Medication info

Diraen Tablet (Dienogest)

Prescription medicationTabletOral
Ingredient · strength
Dienogest›2mg / 1 tablet
Manufacturer / importer
Dongkook Pharmaceutical Co., Ltd.
Appearance
White to off-white round tablet
Packaging
28 tablets/box [28 tablets/PTP X 1]
Approval status
Active

MFDS item code 202203557 · Approved 2022.09.14 · Insurance code 653405870

Summary

Main use
Treatment of endometriosis
Who takes it
Adults
Adult dose
Take 1 tablet daily without a break. If possible, take it with a small amount of water at the same time each day; it may be taken regardless of meals. Take the tablets continuously, regardless of vaginal bleeding. Once all the tablets in the current pack have been taken, start the next pack without a break. You may start taking the tablets on any day of the menstrual cycle. The effect may be reduced if you miss a dose or vomit or have diarrhea within 3-4 hours after taking this medicine. If you have missed 1 or more tablets, take 1 tablet as soon as you remember, then 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
Dongkook Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of endometriosis

  • Endometriosis
View approved original text

This medication is used for endometriosis.

How to take

Adult dose

Take 1 tablet daily without a break. If possible, take it with a small amount of water at the same time each day; it may be taken regardless of meals. Take the tablets continuously, regardless of vaginal bleeding. Once all the tablets in the current pack have been taken, start the next pack without a break. You may start taking the tablets on any day of the menstrual cycle. The effect may be reduced if you miss a dose or vomit or have diarrhea within 3-4 hours after taking this medicine. If you have missed 1 or more tablets, take 1 tablet as soon as you remember, then 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 medication should not be used during pregnancy or if pregnancy is suspected. It should not be administered to patients with a history of venous thromboembolism, cardiovascular disease, liver disease, liver tumors, or hormone-dependent malignancies. Patients with undiagnosed vaginal bleeding or hypersensitivity to the active ingredient or excipients should also avoid use. It is not administered to patients with genetic issues such as lactose intolerance. Patients with severe uterine bleeding should be cautious as this medication may worsen bleeding. Patients with cardiovascular disease or a risk of thrombosis should carefully evaluate risks and benefits before use. The risk may be slightly increased for cancer patients, particularly those with a history of breast cancer, while taking this medication. Patients at risk for osteoporosis should assess their bone density before starting this medication and manage their bone health throughout treatment. Patients with a history of depression should carefully monitor their mental state, discontinuing use if symptoms worsen. Diabetics should closely observe their blood glucose control. This medication may alter menstrual patterns and may cause side effects such as headaches, breast discomfort, depressive mood, and acne. If there are changes in bleeding patterns or severe side effects occur, consult a healthcare provider. It is recommended to use non-hormonal contraceptive methods to prevent pregnancy during treatment. If hypertension occurs or worsens, notify a healthcare provider immediately and seek treatment. This medication is metabolized in the liver, and concurrent use with certain medications may reduce effectiveness or increase side effects. Particular caution is needed when used with drugs that induce or inhibit liver enzymes. This medication should not be used during pregnancy and is not recommended during breastfeeding. It is not administered to children before menarche or the elderly. This medication may affect some clinical test results related to the liver, thyroid, and blood, so these factors should be considered during testing. There is no specific antidote for overdose, but serious adverse reactions are rarely reported. Store out of reach of children and keep in the original container protected from light.

Side effects

  • Petechiae
  • irregular bleeding
  • amenorrhea
  • headache
  • breast discomfort
  • depressive mood
  • acne
  • anemia
  • weight gain
  • weight loss
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  • increased appetite
  • sleep disturbances
  • nervousness
  • decreased libido
  • mood changes
  • anxiety
  • depression
  • mood swings
  • migraine
  • attention deficit
  • dry eyes
  • tinnitus
  • palpitations
  • hypotension
  • dyspnea
  • nausea
  • abdominal pain
  • distension
  • abdominal bloating
  • vomiting
  • diarrhea
  • constipation
  • abdominal discomfort
  • gastrointestinal inflammation
  • gingivitis
  • hair loss
  • dry skin
  • hyperhidrosis
  • pruritus
  • hirsutism
  • nail (toe/finger) breakage
  • dandruff
  • dermatitis
  • abnormal hair growth
  • photosensitivity reaction
  • pigmentation disorders
  • back pain
  • bone pain
  • muscle cramps
  • limb pain
  • limb heaviness
  • urinary tract infection
  • ovarian cysts
  • facial flushing
  • uterine/vaginal bleeding
  • vaginal candidiasis
  • vulvar dryness
  • genital discharge
  • pelvic pain
  • atrophic vaginitis
  • breast lump
  • fibrocystic breast disease
  • breast induration
  • lethargy
  • irritability
  • edema
  • amenorrhea
  • rare bleeding
  • frequent bleeding
  • prolonged bleeding
  • fibrocystic breast disease
  • sialolithiasis
  • skin cyst
  • postoperative infection
  • thyroid cancer
  • premenstrual syndrome
  • vulvar pruritus
  • adenomyosis
  • breast calcification
  • breast discharge
  • breast engorgement
  • mild cervical dysplasia
  • cervical polyp
  • menopausal symptoms
  • nipple pain
  • genital pruritus
  • uterine polyp
  • dry mouth
  • gastroesophageal reflux disease
  • inguinal hernia
  • rectocele
  • cervical myelopathy
  • sensory loss
  • eczema
  • millia
  • skin disorders
  • adjustment disorder
  • mood disorder
  • binge eating disorder
  • panic disorder
  • chest discomfort
  • heat sensation
  • pain
  • fever
  • vaginitis
  • viral upper respiratory infection
  • bacterial vaginitis
  • bacterial vulvovaginitis
  • bronchitis
  • candidiasis
  • onychomycosis
  • folliculitis
  • boil
  • chalazion
  • 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 tear
  • meniscus injury
  • tachycardia
  • cholelithiasis
  • hepatotoxicity
  • diabetes mellitus
  • hypothyroidism
  • retinal detachment
  • nocturia
  • high blood pressure
  • carbohydrate antigen 125 elevation
  • dysmenorrhea
  • chest tenderness
  • dyspepsia
  • dizziness
  • paresthesia
  • urticaria
  • rash
  • fatigue
  • cystitis
  • arthralgia
  • myalgia
  • postoperative pain

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. Additionally, it is important to store it at a cool temperature below 25 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

White to off-white round tablet

Package unit

28 tablets/box [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.