Medication info

Diane 35 Tablets

Prescription medication경구 · 점이Approval withdrawn
Ingredient · strength
Cyproterone Acetate›2mg / 1 tabletEthinyl Estradiol›0.035mg / 1 tablet
Manufacturer / importer
바이엘코리아(주)
Appearance
Beige circular film-coated tablet
Packaging
21 tablets (21 tablets/PTP packaging x 1)
Approval status
Approval withdrawn

MFDS item code 200800969 · Notified 2008.01.24

This product's status changed to Approval withdrawn on 2024.11.05. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of androgen-dependent diseases (acne, hirsutism)
Who uses it
Adults
Adult dosage
Take 1 tablet daily for 21 days as indicated in order, and then have a 7-day break. It is advisable to take it at the same time each day if possible. Bleeding is expected during the 7-day break and usually starts within 2 to 3 days after the last tablet taken. Menstruation may not have ended by the time the new pack is started. When continuing to take this medication, start taking the new pack's tablets after the 7-day break.

Ingredients

Importer
바이엘코리아(주)

Efficacy & effects

Treatment of androgen-dependent diseases (acne, hirsutism)

  • Moderate acne
  • severe acne
  • seborrhea-associated acne
  • androgenic hirsutism
View approved original text

This medication is used to treat moderate to severe acne and androgen-dependent hirsutism in women of childbearing age. It is particularly effective for acne treatment regardless of whether seborrhea is present. However, this medication is recommended only after conventional treatments such as topical agents or systemic antibiotics have failed for acne. Therefore, it helps improve symptoms when previous treatments have been insufficient.

Dosage and Administration

Adult dosage

Take 1 tablet daily for 21 days as indicated in order, and then have a 7-day break. It is advisable to take it at the same time each day if possible. Bleeding is expected during the 7-day break and usually starts within 2 to 3 days after the last tablet taken. Menstruation may not have ended by the time the new pack is started. When continuing to take this medication, start taking the new pack's tablets after the 7-day break.

Precautions

This medication should not be used in combination with other hormonal contraceptives. It consists of the ingredients cyproterone acetate and ethinylestradiol, and is taken for 21 days in a month cycle. The components of this medication are similar to those of combined oral contraceptives, thus similar precautions apply when using it. Smoking increases the risk of cardiovascular side effects, especially thrombosis, while taking this medication, so women over 35 should avoid smoking. This medication should not be administered to patients with breast cancer or genital cancer, those with thrombosis or heart disease, patients with liver dysfunction, pregnant or potentially pregnant women, nursing mothers, and those with certain genetic disorders. Patients with heart disease, kidney disease, hypertension, diabetes, migraine, epilepsy, multiple sclerosis, and varicose veins should use this medication with caution and must consult a physician. While taking this medication, side effects such as nausea, abdominal pain, headache, depressive symptoms, and breast pain may occur, and serious side effects such as thrombosis have also been reported. Before taking the medication, it is essential to consult a physician, and during treatment, regular checks on blood pressure, breast, and cervical health should be conducted. The medication should be discontinued before surgery or if there is a prolonged period of immobility, and despite irregular bleeding, continuing the medication is generally recommended as it will usually resolve naturally. If symptoms of depression worsen, discontinue use and consult a physician, and if any symptoms of liver dysfunction, early symptoms of thrombosis, sudden vision changes, or severe headaches occur, discontinue use immediately and seek medical attention. The risk of thrombosis may increase due to factors such as age, smoking, family history, obesity, hypertension, and migraines, so particular care should be taken if these risk factors are present. This medication may interact with certain drugs, so inform your physician or pharmacist if you are taking other medications. Pregnant or nursing women should not take this medication, and if pregnancy is confirmed, discontinue use immediately. In cases of overdose, symptoms such as nausea, vomiting, and bleeding may occur, but no specific antidote is available and treatment will be symptom-based. This medication may affect some clinical test results, so inform healthcare personnel about its use before any testing.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions, thrombosis, thromboembolic diseases, cerebrovascular accidents, liver tumors, malignant liver tumors, cholestatic jaundice, liver dysfunction, hemolytic uremic syndrome, intra-abdominal bleeding, myocardial infarction, pulmonary embolism, deep vein thrombosis, symptoms of cerebrovascular disorder (headache, confusion, vision changes, paralysis, etc.), acute abdomen, sudden partial or complete blindness, sudden exophthalmos, diplopia, significant increase in blood pressure, acute or chronic liver failure

Mild side effects

Nausea, abdominal pain, weight gain, headache, depressive symptoms, mood changes, breast pain, breast tenderness, intolerance to contact lenses, vomiting, diarrhea, fluid retention, weight loss, migraine, decreased libido, increased libido, breast enlargement, vaginal discharges, breast secretions, rash, nodular erythema, erythema multiforme, increased blood pressure, intermenstrual bleeding, changes in menstrual flow, cervical erosion and changes in vaginal discharge, abdominal cramps, gallstone formation, depression, dizziness, drowsiness, cyanosis

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

Storage

Store this medication in a cool place below 25 degrees Celsius, in a tightly sealed container to prevent air exposure. This will help maintain the medication's effectiveness for a longer time.

Appearance and packaging

Appearance

Beige circular film-coated tablet

Package unit

21 tablets (21 tablets/PTP packaging x 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.