
Do not take Tibogen if you have
an allergy (hypersensitivity) to
tibolone or any of the ingredients
of Tibogen listed at the end of this
Some of the symptoms of an allergic
reaction may include:
shortness of breath
wheezing or troubled
swelling of the face, lips,
tongue or other parts of the
rash, itching or hives on the
If any of the above conditions
appear for the first time while taking
Tibogen, stop taking it at once and
consult your doctor immediately.
Do not take this medicine after the
expiry date printed on the pack or
if the packaging is torn or shows
signs of tampering.
If it has expired or is damaged,
return it to your pharmacist for
If you are not sure whether you
should start taking this medicine,
talk to your doctor
Medical history and regular
As well as benefits, HRT or
Tibogen has some risks which need
to be considered when deciding
whether to starting taking it, or
whether to carry on taking it.
The experience in treating women
with a premature menopause (due to
ovarian failure or surgery) is limited.
If you have a premature menopause
the risks of using HRT or Tibogen
may be different. Please talk to your
doctor. Before you start (or restart)
HRT or Tibogen, your doctor will
ask you about your own and your
family's medical history. Your
doctor may decide to perform a
physical examination. This may
include an examination of your
breasts and/or an internal
examination, if necessary.
Once you have started on Tibogen,
you should see your doctor for
regular check-ups (at least once a
year). At these check-ups, discuss
with your doctor the benefits and
risks of continuing with Tibogen.
Go for regular breast screening, as
recommended by your doctor.
When to take special care with
Tell your doctor if you have ever
had any of the following conditions
before you start the treatment, as
these may return or become worse
during treatment with Tibogen. If so,
you should see your doctor more
often for check-ups:
fibroids inside your womb
growth of the womb lining
outside your womb
(endometriosis) or a history of
excessive growth of the womb
lining (endometrial hyperplasia)
increased risk of developing
blood clots (see "Blood clots in
a vein (thrombosis)")
increased risk of getting an
(such as having a mother, sister
or grandmother who has had
high blood pressure
a liver disorder, such as a
benign liver tumour
migraine or severe headaches
a disease of the immune system
that affects many organs of the
body (systemic lupus
a disease affecting the eardrum
and hearing (otosclerosis)
a very high level of fat in your
fluid retention due to cardiac or
Tell your doctor if you notice any
change in your condition whilst
Stop taking Tibogen and see a
doctor immediately if you notice
any of the following when taking
HRT or Tibogen:
any of the conditions mentioned
in the "Do not take Tibogen"
yellowing of your skin or the
whites of your eyes (jaundice).
These may be signs of a liver
a large rise in your blood
pressure (symptoms may be
headache, tiredness, dizziness)
migraine-like headaches which
happen for the first time
if you become pregnant
if you notice signs of a blood
clot, such as:
painful swelling and
redness of the legs
sudden chest pain
difficulty in breathing
For more information, see "Blood
clots in a vein (thrombosis)"
HRT and cancer
Excessive thickening of the lining
of the womb (endometrial
hyperplasia) and cancer of the
lining of the womb (endometrial
There have been reports and studies
of an increased cell growth or
cancer of the lining of the womb in
women using tibolone. The risk of
cancer of the lining of the womb
increases with the duration of use.
You may have irregular bleeding or
drops of blood (spotting) during the
first 3-6 months of taking Tibogen.
However, if the irregular bleeding:
carries on for more than the
first 6 months
starts after you have been
taking Tibogen for more than
carries on after you have
stopped taking Tibogen;
see your doctor as soon as possible.
Taking oestrogen, estrogen-
progesterone combined HRT or
Tibogen for several years slightly
increases the risk of breast cancer.
The risk increases with the duration
of HRT use and returns to normal
within about 5 years after stopping
Women taking tibolone have a
lower risk than women using
combined HRT and a comparable
risk with oestrogen-only HRT.
Regularly check your breasts. See
your doctor if you notice any
changes such as:
dimpling or sinking of the skin
changes in the nipple
any lumps you can see or feel
Ovarian cancer (cancer of the
ovaries) is very rare, but it is serious.
It can be difficult to diagnose,
because there are no obvious signs
of the disease.
