Medication info
Loraen Tablets (Dienogest (Unmodified))

Loraen Tablets (Dienogest (Unmodified))

Prescription medicationTabletOral
Ingredient · strength
Dienogest Micronized›2mg / 1 tablet
Manufacturer / importer
-
Appearance
White to pale yellow round tablets
Packaging
28 tablets/PTP
Approval status
Active

MFDS item code 202001712 · Approved 2020.03.12 · Insurance code 653404500

Summary

Main use
Treatment of endometriosis
Who takes it
Adults
Adult dose
Take 1 tablet daily without a break in treatment. If possible, take it at the same time each day with a small amount of water; it may be taken with or without food. Continue taking the tablets without interruption, regardless of vaginal bleeding. After finishing the current pack, start the next pack without a break. There is no experience with treatment of endometriosis for longer than 15 months. Treatment may be started on any day of the menstrual cycle. If you forget to take a dose or experience vomiting or 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 tablet was not absorbed because of vomiting or diarrhea, take 1 additional tablet in the same way. Patients with renal impairment: No dose adjustment is needed in patients with renal impairment.

Ingredients

Importer
-

Efficacy & effects

Treatment of endometriosis

  • Endometriosis
View approved original text

Endometriosis is a condition that can cause symptoms such as menstrual pain and infertility. This medication is used to relieve pain and inflammation caused by endometriosis and to inhibit the progression of symptoms.

How to take

Adult dose

Take 1 tablet daily without a break in treatment. If possible, take it at the same time each day with a small amount of water; it may be taken with or without food. Continue taking the tablets without interruption, regardless of vaginal bleeding. After finishing the current pack, start the next pack without a break. There is no experience with treatment of endometriosis for longer than 15 months. Treatment may be started on any day of the menstrual cycle. If you forget to take a dose or experience vomiting or 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 tablet was not absorbed because of vomiting or diarrhea, take 1 additional tablet in the same way. Patients with renal impairment: No dose adjustment is needed in patients with renal impairment.

Precautions

This medication should not be used if you are pregnant or suspect that you may be pregnant. It should not be administered to patients with thrombosis or cardiovascular diseases, or a history of such diseases. Patients with severely impaired liver function or liver tumors should also refrain from taking this medication. It is not to be used in patients with or suspected of having hormone-sensitive malignant tumors, as well as in patients with unexplained vaginal bleeding. Patients allergic to lactose or those with lactose intolerance should avoid taking this medication. Patients experiencing severe uterine bleeding should exercise caution as bleeding may worsen with this medication. Patients with circulatory disorders, hypertension, smoking, etc. may have an increased risk of thrombosis and should use with caution. Patients with a history of breast cancer or at risk of it should be adequately counseled before taking this medication. Patients at risk of osteoporosis should be cautious as this medication may decrease bone density. Patients with a history of depression should be closely monitored as symptoms may worsen. Diabetic patients will need regular checks as blood sugar control may be affected. Women with a history of ectopic pregnancy or tubal dysfunction should carefully evaluate risks and benefits before taking this medication. This medication is metabolized by the CYP3A4 enzyme, which may interact with other medications and could reduce efficacy or increase side effects when used with certain drugs. It is not to be used during pregnancy and is also not recommended during breastfeeding. If contraception is needed, it is advisable to use non-hormonal contraceptive methods while taking this medication. Generally, it is not administered to children and the elderly. While using this medication, changes in menstrual pattern may occur frequently, and side effects such as headache, breast discomfort, depression, and acne have been reported. There is no specific antidote for overdose, but serious toxic reactions are rare. This medication is sensitive to light; therefore, it should be stored in its original packaging and kept out of reach of children.

Side effects

  • Petechiae
  • 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 fluctuations
  • migraines
  • autonomic nervous system imbalance
  • attention deficit
  • dry eyes
  • tinnitus
  • palpitations
  • low blood pressure
  • shortness of breath
  • nausea
  • abdominal pain
  • bloating
  • abdominal distension
  • vomiting
  • diarrhea
  • constipation
  • abdominal discomfort
  • gastrointestinal inflammation
  • gingivitis
  • hair loss
  • dry skin
  • hyperhidrosis
  • pruritus
  • hirsutism
  • nail (toe) breakage
  • dandruff
  • dermatitis
  • abnormal hair growth
  • photosensitivity reaction
  • pigmentation disorders
  • back pain
  • bone pain
  • muscle cramps
  • limb pain
  • heaviness in limbs
  • urinary tract infection
  • ovarian cysts
  • facial flushing
  • uterine/vaginal bleeding
  • vulvovaginal candidiasis
  • vaginal dryness
  • genital discharge
  • pelvic pain
  • atrophic vaginitis
  • breast mass
  • fibrocystic breast disease
  • breast induration
  • asthenia
  • irritability
  • edema
  • fibrocystic breast disease
  • sialolithiasis
  • skin cysts
  • postoperative infection
  • thyroid cancer
  • premenstrual syndrome
  • pruritus vulvae
  • adenomyosis
  • breast calcification
  • breast discharge
  • breast engorgement
  • mild cervical dysplasia
  • cervical polyps
  • menopausal symptoms
  • nipple pain
  • genital pruritus
  • uterine polyps
  • dry mouth
  • gastroesophageal reflux disease
  • inguinal hernia
  • rectocele
  • cervical myelopathy
  • sensory loss
  • eczema
  • miliaria
  • 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
  • abscess
  • molluscum contagiosum
  • influenza
  • 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 serum estrogen
  • elevated blood pressure
  • increased carbohydrate antigen 125
  • dysmenorrhea
  • breast tenderness
  • mastalgia
  • dyspepsia
  • dizziness
  • sensory abnormalities
  • urticaria
  • rash
  • fatigue
  • 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 sealed container. It is recommended to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature. This helps maintain the medication's efficacy and prevents degradation.

Appearance and packaging

Appearance

White to pale yellow round tablets

Package unit

28 tablets/PTP

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.