Home Run Tablet 5 mg (Tadalafil)
Tadalafil 5mg
Tablet · Prescription medication
Cosmax Pharma Co., Ltd.
MFDS item code 202203569 · Approved 2022.09.15
Treatment of erectile dysfunction, benign prostatic hyperplasia, or symptoms when both conditions are present
This drug is mainly used for the treatment of erectile dysfunction and works effectively with sexual stimulation. It is not for use in women. Additionally, it helps alleviate symptoms and signs of benign prostatic hyperplasia. In particular, it is used to improve both symptoms for men who suffer from erectile dysfunction and benign prostatic hyperplasia simultaneously. Therefore, this drug is effective in alleviating symptoms of erectile dysfunction and prostatic hyperplasia in men.
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 appropriateness of continued once-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 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, the physician should carefully assess the benefit/risk for each individual. (See section 11. <Special Populations>) ● Use in men with diabetes No dosage adjustment is required in patients with diabetes.
● Use in children and adolescents This medicine should not be used in people under 18 years of age.
This drug is used for the treatment of erectile dysfunction and benign prostatic hyperplasia, and should only be taken after an appropriate evaluation and diagnosis by a doctor. Sexual activity may place strain on the heart, so patients with cardiovascular disease should confirm their cardiac condition before taking this drug. Although rare, this drug can cause a prolonged erection lasting more than 4 hours. If an erection lasts longer than 4 hours, immediate medical assistance should be sought. During or after taking this drug, using nitrate-based medications or NO donors can cause dangerously low blood pressure; therefore, these drugs should not be taken concurrently. Patients with severe cardiovascular diseases such as myocardial infarction, acute cardiac arrest, unstable angina, arrhythmias, and stroke should not take this drug, and caution is advised for those with cardiovascular risk factors. Some animal studies have observed a decrease in sperm count and concentration, but there is no significant clinical impact; however, caution is advised with long-term use. Patients with left ventricular outflow obstruction or those with very low or poorly controlled high blood pressure should not take this drug. Patients who regularly or intermittently use organic nitrate compounds should not take this drug, and it is not recommended to combine it with other erectile dysfunction treatments. Patients taking alpha-blockers or antihypertensive agents should take this drug cautiously after consulting with a doctor, as it may significantly lower blood pressure. Patients with severely impaired liver or kidney function must consult a doctor before taking this drug, and dosage adjustments may be necessary. This drug is not for use in women, children, or infants, and should not be taken by pregnant or breastfeeding women. Side effects such as dizziness, headache, indigestion, back pain, muscle pain, flushing, limb pain, facial flushing, itching, abnormal sensations, diarrhea, cough, nasopharyngitis, upper respiratory tract infection, abdominal pain, drowsiness, visual disturbance, and auditory disturbance may occur; if symptoms are severe, consult a doctor. If sudden vision loss or hearing decrease occurs while taking this drug, stop taking it immediately and seek medical attention. In case of overdose, visit a medical facility promptly for appropriate treatment, as blood dialysis is ineffective in eliminating this drug. Store this drug out of reach of children and maintain it in its original packaging for safety. It does not significantly affect driving or machine operation; however, it is advisable to check your condition before engaging in such activities.
Headache, dyspepsia, lumbago, muscle pain, congestion, flushing, limb pain, nasopharyngitis, upper respiratory tract infection, cough, diarrhea, urinary tract infection, gastroesophageal reflux disease, abdominal pain, gastroenteritis, hypertension, dizziness, facial flushing, itching, paresthesia, visual impairment, palpitations, facial swelling, angina, chest pain, hypotension, myocardial infarction, orthostatic hypotension, syncope, tachycardia, urticaria, Steven-Johnson syndrome, exfoliative dermatitis, migraine, seizure, transient global amnesia, visual field defect, retinal vein occlusion, retinal artery occlusion, decreased vision, non-arteritic anterior ischemic optic neuropathy, sudden hearing loss or decrease, tinnitus, priapism, angioedema, abnormal electrocardiogram, primary bradycardia, increased blood urea nitrogen, decreased hemoglobin, thrombocytopenia, neck stiffness, urethral pain, renal colic, dry mouth, heartburn, drowsiness, anxiety, sleep disorders, joint pain, muscle cramps, rash, sweating, blurred vision, conjunctivitis, eye pain, increased tear production, eyelid swelling, chest pain, hyperventilation, eye hemorrhage, eyelid edema, conjunctival hemorrhage, dry eye syndrome, abdominal cramping, increased bilirubin, ejaculation disorders, pain in external genitalia, erythema, penile disorders, chest tightness, vomiting, nausea, increased alkaline phosphatase, fatigue, increased hemoglobin, nausea, upper abdominal pain, facial swelling, fever, abnormal laboratory tests, chills, skeletal pain
Not everyone experiences these, and they can vary from person to person.
Store this drug in a tightly closed container, protected from air and moisture. It is recommended to keep it at room temperature between 1°C and 30°C, away from excessively hot or cold places.
Yellow film-coated tablets in the shape of a rounded triangle
14 tablets/box[((14 tablets/PTP)x1)], 30 tablets/box[((10 tablets/PTP)x3)]
Even with the same ingredient, strength, dosage form and how it is taken can differ.
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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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For anything that needs medical judgment, consult a doctor or pharmacist.
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.