Medication info

Hanok Farm Biotibolone Tablet

Prescription medicationTablet경구Expired
Ingredient · strength
Tibolone›2.5mg / 1 tablet
Manufacturer / importer
(주)한국팜비오
Appearance
White rectangular tablet
Packaging
28 tablets (28 tablets/PTP × 1)
Approval status
Expired

MFDS item code 201907968 · Approved 2019.11.18

This product's status changed to Expired on 2024.11.18. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of estrogen deficiency symptoms and prevention of osteoporosis
Who takes it
Adults
Adult dose
This medication is taken once daily, one tablet at the same time every day. The tablet should be taken with water or other beverages, and it is recommended to take it at the same time every day.

Ingredients

Manufacturer
(주)한국팜비오

Efficacy & effects

Improvement of estrogen deficiency symptoms and prevention of osteoporosis

  • Estrogen deficiency symptoms
  • osteoporosis
View approved original text

This medication is used to relieve symptoms caused by estrogen deficiency in women who have been postmenopausal for one year. It is also effective in preventing osteoporosis in postmenopausal women at high risk of fractures who cannot use other osteoporosis prevention medications or have intolerances. In other words, it helps manage hormonal changes due to menopause and maintain bone health.

How to take

Adult dose

This medication is taken once daily, one tablet at the same time every day. The tablet should be taken with water or other beverages, and it is recommended to take it at the same time every day.

Precautions

This medication should not be used by pregnant or breastfeeding women. It should not be taken by individuals with or suspected of having breast cancer or estrogen-dependent tumors. Patients with undiagnosed vaginal bleeding or untreated endometrial hyperplasia should also not use this medication. Patients with a history or current condition of thromboembolism or thrombotic diseases should avoid this medication due to potential risks. Additionally, patients with severe liver dysfunction should also refrain from using this drug. Patients who have hypersensitivity to this medication or have lactose intolerance or certain genetic metabolic disorders should not take it. During treatment, if symptoms such as liver function deterioration, elevated blood pressure, or severe headaches occur, use should be immediately discontinued. Patients with existing conditions such as leiomyomas, endometriosis, hypertension, diabetes, migraines, systemic lupus erythematosus, or asthma should use this medication cautiously and must be monitored carefully as symptoms may worsen or recur. While taking this medication, regular examinations should be conducted to ensure there are no abnormalities in the breasts or uterus, and if bleeding or pain persists, a doctor's consultation is necessary. This medication may increase the risk of thrombosis, stroke, breast cancer, endometrial cancer, and ovarian cancer, so women over 60 should carefully evaluate these risks before using it. Additionally, this drug can affect blood clotting when used with anticoagulants, so dosage adjustments according to a doctor's instructions are necessary if taken together. In case of overdose, symptoms such as vomiting and vaginal bleeding may occur, and there is no specific antidote, so appropriate treatment should be given based on the symptoms. This medication should be kept out of reach of children, and it is important to maintain the original packaging. It must not be used during pregnancy, and if pregnancy is confirmed, it should be stopped immediately.

Side effects and when to seek care immediately

Serious side effects

Migraine-type headache, significant increase in blood pressure, jaundice or liver function deterioration, endometrial cancer, breast cancer, ovarian cancer, venous thromboembolism (deep vein thrombosis or pulmonary embolism), stroke (including ischemic stroke), myocardial infarction, angina, increased risk of ischemic stroke, hemorrhagic stroke, petechiae

Mild side effects

Lower abdominal pain, abnormal hair growth, acne, vaginal discharge, increased thickness of the endometrial wall, postmenopausal bleeding, breast tenderness, vulvar itching, vaginal candidiasis, vaginal bleeding, pelvic pain, cervical dysplasia, genital discharge, vulvovaginitis, breast discomfort, fungal infections, vaginal mycosis, nipple pain, weight gain, dizziness, rash, itching, seborrheic dermatitis, headache, migraine, visual disturbances (including blurred vision), gastrointestinal disturbances

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a sealed container to prevent the ingress of air and moisture, preferably at room temperature below 25 degrees Celsius. By storing in this manner, the effectiveness of the medication can be maintained for a longer period.

Appearance and packaging

Appearance

White rectangular tablet

Package unit

28 tablets (28 tablets/PTP × 1)

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.