Medication info

Finawin Tablet 5 mg (Finasteride)

Prescription medicationApproval withdrawn
Ingredient · strength
Finasteride›Strength being verified
Manufacturer / importer
코스맥스파마(주)
Appearance
Blue circular film-coated tablet
Packaging
30 tablets/PTP (10 tablets/PTP x 3)
Approval status
Approval withdrawn

MFDS item code 201903370 · Approved 2019.05.23

This product's status changed to Approval withdrawn on 2023.07.14. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of symptoms and urinary flow in benign prostatic hyperplasia, reduction of surgical necessity
Who uses it
Adults
Adult dosage
As finasteride, administer orally 5 mg once daily, regardless of meals. Treatment should continue for a minimum of 6 months even if symptoms improve.

Ingredients

Manufacturer
코스맥스파마(주)

Efficacy & effects

Improvement of symptoms and urinary flow in benign prostatic hyperplasia, reduction of surgical necessity

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

This medicine helps improve symptoms caused by benign prostatic hyperplasia. It reduces the enlarged prostate, facilitates urinary flow, and decreases the frequency of acute urinary retention. Additionally, it minimizes the need for surgeries such as transurethral resection of the prostate, thus alleviating the treatment burden for patients. Overall, it effectively improves prostate-related symptoms.

Dosage and Administration

Adult dosage

As finasteride, administer orally 5 mg once daily, regardless of meals. Treatment should continue for a minimum of 6 months even if symptoms improve.

Precautions

This medication should not be used in children and women. Particularly, women who are pregnant or may become pregnant should avoid handling crushed or broken tablets as they may affect male fetuses. During treatment, symptoms of depression or mood changes may occur; if these symptoms appear, it is essential to consult a healthcare professional. Patients with hypersensitivity to this drug, lactose intolerance, soybean oil or peanut allergies should not take it. Patients with liver dysfunction or lipid metabolism disorders should use this medication cautiously, and it is advisable to monitor blood lipid levels during treatment. This drug is generally well-tolerated, but side effects related to sexual function may occur, including erectile dysfunction, decreased libido, and ejaculation disorders. Cases of breast cancer have been reported in some patients after long-term use; however, a direct relationship with this medication is not confirmed. This drug may affect the risk of prostate cancer, so regular examinations are especially necessary for men over 55 years old. Pregnant or breastfeeding women should not take this medication, as exposure during pregnancy can affect the fetus. Its safety and efficacy in children have not been established, so it is not used in this population. No special dosage adjustment is required for the elderly. This medication may affect blood test results, so this should be considered during prostate-related tests, such as PSA levels. There is no specific treatment for overdose, but it is important to adhere to the recommended dosage. Store out of reach of children and do not transfer to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), rash and skin abnormal reactions, severe allergic reactions, chest tightness, difficulty breathing, cold sweat, paleness, shortness of breath or difficulty breathing, asthma attack, breathing difficulties accompanied by cough and fever, jaundice of the skin or eyes, generalized malaise, sudden and very severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, significant decrease in urine output, generalized severe swelling.

Mild side effects

  • Mood changes
  • depression
  • feelings of sadness
  • suicidal thoughts
  • erectile dysfunction
  • decreased libido
  • reduced ejaculation volume
  • ejaculation problems
  • breast enlargement
  • breast tenderness
Show 16 more
  • rash
  • muscle pain
  • myasthenia
  • testicular pain
  • hematuria
  • male infertility
  • dizziness
  • headache
  • indigestion
  • constipation
  • heartburn
  • dryness of mouth
  • numbness in both hands
  • fatigue
  • otitis media
  • liver function abnormality

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 and moisture from entering, and it is best kept at room temperature away from direct sunlight. Proper storage can help maintain the drug's effectiveness for a long time.

Appearance and packaging

Appearance

Blue circular 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.