Medication info
Finasteride Tablets 5 mg (Finasteride)

Finasteride Tablets 5 mg (Finasteride)

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

MFDS item code 201707496 · Approved 2017.10.18 · Insurance code 693902670

Summary

Main use
Improvement of symptoms and urinary flow in benign prostatic hyperplasia, reduction of surgical necessity
Who takes it
Adults
Adult dose
Take 5 mg orally once a day without regard to meals as finasteride. Even if symptoms improve while taking it, a minimum of 6 months of treatment is necessary.

Ingredients

Manufacturer
(주)셀트리온제약

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 medication helps to improve the symptoms of benign prostatic hyperplasia. It reduces the size of the enlarged prostate and improves urinary flow, allowing urine to pass smoothly. It can also reduce the frequency of acute urinary retention, preventing sudden urinary difficulties. By reducing the need for surgical treatment, it alleviates the burden on patients. Overall, it is effective in improving symptoms and complications of benign prostatic hyperplasia.

How to take

Adult dose

Take 5 mg orally once a day without regard to meals as finasteride. Even if symptoms improve while taking it, a minimum of 6 months of treatment is necessary.

Precautions

This medication should not be used by children or women. Particularly, pregnant women or those who may become pregnant should not handle broken pieces of this medication, as it is coated in an intact state to avoid contact with the active ingredient. While taking this medication, depression or mood changes may occur; therefore, if any change in mood is felt, it is necessary to consult a healthcare professional. Patients with hypersensitivity to this medication or specific genetic metabolic issues (e.g., galactose intolerance) should not take it, and patients with liver dysfunction should use it cautiously. Generally, this medication is well tolerated; however, sexual function-related side effects (erectile dysfunction, decreased libido, ejaculation disorders, etc.) may occur, and gynecomastia or breast tenderness has been reported in some patients. Prolonged use has been associated with a potential risk of male breast cancer, although a direct relationship with this medication is not clear. Additionally, the risk of certain high-grade forms of prostate cancer may increase, necessitating regular check-ups. This medication has minimal drug interactions and does not affect the CYP-450 enzyme system, thus co-administering with multiple medications poses no significant issues. Pregnant or breastfeeding individuals should not use this medication, especially during pregnancy, as there is a risk of genital abnormalities in male fetuses. The safety and efficacy in children have not been established, so it should not be used in this population. Elderly patients can use this medication similarly to adults, and dosage adjustment is not necessary. This medication may lower prostate-specific antigen (PSA) levels, which can affect the interpretation of test results, so this should be considered during PSA testing. There is no specific antidote for overdose, but reported adverse reactions are rare. When storing, keep it out of the reach of children and do not transfer to another container.

Side effects and when to seek care immediately

Serious side effects

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

Mild side effects

Feeling depressed, mood changes including depression and suicidal thoughts, erectile dysfunction, decreased libido, ejaculation disorders, gynecomastia, breast tenderness, rash, muscle pain, weakness, anxiety, testicular pain, blood clots, male infertility, heartburn, dizziness, headache, numbness in both hands, lethargy, otitis media, abnormal liver function.

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

Storage

This medication should be stored in a sealed container to block light and prevent air ingress. It is important to maintain a storage temperature between 1°C and 30°C.

Appearance and packaging

Appearance

Blue apple-shaped 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.