LIVIAL 2.5MG TABLETS

Active substance: TIBOLONE

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CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Livial 2.5mg tabs

ARTWORKER:

DT

Q.A.
APPROVED:

CODE:

6464/0443G

DATE OF PROOF:

06/01/14

DATE:

PROOF HISTORY:
v.2 - waymade - 06/01/14

CUSTOMER
APPROVED:
DATE:

Leaflet Flat Size = 296 x 420
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED OCTOBER 2012
REPORTING OF SIDE EFFECTS

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LIVIAL®

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, Livial may have side effects, although not everybody gets them. Most side effects are
mild.
Tell your doctor or pharmacist if you are worried about any side effects which you think may be due to
Livial. (see also section 2.3, 'Stop taking Livial and see a doctor immediately')
4.1 Serious side effects - see a doctor straight away
If you think you may have signs of a serious side effect, see a doctor straight away.
You may need to stop taking Livial:

If your blood pressure rises

If your skin or the whites of your eyes go yellow (jaundice)

If you suddenly have migraine-type headaches (see section 2.5 overleaf)

If you have signs of a blood clot (see section 2.5 overleaf)

If you get any of the problems listed in section 2.1 (Do not take Livial)

2.5mg TABLETS/TIBOLONE 2.5mg TABLETS
(tibolone)
Patient Information Leaflet

This product is known by the above names, but will be usually referred to as Livial throughout this leaflet.
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 or need more advice, ask your doctor, family planning nurse or
pharmacist

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, family planning nurse or pharmacist.
This includes any side effects not listed in this leaflet.
In this leaflet:
1. What Livial does
2. Make sure Livial is OK for you
3. Taking Livial
4. Possible side effects
5. How to store Livial
6. Further Information

4.2 Other side effects

1. What Livial does

Common (affect up to 1 in 10 women):

breast pain

stomach or pelvic pain

unusual hair growth

vaginal bleeding or spotting.
This is usually nothing to worry about in the first few months of taking HRT. If bleeding continues, or
starts after you have been on HRT for a while See Section 2.4.

vaginal problems such as more secretions, itching, irritation and thrush

thickening of the lining of the womb or the lining of the cervix

weight gain.
Uncommon (affects 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 (affects up to 1 in 1000 women):

itchy skin
Some women taking Livial have also reported:

depression, dizziness, headache

joint pain or muscle pain

skin problems such as rash or itching

loss of vision or blurred vision

changes in liver tests
There have been reports of breast cancer and of an increased cell growth or cancer of the lining of the
womb in women using Livial.
Tell your doctor if any of the above mentioned side effects continues or becomes troublesome.

Livial 2.5 mg tablet
The active substance is: tibolone.
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 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"). Livial 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 Livial to prevent osteoporosis after menopause.
There are three different kinds of HRT:

Oestrogen-only HRT

Combined HRT, containing two kinds of female hormone, an oestrogen and a progestogen.

Livial, which contains a substance called tibolone
Livial is different from other HRT. Instead of actual hormones (such as oestrogen and progestogen) it contains
tibolone. Your body breaks down tibolone to make hormones. Its effects and benefits are similar to combined
HRT.

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)

In section 6, ‘More about Livial’ you can find more information about Livial and what it is used for.

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 the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.

Medical History and regular check-ups

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Livial
Do not use after the expiry date printed on the carton label or blister strip. The expiry date refers to the last day
of that month.
Livial should be stored in a dry place below 25°C and protected from light.
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe disposal.
Only keep the tablets if your doctor tells you to.
If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your
pharmacist before taking them.

