Medication info
JK (JKE) Tablet 5mg (Tadalafil)

JK (JKE) Tablet 5mg (Tadalafil)

Prescription medicationTabletOral
Ingredient · strength
Tadalafil›5mg / 1 tablet
Manufacturer / importer
Hana Pharmaceutical Co., Ltd.
Appearance
Yellow film-coated tablet in a rounded triangular shape
Packaging
30 tablets (10 tablets/PTP X 3)
Approval status
Active

MFDS item code 201902789 · Approved 2019.04.30

Summary

Main use
Treatment of symptoms of erectile dysfunction, benign prostatic hyperplasia, or both conditions
Who takes it
Adults · Children
Adult dose
Do not crush this medicine. Swallow the tablet whole. For oral administration. 1. Erectile dysfunction Use in adult men For patients who expect 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 appropriateness of continuous daily dosing should be reassessed periodically. 2. Once-daily dosing 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 dosing 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 adjustments are required in elderly patients. ● Use in men with renal impairment - Erectile dysfunction No dose adjustment is required in patients with mild to moderate renal impairment. Once-daily tadalafil is not recommended for patients with severe renal impairment. [See Precautions for Use, 3.2) and 11.2) Pharmacokinetic Properties.] - Benign prostatic hyperplasia No dose adjustment is required in patients with mild renal impairment. Once-daily tadalafil is not recommended for 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, the physician should carefully assess the individual benefit/risk. (See section 11. <Special Populations>.) ● Use in men with diabetes No dose adjustment is required in patients with diabetes.
Child dose
Do not use in persons under 18 years of age.

Ingredients

Manufacturer
Hana Pharmaceutical Co., Ltd.

Efficacy & effects

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

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

This medication is primarily used to treat erectile dysfunction. However, sexual stimulation is required for it to work for erectile dysfunction, and it is not suitable for women. Additionally, it is effective in alleviating the symptoms and signs of benign prostatic hyperplasia. In men with both erectile dysfunction and benign prostatic hyperplasia, it helps improve both conditions. In summary, this medication is used to treat the symptoms of erectile dysfunction and benign prostatic hyperplasia.

How to take

Adult dose

Do not crush this medicine. Swallow the tablet whole. For oral administration. 1. Erectile dysfunction Use in adult men For patients who expect 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 appropriateness of continuous daily dosing should be reassessed periodically. 2. Once-daily dosing 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 dosing 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 adjustments are required in elderly patients. ● Use in men with renal impairment - Erectile dysfunction No dose adjustment is required in patients with mild to moderate renal impairment. Once-daily tadalafil is not recommended for patients with severe renal impairment. [See Precautions for Use, 3.2) and 11.2) Pharmacokinetic Properties.] - Benign prostatic hyperplasia No dose adjustment is required in patients with mild renal impairment. Once-daily tadalafil is not recommended for 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, the physician should carefully assess the individual benefit/risk. (See section 11. <Special Populations>.) ● Use in men with diabetes No dose adjustment is required in patients with diabetes.

Child dose

Do not use in persons under 18 years of age.

Precautions

This medication is used to treat erectile dysfunction and benign prostatic hyperplasia. Before using this medication, you must have an evaluation by a doctor, especially if you have heart disease. Since sexual activity can put strain on the heart, it should be used after confirming your cardiovascular condition. If an erection lasts more than 4 hours, you should seek immediate medical assistance, as untreated cases can lead to tissue damage to the penis and permanent loss of erectile function. This medication should not be taken with nitrate drugs as it can dangerously lower blood pressure; therefore, patients on nitrates should avoid use. Patients who have recently experienced cardiovascular conditions like myocardial infarction, stroke, or unstable angina should not use this medication. Additionally, patients with genetic retinal diseases or those allergic to the ingredients of this medication should also avoid its use. Patients with penile deformities or certain blood disorders should use this medication cautiously, and those with severely impaired kidney or liver function should also take care. When taken with antihypertensive medications, blood pressure may drop too low, so consult your doctor. It is advisable not to use this medication in conjunction with other erectile dysfunction treatments. During treatment, side effects such as headaches, dyspepsia, back pain, muscle pain, flushing, and limb pain may occur, most of which are mild or moderate. Rarely, serious cardiovascular adverse reactions or visual and hearing impairments have been reported, so if any abnormal symptoms occur, consult a doctor immediately. It is not to be used during pregnancy or by children or women. This medication does not significantly affect driving or operating machinery, but dizziness may occur in some individuals, so caution is advised. In case of overdose, immediate medical attention is necessary, as this medication is not easily removed through hemodialysis. Store this medication out of reach of children and maintain it in its original packaging.

Side effects

Headache, dyspepsia, low back pain, muscle pain, congestion, flushing, limb pain, nasopharyngitis, upper respiratory infection, cough, diarrhea, gastroesophageal reflux disease, abdominal pain, hypertension, dizziness, urinary tract infection, gastroenteritis, hypertension, dizziness, urticaria, Stevens-Johnson syndrome, exfoliative dermatitis, migraine, seizure, transient global amnesia, visual field loss, retinal vein occlusion, retinal artery occlusion, vision reduction, non-arteritic anterior ischemic optic neuropathy, sudden hearing loss, hearing loss, tinnitus, priapism, angioedema, myocardial infarction, sudden cardiac death, stroke, chest pain, palpitations, ventricular arrhythmia, tachycardia, angina, hypotension, orthostatic hypotension, syncope, increased blood urea nitrogen, decreased hemoglobin, thrombocytopenia, chest tightness, vomiting, nausea, increased alkaline phosphatase, fatigue, neck stiffness, urethral pain, kidney pain, dry mouth, heartburn, drowsiness, increased white blood cell count, anxiety, sleep disorder, eye pain, chest pain, joint pain, hyperventilation, eye hemorrhage, eyelid swelling, conjunctival hemorrhage, dry eye syndrome, abdominal cramping, increased bilirubin, ejaculation disorder, pain in the external genitalia, erythema, itching, penile disorder, nasal dryness, increased serum creatinine, hiccups, weakness, abdominal discomfort, abdominal pain, allergic reaction, facial swelling, fever, increased hemoglobin, chills, skeletal pain, limb discomfort, decreased semen, facial swelling, abnormal sensation, visual impairment, palpitations

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

Storage

This medication may be sensitive to air or moisture, so it must be stored in a sealed container. The optimal storage temperature is between 1 degree and 30 degrees Celsius. Storing it this way helps maintain the medication's efficacy for a longer period.

Appearance and packaging

Appearance

Yellow film-coated tablet in a rounded triangular shape

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.

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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.