Tibolone 2.5mg tablets

United Kingdom - English - eMC (Electronic Medicines Compendium)

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Active ingredient:
Tibolone
Available from:
Aristo Pharma Ltd
ATC code:
G03CX01
INN (International Name):
Tibolone
Dosage:
2.5mg
Pharmaceutical form:
Tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 06040101; GTIN: 4251575902374 4251575902381

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.

The name of your medicine is Livial 2.5mg tablets but will be referred

to as Livial throughout this leaflet.

In this leaflet:

1.

What Livial is and what it is used for

2.

What you need to know before you take Livial

3.

How to take Livial

4.

Possible side effects

5.

How to store Livial

6.

Contents of the pack and other information

Livial 2.5mg 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 (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’). 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.

In section 6, ‘Contents of the pack and other information’ you can

find more information about Livial and what it is used for.

For information on when you can start taking Livial, (including after a

hysterectomy) see Section 3.1 (overleaf).

Medical History and regular check-ups

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 Livial

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 breast-feeding.

If any of the above conditions appear for the first time while taking

Livial, 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.

2.2

Warning and precautions

Talk to your doctor, pharmacist or nurse before taking Livial.

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 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 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.

Breast cancer

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.

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

Make an appointment to see your doctor as soon as

possible

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 Livial, the increased risk of ovarian cancer is similar to

other types of HRT.

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.

For signs of a blood clot, see ‘Stop taking Livial and see a doctor

immediately’.

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 heart beat

If you are worried about any of these things, talk to your doctor to

see if you should take HRT

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.

Livial is not intended for contraceptive use.

Treatment with Livial results in a marked dose-dependent decrease

in HDL cholesterol (from -16.7% with a 1.25mg dose to -21.8% for

the 2.5mg dose after 2 years). Total triglycerides and lipoprotein(a)

levels were also reduced. The decrease in total cholesterol and

VLDL-C levels was not dose-dependent. Levels of LDL-C were

unchanged. The clinical implication of these findings is not yet

known.

Oestrogens may cause fluid retention, and therefore patients with

cardiac or renal dysfunction should be carefully observed.

Women with pre-existing hypertriglyceridaemia should be followed

closely during oestrogen replacement or Hormone replacement

therapy, since rare cases of large increases of plasma triglycerides

leading to pancreatitis have been reported with oestrogen therapy in

this condition.

Package leaflet: Information for the user

Livial

®

2.5mg tablets

(tibolone)

1. What Livial is and what it is used for

2. What you need to know before you take Livial

Compare

Women taking Livial have a lower risk than women using

combined HRT and a comparable risk with oestrogen-only HRT.

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.

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).

Treatment with Livial results in a very minor decrease of thyroid

binding globulin (TBG) and total T4. Levels of total T3 are unaltered.

Livial decreases the level of sex-hormone-binding globulin (SHBG),

whereas the levels of corticoid binding globulin (CBG) and circulating

cortisol are unaffected.

2.7

Other medicines and Livial

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).

Tell your doctor or pharmacist if you are taking, have recently taken

or might take any other medicines. This includes 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

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.

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.

2.11

Driving and using machines

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

2.12

Livial contains Lactose

Patients with rare hereditary problems of galactose intolerance, the

Lapp lactase deficiency or glucose-galactose malabsorption should

not take this medicine.

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.

3.1

When can you start taking Livial?

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)…

Start taking Livial straight

away

If you have never used HRT

before

If you were prescribed HRT

because you have had a

hysterectomy

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

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

Always take this medicine exactly as your doctor or pharmacist has

told you. Check with your doctor or pharmacist if you are not sure.

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 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.

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.

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.

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

above)

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

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

Livial’)

4.2

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.

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 (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 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.

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)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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 or search for MHRA Yellow Card in the

Google Play or Apple App Store. By reporting side effects, you can

help provide more information on the safety of this medicine.

Keep out of the sight and reach of children.

Do not store above 25°C. Do not refrigerate. Store in the original

package in order to protect from light and moisture.

Do not take the tablets after the expiry date which is stated on the

carton and blister labels after ‘Exp’. The expiry date refers to the last

day of that month.

If the tablet becomes discoloured or shows any signs of

deterioration, seek the advice of your pharmacist.

Remember if your doctor tells you to stop taking this medicine, return

any unused tablets to your pharmacist for safe disposal. Only keep

this medicine if your doctor tells you to.

What Livial contains

The active ingredient in the Livial is tibolone.

Each tablet contains 2.5mg tibolone.

