TIBOLONE 2.5 mg Coated tablets

Зміст інструкції

1. Tibolone Aristo 2,5 mg tablets
   1. What is Tibolone Aristo and what is it used for
   2. What you need to know before taking Tibolone Aristo
   3. How to take Tibolone Aristo
   4. Possible side effects
   5. How to store Tibolone Aristo
   6. Contents of the pack and other information

Tibolone Aristo 2,5 mg tablets

Equivalent Medicine

Read this leaflet carefully before taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Tibolone Aristo is and what it is used for
• 2. What you need to know before you take Tibolone Aristo
• 3. How to take Tibolone Aristo
• 4. Possible side effects
• 5. How to store Tibolone Aristo
• 6. Contents of the pack and other information

1. What is Tibolone Aristo and what is it used for

Tibolone Aristo is a Hormone Replacement Therapy (HRT). Tibolone Aristo contains the active substance tibolone, a synthetic sex hormone. Tibolone Aristo is indicated in women, in postmenopause after at least 12 months since their last natural menstruation.
Tibolone Aristo is used for:

Relief of symptoms that appear after menopause
During menopause, the amount of hormones produced by a woman's body decreases. This
can cause symptoms such as a feeling of heat in the face, neck and chest (“hot flushes”).
Tibolone Aristo relieves these symptoms after menopause. It will only be prescribed by your doctor if the symptoms seriously compromise your normal daily activities.

2. What you need to know before taking Tibolone Aristo

Medical history and regular check-ups
Hormone replacement therapy or treatment with Tibolone Aristo involves some risks, which
must be considered when deciding whether to start or continue taking the
medicine.
Experience in treating women who have entered menopause prematurely (due to
ovarian failure or surgery) is limited. If you have entered menopause prematurely, the risks associated with hormone replacement therapy or the use of Tibolone Aristo
may be different. Consult your doctor.
Before starting (or restarting) hormone replacement therapy or taking Tibolone Aristo
your doctor will talk to you about your medical problems and family medical history. Your doctor
may also decide to perform a physical examination. The latter may also
include a breast exam and/or a pelvic exam, if necessary.
Once you have started treatment with Tibolone Aristo, you must see your doctor for regular check-ups (at least once a year). On these occasions, discuss with your doctor the
benefits and risks of continuing therapy with Tibolone Aristo.
Have regular breast cancer screening, as recommended by your doctor.
You are also advised to join breast cancer screening programs when they are offered to you. For breast cancer screening, it is important to inform the nurse / healthcare
professional who is actually taking the X-ray that you are using HRT, as this
drug may increase the density of your breasts and this may affect the outcome of the mammogram.
When breast density is increased, a mammogram may not detect all lumps.

Do not take Tibolone Aristo
If any of the conditions described below apply to you. If you have any doubts about any
of the points below, consult your doctorbefore taking this medicine.
If you have or have ever had breast cancer, or if you suspect you have it
If you suffer from a form of cancer sensitive to estrogen, such as cancer of the lining
of the uterus (endometrium), or if you suspect you have it
If you have unexplained vaginal bleeding
If you have excessive thickening of the uterine lining (endometrial hyperplasia) that has not been treated
If you have or have ever had a blood clot in a vein (thrombosis), for example
in the
legs (deep vein thrombosis) or in the lungs (pulmonary embolism)
If you suffer from a blood clotting disorder (such as protein C, protein
S or antithrombin deficiency)
If you suffer from or have recently suffered from a disease caused by blood clots in the
arteries, such as heart attack, stroke or angina
If you suffer from or have ever had a liver disease and liver function test values have not returned to normal
If you suffer from a rare blood disease called "porphyria", which is hereditary
(inherited disease)
If you are allergic (hypersensitive) to tibolone or any of the other ingredients of Tibolone
Aristo (listed in section 6)
If you are pregnant or think you may be pregnant.
If you are breastfeeding
If any of the above conditions appear for the first time during treatment
with
Tibolone Aristo, stop taking it immediately and consult your doctor immediately.

Warnings and precautions
Talk to your doctor or pharmacist before taking Tibolone Aristo.
Before starting treatment, tell your doctor if you suffer from or have ever suffered from any of
the following conditions, as these may recur or worsen during treatment with Tibolone Aristo. In this case, your doctor may need to perform check-ups more often:
fibroids of the uterus
growth of the inner lining of the uterus outside the uterus (endometriosis), or a history
of
excessive growth of the uterine lining (endometrial hyperplasia)
increased risk of developing blood clots (see “Blood clots in a vein
[thrombosis]”)
increased risk of developing an estrogen-sensitive tumor (e.g. if your mother,
a
sister or grandmother has had breast cancer)
high blood pressure
a liver disease, such as a benign liver tumor
diabetes
gallstones
migraine or severe headaches
an autoimmune disease affecting multiple organs (systemic lupus
erythematosus, SLE)
epilepsy
asthma
a disease affecting the eardrum and impairing hearing (otosclerosis)
a very high level of fats (triglycerides) in the blood
problems with your heart
problems with your kidneys

