Tibolone 2,5 mg

Tibolone 2,5 mg Dyna 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 and also in women who had their ovaries removed. Unlike some other medicines used for hormone replacement therapy, Tibolone 2,5 mg Dyna does not stimulate the lining of the womb. Treatment with Tibolone 2,5 mg Dyna therefore does not lead to monthly vaginal bleeding.

This medicine is used for:

• relief of symptoms occurring after menopause: During 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 2,5 mg Dyna alleviates these symptoms after menopause. You will only be prescribed this medicine if your symptoms seriously hinder your daily life.
• prevention of osteoporosis: After menopause some women may develop fragile bones (osteoporosis).
• improvement of bone-mineral density in post-menopausal osteoporosis: If you are at an increased risk of fractures due to osteoporosis and other medicines are not suitable for you, you can use Tibolone 2,5 mg Dyna to prevent fractures after menopause.

Do not take Tibolone 2,5 mg Dyna:

• if you are hypersensitive (allergic) to tibolone or any of the other ingredients of Tibolone 2,5 mg Dyna (see section 6)
• if you have or have ever had a blood clot in a vein (thrombosis), such as in the legs (deep venous thrombosis - DVT) or the lungs (pulmonary embolism)
• if you have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency), including an inherited disorder that makes your blood more likely to clot
• if you have or have ever had a liver disease and your liver function tests have not returned to normal
• if you have inherited genetic mutations: BRCA1 and BRCA2 genes, as you have a higher risk of developing cancer
• in the case of early menstrual periods (before the age of 12 years)
• if you have ever had other non-cancerous breast diseases such as atypical hyperplasia (a precancerous condition that affects cells in the breast) or lobular carcinoma in situ (abnormal cells growing in the lining of the milk glands)
• if you have ever had treatment using radiation therapy to the chest or breast
• if you have ever been exposed to diethylstilbestrol (DES), a synthetic oestrogen medicine
• 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 been diagnosed with thrombophlebitis (a condition that causes a blood clot to form and block one or more veins, often in the legs)
• 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 a rare blood problem called “porphyria” which is passed down in families (inherited)
• if you are pregnant, think you might be pregnant or are breastfeeding your baby.

Warnings and precautions

Take special care with Tibolone 2,5 mg Dyna:

Tibolone 2,5 mg Dyna 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. If you have started menopause you should not take Tibolone 2,5 mg Dyna until 12 months after your last natural period. If you take it sooner than this you may have irregular bleeding.

Stop taking Tibolone 2,5 mg Dyna and see a doctor immediately if any of the following occur:

• 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.

Do not share medicines prescribed for you with any other person. Always take Tibolone 2,5 mg Dyna exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Adults: The usual dose is one tablet daily, preferably at the same time each day. Swallow the tablet whole with a little water.

Natural menopause: Wait for 12 months after your last period before you start taking Tibolone 2,5 mg Dyna.

Menopause as a result of surgery: If you have had a hysterectomy or you are being treated for endometriosis you can start taking Tibolone 2,5 mg Dyna immediately. Your doctor will tell you how long your treatment with Tibolone 2,5 mg Dyna will last. Do not stop treatment early because your symptoms may return.

If you have the impression that the effect of Tibolone 2,5 mg Dyna is too strong or too weak, tell your doctor or pharmacist.

If you take more Tibolone 2,5 mg Dyna than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. Symptoms of overdose may include:

• nausea, vomiting and vaginal bleeding

Take this leaflet and the rest of the remaining Tibolone 2,5 mg Dyna with you so the doctor will know what you have taken.

If you forget to take Tibolone 2,5 mg Dyna: If you forget to take Tibolone 2,5 mg Dyna, take as soon as you remember on the same day, unless you are more than 12 hours late. If you are more than 12 hours late, just skip it, and take your next tablet the next day. Do not take a double dose to make up for forgotten individual doses.

Tibolone 2,5 mg Dyna can have side effects. Not all side effects reported for Tibolone 2,5 mg Dyna are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while using Tibolone 2,5 mg Dyna, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, stop using Tibolone 2,5 mg Dyna and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• fainting

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to Tibolone 2,5 mg Dyna. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• your blood pressure rises
• your skin or the whites of your eyes go yellow (jaundice)
• you suddenly have migraine-type headaches (see section 2 above)
• you have signs of a blood clot (painful swelling and redness of the legs, sudden chest pain, difficulty in breathing)
• stroke (presenting with symptoms such as trouble walking, speaking and understanding as well as paralysis or numbness of the face, arm or leg).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• lower abdominal pain
• abnormal hair growth
• vaginal problems such as discharge, itching, irritation, vaginal bleeding or spotting, breast tenderness, pelvic pain, thickening of the lining of the womb or the lining of the cervix
• weight increase, abnormal pap-smear test results

Less frequent side effects:

• acne
• breast discomfort, fungal infection, vaginal thrush (yeast infection), nipple pain
• memory loss

The following side effects have been reported but the frequency for them to occur is not known:

• fluid retention (swollen hands, ankles or feet)
• gastrointestinal upset, abdominal discomfort
• depression
• dizziness, headache, migraine
• visual disturbances, blurred vision
• liver problems
• skin problems such as rash or itching, scaly patches and red skin, itchy skin
• joint pain, muscle pain.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website.

By reporting side effects, you can help provide more information on the safety of Tibolone 2,5 mg Dyna. You can also send an email directly to the company, [email protected], to ensure safety of the product.

Store all medicines out of reach of children. Store at or below 30 °C. Store in the original package in order to protect from light and moisture. Do not use after the expiry date stated on the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).