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TIBOLONE 2.5 MG TABLETS

Active substance(s): TIBOLONE

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1. What Tibolone is and what it is used for
This medicine is a Hormone Replacement Therapy (HRT).
It contains tibolone, a substance that has favourable effects
on different tissues in the body, such as brain, vagina and
bone. This medicine is used in postmenopausal women
with at least 12 months (1 year) since their last natural
period.
This medicine is used for:
Relief of symptoms occurring after menopause. During
the menopause, the amount of the oestrogen produced by a
woman’s body drops. This can cause symptoms such as hot
face, neck and chest (“hot flushes”). Tibolone alleviates
these symptoms after menopause. You will only be
prescribed this medicine 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 use Tibolone to prevent
osteoporosis after menopause.
In section 6, ‘Contents of the pack and other information’
you can find more information about Tibolone and
what it is used for.
2. What you need to know before you take Tibolone
Medical History and regular check-ups
The use of HRT or Tibolone carries risks that need to be
considered when deciding whether to start 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 Tibolone may be different. Please
talk to your doctor.
Before you start taking or restart HRT or Tibolone
Your doctor will ask 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.
Regular check-ups
Once you have started on Tibolone, 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 Tibolone.
Go for regular breast screening, as recommended by your
doctor.
Some women should not take Tibolone
Do not take Tibolone
If any of the following applies to you. If you are not sure
about any of the points below, talk to your doctor before
taking Tibolone
• If you have or have ever had breast cancer, or if you
are suspected of having it
• If you have cancer which is sensitive to oestrogens,
such as cancer of the womb lining (endometrium), or if
you are suspected of having it
• If you have any unexplained vaginal bleeding
• If you have excessive thickening of the womb lining
(endometrial hyperplasia) that is not being treated.
• If 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 embolism)
• If you have a blood clotting disorder (such as protein
C, protein S, or antithrombin deficiency)
• If you have or recently have had a disease caused
by blood clots in the arteries, such as a heart attack,
stroke or angina
• If you have or have ever had a liver disease and your
liver function tests have not returned to normal
• If you have a rare blood problem called “porphyria”
which is passed down in families (inherited)
• If you are allergic to tibolone or any of the other
ingredients of this medicine (listed in section 6)
• If you are pregnant or think you might be pregnant.
• If you are breastfeeding.
If any of the above conditions appear for the first time while
taking Tibolone, stop taking it at once and consult your
doctor immediately.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking
Tibolone.
If you have ever had any of the following problems, tell
your doctor before you start the treatment, as these may
return or become worse during treatment with Tibolone.
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 oestrogen-sensitive cancer
(such as having a mother, sister or grandmother who
has had breast cancer)
• high blood pressure
• a liver disorder, such as a benign liver tumour
• diabetes
• gallstones
• migraine or severe headaches
• a disease of the immune system that affects many
organs of the body (systemic lupus erythematosus,
SLE)
• epilepsy
• asthma
• a disease affecting the eardrum and hearing
(otosclerosis)
• a very high level of fat in your blood (triglycerides)
• fluid retention due to cardiac or kidney problems
Stop taking Tibolone and see a doctor immediately
If you notice any of the following when taking Tibolone:
• any of the conditions mentioned in the “Do not take
Tibolone ” section
• yellowing of your skin or the whites of your eyes
(jaundice). These may be signs of a liver disease