Effects of HRT on heart or
Heart disease (heart attack)
Tibogen is not recommended for
women who have heart disease, or
have had heart disease recently. If
you have ever had heart disease, talk
to your doctor to see if you should
be taking Tibogen.
Studies with one type of HRT
(containing conjugated oestrogen
plus the progestogen
medroxyprogesterone acetate) have
shown that women may be slightly
more likely to get heart disease
during the first year of taking
medication. For other types of HRT
including Tibogen; the risk may be
similar, although this is not yet
See a doctor as soon as possible
and do not take any more Tibogen
if you get a pain in your chest that
spreads to your arm or neck.
This pain could be a sign of heart
Recent research suggests that HRT
and Tibogen increases the risk of
having a stroke. This increased risk
has mainly been observed in elderly
postmenopausal women above 60
years of age.
If you are worried about any of
these things, or if you have had a
stroke in the past, talk to your doctor
to see if you should take Tibogen.
See a doctor as soon as possible
and do not take any more Tibogen
until your doctor says you can if
you get any unexplained
migraine-type headaches with or
without disturbed vision.
These headaches may be an early
warning sign of a stroke.
Blood clots in a vein (Thrombosis)
Oestrogen and oestrogen-
progestogen combined HRT may
increase the risk of blood clots in
the veins (also called deep vein
thrombosis, or DVT), especially
during the 1st year of taking it. It is
unknown if Tibogen increases the
risk in the same way.
Blood clots can be serious, and if
one travels to the lungs, it can cause
chest pain, breathlessness, fainting
or even death.
You are more likely to get a blood
clot in your veins as you get older
and if any of the following applies
to you. Inform your doctor if any of
these situations apply to you:
you are pregnant or recently
had a baby
you use oestrogens
you are unable to walk for a
long time because of major
surgery, injury or illness (see
also "If you need to have
you are seriously overweight
(BMI greater than 30kg per
you have any blood clotting
problem that needs long-term
treatment with a medicine
used to prevent blood clots
if any of your close relatives
has ever had a blood clot in
the leg, lung or another organ
you have systemic lupus
erythematosus (SLE, a disease
of your immune system)
you have cancer
If any of these apply to you, talk to
your doctor about whether you
should use Tibogen.
For signs of a blood clot, see "Stop
taking Tibogen and see a doctor
HRT will not prevent memory loss.
There is some evidence of a higher
risk of memory loss in women who
start using HRT after the age of 65.
Speak to your doctor for advice.
Tell your doctor if you become
pregnant or are breast-feeding.
Tibogen is for use in
postmenopausal women only. If you
are pregnant or breast-feeding or
think you may be pregnant, do not
Tell your doctor if you react badly
to lactose or milk before you start
Tibogen tablets contain lactose.
Taking other medicines
Tell your doctor or pharmacist if
you are taking any other
medicines, including medicines
that you get without a
prescription, herbal medicines or
other natural products from your
pharmacy, supermarket or health
Some medicines may interfere with
the effect of Tibogen. This applies
to the following medicines:
medicines against blood
clotting (such as warfarin)
medicines for epilepsy (such
as phenobarbitone, phenytoin
medicines for tuberculosis
(such as rifampicin)
herbal remedies containing St
John's Wort (hypericum
You may need different amounts of
your medicine, or you may need to
take different medicines.
Ask your doctor or pharmacist
for advice before taking any
How to take Tibogen
Follow all directions given to you
by your doctor or pharmacist
carefully. You should check with
your doctor or pharmacist if you
When to start it
Tibogen should not be taken until 12
months after your last natural
menstrual bleed. If Tibogen is taken
sooner than this, the chance of
irregular vaginal bleeding may be
Women who have undergone
premature menopause (surgical
removal of ovaries) can start taking
If you are already using a different
type of HRT, your doctor will
advise you when to switch to
How to take it
Take one tablet daily, at about the
same time each day. Taking it at
the same time each day will have
the best effect. It will also help you
remember when to take it.
Swallow the tablet whole without
chewing with some water or other
The Tibogen pack contains 28 white
tablets. The strips with Tibogen are
marked with the days of the week.
