Medication info

SDIOL Half Tablet

Prescription medicationApproval withdrawn
Ingredient · strength
Estradiol Hemihydrate›Strength being verifiedNorethisterone Acetate›Strength being verified
Manufacturer / importer
(주)대웅제약
Appearance
Pink round film-coated tablet
Packaging
28 tablets (28 tablets/PTP) × 1
Approval status
Approval withdrawn

MFDS item code 200403226 · Notified 2004.04.29

This product's status changed to Approval withdrawn on 2023.02.28. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Relief of estrogen deficiency symptoms and prevention of osteoporosis
Who uses it
Adults
Adult dosage
Administer orally once daily, as close to the same time as possible without interruption.

Ingredients

Manufacturer
(주)대웅제약

Efficacy & effects

Relief of estrogen deficiency symptoms and prevention of osteoporosis

  • Estrogen deficiency symptoms
View approved original text

This medication is used for hormone replacement therapy to alleviate symptoms caused by estrogen deficiency in postmenopausal women who have not undergone a hysterectomy, and it also has a preventive effect on osteoporosis for postmenopausal women at high risk of fractures. This helps effectively manage various symptoms that may occur after menopause and skeletal health.

Dosage and Administration

Adult dosage

Administer orally once daily, as close to the same time as possible without interruption.

Precautions

This drug should not be used in patients with or suspected of having estrogen-dependent malignant tumors such as breast cancer or endometrial cancer. Patients with poor liver function or a history of liver disease, as well as those with a history of thrombosis or cardiovascular disease should not take this drug. It should not be administered to women who are pregnant or may become pregnant, nor to breastfeeding women, and patients with certain genetic metabolic disorders should also avoid it. Caution should be exercised when using this drug in patients with a history or current symptoms of uterine fibroids, thrombosis risk factors, hypertension, diabetes, liver disease, or migraines. Irregular bleeding may commonly appear at the beginning of treatment but tends to decrease over time; if persistent bleeding or abnormal symptoms occur, consult a physician immediately. This drug can cause various side effects such as thrombosis, liver tumors, breast pain, swelling, headaches, and skin rashes, so notify healthcare professionals immediately if unusual symptoms occur. Prior to and during hormone replacement therapy, regular physical examinations for blood pressure, breasts, uterus, blood sugar, etc., should be conducted, and treatment may be suspended if adverse findings arise. This drug should be discontinued 4 to 6 weeks prior to surgery, and the risk of thrombosis increases in cases of prolonged immobility, so caution is needed. This drug is not a contraceptive, so separate measures for pregnancy prevention are necessary. The effectiveness may decrease when taken with drugs that induce liver enzymes, and some antibiotics may reduce serum concentrations. Women who are pregnant or may become pregnant should not take this drug, and if pregnancy is confirmed, the drug should be discontinued immediately. Keep out of reach of children, and store in the original container to prevent misuse or deterioration of quality.

Side effects and when to seek care immediately

Serious side effects

  • Allergy
  • severe swelling (edema)
  • thromboembolism
  • increased blood pressure
  • deep vein thrombosis
  • cerebrovascular disorders
  • severe hypertriglyceridemia
  • cholestatic jaundice
  • cholestasis
  • non-jaundiced hepatitis
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  • liver tumors
  • liver adenoma
  • jaundice
  • migraine headaches
  • severe headaches
  • visual disturbances
  • marked increase in blood pressure
  • difficulty breathing
  • thrombotic diseases
  • thrombosis
  • venous or arterial thrombosis
  • endometrial cancer
  • breast cancer
  • heart problems
  • stroke
  • pulmonary embolism

Mild side effects

Headache, dizziness, migraine, visual disturbances, contact lens intolerance, palpitations, abdominal pain, nausea, dyspepsia, abdominal bloating, vomiting, rash, itching, nodular erythema, hirsutism, acne, muscle cramps, scattered bleeding including uterine/vaginal bleeding, breast pain, breast tenderness, dysmenorrhea, vaginal discharge, premenstrual syndrome, breast size increase, swelling, fatigue

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 and moisture from entering. Also, be careful not to freeze it, and store in a cool, dry place. It is advised to store below 25 degrees Celsius, avoiding direct sunlight.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

28 tablets (28 tablets/PTP) × 1

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.