includes medicines obtained without a prescription, herbal
medicines or other natural products.
Tibolone with food and drink
You can eat or drink normally while you are taking
Tibolone
Pregnancy and breast-feeding
Tibolone is for use in postmenopausal women only. If you
become pregnant, stop taking Tibolone and contact your
doctor.
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
Driving and using machines
Tibolone has no known effect on the ability to drive or use
machines.
Tibolone contains Lactose
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
using Tibolone.
3. How to take Tibolone
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure. Tibolone is administered
orally.
The recommended dose is one tablet every day. Take this
dose unless your doctor or pharmacist told you to do
something different.
Press the tablet so that it comes through the foil. Swallow
the tablet with some water or other drink, without chewing.
Take Tibolone at the same time each day.
The strips of tablets are marked with the days of the week.
Start by taking a tablet marked with the current day. For
example, if it is Monday, take a tablet marked Monday on
the top row of the strip. Follow the arrows until the strip is
empty. Start the next strip the next day. Do not leave a break
between strips or packs.
You should not take Tibolone until 12 months after your
last natural menstruation. If Tibolone is taken before this
period of time, the likelihood of irregular vaginal
hemorrhaging may be increased.
Your doctor will aim to prescribe the lowest dose to treat
your symptoms for as short as necessary. Speak to your
doctor if you think this dose is too strong or not strong
enough.
If you take more Tibolone than you should
It is unlikely that taking more than one tablet will do you
any harm, but you may feel sick, be sick or have some
vaginal bleeding. If you take more Tibolone than you
should, you should see a doctor or pharmacist immediately.
If you have taken too much Tibolone , immediately contact
your doctor, pharmacist or Poison control center.
If you forget to take Tibolone
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, just skip it, and take your next
tablet at the usual time. Don’t take a double dose.
If you need to have surgery
If you are going to have surgery, tell the surgeon that you
are taking Tibolone . You may need to stop taking Tibolone
about 4 to 6 weeks before the operation to reduce the risk of
a blood clot (see section 2, ‘Blood clots in a vein’). Ask
your doctor when you can start taking Tibolone again.
4. Possible side effects
The following diseases are reported more often in women
using HRT compared to women not using HRT:
• breast cancer
• abnormal growth or cancer of the lining of the womb
(endometrial hyperplasia or cancer)
• ovarian cancer
• blood clots in the veins of the legs or lungs (venous
thromboembolism)
• heart disease
• stroke
• probable memory loss if HRT is started over the age
of 65 For more information about these side effects, see
section 2.
Like all medicines, this medicine can cause side effects,
although not everybody gets them. Most side effects are
mild.
Other side effects
Common (may affect up to 1 in 10 women):
• breast pain
• stomach or pelvic pain
• unusual hair growth
• vaginal bleeding or spotting.
• vaginal problems such as more secretions, itching,
irritation and thrush
• weight gain.
Uncommon (may affect up to 1 in 100 women):
• swollen hands, ankles or feet – a sign of fluid retention
• stomach upset
• acne
• painful nipples or breasts feeling uncomfortable
• vaginal infections
Rare (may affect up to 1 in 1000 women):
• itchy skin
Some women taking Tibolone have also reported:
• depression, dizziness, migraine, headache
• joint pain or muscle pain
• skin problems such as rash or itching
• loss of vision or blurred vision
• Gastrointestinal disorders
• changes in liver tests
• Water retention
There have been reports of breast cancer and of an
increased cell growth or cancer of the lining of the womb in
women using Tibolone.
- Tell your doctor if any of the above mentioned side
effects continues or becomes troublesome.
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 “pregnancy patches” (chloasma)
- painful reddish skin nodules (erythema nodosum)
- rash with target-shaped reddening or sores (erythema
multiforme)
- “Purpura vascular”- small haemorrhagic points on
the skin
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed in
this leaflet. You can also report side effects directly via
MHRA
Yellow
Card
Scheme,
Website:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow
Card in the Google Play or Apple App Store. By reporting
side affects you can help provide more information on the
safety of this medicine.
5. How to store Tibolone
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the carton after ‘EXP’. The expiry date refers to
the last day of that month.
This medicine does not require any special storage
conditions.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away

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Read all of this leaflet carefully before you start taking
this medicine because it contains important information
for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor,
pharmacist or nurse.
• This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
• If you get any side effects talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Tibolone is and what it is used for
2. What you need to know before you take Tibolone
3. How to take Tibolone
4. Possible side effects
5. How to store Tibolone
6. Contents of the pack and other information

• 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)”.
Note: Tibolone is not a contraceptive. If it is less than 12
months since your last menstrual period or you are under 50
years old, you may still need to use additional contraception
to prevent pregnancy. Speak to your doctor for advice.
HRT and Cancer
Excessive thickening of the lining of the womb
(endometrial hyperplasia) and cancer of the lining of
the womb (endometrial cancer)
There have been reports 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 the
longer you take the medicine.
Irregular bleeding
You may have irregular bleeding or drops of blood
(spotting) during the first 3-6 months of taking Tibolone.
But if the bleeding or spotting:
• Carries on for more than the first 6 months
• Starts after you have been taking Tibolone for more
than 6 months
• Carries on even after you’ve stopped taking Tibolone
• See your doctor as soon as possible.
Breast cancer
Evidence suggests that taking combined oestrogenprogestogen and possibly also oestrogen-only HRT
increases the risk of breast cancer. The extra risk depends
on how long you take HRT. The additional risk becomes
clear within a few years. However, it returns to normal
within a few years (at most 5) after stopping treatment.
Compare
Women taking Tibolone have a lower risk of breast
cancer than women using combined HRT and a higher risk
than women using 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
Ovarian cancer is rare – much rarer than breast cancer. The
use of oestrogen-only or combined oestrogen-progestagen
HRT has been associated with a slightly increased risk of
ovarian cancer.
The risk of ovarian cancer varies with age. For example, in
women aged 50 to 54 who are not taking HRT, about 2
women in 2000 will be diagnosed with ovarian cancer over
a 5-year period. For women who have been taking HRT for
5 years, there will be about 3 cases per 2000 users (i.e.
about 1 extra case).
With use of Tibolone, the increased risk of ovarian cancer is
similar to other types of HRT.
Effect of HRT on heart and circulation
Blood clots in a vein (thrombosis)
The risk of blood clots in the veins is about 1.3 to 3-times
higher in HRT users than in non-users, especially during the
first year of taking it.
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 section 3, If
you need to have surgery)
• you are seriously overweight (BMI >30 kg/m2)
• 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)
• you have cancer.
For signs of a blood clot, see “Stop taking Tibolone and see
a doctor immediately”.
Compare
Looking at women in their 50s who are not taking HRT, on
average, over a 5 year period, 4 to 7 in 1000 would be
expected to get a blood clot in a vein.
For women in their 50s who have been taking oestrogenprogestogen HRT for over 5 years, there will be 9 to 12
cases in 1000 users (i.e. an extra 5 cases).
With use of Tibolone the increased risk of getting a blood
clot in a vein is lower than with other types of HRT.
Heart disease (heart attack)
There is no evidence that HRT or Tibolone will prevent a
heart attack.
Women over the age of 60 who use oestrogen-progestogen
HRT are slightly more likely to develop heart disease than
those not taking any HRT. As the risk of heart disease
strongly depends on age, the number of extra cases of heart
disease due to use of oestrogen-progestogen HRT is very
low in healthy women close to menopause, but will rise
with more advanced age. There is no evidence to suggest
that the risk of myocardial infarction with Tibolone is
different to the risk of other HRT.
Stroke
Recent research suggests that HRT and Tibolone slightly
increases the risk of having a stroke. The increased risk is
seen mainly in women over 60 years old.
Compare
Looking at women in their 50s who are not taking Livial
- on average, over a 5-year period, 3 in 1000 would be
expected to have a stroke.
For women in their 50s who are taking Livial, the figure
would be 7 in 1000 (i.e. an extra 4 cases).
Looking at women in their 60s who are not taking Livial
- on average, over a 5-year period, 11 in 1000 would be
expected to have a stroke.
For women in their 60s who are taking Livial, the figure
would be 24 in 1000 (i.e. an extra 13 cases).
Other conditions
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.
Other medicines and Tibolone
Some medicines may interfere with the effect of Tibolone.
This might lead to irregular bleeding. This applies to the
following medicines:
• Medicines against blood clotting (such as warfarin)
• Medicines for epilepsy (such as phenobarbital,
phenytoin and carbamazepin)
• Medicines for tuberculosis (such as rifampicin)
• Herbal remedies containing St John’s Wort
(Hypericum perforatum).
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines. This

