Medication info

Sofina Tablet (Finasteride)

Prescription medicationTablet경구Expired
Ingredient · strength
Finasteride›5mg / 1 tablet
Manufacturer / importer
원광제약(주)
Appearance
Blue circular film-coated tablet
Packaging
30 tablets/PTP[(10 tablets/PTP X 3)]
Approval status
Expired

MFDS item code 202002327 · Approved 2020.04.02

This product's status changed to Expired on 2025.04.02. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of benign prostatic hyperplasia symptoms and urinary flow, reduction of the need for surgery
Who takes it
Adults
Adult dose
Administer Finasteride 5 mg orally once a day, regardless of meals. Treatment for at least 6 months is required even if symptoms improve during use.

Ingredients

Manufacturer
원광제약(주)

Efficacy & effects

Improvement of benign prostatic hyperplasia symptoms and urinary flow, reduction of the need for surgery

  • Benign prostatic hyperplasia
  • thickened prostate
  • acute urinary retention
View approved original text

This drug improves the main symptoms of benign prostatic hyperplasia, helping to reduce the thickened prostatic tissue to facilitate smooth urine flow. It also decreases the frequency of acute urinary retention, reducing discomfort, and lowering the necessity for prostate surgery. Therefore, this drug is used to alleviate and treat symptoms of benign prostatic hyperplasia.

How to take

Adult dose

Administer Finasteride 5 mg orally once a day, regardless of meals. Treatment for at least 6 months is required even if symptoms improve during use.

Precautions

This drug should not be used in children or women. Particularly, pregnant women or those who may become pregnant should avoid even touching broken pieces of this drug, as its components can affect male fetuses. Mental symptoms such as mood changes or depression may occur, so if such symptoms arise, consult a healthcare professional immediately. This drug should not be used by individuals with allergies to it or with hypersensitivity to lactose, soy oil, beans, peanuts, etc. Patients with impaired liver function or issues with blood lipid levels should use this drug cautiously and monitor their condition through blood tests if necessary. This drug generally has few side effects and is tolerable, but side effects related to sexual function may occur. For example, erectile dysfunction, decreased libido, and ejaculation disorders have been reported. Long-term use has been associated with male breast cancer, but there is still no clear direct correlation with this drug. Moreover, this drug may increase certain high-grade risks of prostate cancer, so men over 55 should discuss thoroughly with healthcare providers and undergo regular examinations. Pregnant women should not take or come into contact with this drug, and nursing mothers are also advised to avoid using it. The safety and efficacy of this drug have not been established in children, so it should not be administered to them. Elderly patients can use this drug just like other adults and do not require dosage adjustments. This drug can affect blood test results, so regular monitoring is required during treatment to check their condition. There is no specific treatment for overdose, but adhering to the recommended dosage is important. This drug should be kept out of reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), angioedema (including swelling of the lips, tongue, throat, and face), rash (severe if accompanied by fever), liver function abnormalities (jaundice), depression, suicidal thoughts

Mild side effects

  • Erectile dysfunction
  • decreased libido
  • reduced semen volume
  • ejaculation disorders
  • breast enlargement
  • breast tenderness
  • rash
  • itching
  • muscle pain
  • weakness
Show 16 more
  • depression
  • suicidal thoughts
  • anxiety
  • testicular pain
  • blood abnormalities
  • male infertility
  • dyspepsia
  • constipation
  • gastrointestinal disorders (heartburn)
  • dry mouth
  • tingling in both hands
  • fatigue
  • dizziness
  • otitis media
  • liver function abnormalities
  • headache

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

Storage

This drug should be stored in a tightly closed container to prevent air or moisture ingress, and it is recommended to be kept at room temperature between 1°C and 30°C. Storing it this way helps maintain the drug's effectiveness over 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.