Stop taking Tibolone Aristo and consult your doctor immediately:
If, during hormone replacement therapy or while taking Tibolone Aristo, you notice any of the following conditions:
any of the conditions indicated in the “Do not take Tibolone Aristo” section
yellowing of the skin or whites of the eyes (jaundice). These may be signs of a
liver disease
a marked increase in blood pressure (symptoms may include headache,
fatigue, dizziness)
headaches similar to migraines that occur 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 breathing For more information, see “Blood clots in a vein (thrombosis)”.

Note:Tibolone Aristo is not a contraceptive. If less than 12 months have passed since your last menstrual period or if you are under 50 years of age, you may still need to use an
additional contraceptive to prevent pregnancy. Ask your doctor for advice.

Hormone replacement therapy and cancer
Excessive thickening of the uterine lining (endometrial hyperplasia) and cancer of the
uterine lining (endometrial carcinoma)
Observational studies have consistently shown that women treated with tibolone have an
increased risk of being diagnosed with cancer of the uterine lining. This risk increases with
the duration of treatment.

Irregular bleeding
During the first 3-6 months of treatment with Tibolone Aristo you may experience
irregular bleeding or spotting (small losses of blood). If the bleeding or spotting:
persists beyond the first 6 months
starts after you have been taking Tibolone Aristo for more than 6 months
persists even after you have stopped Tibolone Aristo

→see your doctor as soon as possible.
Breast cancer
Evidence suggests that the combination of estrogen-progestogens and possibly
also estrogen-only hormone replacement therapy increases the risk of breast cancer. The additional risk depends on how long hormone replacement therapy has been started.
The additional risk becomes apparent within a few years. However, within a few years (at
most 5) after stopping treatment, it returns to normal.
Comparison
Women taking Tibolone Aristo have a lower risk than women
undergoing combined hormone replacement therapy and a similar risk in the case of estrogen-only hormone replacement therapy.

Check your breasts regularly. See your doctor as soon as possible if you notice any
changes, such as:
dimples or indentations of the skin
changes in the nipple
any visible or palpable lumps

Ovarian cancer
Ovarian cancer is rare – much rarer than breast cancer. The use of estrogen-only or combined estrogen-progestogen hormone replacement therapy has been associated with a
slight increase in the risk of ovarian cancer.
The risk of ovarian cancer varies depending on age. For example, in women aged between
50 and 54 who are not undergoing hormone replacement therapy, about 2 women out of 2,000
will be diagnosed with ovarian cancer within 5 years. For women who are
undergoing hormone replacement therapy for 5 years, there will be about 3 cases per 2,000 women
treated (i.e. about 1 additional case).
With the use of Tibolone Aristo, the increased risk of ovarian cancer is similar to other types of
hormone replacement therapy.

Effects of hormone replacement therapy on the heart and circulation
Blood clots in a vein (thrombosis)
The risk of blood clots in the veins is approximately 1.3-3 times higher in women undergoing
hormone replacement therapy than in women not undergoing it, especially during the first year
of therapy.
Blood clots can be serious and, if they move to the lungs, can cause chest pain,
shortness of breath, fainting or even death.
You are more likely to develop a blood clot in your veins as you get older and
in the
following cases. If any of these situations apply to you, tell your doctor:
if you are taking estrogens
if you cannot walk for a long time due to major surgery, trauma or
illness (see also section 3, “In case of surgery”). The risk of a
thromboembolic disease may be temporarily increased due to
prolonged immobilization (such as bed rest, a broken leg), serious injuries or
major surgery. In patients using hormone replacement therapy, as with all patients, careful precautionary measures must be followed after
surgery to prevent venous thromboembolic disease.
if you are severely overweight (BMI >30 kg/m )
if you suffer from any blood clotting disorder requiring long-term treatment with an anticoagulant
if any of your close relatives have ever had blood clots in the legs, in the
lungs or in other organs
if you suffer from systemic lupus erythematosus (SLE)
if you have cancer.
For the signs of a blood clot, see the section “Stop taking Tibolone Aristo and
consult
your doctor immediately”.
Comparison
Considering women of 50 years who are not undergoing hormone replacement therapy, it is expected
that on average, over a period of 5 years, 4 to 7 out of 1,000 will develop a blood clot in
a vein.
For women of 50 years undergoing estrogen-progestogen hormone replacement therapy for more than 5 years, the cases will be 9 to 12 out of 1,000 (i.e. 5 additional cases).
With the use of Tibolone Aristo, the increased risk of developing a blood clot in a vein is
lower than with other types of hormone replacement therapy.