6. Further information
Your medicine is called Livial 2.5mg tablets/Tibolone 2.5mg tablets. Each tablet contains 2.5mg of the active
ingredient, tibolone in a white, round, tablet marked 'Organon *' and MK 2' on the reverse side.
Livial 2.5mg tablets/Tibolone 2.5mg tablets also contain the following inactive ingredients:
lactose, starch, ascorbyl palmitate and magnesium stearate.
Livial 2.5mg tablets/Tibolone 2.5mg tablets are available as 1 or 3 blister strips of 28 tablets in boxes of 28 and
84 tablets respectively.
POM

PL No: 6464/0443

This product is manufactured by Organon (Ireland), Limited, Sword, Ireland and is procured from within the EU
and repackaged by the Product Licence holder:
Waymade Plc, Miles Gray Road, Basildon, Essex SS14 3FR

2. Make sure Livial is OK for you
For information on when you can start taking Livial, (including after a hysterectomy) see Section 3.1
(overleaf)

The use of HRT or Livial carries risks that need to be considered when deciding whether to start taking it, or
whether to carry on taking it. This is especially important if you are more than 60 years old.
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 Livial may be different. Please talk to your doctor.
Before you start taking or restart HRT or Livial
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.
Tell your doctor if you have any medical problems or illnesses.
Regular check-ups
Once you have started on Livial, 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 Livial.
Go for regular breast screening, as recommended by your doctor.
Be sure to

go for regular breast screening and cervical smear tests

regularly check your breasts for any changes such as dimpling of the skin, changes in the nipple,
or any lumps you can see or feel
2.1 Some women should not take Livial
Do not take Livial
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 this medicine

Leaflet revision and issue date (Ref.) 06.01.2014
Livial is a registered trademark of N.V.Organon.




More about Livial
The most important natural sex hormones in women are oestrogens and progesterone.
These hormones are produced in the ovaries. They are needed for normal sexual development and control the
menstrual cycle.
The menopause is the time (usually around the age of 50) when the ovaries gradually stop producing
oestrogens. If the ovaries are removed surgically before the menopause, the decrease in hormone production
occurs very quickly. The decrease in hormone production often leads to symptoms such as hot flushes and
night sweats. The shortage of sex hormones may also cause the lining of the vagina to become thin and dry.
So sexual intercourse may be painful and vaginal infections may occur more frequently. Some women also
experience mood changes, nervousness, depression, irritability and loss of sexual desire.




Oestrogens are also important for bone formation. Bone is built up during youth, and peak bone mass is
reached between the age of 20 and 30. After that, bone mass decreases, at first slowly, but later in life more
quickly, especially after the menopause. Gradually, the bones become brittle and may easily break
(osteoporosis), especially in your spine, hip and wrists. Osteoporosis may also cause back pain, loss of height
and a curved back.




Livial contains tibolone, a substance that has beneficial effects on different tissues in the body, such as the
brain, vagina and bone. This results in the relief of symptoms such as hot flushes and night sweats, and an
improvement in the lining of the vagina, mood and sexual desire. Livial can also stop the process of bone loss
that occurs in your spine, hip and wrists after the menopause. Unlike some hormone replacement therapies,
Livial does not stimulate the lining of the womb. So treatment with Livial does not cause monthly
vaginal bleeding.









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 (hypersensitive) to tibolone or any of the other ingredients of Livial (listed in
section 6 More about Livial)
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 this medicine, stop taking it at once and
consult your doctor immediately.
If you have started the menopause you should not take Livial until 12 months after your last natural period.
If you take it sooner than this you may have irregular bleeding.

Pg 2

CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Livial 2.5mg tabs

ARTWORKER:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

CODE:

6464/0443G

DATE OF PROOF:

06/01/14

DATE:

PROOF HISTORY:
v.2 - waymade - 06/01/14

DATE:

Leaflet Flat Size = 296 x 420
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED OCTOBER 2012
REPORTING OF SIDE EFFECTS

Pg 2

2.2 When to take special care with Livial
Tell your doctor if you have ever had any of the following problems, before you start the treatment, as these
may return or become worse during treatment with Livial. 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

2.3 Stop taking Livial and see a doctor immediately
If you notice any of the following when taking HRT or Livial:

any of the conditions mentioned in the "Do not take Livial" section

yellowing of your skin or the whites of your eyes (jaundice). These may be signs of a liver disease

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: Livial 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.
2.4 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 Livial.
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
Livial. But if the bleeding or spotting:

Carries on for more than the first 6 months

Starts after you have been taking Livial for more than 6 months

Carries on even after you’ve stopped taking Livial
see your doctor as soon as possible.

