Medication info
Victoris Tablet 5mg (Tadalafil)

Victoris Tablet 5mg (Tadalafil)

Prescription medicationTabletOral
Ingredient · strength
Tadalafil›5mg / 1 tablet
Manufacturer / importer
Kukje Pharmaceutical Co., Ltd.
Appearance
Yellow round film-coated tablets
Packaging
28 tablets (7 tablets/PTP × 4)
Approval status
Active

MFDS item code 201502213 · Approved 2015.04.14

Summary

Main use
Treatment of symptoms of erectile dysfunction, benign prostatic hyperplasia, or both conditions when present together
Who takes it
Adults · Children
Adult dose
Do not crush this medicine. Take one tablet whole. For oral administration. 1. Erectile dysfunction Use in adult men For patients who anticipate frequent use of tadalafil (at least 2 times per week), the recommended dose is up to 5mg once daily, taken at approximately the same time each day. The appropriateness of continuous daily dosing should be reevaluated periodically. 2. Once-daily regimen for benign prostatic hyperplasia The recommended dose of this medicine for once-daily use is 5mg, taken at approximately the same time each day. 3. Once-daily regimen for erectile dysfunction and benign prostatic hyperplasia The recommended dose of this medicine for once-daily use is 5mg, taken at approximately the same time each day, regardless of the timing of sexual activity. 4. Special populations ● Use in older men Dosage adjustments are not necessary in older patients. ● Use in men with renal impairment - Erectile dysfunction No dose adjustment is necessary in patients with mild to moderate renal impairment. Once-daily tadalafil is not recommended for patients with severe renal impairment. [See Precautions for Use sections 3.2) and 11.2) Pharmacokinetic properties]. - Benign prostatic hyperplasia No dose adjustment is necessary in patients with mild renal impairment. Once-daily tadalafil is not recommended for patients with severe renal impairment. [See Precautions for Use sections 3.3) and 11.2) Pharmacokinetic properties]. ● Use in men with hepatic impairment Once-daily dosing has not been evaluated in patients with hepatic impairment. Therefore, when prescribing, the physician should carefully assess the individual benefit/risk. (See section 11. <Special Populations>) ● Use in men with diabetes No dose adjustment is necessary in patients with diabetes.
Child dose
● Use in children and adolescents This medicine should not be used in people under 18 years of age.

Ingredients

Manufacturer
Kukje Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of symptoms of erectile dysfunction, benign prostatic hyperplasia, or both conditions when present together

  • Erectile dysfunction
  • signs and symptoms of benign prostatic hyperplasia
View approved original text

This medication is used for the treatment of erectile dysfunction, which requires sexual stimulation for effect. It is not intended for use in women. It also helps alleviate symptoms and signs caused by benign prostatic hyperplasia. In males with both erectile dysfunction and benign prostatic hyperplasia, it is effective in treating the symptoms and signs of both conditions. In other words, this medication is used to improve both erectile dysfunction and benign prostatic hyperplasia.

How to take

Adult dose

Do not crush this medicine. Take one tablet whole. For oral administration. 1. Erectile dysfunction Use in adult men For patients who anticipate frequent use of tadalafil (at least 2 times per week), the recommended dose is up to 5mg once daily, taken at approximately the same time each day. The appropriateness of continuous daily dosing should be reevaluated periodically. 2. Once-daily regimen for benign prostatic hyperplasia The recommended dose of this medicine for once-daily use is 5mg, taken at approximately the same time each day. 3. Once-daily regimen for erectile dysfunction and benign prostatic hyperplasia The recommended dose of this medicine for once-daily use is 5mg, taken at approximately the same time each day, regardless of the timing of sexual activity. 4. Special populations ● Use in older men Dosage adjustments are not necessary in older patients. ● Use in men with renal impairment - Erectile dysfunction No dose adjustment is necessary in patients with mild to moderate renal impairment. Once-daily tadalafil is not recommended for patients with severe renal impairment. [See Precautions for Use sections 3.2) and 11.2) Pharmacokinetic properties]. - Benign prostatic hyperplasia No dose adjustment is necessary in patients with mild renal impairment. Once-daily tadalafil is not recommended for patients with severe renal impairment. [See Precautions for Use sections 3.3) and 11.2) Pharmacokinetic properties]. ● Use in men with hepatic impairment Once-daily dosing has not been evaluated in patients with hepatic impairment. Therefore, when prescribing, the physician should carefully assess the individual benefit/risk. (See section 11. <Special Populations>) ● Use in men with diabetes No dose adjustment is necessary in patients with diabetes.