The other ingredients are: lactose monohydrate, potato starch,

ascorbyl palmitate and magnesium stearate.

What Livial looks like and the contents of the pack

Livial is a white, round, tablet marked 'Organon

' and 'MK 2' on the

reverse side.

Livial 2.5mg tablets are available as 1 or 3 blister strips of 28 tablets

in boxes of 28 and 84 tablets respectively.

Manufactured by: N.V. Organon, Kloosterstraat 6, AB Oss, 5349,

The Netherlands.

Procured within the EU and repackaged by the product licence

holder:

B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex,

HA4 0NU, UK.

Livial

®

2.5mg tablets PL 18799/2817

Leaflet date: 31.05.2019

Livial

is a registered trademark of Merck Sharp & Dohme B.V.

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.

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Call 0208 515 3763 to obtain the

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POM

3. How to take Livial

4. Possible side effects

5. How to store Livial

6. Contents of the pack and other information

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.

The name of your medicine is Tibolone 2.5mg tablets but will be

referred to as Tibolone throughout this leaflet.

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

Tibolone 2.5mg 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 (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.

There are three different kinds of HRT:

Oestrogen-only HRT

Combined HRT, containing two kinds of female hormone, an

oestrogen and a progestogen

Tibolone, which contains a substance called tibolone

Tibolone 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.

In section 6, ‘Contents of the pack and other information’ you can

find more information about Tibolone and what it is used for.

For information on when you can start taking Tibolone, (including

after a hysterectomy) see Section 3.1 (overleaf).

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. 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 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.

Tell your doctor if you have any medical problems or illnesses.

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.

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 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 breast-feeding.

If any of the above conditions appear for the first time while taking

Tibolone, stop taking it at once and consult your doctor immediately.

If you have started the menopause you should not take Tibolone until

12 months after your last natural period. If you take it sooner than

this you may have irregular bleeding.

2.2

Warning 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

2.3

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

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.

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 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 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.

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

Make an appointment to see your doctor as soon as

possible

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.

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.

For signs of a blood clot, see ‘Stop taking Tibolone and see a doctor

immediately’.

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. Other things that can increase the risk of

stroke include:

Getting older

High blood pressure

Smoking

Drinking too much alcohol

An irregular heart beat

If you are worried about any of these things, talk to your doctor to

see if you should take HRT

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.

Tibolone is not intended for contraceptive use.

Treatment with Tibolone results in a marked dose-dependent

decrease in HDL cholesterol (from -16.7% with a 1.25mg dose to -

21.8% for the 2.5mg dose after 2 years). Total triglycerides and

lipoprotein(a) levels were also reduced. The decrease in total

cholesterol and VLDL-C levels was not dose-dependent. Levels of

LDL-C were unchanged. The clinical implication of these findings is

not yet known.

Oestrogens may cause fluid retention, and therefore patients with

cardiac or renal dysfunction should be carefully observed.

Women with pre-existing hypertriglyceridaemia should be followed

closely during oestrogen replacement or Hormone replacement

Package leaflet: Information for the user

Tibolone 2.5mg tablets

1. What Tibolone is and what it is used for

2. What you need to know before you take

Tibolone

Compare

Women taking Tibolone have a lower risk than women using

combined HRT and a comparable risk with oestrogen-only HRT.

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 Tibolone, the increased risk of getting a blood clot

in a vein is lower than with other types of HRT.

Compare

Looking at women in their 50s who are not taking Tibolone –

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 Tibolone, the figure

would be 7 in 1000 (i.e. an extra 4 cases).

Looking at women in their 60s who are not taking Tibolone –

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 Tibolone, the figure

would be 24 in 1000 (i.e. an extra 13 cases).

therapy, since rare cases of large increases of plasma triglycerides

leading to pancreatitis have been reported with oestrogen therapy in

this condition.

Treatment with Tibolone results in a very minor decrease of thyroid

binding globulin (TBG) and total T4. Levels of total T3 are unaltered.

Tibolone decreases the level of sex-hormone-binding globulin

(SHBG), whereas the levels of corticoid binding globulin (CBG) and

circulating cortisol are unaffected.

2.7

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 includes 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

Tibolone with food and drink

You can eat or drink normally while you are taking Tibolone.

2.10

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.

2.11

Driving and using machines

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

2.12

Tibolone contains Lactose

Patients with rare hereditary problems of galactose intolerance, the

Lapp lactase deficiency or glucose-galactose malabsorption should

not take this medicine.

