Medication info

Gunil Estradiol Valerate Tablet

Prescription medication경구Approval withdrawn
Ingredient · strength
Estradiol Valerate›2mg / 1 tablet
Manufacturer / importer
건일제약(주)
Appearance
Blue to light blue, biconvex, round tablet
Packaging
28 tablets/PTP [28 tablets/PTP x 1]
Approval status
Approval withdrawn

MFDS item code 202300636 · Notified 2023.02.21

This product's status changed to Approval withdrawn on 2024.04.08. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Effect for menopausal symptoms and prevention of osteoporosis
Who takes it
Adults · Children
Adult dose
Take 1 mg or 2 mg of estradiol valerate orally after a meal once daily. Continue treatment and take the next new package immediately without stopping. Adjust dosage appropriately based on treatment progression. Women with a uterus must also take progestogen preparations for 12 days each month. Women receiving periodic, sequential combination hormone replacement therapy should start taking this medication the day after the previous treatment has completely concluded.
Child dose
This medication is not used in children and adolescents.

Ingredients

Manufacturer
건일제약(주)

Efficacy & effects

Effect for menopausal symptoms and prevention of osteoporosis

  • Menopausal symptoms
  • Osteoporosis
View approved original text

This medication is used to relieve menopausal symptoms in women during menopause and to prevent osteoporosis in women at high risk of fractures. Especially for women with a uterus, it is important to take progestogen preparations for 12 days each month, so adhering to the correct dosing method is essential. This treatment helps alleviate menopausal discomfort and maintain bone health.

How to take

Adult dose

Take 1 mg or 2 mg of estradiol valerate orally after a meal once daily. Continue treatment and take the next new package immediately without stopping. Adjust dosage appropriately based on treatment progression. Women with a uterus must also take progestogen preparations for 12 days each month. Women receiving periodic, sequential combination hormone replacement therapy should start taking this medication the day after the previous treatment has completely concluded.

Child dose

This medication is not used in children and adolescents.

Precautions

This medication can increase the risk of endometrial cancer in postmenopausal women, so women with a uterus may require additional hormone therapy under a doctor's supervision. There is a risk of thrombosis, particularly deep vein thrombosis or pulmonary embolism, so careful monitoring is necessary if risk factors are present, and usage should be immediately discontinued if symptoms occur. If new or worsening severe headaches or migraines occur, therapy should be stopped, and if sudden vision disturbances appear, such as symptoms of vascular occlusion, treatment must be halted immediately. If jaundice, liver function abnormalities, increased blood pressure, or worsening seizures occur, use should be discontinued immediately, and pregnant or potentially pregnant women or breastfeeding mothers should not use this medication. Patients with estrogen-dependent tumors or a history of cardiovascular disease or thromboembolism, as well as those with severely impaired liver or kidney function, should not take this medication. Patients with a history of migraines, hypertension, diabetes, liver disease, asthma, or such specific conditions, or with a family history require careful administration and regular check-ups and monitoring. This medication may interact with other drugs, so it is essential to discuss current medications with a doctor or pharmacist. It should never be taken during pregnancy or breastfeeding, and if pregnancy is confirmed while taking this medication, it must be discontinued immediately. This medication is not used for children and adolescents due to the potential for side effects such as premature closure of growth plates. Long-term use of this medication may increase the risk of breast cancer, endometrial cancer, and ovarian cancer, making regular cancer screenings and gynecological exams very important. If prolonged immobility is anticipated before and after a surgery, it is recommended to temporarily stop this medication 4-6 weeks prior to surgery and resume once recovery and activity have returned post-surgery. This medication should be stored out of reach of children and kept in its original container to prevent misuse or deterioration in quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with fever, blisters, skin peeling, pain of oral/ocular mucosa, difficulty breathing or shortness of breath, asthma attacks, cough with fever accompanied respiratory distress, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and extremely severe headaches, thunderclap headaches, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

Weight gain or loss, depressed mood, anxiety, decreased or increased libido, headache, dizziness, migraine, intolerance to contact lenses, palpitations, abdominal pain, nausea, dyspepsia, abdominal bloating, vomiting, rash, itching, nodular erythema, hives, hirsutism, acne, muscle cramps, including uterine/vaginal bleeding in the form of petechiae, breast pain, breast tenderness, menstrual pain, vaginal discharge, premenstrual syndrome, breast size increase, edema

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

Storage

This medication should be stored in a tightly sealed container to prevent air or moisture from entering, at room temperature between 1 to 30 degrees Celsius. Storing it this way helps maintain its efficacy and safety.

Appearance and packaging

Appearance

Blue to light blue, biconvex, round tablet

Package unit

28 tablets/PTP [28 tablets/PTP x 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.