Medication info
Finasteride Tablet 5 mg (Finasteride)

Finasteride Tablet 5 mg (Finasteride)

Prescription medicationTablet경구
Ingredient · strength
Finasteride›5mg / 1 tablet
Manufacturer / importer
화일약품(주)
Appearance
Blue round film-coated tablet
Packaging
30 tablets/PTP (10 tablets/PTP X 3)
Approval status
Active

MFDS item code 201902353 · Approved 2019.04.17 · Insurance code 684501540

Summary

Main use
Improves symptoms and urinary flow in benign prostatic hyperplasia, reduces the need for surgery
Who takes it
Adults
Adult dose
As finasteride, administer 5 mg orally once daily, irrespective of meals. Even if symptoms improve upon administration, treatment for at least six months is necessary.

Ingredients

Manufacturer
화일약품(주)

Efficacy & effects

Improves symptoms and urinary flow in benign prostatic hyperplasia, reduces the need for surgery

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

This medication improves the symptoms of benign prostatic hyperplasia, reduces the enlarged prostate, and facilitates urine flow. It also lowers the frequency of acute urinary retention, thereby assisting in reducing the need for prostatic surgeries such as transurethral resection of the prostate or prostatectomy. Overall, it is used to maintain prostate health and effectively manage symptoms.

How to take

Adult dose

As finasteride, administer 5 mg orally once daily, irrespective of meals. Even if symptoms improve upon administration, treatment for at least six months is necessary.

Precautions

This medication should not be used in children or women. In particular, women who are pregnant or may become pregnant should not handle broken pieces of this medication, as its ingredients may affect the development of male fetus genitalia. Depression or mood changes may occur during the use of this medication. Patients should consult medical personnel immediately if such symptoms are experienced. Patients with hypersensitivity to this medication or lactose intolerance, soybean oil or peanut allergies should avoid using it. Patients with impaired liver function or dyslipidemia should use this medication cautiously and may need blood tests to monitor their condition. This medication generally has few side effects and good tolerability, but some patients may experience erectile dysfunction, decreased libido, or ejaculatory disorders. If these symptoms persist, the medical personnel should be notified. There have been reports linking long-term use to male breast cancer, but a definitive causal relationship has not been established; therefore, regular check-ups are necessary. Some studies have reported results related to prostate cancer risk with this medication, so men aged 55 and older should undergo regular testing before and during use. This medication has minimal interactions with other medications, but patients should inform medical personnel if they are on other medications. Pregnant or breastfeeding women should not use this medication, and women who may become pregnant should be careful not to handle broken pieces of this medication. Safety and efficacy in children have not been confirmed, so it should not be used in this population. Elderly patients can take this medication similarly to the general adult population, and no specific dose adjustment is necessary. This medication may lower prostate-specific antigen (PSA) levels, so this should be considered when receiving PSA tests. There is no specific antidote for overdose, but care should be taken not to exceed the recommended dose. Store out of reach of children and do not transfer to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, paleness, rash (severe with fever), blisters, skin peeling, pain in oral/eye mucous membranes, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), severe general fatigue, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, coma

Mild side effects

  • Mood changes
  • depression
  • suicidal thoughts
  • erectile dysfunction
  • decreased libido
  • ejaculatory disorders
  • breast enlargement
  • breast tenderness
  • rash
  • muscle pain
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  • weakness
  • testicular pain
  • blood in semen
  • anxiety
  • male infertility
  • heartburn
  • dizziness
  • headache
  • fatigue
  • tingling in both hands
  • hypersensitivity
  • 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 sealed container to prevent air or moisture from entering, and it is best kept at room temperature between 1 and 30 degrees Celsius. By doing so, the components of the medication remain unchanged and its efficacy is well preserved.

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.