Medication info
Finasteride Tablets 5mg

Finasteride Tablets 5mg

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

MFDS item code 201300109 · Approved 2013.01.07 · Insurance code 654304680

Summary

Main use
Improvement of symptoms and urinary flow in benign prostatic hyperplasia, reduction of need for surgery
Who takes it
Adults
Adult dose
As finasteride, take 5 mg orally once daily without regard to meals. Even if symptoms improve during treatment, a minimum of 6 months of therapy is necessary.

Ingredients

Manufacturer
오스틴제약(주)

Efficacy & effects

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

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

This medication helps improve symptoms caused by benign prostatic hyperplasia. It reduces the enlarged prostate tissue, facilitating urine flow, and decreases the frequency of acute urinary retention. Additionally, it reduces the necessity for surgeries like transurethral resection of the prostate or prostatectomy. Therefore, this drug is effective for the treatment of benign prostatic hyperplasia.

How to take

Adult dose

As finasteride, take 5 mg orally once daily without regard to meals. Even if symptoms improve during treatment, a minimum of 6 months of therapy is necessary.

Precautions

This medication should not be used in children or women. Particularly, women who are pregnant or may become pregnant should avoid direct contact with broken tablets of this medication because it may affect male fetuses. Mental health issues such as mood changes or depression have also been reported, so if you experience depressive symptoms or unusual behaviors while using this medication, consult a healthcare professional immediately. Patients with hypersensitivity to this medication or genetic issues like lactose intolerance should avoid use. Patients with compromised liver function should use this medication with caution. Generally, this medication has few and temporary side effects, but adverse reactions such as sexual dysfunction, rash, and breast pain may occur. There have also been reports related to male breast cancer with long-term use, so caution is warranted. This medication may slightly increase the risk of prostate cancer, so men over 55 years old should undergo regular screening. This medication does not have significant interactions with other drugs, but it is advisable to consult a doctor if you are taking other medications. Pregnant or breastfeeding women should not take this medication, and women who may become pregnant should be careful when handling the drug. Safety for children has not been established, so it is not used in pediatric patients. Elderly patients can use it without special dosage adjustment, though their condition should be monitored closely. This medication may lower prostate-specific antigen (PSA) levels, so caution is needed when interpreting test results. There are no specific treatments for overdose, but it's important to adhere to the recommended dosage. Finally, keep this medication out of reach of children and store it in its original container.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema (including swelling of the lips, tongue, throat, and face), hypersensitivity reactions, liver function abnormalities (with potential for jaundice), male breast cancer, increased risk of high-grade prostate cancer (Gleason score 8-10)

Mild side effects

  • Depressed mood
  • depression
  • suicidal thoughts
  • mood changes
  • erectile dysfunction
  • decreased libido
  • decreased semen
  • ejaculatory disorders
  • breast enlargement
  • breast pain
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  • rash
  • muscle pain
  • myasthenia
  • anxiety
  • testicular pain
  • hyperemia
  • male infertility
  • decreased semen quality
  • heartburn
  • dizziness
  • headache
  • dyspepsia
  • constipation
  • dry mouth
  • itching
  • fatigue
  • bilateral hand numbness
  • otitis media
  • mild liver function abnormalities
  • mild hypersensitivity.

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

Storage

This medication is sensitive to light and should be stored in a container that does not permit light exposure. Additionally, it is important to store the medication at room temperature, meaning between 1°C and 30°C. This will help maintain the drug’s effectiveness and prevent deterioration.

Appearance and packaging

Appearance

Blue round film-coated tablet

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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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.