Heart disease (heart attack)
There is no evidence that hormone replacement therapy or Tibolone Aristo prevents heart
attack.
Women over the age of 60 undergoing estrogen-progestogen hormone replacement therapy are slightly more likely to develop heart disease than those not undergoing any hormone replacement therapy.
Despite the risk of heart disease depending strongly on age, the number of additional cases of
heart disease is very low in healthy women close to menopause, but increases with
age.
There is no evidence to suggest that the risk of myocardial infarction given by the use of tibolone is
different from the risk given by other hormone replacement therapies.

Stroke
The risk of stroke is approximately 1.5 times higher in women undergoing hormone replacement therapy
than in those not undergoing any hormone replacement therapy. The number of additional cases of stroke due to the use of hormone replacement therapy will increase with age.
Comparison
Considering women of 50 years who are not taking tibolone, it is expected that on average, over a period of
5 years, 3 women out of 1,000 will have a stroke. For women of 50 years
who are taking tibolone, the figure rises to 7 women out of 1,000 (i.e. 4 additional cases).
Considering women of 60 yearswho are not taking tibolone, it is expected that on average, over a period of
5 years, 11 women out of 1,000will have a stroke.
For women of 60 yearswho are taking tibolone, the figure rises to 24 out of 1,000
(i.e. 13 additional cases).

Other conditions
Hormone replacement therapy does not prevent memory loss. There is some evidence
of an increased risk of memory loss in women who start hormone replacement therapy after the age of 65. Ask your doctor for advice.
Treatment with tibolone causes changes in cholesterol levels
Patients with heart or kidney dysfunction: estrogens can cause fluid retention, and
therefore patients with heart or kidney dysfunction must be carefully
monitoredPatients with lipid metabolic disorder (hypertriglyceridemia): women with pre-
existing hypertriglyceridemia must be carefully monitored during therapy with
tibolone, as in this situation rare cases of significant increases
in plasma triglycerides and subsequent pancreatitis with estrogen therapy have been reported.

Other medicines and Tibolone Aristo
Some medicines may interfere with the effect of Tibolone Aristo. This could cause
irregular bleeding. This applies to the following medicines:
medicines against blood coagulation(such as warfarin)
medicines for epilepsy(such as phenobarbital, phenytoin and carbamazepine)
medicines for tuberculosis(such as rifampicin or rifabutin)
herbal remedies containing St John's wort(Hypericum perforatum).
Concomitant use of tibolone may increase the effect of anticoagulants (medicines against
blood coagulation).
Concomitant use with tibolone may have an influence on medicines with active ingredients (such
as midazolam) that are metabolized by certain enzymes (so-called cytochrome-P450 enzymes).
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.
Laboratory tests
If you need a blood test, tell your doctor or laboratory staff that you are
taking Tibolone Aristo because this medicine may affect the results of some tests.

Pregnancy and breastfeeding
Do not take Tibolone Aristo if you are pregnant or if you are breastfeeding.
The use of Tibolone Aristo is reserved for postmenopausal women. If you become pregnant,
stop taking Tibolone Aristo and consult your doctor.

Driving and using machines
Tibolone Aristo has no known effect on the ability to drive vehicles or use
machinery.

Tibolone Aristo contains lactose monohydrate
If your doctor has diagnosed you with intolerance to certain sugars, consult him before taking
this medicine.
For those who practice sports: the use of the drug without therapeutic necessity constitutes doping and
may still result in positive doping tests.

3. How to take Tibolone Aristo

Take this medicine exactly as your doctor has told you. If you have any doubts
consult your doctor or pharmacist.

How much Tibolone Aristo to take and how often
Your doctor will ensure that you are prescribed the lowest dose to treat your symptoms, for the shortest time
possible. Talk to your doctor if you think this dose is too high or not high enough.
Unless your doctor tells you otherwise, the recommended dose is:
One tablet daily after a meal, preferably at the same time each day.
Do not take a progestin preparation in addition to Tibolone Aristo.

How to take Tibolone Aristo
Take the tablets with some water or other beverage, preferably at the same time each
day.

What to consider at the beginning of treatment with Tibolone Aristo
If you have reached menopause naturally, you should not start taking Tibolone Aristo until at least
1 year has passed since your last natural menstrual period. If, however, your ovaries have been
surgically removed, you can start taking Tibolone Aristo immediately.
If you want to start taking Tibolone Aristo and you have experienced irregular or
unexpected vaginal bleeding, contact your doctor before starting treatment with Tibolone Aristo, so that
they can rule out any malignant condition.
If you want to switch to Tibolone Aristo from a medicine containing an estrogen and a
progestin, consult your doctor to find out what needs to be considered.

