Medication info
Eldarafil Tablet 5 mg (Tadalafil)

Eldarafil Tablet 5 mg (Tadalafil)

Prescription medicationTabletOral
Ingredient · strength
Tadalafil›5mg / 1 tablet
Manufacturer / importer
HLB Pharmaceuticals Co., Ltd.
Appearance
Yellow oval film-coated tablet with a score line
Packaging
30 tablets/box [10 tablets/PTP×3]
Approval status
Active

MFDS item code 202500970 · Approved 2025.04.23

Summary

Main use
Treatment of symptoms of erectile dysfunction, benign prostatic hyperplasia, or both conditions occurring 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 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 continuous daily dosing should be reassessed periodically. 2. Once-daily dosing for benign prostatic hyperplasia The recommended dose of this medicine for once-daily dosing 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 dosing 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 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 Precautions for Use 3.2) and Pharmacokinetic Properties 11.2)]. - 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 Precautions for Use 3.3) and Pharmacokinetic Properties 11.2)]. ● 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 benefit/risk for each patient. (See section 11. <Special Populations>) ● Use in men with diabetes No dosage adjustment is required in patients with diabetes.
Child dose
Under 18 years: This medicine should not be used in people under 18 years of age.

Ingredients

Manufacturer
HLB Pharmaceuticals Co., Ltd.

Efficacy & effects

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

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

This medication is primarily used for the treatment of erectile dysfunction in men. The medication requires sexual stimulation to be effective in the presence of erectile dysfunction. It also helps relieve symptoms caused by benign prostatic hyperplasia. This medication is effectively used to improve symptoms in men who experience both erectile dysfunction and benign prostatic hyperplasia. However, it is not indicated for use in women.

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 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 continuous daily dosing should be reassessed periodically. 2. Once-daily dosing for benign prostatic hyperplasia The recommended dose of this medicine for once-daily dosing 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 dosing 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 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 Precautions for Use 3.2) and Pharmacokinetic Properties 11.2)]. - 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 Precautions for Use 3.3) and Pharmacokinetic Properties 11.2)]. ● 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 benefit/risk for each patient. (See section 11. <Special Populations>) ● Use in men with diabetes No dosage adjustment is required in patients with diabetes.

Child dose

Under 18 years: This medicine should not be used in people under 18 years of age.

Precautions

This medication is used to treat erectile dysfunction and benign prostatic hyperplasia. Before use, it is essential to consult with a healthcare professional to evaluate overall health status, including cardiovascular conditions. Sexual activity can impose strain on the heart; therefore, special caution is required for individuals with heart disease or risk factors. If symptoms such as chest pain, palpitations, or dizziness occur during sexual activity, it should be discontinued immediately and healthcare professionals should be informed. If an erection lasts longer than 4 hours after taking this medication, seek medical attention immediately, as this could be a serious condition that may harm penile tissue. This medication should not be taken with nitrates, as it can cause a dangerous drop in blood pressure; victims of nitrate or NO donor therapies should never use this medication. Patients with a recent history of serious cardiovascular diseases such as myocardial infarction, unstable angina, or stroke should not be prescribed this medication. Those with anatomical abnormalities of the penis or specific blood disorders should use this medication more cautiously, as well as those with severe kidney or liver impairment. It is also safest not to use this medication in combination with other erectile dysfunction treatments, and patients with lactose intolerance should avoid taking it. Side effects such as headaches, dyspepsia, back pain, muscle aches, nasal congestion, flushing, limb pain, facial redness, itching, abnormal sensations, vision impairment, palpitations, dizziness, nasopharyngitis, upper respiratory tract infections, coughing, diarrhea, urinary tract infections, gastroesophageal reflux disease, abdominal pain, increased blood urea nitrogen, tachycardia, vomiting, nausea, fatigue, neck rigidity, urethral pain, kidney pain, dry mouth, heartburn, drowsiness, increased white blood cell count, thrombocytopenia, anxiety, and sleep disorders may occur, most of which are mild or temporary. Rarely, sudden problems with vision or hearing may occur; if these symptoms arise, discontinue use immediately and consult a healthcare professional. This medication is not recommended for women, children, or pregnant individuals. Caution is advised if taken with alcohol, as it may cause symptoms such as blood pressure decrease or dizziness. In case of overdose, standard supportive care is required, and blood dialysis will not remove the drug. This medication should be kept out of reach of children and stored in its original packaging.

Side effects

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

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

Storage

Store this medication in a tightly closed container to protect it from air and moisture. The recommended storage temperature is between 1 and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

Yellow oval film-coated tablet with a score line

Package unit

30 tablets/box [10 tablets/PTP×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.