Start by taking the tablet marked
with that day. For example, if it is a
Monday, take a tablet marked
Monday on the upper row of the
strip. Follow the directions of the
arrows and continue taking one
tablet each day until the strip is
Do not leave a break between strips
How long to use it
HRT should be prescribed at the
lowest effective dose and for the
shortest duration necessary. Your
doctor can advise you how long you
may need to take Tibogen.
In general, improvement of the
symptoms will occur within a few
Optimum results are achieved when
treatment is continued for at least 3
If you forget to take it
If you forget to take a tablet, take it
as soon as you remember, unless
you are more than 12 hours late. If
you are more than 12 hours late,
skip the dose you missed and take
your next dose when you are meant
Do not take a double dose to make
up for the forgotten dose.
If you take too much
If you have taken more tablets
than you have been prescribed,
immediately telephone your
doctor or for Australia the
Poisons Information Centre on 13
11 26, for New Zealand, the
National Poisons Centre on 0800
764 766 for advice.
Signs of an overdose may include
feeling sick or vomiting. Vaginal
bleeding may also occur after a few
While you are using
If you are about to be started on
any new medicine, remind your
doctor and pharmacist that you
are taking Tibogen.
Tell any other doctors, dentists
and pharmacists who treat you
that you are taking this medicine.
If you need to have surgery
Tell your doctor and your surgeon
that you are taking Tibogen if you
are going to have surgery.
You may need to stop taking
Tibogen about 4-6 weeks before the
operation to reduce the risk of a
blood clot (see "Blood clots in a
vein"). Ask your doctor when you
can start taking Tibogen again.
If you become pregnant while
taking this medicine, tell your
Things you must not do
Do not take Tibogen to treat any
other complaints unless your
doctor tells you to.
Do not give your medicine to
anyone, even if they have the same
condition as you.
Tell your doctor or pharmacist as
soon as possible if you do not feel
well while you are taking Tibogen.
The following diseases are reported
more often in women using HRT
compared to women not using HRT:
abnormal growth or cancer of
the lining of the womb
(endometrial hyperplasia or
blood clots in the veins of the
legs or lungs (venous
probable memory loss if HRT
is started over the age of 65
Tibogen helps most women with
menopausal symptoms, but it may
have unwanted side effects in a few
people. All medicines can have side
effects. Sometimes they are serious,
most of the time they are not. You
may need medical attention if you
get some side effects.
Do not be alarmed by the
following lists of side effects. You
may not experience any of them.
Ask your doctor or pharmacist to
answer any questions you may
Tell your doctor or pharmacist if
you notice any of the following and
they worry you:
vaginal bleeding or spotting
unnatural hair growth
vaginal symptoms, such as
discharge, itching, and
Less common side effects may
Other side effects observed with
Tibogen in market use were:
dizziness, headache, migraine,
rash or itching
joint pain, muscle pain
changes in liver function
There have been reports of breast
cancer and of an increased cell
growth or cancer of the lining of the
womb in women using Tibogen.
Please see "Medical history and
regular check-ups" for conditions
where Tibogen should be stopped.
The following side effects have
been reported with other HRTs:
gall bladder disease
various skin disorders:
discolouration of the skin
especially of the face or
neck known as
painful reddish skin
rash with target-shaped
reddening or sores
Tell your doctor or pharmacist if
you notice any side effects not
mentioned in this leaflet.
After Using Tibogen
Keep your Tibogen tablets in a
safe place out of the reach of
Keep your Tibogen tablets in the
original package in a cool dry
place where the temperature stays
Do not use after the expiry date
stated on the blister and outer box.
If your doctor tells you to stop
taking this medicine or the expiry
date has passed, ask your
pharmacist what to do with any
medicine that is left over.
What it looks like
Packs contain one or three blister
strip(s) of 28 white round flat tablets.
Tibogen tablet contains 2.5 mg of
the active ingredient called tibolone.
Tibogen also contains the following
Do not use the product if the blister
pack or tablets are damaged or
Tibogen is supplied in Australia by:
Medi-Gen Pharma Pty Ltd
Level 26, 530 Collins Street,
Melbourne, VIC 3000
AUST R 220602
This leaflet was prepared
24 August 2014