Child dose

● Use in children and adolescents This medicine should not be used in people under 18 years of age.

Precautions

This medication is used for the treatment of erectile dysfunction and benign prostatic hyperplasia. Before taking, be sure to consult with a healthcare professional to evaluate heart health status. Sexual activity may put a strain on the heart, so caution is needed in patients with cardiovascular disease. If an erection lasts longer than 4 hours, seek immediate medical assistance, as untreated cases may result in permanent damage. Taking this medication with nitrate preparations or NO donors may cause dangerously low blood pressure, so such combinations should be avoided. Patients who have recently suffered from cardiovascular diseases such as myocardial infarction, angina, heart failure, or stroke should not take this medication. Patients with genetic retinal diseases or those allergic to this medication should also not use it. Using this medication together with other erectile dysfunction treatments is not recommended as safety has not been established. Patients with severely impaired kidney or liver function should use this medication cautiously, and caution is advised when used in conjunction with alpha-blockers or antihypertensive agents due to the risk of blood pressure lowering. This medication may cause side effects such as headache, dyspepsia, back pain, muscle pain, flushing, and more. If sudden vision loss or hearing reduction occurs, discontinue use immediately and consult a healthcare professional. In case of overdose, standard treatment should be applied, and blood dialysis is not effective. Keep out of reach of children and maintain in its original packaging. It has minimal impact on driving or operating machinery, but it is advisable to check one's condition after taking the medication.

Side effects

  • headache
  • dyspepsia
  • low back pain
  • muscle pain
  • congestion
  • flushing
  • limb pain
  • nasopharyngitis
  • upper respiratory infection
  • cough
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  • diarrhea
  • urinary tract infection
  • gastroesophageal reflux disease
  • abdominal pain
  • dizziness
  • hypertension
  • angioedema
  • migraine
  • seizures
  • transient global amnesia
  • visual field defects
  • retinal vein occlusion
  • retinal artery occlusion
  • decreased vision
  • color vision changes
  • sudden hearing decrease or loss
  • tinnitus
  • increased erection
  • spontaneous penile erection
  • angina
  • chest pain
  • hypotension
  • myocardial infarction
  • orthostatic hypotension
  • palpitations
  • fainting
  • tachycardia
  • urticaria
  • Stevens-Johnson syndrome
  • exfoliative dermatitis
  • angioedema
  • muscle weakness
  • facial swelling
  • fatigue
  • pain
  • peripheral edema
  • abnormal liver function test results
  • dry mouth
  • dysphagia
  • esophagitis
  • gastritis
  • increased GGTP
  • loose stools
  • nausea
  • upper abdominal pain
  • vomiting
  • gastroesophageal reflux
  • hemorrhoidal bleeding
  • rectal bleeding
  • joint pain
  • neck pain
  • sensory loss
  • insomnia
  • paresthesia
  • drowsiness
  • dizziness
  • renal impairment
  • dyspnea
  • nasal bleeding
  • pharyngitis
  • itching
  • rash
  • sweating
  • blurred vision
  • conjunctivitis
  • eye pain
  • increased tear production
  • eyelid swelling
  • facial flushing
  • limb discomfort
  • decreased sperm
  • increased blood urea nitrogen
  • decreased hemoglobin
  • thrombocytopenia
  • chest tightness
  • nausea
  • increased alkaline phosphatase
  • fatigue
  • neck stiffness
  • urethral pain
  • kidney pain
  • heartburn
  • gastrointestinal disorders
  • drowsiness
  • leukocytosis
  • anxiety
  • sleep disorders
  • eye pain
  • chest pain
  • joint pain
  • hyperventilation
  • eye hemorrhage
  • eyelid swelling
  • conjunctival hemorrhage
  • dry eyes
  • abdominal cramps
  • increased bilirubin
  • ejaculation disorders
  • pain in external genitalia
  • erythema
  • penile disorders
  • myocardial infarction
  • tinnitus
  • nasal bleeding
  • dry nose
  • increased serum creatinine
  • hiccups
  • weakness
  • abdominal discomfort
  • abdominal pain
  • allergic reaction
  • facial swelling
  • fever
  • increased SGOT
  • increased hemoglobin
  • chills
  • skeletal pain

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is advisable to keep storage temperatures between 1 degree Celsius and 30 degrees Celsius. This will help maintain the medication's efficacy and safety for a longer period.

Appearance and packaging

Appearance

Yellow round film-coated tablets

Package unit

28 tablets (7 tablets/PTP × 4)

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.