Medication info
TruePASS Orally Disintegrating Tablet 8mg (Silodosin)

TruePASS Orally Disintegrating Tablet 8mg (Silodosin)

Prescription medicationOrally disintegrating TabletOral
Ingredient · strength
Silodosin›8mg / 1 tablet
Manufacturer / importer
JW Pharmaceutical Corp.
Appearance
White or yellowish round orally disintegrating tablet
Packaging
30 tablets (10 tablets/PTP x 3)
Approval status
Active

MFDS item code 201502717 · Approved 2015.04.30 · Insurance code 644913990

Summary

Main use
Improvement of voiding difficulties associated with benign prostatic hyperplasia
Who takes it
Adults
Adult dose
Immediately after removing this medicine from its individual package, place it directly on the tongue and allow it to dissolve completely, then take it without water. Administer 4mg orally to adults twice daily after breakfast and dinner, or 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, such as by initiating treatment at a low dose (2mg per dose, twice daily).

Ingredients

Manufacturer
JW Pharmaceutical Corp.

Efficacy & effects

Improvement of voiding difficulties associated with benign prostatic hyperplasia

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

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

How to take

Adult dose

Immediately after removing this medicine from its individual package, place it directly on the tongue and allow it to dissolve completely, then take it without water. Administer 4mg orally to adults twice daily after breakfast and dinner, or 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, such as by initiating treatment at a low dose (2mg per dose, twice daily).

Precautions

This medication should not be administered to certain patients. It should be avoided by those who are allergic to any component of this product, have severely impaired kidney function, have significantly impaired liver function, and those currently taking certain potent medications. Furthermore, caution should be exercised when used by individuals with orthostatic hypotension or those experiencing kidney and liver function issues, as well as individuals taking specific antihypertensives, other alpha-blockers, or PDE5 inhibitors. When taking this medication, various side effects may occur, so it is necessary to be vigilant. For example, ejaculatory dysfunction, dry mouth, diarrhea, dizziness, nasal congestion, headache, and others have been commonly reported, with rare occurrences of severe symptoms such as syncope or liver dysfunction. If any abnormal symptoms arise during use, immediate consultation with a physician or pharmacist is advised, and it may be necessary to reduce or discontinue the dosage depending on the case. This medication can lower blood pressure, thus careful monitoring of blood pressure changes during positional changes is essential. Caution should also be exercised when driving or working in high places due to the possibility of dizziness and related symptoms. In cases of overdose, a significant drop in blood pressure may occur, so the prescribed dosage must be adhered to strictly. For those taking antihypertensives, special attention is required regarding changes in blood pressure when taken in conjunction with this medication, and dose adjustments may be necessary. This medication helps alleviate the symptoms of benign prostatic hyperplasia, but it does not treat the underlying cause; if ineffective, other treatment options should be considered. Since it may present symptoms similar to prostate cancer, it is crucial to verify the absence of prostate cancer prior to use. Patients scheduled for cataract surgery should inform the medical staff about possible ocular abnormalities related to the use of this medication during the surgery. For elderly patients, starting at a low dose and monitoring closely is advisable due to possible declines in kidney and liver function. This medication should be kept out of reach of children, and it is advisable to avoid transferring it to another container. Additionally, since this medication is metabolized by specific enzymes, concurrent administration with potent enzyme inhibitors should be avoided as it may lead to increased blood concentration. Caution is also needed when taking this medication with other antihypertensives, alpha-blockers, or PDE5 inhibitors, as a significant drop in blood pressure may occur. Lastly, this medication contains components that have been reported to have potential carcinogenicity in animal studies, so long-term use requires caution.

Side effects

  • Ejaculatory dysfunction
  • dry mouth
  • diarrhea
  • loose stools
  • orthostatic dizziness
  • nasal congestion
  • dizziness
  • headache
  • TG increase
  • CRP increase
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  • ALT increase
  • AST increase
  • γ-GTP increase
  • syncope
  • loss of consciousness
  • liver dysfunction
  • jaundice
  • erectile dysfunction
  • urinary incontinence
  • stomatitis
  • gastric discomfort
  • constipation
  • vomiting
  • nausea
  • loss of appetite
  • stomach ache
  • 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
  • lethargy
  • shoulder stiffness
  • numbness in hands and feet
  • feeling of foggy head
  • drowsiness
  • decreased libido
  • heaviness in the head
  • mood disturbance
  • nosebleed
  • runny nose
  • cough
  • edema
  • atrial fibrillation
  • bradycardia
  • tachycardia
  • arrhythmia
  • loss of function ectopic contractions
  • orthostatic hypotension
  • blood pressure drop
  • blood pressure rise
  • rash
  • eczema
  • hives
  • itching
  • intraoperative iris dilatation syndrome
  • blurred vision
  • eye congestion
  • eye itching
  • conjunctival hemorrhage
  • total bilirubin increase
  • Al-P increase
  • LDH increase
  • BUN increase
  • creatinine increase
  • decreased white blood cell count
  • decreased red blood cell count
  • decreased hemoglobin
  • decreased hematocrit
  • increased white blood cell count
  • decreased platelet count
  • gynecomastia
  • total cholesterol increase
  • urinary sugar increase
  • urine sediment
  • facial flushing
  • tinnitus
  • bitter taste
  • chest pain
  • back pain
  • lower limb fatigue
  • sweating
  • serum potassium increase
  • total protein decrease
  • prostate-specific antigen increase
  • uric acid increase
  • urinary protein increase
  • retrograde ejaculation
  • nasopharyngitis
  • urinary tract infection
  • voiding disorder
  • excessive sedation
  • decreased orgasm
  • leg numbness
  • palpitations
  • itching
  • vision impairment
  • fever
  • chills
  • lower limb fatigue
  • chest discomfort
  • shoulder pain
  • elevated serum uric acid
  • elevated serum creatinine

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 tightly closed container that blocks light. It is important to maintain a storage temperature between 1°C and 30°C room temperature. This will help ensure the medication's effectiveness and safety over time.

Appearance and packaging

Appearance

White or yellowish round orally disintegrating 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.