Medication info
Rozan Tablets (Dienogest (Micronized))

Rozan Tablets (Dienogest (Micronized))

Prescription medicationTabletOral
Ingredient · strength
Dienogest Micronized›2mg / 1 tablet
Manufacturer / importer
SHIN POONG PHARM. CO., LTD
Appearance
White, round, biconvex film-coated tablet
Packaging
28 tablets/box (14 tablets/PTP x 2)
Approval status
Active

MFDS item code 201804326 · Approved 2018.10.31 · Insurance code 648507810

Summary

Main use
Treatment of endometriosis
Who takes it
Adults
Adult dose
Take 1 tablet daily without a break. 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 vaginal bleeding, and start the next pack without a break after finishing the current pack. You may start taking the tablets on any day of the menstrual cycle. The effect may be reduced if you forget to take a dose or experience vomiting or diarrhea within 3-4 hours after taking this medicine. If you have forgotten 1 or more tablets, take 1 tablet as soon as you remember, and continue taking the tablets at your usual time the next day. If a tablet has not been absorbed due to vomiting or diarrhea, take 1 additional tablet in the same way. Patients with renal impairment: No dose adjustment is necessary in patients with renal impairment.

Ingredients

Importer
SHIN POONG PHARM. CO., LTD

Efficacy & effects

Treatment of endometriosis

  • Endometriosis
View approved original text

Endometriosis is a condition where the endometrial tissue is located outside of the uterus, causing pain or infertility. This medication is used to relieve pain and improve symptoms associated with endometriosis.

How to take

Adult dose

Take 1 tablet daily without a break. 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 vaginal bleeding, and start the next pack without a break after finishing the current pack. You may start taking the tablets on any day of the menstrual cycle. The effect may be reduced if you forget to take a dose or experience vomiting or diarrhea within 3-4 hours after taking this medicine. If you have forgotten 1 or more tablets, take 1 tablet as soon as you remember, and continue taking the tablets at your usual time the next day. If a tablet has not been absorbed due to vomiting or diarrhea, take 1 additional tablet in the same way. Patients with renal impairment: No dose adjustment is necessary in patients with renal impairment.

Precautions

This medication should not be used in cases of pregnancy or suspected pregnancy. It should not be administered to patients with venous thromboembolism or cardiovascular diseases, or with a history of such conditions. Patients with severely impaired liver function or liver tumors should also not use this medication. Administration should be avoided in patients with hormone-sensitive malignant tumors or unexplained vaginal bleeding. Patients with allergies to lactose or lactose absorption disorders should not use this medication. In cases of severe uterine bleeding, caution should be exercised as this medication may worsen the bleeding, and if bleeding is severe or persistent, discontinuation of the medication should be considered. Patients with circulatory disorders may experience an increased risk of thrombosis during treatment, so careful administration is required. For cancer patients, especially those with breast cancer, the risk may be slightly increased, so consultation with a physician is necessary. Patients at risk of osteoporosis should be evaluated for bone health status before and during this medication and should ensure sufficient intake of calcium and vitamin D. Patients with a history of depression should be closely monitored, and if symptoms worsen, the medication may be discontinued. Diabetic patients should closely monitor their blood sugar control, especially those with a history of gestational diabetes. Women with a history of ectopic pregnancy or tubal dysfunction should carefully evaluate the risks and benefits of using this medication. Non-hormonal contraceptive methods are recommended during the course of this medication. If blood pressure rises during treatment, discontinuation and suitable treatment may be necessary. This medication should not be used during pregnancy and is not recommended during breastfeeding. This medication may have various side effects, so if symptoms such as headache, breast discomfort, depression, or skin changes occur during use, consultation with a physician is necessary. Furthermore, this medication may affect the results of liver or other organ function tests, so regular testing may be required. Drug interactions may occur, so if other medications are being taken, it is essential to inform a physician or pharmacist.

Side effects

  • Petechial hemorrhage
  • irregular bleeding
  • amenorrhea
  • headache
  • breast discomfort
  • depressed mood
  • acne
  • anemia
  • weight gain
  • weight loss
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  • increased appetite
  • sleep disturbances
  • irritability
  • decreased libido
  • mood changes
  • anxiety
  • depression
  • mood swings
  • migraine
  • autonomic nervous system imbalance
  • attention deficit
  • dry eyes
  • tinnitus
  • palpitations
  • hypotension
  • dyspnea
  • nausea
  • abdominal pain
  • bloating
  • abdominal distension
  • vomiting
  • diarrhea
  • constipation
  • abdominal discomfort
  • gastrointestinal inflammation
  • gingivitis
  • hair loss
  • dry skin
  • sweating
  • pruritus
  • hypertrichosis
  • broken nails
  • dandruff
  • dermatitis
  • abnormal hair growth
  • photosensitivity reaction
  • pigment disorders
  • back pain
  • bone pain
  • muscle cramps
  • limb pain
  • limb heaviness
  • urinary tract infection
  • ovarian cysts
  • facial flushing
  • uterine/vaginal bleeding
  • vulvovaginal candidiasis
  • vaginal dryness
  • genital discharge
  • pelvic pain
  • atrophic vaginitis
  • breast lump
  • fibrocystic breast disease
  • breast hardening
  • weakness
  • hyperreactivity
  • edema
  • fibrocystic breast disease
  • salivary gland calcification
  • skin cyst
  • postoperative infection
  • thyroid cancer
  • premenstrual syndrome
  • vulvar pruritus
  • adenomyosis
  • breast calcifications
  • breast congestion
  • mild cervical dysplasia
  • cervical polyps
  • menopausal symptoms
  • nipple pain
  • genital pruritus
  • uterine polyps
  • dry mouth
  • gastroesophageal reflux disease
  • inguinal hernia
  • retrorectal condition
  • cervical spondylotic myelopathy
  • sensory loss
  • eczema
  • miliaria
  • skin diseases
  • 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
  • milium
  • flu
  • otitis externa
  • human papillomavirus infection
  • pharyngitis
  • pneumonia
  • rhinitis
  • cystitis
  • disc disease
  • neck pain
  • uterine fibroids
  • oropharyngeal pain
  • asthma
  • cough
  • vocal cord polyps
  • ligament tear
  • meniscus injury
  • tachycardia
  • cholelithiasis
  • hepatotoxicity
  • diabetes mellitus
  • hypothyroidism
  • retinal detachment
  • nocturia
  • decreased estrogen levels
  • increased blood pressure
  • elevated carbohydrate antigen 125
  • dysmenorrhea
  • chest tenderness
  • breast pain
  • indigestion
  • dizziness
  • sensory disturbances
  • hives
  • rash
  • fatigue
  • arthralgia
  • myalgia
  • postoperative pain

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, and it is recommended to store it at room temperature between 1 degree and 30 degrees Celsius. Storing it this way will help maintain the medication's efficacy safely.

Appearance and packaging

Appearance

White, round, biconvex film-coated tablet

Package unit

28 tablets/box (14 tablets/PTP x 2)

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.