Tibiole Tablet (Tibolone)

Adult dose

This medication is taken as one tablet daily at the same time. It is recommended to take the tablet with water or other beverages at the same time every day. No dosage adjustment is needed for the elderly.

This medication should not be used by pregnant or breastfeeding women as it may be harmful to the fetus or baby if taken during pregnancy or breastfeeding. Patients with or suspected of having breast cancer, or those with a history of breast cancer should not take this medication as it may increase the risk of breast cancer recurrence. Patients with estrogen-dependent malignancies, such as suspected or existing endometrial cancer, should also not use this medication. This medication may pose risks if there is unexplained vaginal bleeding or untreated endometrial hyperplasia. Patients who have previously or currently experienced venous thrombosis or embolism should not take this medication due to a high risk of thrombus formation. Patients with thromboembolic disease or a history of arterial thrombosis should also avoid using this medication. It is safest not to use this medication if there are liver function issues or acute liver disease that have not returned to normal function. Patients with hypersensitivity to any components or excipients of this medication should avoid taking it. Patients with a specific condition called porphyria should also not use this medication. This medication contains lactose and should not be given to patients with lactose intolerance or related genetic disorders. If symptoms such as jaundice, worsening liver function, increased blood pressure, or migraines occur, the medication should be discontinued immediately. Patients with specific conditions or a history of conditions such as uterine tumors, endometriosis, hypertension, diabetes, gallstones, migraines, systemic lupus erythematosus, epilepsy, or asthma should be closely monitored while taking this medication. During treatment with this medication, there may be abnormal symptoms related to the breast or uterus, bleeding, or pain, so any such changes should be discussed with a physician. Due to the serious side effects risk including breast cancer, endometrial cancer, stroke, and thrombosis, regular check-ups and risk assessments are necessary for prolonged use of this medication. This medication may affect blood coagulation, so dosage adjustments and caution are required when used together with anticoagulants. When taken with medications that induce specific liver enzymes, the effectiveness of this medication may be reduced, so it is essential to inform healthcare providers about all medications being taken. If this medication is taken during pregnancy, it should be discontinued immediately, as there is insufficient clinical data to fully determine the risks to the fetus. In case of overdose, symptoms may include vomiting, nausea, vaginal bleeding, etc., and since there is no specific antidote, symptomatic treatment is necessary. This medication should be kept out of reach of children and stored securely in its original packaging. This medication cannot be used for contraceptive purposes, and the patient’s health status and medical history must be carefully reviewed before and during treatment with regular check-ups.

Serious side effects

Jaundice or liver function deterioration, significant blood pressure increase, headache resembling migraines, increased risk of breast cancer recurrence, increased risk of endometrial cancer, stroke, venous thromboembolism (VTE), myocardial infarction, ischemic stroke, increased risk of thrombosis in patients with a history of thrombus formation

Mild side effects

• Lower abdominal pain
• abnormal hair growth
• acne
• vaginal discharge
• increased endometrial thickness
• postmenopausal bleeding
• breast tenderness
• genital itching
• vaginal candidiasis
• vaginal bleeding

This medication should be stored in a tightly closed container to protect it from air and moisture. It is recommended to keep it in a cool room temperature below 25 degrees Celsius.

Appearance

White oblong tablet

Package unit

28 tablets (28 tablets/PTP X 1)