Medication info
Eurordat Soft Capsule 0.5mg (Dutasteride)

Eurordat Soft Capsule 0.5mg (Dutasteride)

Prescription medicationSoft capsuleOral
Ingredient · strength
Dutasteride›0.5mg / 1 capsule
Manufacturer / importer
CTC Bio, Co., Ltd.
Appearance
An opaque, cloudy yellow rectangular soft capsule containing a colorless transparent liquid.
Packaging
30 capsules (10 capsules/ PTP packaging * 3)
Approval status
Active

MFDS item code 201603673 · Approved 2016.06.21 · Insurance code 669502020

Summary

Main use
Treatment of benign prostatic hyperplasia and male pattern hair loss in adult men
Who takes it
Adults
Adult dose
The recommended dose of this medicine is 1 capsule (0.5mg) once daily. Because exposure to the capsule contents may cause irritation of the oropharyngeal mucosa, swallow this medicine whole without chewing or splitting it. This medicine may be taken with or without food. No dose adjustment is necessary in patients with renal impairment or older adults. The recommended dose of this medicine in patients with hepatic impairment has not been established because no data are available on administration to these patients.

Ingredients

Manufacturer
CTC Bio, Co., Ltd.

Efficacy & effects

Treatment of benign prostatic hyperplasia and male pattern hair loss in adult men

  • Benign prostatic hyperplasia
  • acute urinary retention
  • male-pattern hair loss
View approved original text

This medication helps improve symptoms caused by benign prostatic hyperplasia, reduces the risk of acute urinary retention, and decreases the need for related surgeries. It is also effective for treating male-pattern hair loss in adult males, particularly those aged between 18 and 50 years. Through this medication, positive effects on prostate health and hair loss improvement can be expected.

How to take

Adult dose

The recommended dose of this medicine is 1 capsule (0.5mg) once daily. Because exposure to the capsule contents may cause irritation of the oropharyngeal mucosa, swallow this medicine whole without chewing or splitting it. This medicine may be taken with or without food. No dose adjustment is necessary in patients with renal impairment or older adults. The recommended dose of this medicine in patients with hepatic impairment has not been established because no data are available on administration to these patients.

Precautions

This medication can be absorbed through the skin, so women who are pregnant or who may become pregnant should not touch or handle this medication. If the capsule leaks and comes into contact with the skin, the affected area should be washed thoroughly with soap and water immediately. This medication is prohibited for use in children under 18 years of age, and its safety and efficacy in this age group has not been confirmed. Patients who are allergic to this medication or its ingredients should not take it. Adult males planning to conceive should consult a doctor before careful use, as this medication may affect reproductive capacity. Caution is needed when administering this medication to patients with urinary obstruction or liver dysfunction, and symptoms should be closely monitored. Since this medication is metabolized in the liver, patients with liver impairment should definitely consult a doctor before taking it. Patients taking strong CYP3A4 enzyme inhibitors should be cautious as the blood concentration of this medication may increase. During treatment with this medication, adverse sexual responses such as erectile dysfunction, decreased libido, and ejaculation disorders may occur, and in some cases, these conditions may persist even after discontinuation. In clinical trials, rare breast-related adverse reactions such as breast tenderness or breast enlargement have been reported. This medication may reduce PSA levels for prostate cancer testing, so caution is required in interpreting PSA levels after use, and regular testing is recommended. During the use of this medication, blood donation should be avoided, and blood donation can only occur at least 6 months after the last dose. There is no specific antidote in case of overdose, so appropriate supportive treatment should be administered based on symptoms. Keep this medication out of reach of children, and store it in its original container to prevent deterioration or misuse. It does not affect driving or operating machinery, but caution should be exercised if adverse reactions occur. In patients with heart failure, the risk of heart failure may increase when this medication is combined with other drugs, so caution is needed. This medication may interact with multiple drugs, so if taking other medications, consult a doctor or pharmacist. Pregnant women should not use this medication, and breastfeeding is also prohibited. Adverse reactions may still occur even with long-term use of this medication, so regular evaluation by healthcare professionals is necessary.

Side effects

  • Erectile dysfunction
  • decreased libido
  • ejaculation disorder
  • gynecomastia
  • headache
  • gastrointestinal discomfort and pain
  • sexual dysfunction
  • breast disorders
  • dizziness
  • rash
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  • itching
  • urticaria
  • localized edema
  • severe skin reactions
  • angioedema
  • allergic reactions
  • depressed mood
  • alopecia
  • hypertrichosis
  • testicular pain
  • testicular swelling
  • heart failure
  • indigestion
  • insomnia
  • abdominal pain
  • diarrhea
  • fever
  • congestion
  • thrombotic stroke
  • lung cancer
  • pulmonary embolism
  • pneumonia
  • dry mouth
  • constipation
  • cramps
  • oro-facial dystonia
  • vomiting
  • colorectal polyp
  • epigastric discomfort
  • asthenia
  • deep vein thrombosis
  • chills
  • gastroesophageal reflux
  • hemorrhoids
  • pain
  • pharyngitis
  • appendicitis
  • fractures
  • viral infection
  • fatigue
  • increased SGPT
  • rash
  • sexual dysfunction
  • acne
  • fungal dermatitis
  • seborrhea
  • skin disorders
  • folliculitis
  • palpitations
  • seborrhea
  • warts
  • contact dermatitis
  • dry skin
  • peptic ulcer
  • gastritis
  • gastroenteritis
  • drowsiness
  • bilirubinemia
  • upper respiratory infection
  • unspecified abrasion
  • surgical intervention
  • laceration
  • hyperuricemia
  • hypertriglyceridemia
  • weight gain
  • sensory disturbances
  • decreased testosterone
  • skeletal pain
  • plantar fasciitis
  • purpura
  • nosebleed
  • blepharitis
  • benign laryngeal neoplasm
  • kidney stones
  • dysgeusia
  • telangiectasia
  • urination abnormalities
  • hematuria
  • seminal fluid abnormalities

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 exposure to air or moisture, and it is best to keep it in a cool place away from direct sunlight and below 30 degrees Celsius. This will help maintain the medication's efficacy for a prolonged period.

Appearance and packaging

Appearance

An opaque, cloudy yellow rectangular soft capsule containing a colorless transparent liquid.

Package unit

30 capsules (10 capsules/ PTP packaging * 3)

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.