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Package Leaflet: Information for the user
Tibolone 2.5 mg tablets
Tibolone

medicines you no longer use. These measures will help
protect the environment.
6. Contents of the pack and other information
What Tibolone contains
The active substance is tibolone.
The other ingredients are potato starch, lactose
monohydrate, ascorbyl palmitate, anhydrous lactose and
magnesium stearate.
What Tibolone looks like and the contents of the pack
Tibolone tablets are White to off white, circular with flat
face beveled edge, uncoated tablet debossed with ‘TO
above 2’ on one side and plain on other side.
Approximate Diameter 6.00±0.20 mm.
Tibolone tablets are packaged in blisters consisting of a
transparent polyvinyl chloride film and an aluminium
blister foil. The following packages are available: Carton
packs containing 1, 3 blisters of 28 tablets and Carton packs
containing 2, 3 blisters of 10 tablets.
The Marketing Authorisation Holder:
Generic Partners UK Ltd
1 Doughty Street
London
WC1N 2PH
The Manufacturer:
Geryon Pharma Limited
18 Owen Drive
Liverpool
Merseyside
L24 1YA
Distributor:
Creo Pharma Ltd
Felsted Business Centre
Felsted
Essex CM6 3LY
United Kingdom
This leaflet was revised in 01/2018
More about Tibolone
In women, the most important sex hormones are estrogens
and progestagens. These hormones are necessary for the
normal sexual development of women and have an
important role in regulating the menstrual cycle. Estrogens
play an important role in the formation of bones. The bones
are formed during youth and the peak of bone mass is
reached between the 20-30 years of age. After this age, the
bone mass decreases, first slowly, but in later ages the loss
of bone mass is accelerated, especially after menopause.
The period in which this happens (usually around the age of
50) is called climacteric or menopause. If the ovaries are
removed surgically (ovariectomy) before menopause, the
decrease in hormone production will occur very abruptly.
In many cases, this decrease in hormone production leads to
well-known menopausal complaints, such as hot flashes
and night sweats. Lack of sex hormones can also cause the
vaginal wall to become thinner and drier. For this reason,
intercourse can become painful and vaginal infections may
be more frequent. In many women, these physical problems
are accompanied by mood swings, nervousness,
depression, irritability, and loss of sexual desire.
One problem that often goes unnoticed is the rapid bone
loss that occurs in many women after menopause. For this
reason, the bones become brittle and can break easily
(osteoporosis), especially the spine, hip and wrists.
Osteoporosis can also cause back pain, weight loss and
back curvature.
Tibolone contains tibolone, a substance that has beneficial
effects of sex hormones on different tissues of the body
such as brain, vagina and bone.
This results in Tibolone relieving menopausal complaints,
such as hot flashes and night sweats. This medicine also has
a stimulating effect on the inner lining of the vagina, and a
favourable effect on mood and sexual desire.
Tibolone stops and also treats the osteoporosis process, ie
the bone loss that occurs after menopause, in the spine, hip
and wrists. Unlike other medications used in hormone
replacement therapy, Tibolone does not stimulate the lining
of the uterus (endometrium). Therefore, treatment with
Tibolone does not cause monthly vaginal bleeding.

CRE-TBL-PIL-354_04
30/01/2018

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