Medication info
Bu-kwang Tadalafil Tablet 5mg

Bu-kwang Tadalafil Tablet 5mg

Prescription medicationTabletOral
Ingredient · strength
Tadalafil›5mg / 1 tablet
Manufacturer / importer
Bu-kwang Pharmaceutical Co., Ltd.
Appearance
Yellow oval film-coated tablet
Packaging
30 tablets (10 tablets/PTP x 3)
Approval status
Active

MFDS item code 201501707 · Approved 2015.03.31

Summary

Main use
Treatment of symptoms of benign prostatic hyperplasia, erectile dysfunction, or both conditions when they occur together
Who takes it
Adults · Children
Adult dose
Do not crush this medicine. Take one tablet whole. For oral use. 1. Erectile dysfunction Use in adult men For patients who are expected to use tadalafil frequently (at least twice a week), the recommended dose is up to 5mg once daily, taken at approximately the same time each day. The suitability of continuous daily dosing should be periodically reassessed. 2. Once-daily use for benign prostatic hyperplasia The recommended dose of this medicine for once-daily use is 5mg, taken at approximately the same time every day. 3. Once-daily use 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 every day, regardless of the timing of sexual activity. 4. Special populations ● Use in elderly men No dosage adjustment is required in elderly patients. ● Use in men with renal impairment - Erectile dysfunction No dosage adjustment is required in patients with mild to moderate renal impairment. Once-daily tadalafil is not recommended for patients with severe renal impairment. [See sections 3.2) of Precautions for Use and 11.2) Pharmacokinetic Properties]. - Benign prostatic hyperplasia No dosage adjustment is required in patients with mild renal impairment. Once-daily tadalafil is not recommended for patients with severe renal impairment. [See sections 3.3) of Precautions for Use and 11.2) Pharmacokinetic Properties]. ● Use in men with hepatic impairment Once-daily dosing has not been evaluated in patients with hepatic impairment. Therefore, if prescribing this medicine, the physician should carefully assess the benefit/risk for each individual patient. (See section 11. <Special Populations>) ● Use in men with diabetes No dosage adjustment is required in patients with diabetes.
Child dose
Do not use in persons under 18 years of age.

Ingredients

Manufacturer
Bu-kwang Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • Signs and symptoms of erectile dysfunction
  • benign prostatic hyperplasia
View approved original text

This medication is used for the treatment of erectile dysfunction, and sexual arousal is required for it to be effective. It also helps alleviate symptoms and signs caused by benign prostatic hyperplasia. In particular, it is effective in treating both symptoms in men with erectile dysfunction and benign prostatic hyperplasia. However, this medication is not intended for use in women. Therefore, it is used to improve erectile dysfunction and symptoms of prostatic hyperplasia in men.

How to take

Adult dose

Do not crush this medicine. Take one tablet whole. For oral use. 1. Erectile dysfunction Use in adult men For patients who are expected to use tadalafil frequently (at least twice a week), the recommended dose is up to 5mg once daily, taken at approximately the same time each day. The suitability of continuous daily dosing should be periodically reassessed. 2. Once-daily use for benign prostatic hyperplasia The recommended dose of this medicine for once-daily use is 5mg, taken at approximately the same time every day. 3. Once-daily use 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 every day, regardless of the timing of sexual activity. 4. Special populations ● Use in elderly men No dosage adjustment is required in elderly patients. ● Use in men with renal impairment - Erectile dysfunction No dosage adjustment is required in patients with mild to moderate renal impairment. Once-daily tadalafil is not recommended for patients with severe renal impairment. [See sections 3.2) of Precautions for Use and 11.2) Pharmacokinetic Properties]. - Benign prostatic hyperplasia No dosage adjustment is required in patients with mild renal impairment. Once-daily tadalafil is not recommended for patients with severe renal impairment. [See sections 3.3) of Precautions for Use and 11.2) Pharmacokinetic Properties]. ● Use in men with hepatic impairment Once-daily dosing has not been evaluated in patients with hepatic impairment. Therefore, if prescribing this medicine, the physician should carefully assess the benefit/risk for each individual patient. (See section 11. <Special Populations>) ● Use in men with diabetes No dosage adjustment is required in patients with diabetes.