How long you should take Tibolone Aristo
Your doctor will ensure that the treatment is as short as possible.
Symptoms usually improve within a few weeks.

If you take more Tibolone Aristo than you should
If you have taken an overdose of Tibolone Aristo, contact your doctor or
pharmacist immediately.
Symptoms of toxicity are unlikely, even if you take more than one tablet
at a time. In the event of an acute overdose, you may feel unwell
(nausea), vomit and experience withdrawal bleeding. Contact your doctor so that these
symptoms can be treated.

If you forget to take Tibolone Aristo
If you forget to take a tablet at the usual time, take it as soon as possible, unless
more than 12 hours have passed since the missed dose. In this case, skip the missed tablet
and take the next tablet at the usual time.
Do not take a double dose.
If you have any questions about the use of Tibolone Aristo, ask your doctor or pharmacist.

If you are to have surgery
If you are about to have surgery, tell the surgeon that you are taking Tibolone
Aristo. It may be necessary to stop taking Tibolone Aristo approximately 4-6
weeks before the surgery, in order 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
Aristo again.

4. Possible side effects

The following conditions are reported more frequently in women undergoing hormone replacement therapy
than in those who are not:
breast cancer
abnormal growth or tumor of the uterine lining (endometrial hyperplasia or endometrial
cancer)
ovarian cancer
blood clots in the veins of the legs or lungs (venous thromboembolism)
heart disease
stroke
probable memory loss if hormone replacement therapy is started after the age of 65.
For further information on these side effects, see paragraph 2 “What you need to know
before taking Tibolone Aristo”.
Like all medicines, Tibolone Aristo can cause side effects, although not everyone will experience them.

Tell your doctor or pharmacistif you are concerned about any side effects that
you believe
may be due to Tibolone Aristo (see also paragraph 2 “Stop taking Tibolone
Aristo and consult your doctor immediately”).
Common side effects that have been observed in clinical studies (affect up to 1 in 10 women):
vaginal bleeding or spotting
stomach pain
weight gain
breast pain
unusual hair growth
vaginal problems, such as increased discharge, itching and irritation
thickening of the uterine lining
vaginal fungal infection (e.g. candidiasis)
pelvic pain
changes in cervical tissue
inflammation of the lips and vagina (so-called vulvovaginitis)
cervical smear abnormalities
Uncommon side effects (affect up to 1 in 100 women):
acne
painful nipples or breasts
fungal infections
Other side effects reported with Tibolone Aristo following its marketing:
dizziness, headache, migraine
depression
skin problems such as rash or itching
loss of vision or blurred vision
stomach pain or intestinal disorders
fluid retention
joint pain or muscle pain
changes in liver function tests
In women using Tibolone Aristo, cases of uterine lining cancer, breast cancer and stroke have been reported (see "Warnings and precautions" in paragraph 2).
The following side effects have been reported with other hormone replacement therapies:
gallbladder disease
various skin disorders:
skin discoloration, especially on the face or neck, a condition known as
"chloasma" or "pregnancy spots"
painful, reddish skin nodules (erythema nodosum)
skin rash with redness or target-shaped blisters (erythema multiforme)
skin bleeding (vascular purpura)
Talk to your doctor if you experience irregular vaginal bleeding or spotting or if you experience any of the
above side effects or if they worsen.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.
You can also report side effects directly through the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Tibolone Aristo

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 package/blister after Exp.
The expiry date refers to the last day of that month.
Do not use this medicine if you notice that the blister is damaged.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.
This medicine does not require any particular storage conditions.

6. Contents of the pack and other information

What Tibolone Aristo contains

• The active ingredient is Tibolone. Each tablet contains 2.5 mg of tibolone.
• The other ingredients are: potato starch, lactose monohydrate, magnesium stearate ( PhEur) (of vegetable origin), ascorbic acid palmitate ( PhEur).

Description of the appearance of Tibolone Aristo and contents of the pack
Tibolone Aristo is presented in the form of round, flat tablets, of a colour ranging from white to off-white,
with a diameter of approximately 6 mm.
Tibolone Aristo is available in packs of 1x28 tablets and 3x28 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Germany

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Belgium Tibolone Aristo 2.5 mg tabletten/comprimés/Tabletten
Finland Tibolon Aristo 2.5 tabletit
Ireland Tibolone Aristo 2.5 mg tablets
Italy Tibolone Aristo 2.5 mg compresse
Norway Tibolon Aristo 2.5 mg tablets
Poland Tibolone Aristo
Slovakia Tibolónu Aristo 2.5 mg tablety
Spain Tibolona Aristo 2.5 mg comprimidos EFG
Sweden Tibolon Aristo 2.5 mg tabletter
United Kingdom Tibolone 2.5 mg tablets
Czech Republic Tibolon Aristo