Medication info
Finasteride 5 mg Tablets (Finasteride)

Finasteride 5 mg Tablets (Finasteride)

Prescription medicationTablet경구
Ingredient · strength
Finasteride›5mg / 1 tablet
Manufacturer / importer
주식회사케이에스제약
Appearance
Blue apple-shaped film-coated tablets
Packaging
30 tablets/PTP[(10 tablets/PTP*3)]
Approval status
Active

MFDS item code 202003376 · Approved 2020.05.11 · Insurance code 059000850

Summary

Main use
Improvement of symptoms and urinary flow associated with benign prostatic hyperplasia, reduction in need for surgery
Who takes it
Adults
Adult dose
As finasteride, 5 mg is administered once daily by mouth, regardless of meals. Treatment must continue for at least 6 months even if symptoms improve.

Ingredients

Manufacturer
주식회사케이에스제약

Efficacy & effects

Improvement of symptoms and urinary flow associated with benign prostatic hyperplasia, reduction in need for surgery

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

This medication improves symptoms due to benign prostatic hyperplasia and helps to reduce an enlarged prostate, facilitating urine flow. It also lowers the frequency of acute urinary retention and helps reduce the need for prostate surgery (including transurethral resection of the prostate and open surgery). Therefore, it effectively improves symptoms of benign prostatic hyperplasia.

How to take

Adult dose

As finasteride, 5 mg is administered once daily by mouth, regardless of meals. Treatment must continue for at least 6 months even if symptoms improve.

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 it may pose a potential risk to male fetuses. During the use of this medication, depressive moods or psychological changes such as depression may occur, so if these symptoms develop, medical consultation is necessary. People allergic to this medication or its ingredients, women, children, and pregnant women must not take this medication. Additionally, patients with certain genetic diseases such as lactose intolerance should also refrain from taking this medication. Patients with impaired liver function should take this medication with caution. This medication generally has few side effects and they are usually temporary; however, issues related to sexual function have been reported, and some patients may experience erectile dysfunction, reduced libido, or ejaculation disorders. Prolonged use has been associated with reports of male breast cancer, but a direct correlation with this medication is not yet clear. This medication may slightly increase the risk of certain high-grade forms of prostate cancer, so regular examinations are necessary before and during use. There are few interactions with other medications, and it does not affect metabolic enzymes, so taking it with various medications does not generally cause major issues. Pregnant or nursing individuals should not take this medication, especially during pregnancy, as it poses a risk to male fetuses. Safety and efficacy in children have not been confirmed, so it is not to be used. Elderly patients can take this medication at similar dosages to adults, and no specific dosage adjustments are necessary. This medication can lower prostate-specific antigen (PSA) levels, so interpretation during prostate cancer testing should take this into account, and if PSA levels rise during treatment, it should be evaluated carefully. There are no specific antidotes for overdose; however, no adverse reactions have been reported.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), angioedema, chest tightness, difficulty breathing, cold sweats, pallor, severe rash with high fever, blisters, skin peeling, pain in mouth/eye mucous membranes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances,

Mild side effects

Erectile dysfunction, decreased libido, decreased ejaculate volume, ejaculation disorders, breast enlargement, breast tenderness, rash, muscle pain, myasthenia, depression, suicidal thoughts, anxiety, testicular pain, hematuria, male infertility, male breast cancer, dyspepsia, constipation, gastrointestinal disturbances (heartburn), thirst, itching, numbness in both hands, headache, fatigue, dizziness, otitis media, abnormal liver function

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

Storage

This medication is sensitive to light and must be stored in a container that does not allow light in. The storage temperature should be maintained at room temperature between 1 to 30 degrees Celsius. Storing it this way helps to maintain the drug’s efficacy and safety.

Appearance and packaging

Appearance

Blue apple-shaped film-coated tablets

Package unit

30 tablets/PTP[(10 tablets/PTP*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.