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Heart disease (heart attack)

There is no evidence that HRT or Livial 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 Livial is different to the risk of other
HRT.
Stroke
Recent research suggests that HRT and Livial slightly increases the risk of having a stroke. The increased risk
is seen mainly in women over 60 years old. Other things that can increase the risk of stroke include:

Getting older

High blood pressure

Smoking

Drinking too much alcohol

An irregular heartbeat
If you are worried about any of these things, talk to your doctor to see if you should take HRT
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).
2.6 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.
2.7 Using other medicines
Some medicines may interfere with the effect of Livial. 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).
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including
medicines obtained without a prescription, herbal medicines or other natural products.
2.8 Having an Operation
If you are going to have an operation, make sure your doctor knows about it. You may need to stop taking
HRT about 4 to 6 weeks before the operation, to reduce the risk of a blood clot. Your doctor will tell you when
you can start taking HRT again.
2.9 Taking Livial with Food and Drink
You can eat or drink normally while you are taking Livial.
2.10 Pregnancy and Breast-Feeding
Livial is for use in postmenopausal women only. If you become pregnant, stop taking Livial and contact your
doctor.
2.11 Driving and Using Machines

Breast cancer

Livial has no known effect on the ability to drive or use machines.

Evidence suggests that taking combined oestrogen-progestogen 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

2.12 Livial contains Lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before
using Livial.
If you are worried about anything in this section, talk to your doctor about the risks and benefits of HRT.

3. Taking Livial

Women taking Livial have a lower risk than women using combined HRT and a comparable risk with
oestrogen-only HRT.

3.1 When can you start taking Livial?

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

If it is not yet 12 months since your last
natural period…

Wait before taking Livial
(see Section 2.1)…

If you are changing over from a period-free
HRT ... (see note below)...

Make an appointment to see your doctor as soon as possible

If you have never used HRT before ...

Ovarian cancer
Ovarian cancer is rare. A slightly increased risk of ovarian cancer has been reported in women taking HRT for
at least 5 to 10 years.
Compare
For women aged 50 to 69 who are not taking HRT, on average about 2 women in 1000 will be diagnosed
with ovarian cancer over a 5-year period. For women who have been taking HRT for 5 years, there will be
between 2 and 3 cases per 1000 users (i.e. up to 1 extra case).
With use of Livial, the increased risk of ovarian cancer is similar to other types of HRT.

If you were prescribed HRT because you
have had a hysterectomy ...

Start taking Livial straight away

If you are being treated for endometriosis
(a condition in which parts of the womb
lining move around the body) ...
If you are changing over from another type
of HRT with which you have periods ...
(see the note below)...

Wait for your next period.
Start taking Livial as soon as your
period ends.

2.5 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.

If you are changing over from another type of HRT
There are several different types of HRT, such as tablets patches and gels. Most contain either oestrogen, or
oestrogen and progestogen. With some you still have periods, and with some you don't (these are called
period-free HRT).
3.2 How to take Livial
The usual 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 Livial 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.
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.

For signs of a blood clot, see “Stop taking Livial 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 oestrogen-progestogen HRT for over 5 years, there will
be 9 to 12 cases in 1000 users (i.e. an extra 5 cases).
With use of Livial, the increased risk of getting a blood clot in a vein is lower than with other types of HRT.

3.3 If you take more Livial 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.
3.4 If you forget to take Livial
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.
3.5 If you need to have surgery
If you are going to have surgery, tell the surgeon that you are taking Livial. You may need to stop taking Livial
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 Livial again.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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