Medication info

Finasteride 5 mg Tablet (Finasteride)

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Finasteride›5mg / 1 tablet
Manufacturer / importer
하이플생명과학(주)
Appearance
Blue round film-coated tablet
Packaging
30 tablets/PTP [(10 tablets/PTP x 3)]
Approval status
Approval withdrawn

MFDS item code 201903317 · Approved 2019.05.22

This product's status changed to Approval withdrawn on 2024.03.28. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Effectiveness in improving symptoms and urinary flow related to benign prostatic hyperplasia, and reducing the need for surgery
Who takes it
Adults
Adult dose
5 mg of finasteride is taken orally once a day without regard to meals. Even if symptoms improve during treatment, a minimum of 6 months of treatment is required.

Ingredients

Manufacturer
하이플생명과학(주)

Efficacy & effects

Effectiveness in improving symptoms and urinary flow related to benign prostatic hyperplasia, and reducing the need for surgery

  • Symptoms of benign prostatic hyperplasia
  • enlarged prostate
  • acute urinary retention
View approved original text

This medication helps improve symptoms due to benign prostatic hyperplasia. It reduces the size of the enlarged prostate to improve urinary flow and decrease the frequency of acute urinary retention. It also reduces the need for surgical procedures such as transurethral resection of the prostate or prostatectomy, thereby alleviating the treatment burden for patients. It is used to effectively manage prostate-related symptoms and improve the quality of life.

How to take

Adult dose

5 mg of finasteride is taken orally once a day without regard to meals. Even if symptoms improve during treatment, a minimum of 6 months of treatment is required.

Precautions

This medication should not be used by children or women, particularly by pregnant women or those who may become pregnant, to avoid contact with broken pieces of the tablet. It should not be taken by pregnant women as it may affect the development of male fetal genitalia. Additionally, while taking this medication, depression or mood changes may occur, so mental status should be carefully monitored. Patients with allergic reactions to this medication or genetic lactose intolerance should not use it. Patients with liver function abnormalities should use this medication cautiously, as adverse reactions such as sexual dysfunction, breast-related symptoms, and skin rashes have been reported. Rarely, long-term use may increase the risk of breast cancer and high-grade prostate cancer, requiring regular check-ups. This medication has minimal interactions with other drugs; however, if any abnormal symptoms occur during use, immediate consultation with a healthcare professional is recommended. Pregnant or nursing women should not take this medication, and administration to children is also prohibited. Elderly patients can use it without special dose adjustments, but it is important to note that therapeutic effects do not appear immediately, necessitating ongoing observation. This medication may influence prostate cancer diagnoses, thus care should be taken when performing PSA level tests, and regular evaluations by healthcare professionals during treatment are necessary. In case of overdose, there is no specific antidote, but it is important to adhere to the recommended dosage and keep it out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema (including swelling of the lips, tongue, throat, and face), hypersensitivity reactions, rash

Mild side effects

  • Erectile dysfunction
  • decreased libido
  • reduced ejaculate
  • ejaculation disorders
  • gynecomastia
  • breast tenderness
  • rash
  • muscle pain
  • myasthenia
  • depression
Show 14 more
  • testicular pain
  • blood in semen
  • male infertility
  • sexual dysfunction
  • heartburn
  • dizziness
  • headache
  • indigestion
  • constipation
  • dry mouth
  • tingling in both hands
  • fatigue
  • otitis media
  • liver function abnormalities

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

Storage

This medication should be stored in a tightly closed container that is air-tight and kept at a temperature between 1 and 30 degrees Celsius. Storing it this way maintains the efficacy of the medication and prevents degradation.

Appearance and packaging

Appearance

Blue round film-coated tablet

Package unit

30 tablets/PTP [(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.