Medication info
Hanarongjeong 5mg (Tadalafil)

Hanarongjeong 5mg (Tadalafil)

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

MFDS item code 201501367 · Approved 2015.03.16

Summary

Main use
Treatment of erectile dysfunction, benign prostatic hyperplasia, and symptoms when both conditions are present
Who takes it
Adults · Children
Adult dose
Do not crush this medicine. Swallow one tablet whole. For oral administration. 1. Erectile dysfunction Use in adult men For patients who are expected to use tadalafil frequently (at least 2 times per week), the recommended dose is up to 5mg once daily, taken at approximately the same time each day. The suitability of continued daily dosing should be reassessed periodically. 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 each 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 each 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 in patients with severe renal impairment. [See Precautions for Use 3.2) 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 in patients with severe renal impairment. [See Precautions for Use 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, 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
Jeil Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of erectile dysfunction, benign prostatic hyperplasia, and symptoms when both conditions are present

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

This medication is used for the treatment of erectile dysfunction in men, and sexual stimulation is necessary to improve the ability to achieve an erection. It is also effective in alleviating symptoms caused by benign prostatic hyperplasia. If a patient experiences both erectile dysfunction and benign prostatic hyperplasia, this medication helps improve the symptoms of both conditions. However, this medication is not suitable for women. Overall, it effectively treats male sexual function and prostate-related symptoms.

How to take

Adult dose

Do not crush this medicine. Swallow one tablet whole. For oral administration. 1. Erectile dysfunction Use in adult men For patients who are expected to use tadalafil frequently (at least 2 times per week), the recommended dose is up to 5mg once daily, taken at approximately the same time each day. The suitability of continued daily dosing should be reassessed periodically. 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 each 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 each 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 in patients with severe renal impairment. [See Precautions for Use 3.2) 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 in patients with severe renal impairment. [See Precautions for Use 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, 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, and proper evaluation and diagnosis by healthcare professionals are required before use. Sexual activity may put stress on the heart, so patients with cardiovascular diseases must check their heart condition before taking this medication. If an erection lasts for more than 4 hours, seek immediate medical assistance, as improper treatment may result in penile tissue damage and loss of erectile function. Taking this medication with nitrate drugs or nitric oxide donors may severely lower blood pressure, so do not take them together. Patients with recent history of cardiovascular diseases such as myocardial infarction, angina, stroke, or uncontrolled hypertension and hypotension should not take this medication. Patients with genetic retinal disorders or allergies to any component of this medication should not use it, and it is not recommended to combine with other erectile dysfunction treatments. Patients with penile deformities or blood disorders should use this medication cautiously, and those with severely impaired kidney or liver function should also exercise caution. When taking it with alpha-blockers or antihypertensive agents that lower blood pressure, blood pressure may drop too low, so please consult your healthcare provider. This medication is metabolized by the CYP3A4 enzyme, so dosage adjustments and caution are required when taken with drugs that inhibit or induce this enzyme. It should not be used in pregnant or breastfeeding women or in children. It has minimal effects on driving or operating machinery, but caution should be exercised as symptoms like dizziness may occur. In case of overdose, standard treatment should be received, and dialysis has little effect on the elimination of this medication. Store this medication out of reach of children and in its original packaging to protect it from air and moisture. Common side effects may include headaches, indigestion, muscle pain, flushing, and if severe symptoms occur, consult healthcare professionals immediately. If sudden vision loss or hearing decrease occurs, stop taking the medication immediately and seek medical attention.

Side effects

  • Headache
  • dyspepsia
  • low back pain
  • muscle pain
  • congestion
  • flushing
  • limb pain
  • nasopharyngitis
  • upper respiratory tract infection
  • cough
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  • diarrhea
  • urinary tract infection
  • gastroesophageal reflux disease
  • abdominal pain
  • hypertension
  • dizziness
  • 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 disorders
  • drowsiness
  • increased white blood cell count
  • decreased platelet count
  • decreased hemoglobin
  • eye pain
  • chest pain
  • joint pain
  • hyperventilation
  • eye bleeding
  • eyelid swelling
  • conjunctival bleeding
  • dry eyes
  • abdominal cramps
  • increased bilirubin
  • ejaculation disorders
  • pain in the external genitalia
  • erythema
  • itching
  • penile disorders
  • myocardial infarction
  • tinnitus
  • epistaxis
  • nasal dryness
  • increased creatinine in the blood
  • hiccups
  • weakness
  • abdominal discomfort
  • abdominal pain
  • allergic reactions
  • facial edema
  • fever
  • changes in SGOT
  • increased hemoglobin
  • urticaria
  • Stevens-Johnson syndrome
  • exfoliative dermatitis
  • migraine
  • seizures
  • transient global amnesia
  • visual field defects
  • retinal vein occlusion
  • retinal artery occlusion
  • decreased vision
  • angioedema
  • angioedema
  • sudden decrease or loss of hearing
  • tinnitus
  • angioedema

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

Storage

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. The storage temperature should be maintained at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

28 tablets (7 tablets/PTP X 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.

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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.