Medication info

Alpha-M 5 mg Tablet (Finasteride)

Prescription medicationTablet경구Expired
Ingredient · strength
Finasteride›5mg / 1 tablet
Manufacturer / importer
알파제약(주)
Appearance
Blue round film-coated tablet
Packaging
30 tablets/PTP (10 tablets/PTP x 3)
Approval status
Expired

MFDS item code 201902473 · Approved 2019.04.22

This product's status changed to Expired on 2024.04.22. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of symptoms and urinary flow in benign prostatic hyperplasia, reduction in the need for surgery
Who takes it
Adults
Adult dose
As finasteride, take 5 mg once daily orally, with or without food. Treatment is necessary for a minimum of 6 months even if symptoms improve during administration.

Ingredients

Manufacturer
알파제약(주)

Efficacy & effects

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

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

This medication helps improve symptoms caused by benign prostatic hyperplasia. The thickened prostate tissue decreases, allowing urinary flow to become smoother and reducing the likelihood of acute urinary retention. It also diminishes the necessity for prostate-related surgeries, such as transurethral resection or prostatectomy. As a result, it is effective in enhancing the quality of life for patients. Overall, this medication improves symptoms of benign prostatic hyperplasia and reduces the need for surgery.

How to take

Adult dose

As finasteride, take 5 mg once daily orally, with or without food. Treatment is necessary for a minimum of 6 months even if symptoms improve during administration.

Precautions

This medication should not be administered to children or women. Especially, pregnant women or those who may become pregnant should avoid contact with broken pieces of this drug. This medication may cause mental health issues such as depression or mood changes; if such symptoms occur, it is essential to consult a professional immediately. Patients with an allergic reaction to this medication or genetic issues like lactose intolerance should not take it. Patients with liver function impairment should use this medication with extra caution. This medication may cause side effects related to sexual function; erectile dysfunction, decreased libido, and ejaculatory disorders have been reported, so if these symptoms occur, a consultation with a healthcare professional is necessary. Rarely, long-term use may be associated with the occurrence of breast cancer, so caution is warranted. This medication may slightly increase the risk of prostate cancer, thus regular examinations are necessary for men over 55 years of age. While this medication has minimal interactions with other drugs, if you are taking any other medications, it is essential to inform your healthcare professional. Pregnant women should not take this medication or come into contact with broken pieces, and breastfeeding women should also avoid taking it. Safety and efficacy in children have not been established; therefore, it is not used in this population. Elderly patients can use this medication without special dosage adjustments, but side effects should be monitored carefully. This medication can lower prostate-specific antigen (PSA) levels, hence this should be considered when interpreting PSA test results. There are no specific treatments for overdose, but it is crucial to adhere to the recommended dosage. Lastly, this medication should be kept out of reach of children and not transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweats, pallor, rash (with high fever, severe rash, blisters, skin peeling, pain in the mouth/eyes included), jaundice in the skin or eyes, severe liver impairments, severe allergic reactions

Mild side effects

  • Erectile dysfunction
  • decreased libido
  • decreased ejaculate
  • ejaculatory disorders
  • breast enlargement
  • breast tenderness
  • rash
  • muscle pain
  • myasthenia
  • depression
Show 14 more
  • testicular pain
  • hematuria
  • male infertility
  • heartburn
  • dizziness
  • headache
  • itching
  • malaise
  • otitis media
  • liver function impairment
  • dyspepsia
  • constipation
  • dry mouth
  • bilateral hand numbness

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 ingress, and the storage temperature should be maintained at room temperature, avoiding extremes of heat or cold. This will help preserve the medication's efficacy.

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.