Medication info

Humelina Tablet 0.5 mg (Dutasteride)

Prescription medicationTabletOralExpired
Ingredient · strength
Dutasteride›0.5mg / 1 tablet
Manufacturer / importer
Huons Co., Ltd.
Appearance
Light yellow oval film-coated tablet
Packaging
30 tablets (10 tablets/PTP X 3)
Approval status
Expired

MFDS item code 202004007 · Approved 2020.05.28

This product's status changed to Expired on 2025.05.28. It may no longer be sold, so consult a doctor or pharmacist before taking it.

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 tablet (0.5 mg) once daily. Swallow this medicine whole without chewing or splitting it. This medicine may be taken with or without food. No dosage adjustment is necessary in patients with renal impairment or elderly patients. Since there are no data on administration of this medicine to patients with hepatic impairment, the recommended dose in these patients has not been established.

Ingredients

Manufacturer
Huons Co., Ltd.

Efficacy & effects

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

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

This medication helps improve the symptoms of benign prostatic hyperplasia (BPH), reduces the risk of acute urinary retention, and decreases the need for related surgeries. It is also used for the treatment of male pattern hair loss in adult men.

How to take

Adult dose

The recommended dose of this medicine is 1 tablet (0.5 mg) once daily. Swallow this medicine whole without chewing or splitting it. This medicine may be taken with or without food. No dosage adjustment is necessary in patients with renal impairment or elderly patients. Since there are no data on administration of this medicine to patients with hepatic impairment, the recommended dose in these patients has not been established.

Precautions

This medication can be absorbed through the skin, so pregnant women or those who may become pregnant should not touch or handle it. Special care should be taken to avoid direct contact with broken or crushed pieces of this medication. Children should also be prevented from touching broken pieces of this medication, and it should not be administered to children under 18 years of age. This medication is not for use in women, and patients with hypersensitivity should avoid its use. Adult men planning to conceive should use this drug cautiously under a physician's guidance, as it may affect reproductive capacity. Patients with difficulties in urination or liver dysfunction should exercise caution when using this medication, and consult medical personnel immediately if serious adverse reactions occur. Caution is also required when co-administering with certain strong CYP3A4 inhibitors as the blood concentration of this medication may change. During treatment, sexual dysfunction-related adverse reactions may occur and may persist even after discontinuation, requiring observation of the condition. Regular PSA levels must be checked for prostate cancer risk assessment, as PSA levels can change after taking this medication and interpretation should be done carefully. Blood donation is prohibited during treatment with this medication, and at least 6 months must pass after the last dose before donating blood. In case of overdose, there is no specific antidote so it is important to receive symptomatic supportive treatment. Keep this medication out of reach of children, and store it in its original container to prevent misuse or degradation of quality. Although this medication is known not to significantly affect driving or machinery operation, caution is necessary as it may vary between individuals.

Side effects

  • Erectile dysfunction
  • decreased libido
  • ejaculation disorder
  • gynecomastia
  • headache
  • gastrointestinal discomfort and pain
  • sexual dysfunction
  • breast disorder
  • dizziness
  • rash
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  • itching
  • hives
  • localized swelling
  • severe skin reactions
  • angioedema
  • depressed mood
  • alopecia
  • hirsutism
  • testicular pain
  • testicular swelling
  • heart failure
  • dyspepsia
  • insomnia
  • abdominal pain
  • diarrhea
  • allergy
  • fever
  • congestion
  • thrombotic stroke
  • lung cancer
  • pulmonary embolism
  • pneumonia
  • dry mouth
  • constipation
  • cramps
  • facial spasm
  • vomiting
  • colorectal polyps
  • epigastric discomfort
  • asthenia
  • deep vein thrombosis
  • chills
  • gastroesophageal reflux
  • hemorrhoids
  • pain
  • fatigue
  • increased SGPT
  • rash
  • sexual dysfunction
  • pharyngitis
  • appendicitis
  • fracture
  • viral infection
  • acne
  • fungal dermatitis
  • seborrhea
  • skin disease
  • increased SGOT
  • folliculitis
  • eczema
  • fatty liver
  • chest pain
  • palpitations
  • warts
  • contact dermatitis
  • skin dryness
  • peptic ulcer
  • gastritis
  • gastroenteritis
  • drowsiness
  • hyperbilirubinemia
  • upper respiratory infection
  • unspecified abrasion
  • surgical intervention
  • laceration
  • hyperuricemia
  • hypertriglyceridemia
  • weight gain
  • sensory disturbances
  • decreased testosterone
  • skeletal pain
  • plantar fasciitis
  • purpura
  • epistaxis
  • blepharitis
  • benign laryngeal neoplasm
  • kidney stone
  • taste distortion
  • capillary dilation

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. It is recommended to keep it at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the effectiveness and safety of the medication.

Appearance and packaging

Appearance

Light yellow oval film-coated tablet

Package unit

30 tablets (10 tablets/PTP X 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.