Tibolone Aristo

Package Leaflet: Information for the User

Tibolone Aristo, 2.5 mg, Tablets

Tibolone

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Tibolone Aristo and what is it used for
• 2. Important information 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

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

Tibolone Aristo is used for hormone replacement therapy (HRT). It contains tibolone, a synthetic sex hormone. Tibolone Aristo is used for women who have undergone menopause, at least 12 months after their last natural menstrual period.

Relief of symptoms occurring after menopause.

During menopause, the amount of estrogen produced by the woman's body decreases. This can cause symptoms such as hot flashes on the face, neck, and chest.

Tibolone Aristo relieves these symptoms after menopause. Tibolone Aristo will only be prescribed if the above symptoms significantly impair the patient's daily life.

2. Important information before taking Tibolone Aristo

Medical history and regular check-ups

Taking HRT or Tibolone Aristo involves risks that need to be analyzed before deciding to start or continue taking the medicine.

When not to take Tibolone Aristo

If any of the following conditions apply to you, or if you are unsure about any of the following points, consult your doctor before taking Tibolone Aristo:

If you have or have had breast cancer, or if there is a suspicion of breast cancer.

If you have an estrogen-dependent tumor, such as endometrial cancer, or if there is a suspicion of such a tumor.

If you have vaginal bleeding of unknown origin.

If you have untreated endometrial hyperplasia (thickening of the lining of the uterus).

If you have or have had blood clots in the veins (thrombosis), such as deep vein thrombosis or pulmonary embolism.

If you have blood clotting disorders (e.g., protein C, protein S, or antithrombin deficiency).

If you have or have had diseases caused by blood clots in the arteries, such as heart attack, stroke, or angina.

If you have or have had liver disease and liver function tests have not returned to normal.

If you have a rare blood disorder called porphyria, which is inherited.

If you are allergic 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 occur for the first time while taking Tibolone Aristo, stop taking the medicine and consult your doctor immediately.

Warnings and precautions

Before taking Tibolone Aristo, discuss with your doctor or pharmacist.

Stop taking Tibolone Aristo and contact your doctor immediately

if any of the following conditions occur while taking HRT or Tibolone Aristo:

• any of the conditions listed in "When not to take Tibolone Aristo"
• jaundice (yellowing of the skin or whites of the eyes)
• a significant increase in blood pressure
• a migraine headache for the first time
• if you become pregnant
• if you experience symptoms of a blood clot, such as:

swelling and redness of the legs

sudden chest pain

difficulty breathing

HRT and cancer

Endometrial hyperplasia (thickening of the lining of the uterus) and endometrial cancer

Observational studies have shown that women taking tibolone (the active substance in Tibolone Aristo) have an increased risk of developing endometrial cancer. This risk increases with the duration of treatment.

Irregular bleeding

Irregular bleeding or spotting may occur during the first 3-6 months of taking Tibolone Aristo. However, if bleeding or spotting:

continues for more than 6 months

starts after 6 months of taking Tibolone Aristo

continues after stopping Tibolone Aristo

→ consult your doctor immediately.

Breast cancer

Data confirm that taking tibolone increases the risk of breast cancer. The additional risk depends on the duration of treatment.

Check your breasts regularly. Consult your doctor if you notice any of the following changes:

dimpling of the skin

changes in the nipple

any lumps that can be seen or felt

Ovarian cancer

Ovarian cancer is rare, much rarer than breast cancer. Taking HRT that contains only estrogen or a combination of estrogen and progestogen has been associated with a slightly increased risk of ovarian cancer.

Effect of HRT on the heart and blood vessels

Blood clots in the veins (thrombosis)

The risk of blood clots in the veins is about 1.3 to 3 times higher in women taking HRT than in women not taking HRT, especially in the first year of treatment.

Heart disease (heart attack)

There is no evidence that HRT or Tibolone Aristo prevents heart attacks.

Stroke

The risk of stroke is 1.5 times higher in women taking HRT than in women not taking HRT.

