Medication info
Diane Tablet (Dienogest (Micronized))

Diane Tablet (Dienogest (Micronized))

Prescription medicationTabletOral
Ingredient · strength
Dienogest Micronized›2mg / 1 tablet
Manufacturer / importer
Darim Biotech Co., Ltd.
Appearance
White round tablet
Packaging
28 tablets (14 tablets/PTPX2)
Approval status
Active

MFDS item code 201902650 · Approved 2019.04.25 · Insurance code 664602310

Summary

Main use
Treatment of endometriosis
Who takes it
Adults
Adult dose
Take 1 tablet once daily without a break between packs. If possible, take it at the same time each day with a small amount of water. It may be taken with or without food. Take the tablets continuously, regardless of whether vaginal bleeding occurs. After finishing a pack, start the next pack without a break. Treatment may be started on any day of the menstrual cycle. If you forget to take a dose, or if you vomit or have diarrhea within 3-4 hours after taking this medicine, its effectiveness may be reduced. If you have missed 1 or more tablets, take 1 tablet as soon as you remember, and continue taking the tablets at the usual time the next day. If a dose was not absorbed because of vomiting or diarrhea, take 1 additional tablet in the same way. Patients with renal impairment: No dosage adjustment is necessary in patients with renal impairment.

Ingredients

Manufacturer
Darim Biotech Co., Ltd.

Efficacy & effects

Treatment of endometriosis

  • Endometriosis
View approved original text

This medicine is used to relieve the symptoms of endometriosis. It helps when endometrial tissue grows outside the uterus, causing pain or discomfort. It can help effectively control pain associated with endometriosis and suppress the progression of lesions. Therefore, it is used for the treatment of endometriosis.

How to take

Adult dose

Take 1 tablet once daily without a break between packs. If possible, take it at the same time each day with a small amount of water. It may be taken with or without food. Take the tablets continuously, regardless of whether vaginal bleeding occurs. After finishing a pack, start the next pack without a break. Treatment may be started on any day of the menstrual cycle. If you forget to take a dose, or if you vomit or have diarrhea within 3-4 hours after taking this medicine, its effectiveness may be reduced. If you have missed 1 or more tablets, take 1 tablet as soon as you remember, and continue taking the tablets at the usual time the next day. If a dose was not absorbed because of vomiting or diarrhea, take 1 additional tablet in the same way. Patients with renal impairment: No dosage adjustment is necessary in patients with renal impairment.

Precautions

This medicine should not be used in patients who are pregnant or suspected to be pregnant. It should not be administered to patients with a history of venous thromboembolism, cardiovascular disease, or arterial disease. Patients with diabetes accompanied by vascular lesions, severely impaired liver function, or liver tumors should also refrain from taking this medicine. Additionally, patients with hormone-dependent malignant tumors or undiagnosed vaginal bleeding are prohibited from using this medicine. Furthermore, patients with hypersensitivity to any components of this medicine or with genetic issues such as lactose intolerance should not take it. Patients with severe uterine bleeding should be cautious, as the bleeding may worsen while taking this medicine. In patients with circulatory disorders, the risk of thrombosis may increase, so administration should be done carefully. Cancer patients, particularly women at risk of breast cancer, should consider the risks and benefits thoroughly before taking this medicine. Patients at risk of osteoporosis should assess their bone health before taking this medicine, and patients with a history of depression should closely monitor their condition during treatment. Diabetic patients should take it while carefully checking their blood sugar control, and women with a history of ectopic pregnancy or tubal dysfunction require careful judgment before administration. During the first month of administration, it is common to experience side effects such as headache, breast discomfort, depression, and acne. Changes in menstrual cycle, changes in bleeding patterns are also commonly reported, and if severe bleeding or amenorrhea persists, consultation with a healthcare professional is necessary. Additionally, rare side effects such as skin rash, hair loss, gastrointestinal disorders, and muscle pain may occur, so if symptoms are severe, consult an expert immediately. It is essential to confirm pregnancy status during the administration of this medicine, and if contraception is necessary, it is recommended to use non-hormonal contraceptive methods. If high blood pressure develops or worsens during treatment, the medication should be discontinued, and appropriate measures should be taken. If there is a history of chloasma, precaution should be taken to avoid exposure to sunlight or ultraviolet light, and caution should be applied since follicular cysts may develop. This medicine is metabolized in the liver, so taking it with certain drugs may reduce its effectiveness or increase side effects. Caution is needed when using it in combination with drugs that induce or inhibit liver enzymes; if you are taking other medications, please inform your healthcare provider. This medicine is not used during pregnancy and is also not recommended during breastfeeding. While ovulation may be suppressed when taking this medicine, contraceptive effects are uncertain, so additional contraception methods may be necessary. This medicine is not administered to children before menarche or to the elderly. It is important to check health status through clinical tests assessing liver, thyroid, adrenal, and kidney functions before and during administration. There is no specific antidote for overdose, but the risk of acute adverse reactions is relatively low. This medicine should be kept out of the reach of children and stored in its original container protected from light.