Child dose

Do not use in persons under 18 years of age.

Precautions

This medication is used for the treatment of erectile dysfunction and benign prostatic hyperplasia. Before taking this medication, the doctor should carefully assess the overall health condition of the patient, including cardiac conditions. Patients with heart disease or who have recently experienced myocardial infarction, unstable angina, heart failure, stroke, etc., should not use this medication. Additionally, this medication can cause a rapid drop in blood pressure when taken with nitrates, so patients taking nitrates should never use it. If heart-related symptoms occur during the use of this medication, sexual activity should be stopped immediately and the doctor should be consulted. If an erection lasts longer than 4 hours or is accompanied by pain, medical attention should be sought immediately. If not treated, it can lead to penile tissue damage and permanent erectile dysfunction. Patients with severely impaired kidney or liver function should use this medication with caution, and when taken with alpha-blockers or antihypertensives, there is a risk of lowering blood pressure, so consultation with a doctor is recommended. This medication contains lactose, so those with lactose intolerance should not take it. Additionally, co-administration with other erectile dysfunction treatments is not recommended as safety has not been confirmed. If sudden vision loss or hearing decrease occurs, use should be stopped immediately and a doctor's examination should be sought. This medication is not to be used by pregnant or breastfeeding women, or children. In case of overdose, standard emergency treatment should be received, as this medication is not easily removed by hemodialysis. This medication should be kept out of reach of children and it is advisable to maintain its original packaging. Caution should be taken when consuming this medication with alcohol as it may intensify side effects such as blood pressure drop and dizziness. Major side effects of this medication include headache, dyspepsia, back pain, muscle pain, flushing, and most are mild or moderate symptoms. Serious adverse reactions should prompt immediate consultation with a doctor.

Side effects

  • Headache
  • indigestion
  • 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
  • priapism
  • increased blood urea nitrogen
  • tachycardia
  • palpitations
  • eye congestion
  • increased SGPT
  • chest pressure
  • vomiting
  • nausea
  • increased alkaline phosphatase
  • fatigue
  • neck stiffness
  • urethral pain
  • kidney pain
  • dry mouth
  • heartburn
  • gastrointestinal disease
  • drowsiness
  • increased white blood cell count
  • decreased platelet count
  • anxiety
  • sleep disorders
  • decreased hemoglobin
  • eye pain
  • chest pain
  • joint pain
  • hyperventilation
  • eye bleeding
  • eyelid swelling
  • conjunctival hemorrhage
  • dry eyes
  • abdominal cramps
  • increased bilirubin
  • ejaculation disorder
  • pain in external genitalia
  • erythema
  • itching
  • penile disorder
  • myocardial infarction
  • tinnitus
  • nosebleeds
  • dry nose
  • increased serum creatinine
  • hiccups
  • asthenia
  • abdominal discomfort
  • abdominal pain
  • allergic reaction
  • facial swelling
  • fever
  • increased SGOT
  • increased hemoglobin
  • hives
  • Stevens-Johnson syndrome
  • exfoliative dermatitis
  • migraine
  • seizures
  • transient global amnesia
  • visual field loss
  • retinal vein occlusion
  • retinal artery occlusion
  • decreased vision
  • sudden hearing loss
  • hearing loss
  • tinnitus
  • angioedema
  • angioedema
  • low back pain
  • muscle pain
  • dizziness

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

Storage

This medication should be stored in a tightly closed container to prevent air or moisture ingress, and it is best stored at room temperature between 1 to 30 degrees Celsius. Proper storage will ensure the medication's efficacy is safely maintained.

Appearance and packaging

Appearance

Yellow oval film-coated 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.