Other conditions

HRT does not prevent memory loss. There is some evidence that starting HRT after the age of 65 may increase the risk of memory loss.

Tibolone Aristo and other medicines

Certain medicines may affect the action of Tibolone Aristo, which may lead to irregular bleeding. These include:

blood-thinning medicines (e.g., warfarin)

medicines for epilepsy (e.g., phenobarbital, phenytoin, and carbamazepine)

medicines for tuberculosis (e.g., rifampicin or rifabutin)

herbal preparations containing St. John's Wort (Hypericum perforatum)

Laboratory tests

If a blood test is required, inform your doctor or laboratory staff that you are taking Tibolone Aristo, as this medicine may affect the results of some tests.

Pregnancy and breastfeeding

Do not take Tibolone Aristo if you are pregnant or breastfeeding.

Driving and using machines

Tibolone Aristo does not affect the ability to drive or use machines.

Tibolone Aristo contains lactose monohydrate

If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Tibolone Aristo

Always take this medicine exactly as your doctor has told you.

What dose of Tibolone Aristo to take and how often

Your doctor will prescribe the lowest dose that relieves your symptoms for the shortest possible time.

How to take Tibolone Aristo

Take the tablets with a small amount of water or other liquid, preferably at the same time each day.

What to consider before starting Tibolone Aristo

If menopause occurred naturally, start taking Tibolone Aristo at least 1 year after your last natural menstrual period.

How long to take Tibolone Aristo

Your doctor will decide on the shortest possible treatment duration.

If you take more Tibolone Aristo than you should

If you take more Tibolone Aristo than you should, contact your doctor or pharmacist immediately.

If you forget to take Tibolone Aristo

If you forget to take a tablet at the usual time, take it as soon as possible, provided it is within 12 hours of the missed dose.

If you need to have surgery

If you are going to have surgery, tell your surgeon that you are taking Tibolone Aristo.

4. Possible side effects

The following diseases have been reported more frequently in patients taking HRT compared to patients not taking HRT:

breast cancer

endometrial hyperplasia or cancer

ovarian cancer

blood clots in the veins

heart disease

stroke

possible memory loss if HRT is started after the age of 65

Like all medicines, Tibolone Aristo can cause side effects, although not everybody gets them.

How to report side effects

If you get any side effects, talk to your doctor or pharmacist.

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 carton and blister after EXP.

There are no special storage instructions for this medicine.

Do not use this medicine if you notice any damage to the blister.

Medicines should not be disposed of via wastewater or household waste.

6. Contents of the pack and other information

What Tibolone Aristo contains

• The active substance is tibolone. Each tablet contains 2.5 mg of tibolone.
• The other ingredients are: lactose monohydrate, potato starch, ascorbyl palmitate, magnesium stearate.

What Tibolone Aristo looks like and contents of the pack

Tibolone Aristo is a white or almost white, flat, round tablet with a diameter of about 6 mm.

Tibolone Aristo is available in packs of 1 x 28 tablets, 1 x 30 tablets, and 3 x 28 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Aristo Pharma Sp. z o.o.
Baletowa 30
02-867 Warsaw

Manufacturer

Aristo Pharma GmbH
Wallenroder Str. 8-10
13435 Berlin
Germany

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Spain:
Tibolona Aristo 2,5 mg comprimidos EFG

Germany:
Tibolon Aristo 2,5 mg Tabletten

Belgium:
Tibolone Aristo 2,5 mg tabletten/comprimés/Tabletten

Italy:
Tibolone Aristo

United Kingdom:
Tibolone 2.5 mg tablets

Czech Republic:
Tibolon Aristo

Ireland:
Tibolone Aristo 2.5 mg tablets

Poland:
Tibolone Aristo

Slovakia:
Tibolónu Aristo 2,5 mg tablety

Sweden:
Tibolon Aristo 2,5 mg tabletter

Norway:
Tibolon Aristo 2,5 mg tablets

Finland:
Tibolon Aristo 2,5 tabletit

Date of last revision of the leaflet:November 2023