Side effects

  • Petechiae
  • irregular bleeding
  • amenorrhea
  • headache
  • breast discomfort
  • depressed mood
  • acne
  • anemia
  • weight gain
  • weight loss
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  • increased appetite
  • sleep disorders
  • irritability
  • decreased libido
  • mood changes
  • anxiety
  • depression
  • mood fluctuations
  • migraine
  • autonomic imbalance
  • attention disorders
  • dry eyes
  • tinnitus
  • palpitations
  • hypotension
  • dyspnea
  • nausea
  • abdominal pain
  • bloating
  • abdominal distention
  • vomiting
  • diarrhea
  • constipation
  • abdominal discomfort
  • gastrointestinal inflammation
  • gingivitis
  • hair loss
  • dry skin
  • sweating
  • pruritus
  • hypertrichosis
  • nail breakage
  • dandruff
  • dermatitis
  • abnormal hair growth
  • photosensitivity reaction
  • pigment disorder
  • back pain
  • bone pain
  • muscle cramps
  • limb pain
  • limb heaviness
  • urinary tract infection
  • ovarian cyst
  • facial flushing
  • uterine/vaginal bleeding
  • vaginal candidiasis
  • vulvar dryness
  • genital discharge
  • pelvic pain
  • atrophic vaginitis
  • breast lump
  • fibrocystic breast disease
  • breast induration
  • lethargy
  • hypersensitivity
  • swelling
  • fibrocystic breast disease
  • salivary gland sialolithiasis
  • skin cyst
  • postoperative infection
  • thyroid cancer
  • premenstrual syndrome
  • vulvar pruritus
  • adenomyosis
  • breast calcification
  • breast congestion
  • mild cervical dysplasia
  • cervical polyp
  • menopause symptoms
  • nipple pain
  • genital pruritus
  • uterine polyp
  • dry mouth
  • gastroesophageal reflux disease
  • inguinal hernia
  • rectocele
  • cervical spondylopathy
  • sensory loss
  • eczema
  • miliaria
  • skin disease
  • adjustment disorders
  • affective disorders
  • binge eating disorder
  • panic disorder
  • chest discomfort
  • warmth sensation
  • pain
  • fever
  • vaginitis
  • viral upper respiratory infection
  • bacterial vaginitis
  • bacterial vulvovaginitis
  • bronchitis
  • candidiasis
  • onychomycosis
  • folliculitis
  • boil
  • chalaza
  • influenza
  • otitis externa
  • human papillomavirus infection
  • pharyngitis
  • pneumonia
  • rhinitis
  • cystitis
  • intervertebral disc disease
  • neck pain
  • uterine fibroids
  • oropharyngeal pain
  • asthma
  • cough
  • vocal cord polyp
  • ligament rupture
  • meniscal injury
  • tachycardia
  • cholelithiasis
  • hepatotoxicity
  • diabetes
  • hypothyroidism
  • retinal detachment
  • nocturia
  • decreased blood estrogen
  • increased blood pressure
  • increased carbohydrate antigen 125
  • dysmenorrhea
  • breast tenderness
  • mastalgia
  • dyspepsia
  • dizziness
  • paresthesia
  • urticaria
  • rash
  • fatigue
  • arthralgia
  • myalgia
  • postoperative pain

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

Storage

This medicine should be stored in a tightly sealed container to protect it from air and moisture. Additionally, it is important to store it in a cool place below 25 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

White round tablet

Package unit

28 tablets (14 tablets/PTPX2)

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.