Medication info

Espas Tablet 4 mg (Silodosin)

Prescription medicationTabletOralExpired
Ingredient · strength
Silodosin›4mg / 1 tablet
Manufacturer / importer
Samchundang Pharmaceutical Co., Ltd.
Appearance
White round film-coated tablet
Packaging
60 tablets (10 tablets/PTP x 6)
Approval status
Expired

MFDS item code 201508426 · Approved 2015.12.24

This product's status changed to Expired on 2025.12.24. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of urinary disorders associated with benign prostatic hyperplasia
Who takes it
Adults
Adult dose
Adults: Administer orally either 1 tablet of 4mg twice daily after breakfast and dinner, or 2 tablets of 4mg (8mg) once daily with a meal. However, increased plasma concentrations of silodosin have been reported in patients with renal impairment, and plasma concentrations may also increase in patients with hepatic impairment. Therefore, monitor the patient's condition and adjust the dose as appropriate according to symptoms, including initiating treatment at a low dose (2mg per dose, twice daily).

Ingredients

Manufacturer
Samchundang Pharmaceutical Co., Ltd.

Efficacy & effects

Improvement of urinary disorders associated with benign prostatic hyperplasia

  • Urination disorders associated with benign prostatic hyperplasia
View approved original text

This medication is used to improve urination disorders caused by benign prostatic hyperplasia.

How to take

Adult dose

Adults: Administer orally either 1 tablet of 4mg twice daily after breakfast and dinner, or 2 tablets of 4mg (8mg) once daily with a meal. However, increased plasma concentrations of silodosin have been reported in patients with renal impairment, and plasma concentrations may also increase in patients with hepatic impairment. Therefore, monitor the patient's condition and adjust the dose as appropriate according to symptoms, including initiating treatment at a low dose (2mg per dose, twice daily).

Precautions

This medication should not be used by patients with known allergies to any of its components, severe renal impairment, or severe hepatic dysfunction. Additionally, patients taking strong CYP3A4 enzyme inhibitors should avoid concomitant use. Caution is advised when administering to patients with orthostatic hypotension symptoms or those with slight impairment of liver or kidney function. Patients taking antihypertensives, other alpha-blockers, and PDE5 inhibitors should be cautious as blood pressure may drop excessively when taken together. During the use of this medication, side effects such as ejaculation disorders, dizziness, headaches, dry mouth, diarrhea, nasal congestion may occur; if any abnormalities present, consult a medical professional immediately. In particular, there may be instances of sudden blood pressure drop causing fainting, hence care is required with changes in position, and caution is advised when driving or performing hazardous tasks. Overdose may lead to hypotension, thus prescribed doses should be strictly adhered to, and blood pressure should be carefully monitored when taken with other antihypertensive medications. While this medication helps alleviate symptoms of benign prostatic hyperplasia, as symptoms may resemble those of prostate cancer, evaluation for the presence of prostate cancer should be conducted before administration. Patients planning cataract surgery must inform their healthcare provider about this medication, and it is not to be used in patients with severe liver dysfunction. This medication should be kept out of the reach of children, and transferring to another container should be avoided as it may affect the medication's quality. In elderly patients, starting with a lower dose is recommended, considering liver and kidney function, and careful observation should be maintained during dosage.

Side effects

  • Sexual dysfunction
  • dry mouth
  • diarrhea
  • loose stools
  • orthostatic dizziness
  • nasal congestion
  • lightheadedness
  • dizziness
  • headache
  • elevated TG
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  • increased CRP
  • elevated ALT
  • elevated AST
  • increased γ-GTP
  • syncope
  • loss of consciousness
  • liver dysfunction
  • jaundice
  • erectile dysfunction
  • urinary incontinence
  • stomatitis
  • gastric discomfort
  • constipation
  • vomiting
  • nausea
  • loss of appetite
  • gastric pain
  • abdominal pain
  • abdominal bloating
  • upper abdominal discomfort
  • lower abdominal pain
  • gastric ulcer
  • gastritis
  • atrophic gastritis
  • heartburn
  • gastric burning
  • duodenal ulcer
  • increased flatulence
  • increased bowel movements
  • feeling of incomplete evacuation
  • anal discomfort
  • fatigue
  • shoulder stiffness
  • numbness in hands and feet
  • feeling of foggy head
  • drowsiness
  • decreased libido
  • fullness in the head
  • mood disturbances
  • epistaxis
  • runny nose
  • cough
  • edema
  • atrial fibrillation
  • bradycardia
  • tachycardia
  • arrhythmia
  • loss of functional extrasystoles
  • orthostatic hypotension
  • decreased blood pressure
  • increased blood pressure
  • rash
  • eczema
  • urticaria
  • itching
  • intraoperative iris relaxation syndrome
  • blurred vision
  • eye redness
  • eye itching
  • conjunctival hemorrhage
  • increased total bilirubin
  • elevated Al-P
  • increased LDH
  • elevated BUN
  • increased creatinine
  • decreased white blood cell count
  • decreased red blood cell count
  • decreased hemoglobin
  • reduced hematocrit
  • increased white blood cell count
  • decreased platelet count
  • facial swelling
  • tongue swelling
  • pharyngeal edema
  • gynecomastia
  • elevated total cholesterol
  • increased urinary glucose
  • urinary sediment
  • facial flushing
  • tinnitus
  • bitter taste
  • chest pain
  • low back pain
  • lower limb fatigue
  • sweating
  • flushing
  • increased serum potassium
  • decreased total protein
  • increased prostate-specific antigen
  • elevated uric acid
  • increased urinary protein
  • nasopharyngitis
  • urinary tract infection
  • voiding dysfunction
  • nausea
  • dyspepsia
  • abdominal discomfort
  • increased bowel movements
  • excessive sedation
  • decreased orgasm
  • leg numbness
  • palpitations
  • itching
  • visual disturbance
  • decreased platelet count
  • fever
  • chills
  • lower limb fatigue
  • chest discomfort
  • low back pain
  • shoulder pain
  • increased blood uric acid
  • increased blood creatinine
  • frequent urination
  • worsening of dry mouth
  • hematuria
  • herpes zoster

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

Storage

This medication should be stored in a tightly sealed container that protects it from light and kept at room temperature between 1°C and 30°C. Storing it in this way helps maintain its efficacy over time.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

60 tablets (10 tablets/PTP x 6)

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.