If you have been told by your doctor that you have an intolerance to

some sugars, contact your doctor before using Tibolone.

If you are worried about anything in this section, talk to your doctor

about the risks and benefits of HRT.

3.1

When can you start taking Tibolone?

If it is not yet 12 months since

your last natural period…

Wait before taking Tibolone

(see Section 2.1)…

If you are changing over from a

period free HRT… (see note

below)…

Start taking Tibolone straight

away

If you have never used HRT

before

If you were prescribed HRT

because you have had a

hysterectomy

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 Tibolone as soon as your

period ends

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 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.

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.

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.

3.3

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.

3.4

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.

3.5

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.

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.

Tell your doctor or pharmacist if you are worried about any

side effects which you think may be due to Tibolone. (see also

section 2.3, 'Stop taking Tibolone 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 Tibolone:

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

above)

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

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

Tibolone’)

4.2

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.

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 (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, 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 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)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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 or search for MHRA Yellow Card in the

Google Play or Apple App Store. By reporting side effects, you can

help provide more information on the safety of this medicine.

Keep out of the sight and reach of children.

Do not store above 25°C. Do not refrigerate. Store in the original

package in order to protect from light and moisture.

Do not take the tablets after the expiry date which is stated on the

carton and blister labels after ‘Exp’. The expiry date refers to the last

day of that month.

If the tablet becomes discoloured or shows any signs of

deterioration, seek the advice of your pharmacist.

Remember if your doctor tells you to stop taking this medicine, return

any unused tablets to your pharmacist for safe disposal. Only keep

this medicine if your doctor tells you to.

What Tibolone contains

The active ingredient in the Tibolone is tibolone.

Each tablet contains 2.5mg tibolone.

The other ingredients are: lactose monohydrate, potato starch,

ascorbyl palmitate and magnesium stearate.

What Tibolone looks like and the contents of the pack

Tibolone is a white, round, tablet marked 'Organon

' and 'MK 2' on

the reverse side.

Tibolone 2.5mg tablets are available as 1 or 3 blister strips of 28

tablets in boxes of 28 and 84 tablets respectively.

Manufactured by: N.V. Organon, Kloosterstraat 6, AB Oss, 5349,

The Netherlands.

Procured within the EU and repackaged by the product licence

holder:

B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex,

HA4 0NU, UK.

Tibolone 2.5mg tablets PL 18799/2817

Leaflet date: 31.05.2019

More about Tibolone

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.

Tibolone 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. Tibolone can also stop the process of bone loss that

occurs in your spine, hip and wrists after the menopause. Unlike

some hormone replacement therapies, Tibolone does not stimulate

the lining of the womb. So treatment with Tibolone does not cause

monthly vaginal bleeding.

Blind or partially sighted?

Is this leaflet hard to see or read?

Call 0208 515 3763 to obtain the

leaflet in a format suitable for you

POM

3. How to take Tibolone

4. Possible side effects

5. How to store Tibolone

6. Contents of the pack and other information

Product Summary

Trade Name of the Medicinal Product

Not applicable.

2.

Qualitative and Quantitative Composition

Not applicable.

3.

Pharmaceutical Form

Not applicable.

Clinical Particulars

4.1.

Therapeutic Indications

Not applicable.

4.2.

Posology and Method of Administration

Not applicable.

4.3.

Contra-indications

Not applicable.

4.4.

Special Warnings and Precautions for Use

Not applicable.

4.5.

Interactions with other Medicaments and other forms of Interaction

Not applicable.

4.6

Pregnancy and Lactation

Not applicable.

4.7

Effects on Ability to Drive and Use Machines

Not applicable.

4.8

Undesirable Effects

Not applicable.

4.9

Overdose

Not applicable.

Pharmacological Properties

Pharmacodynamic Properties

Not applicable.

5.2

Pharmacokinetic Properties

Not applicable.

5.3

Preclinical Safety Data

Not applicable.

Pharmaceutical Particulars

6.1.

List of Excipients

Not applicable.

6.2.

Incompatibilities

Not applicable.

6.3.

Shelf Life

Not applicable.

6.4.

Special Precautions for Storage

Not applicable.

6.5.

Nature and Contents of Container

Not applicable.

6.6.

Instruction for Use/Handling

Not applicable.

Administrative Data

Marketing Authorisation Holder

Not applicable.

8.

Marketing Authorization Number

Not applicable.

9.

Date of First Authorisation/Renewal of Authorisation

Not applicable.

10.

Date of (Partial) Revision of the Text

Not applicable.

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