Medication info
Tadalafil 5 mg Tablets

Tadalafil 5 mg Tablets

Prescription medicationTabletOral
Ingredient · strength
Tadalafil›5mg / 1 tablet
Manufacturer / importer
Yuhan Corporation
Appearance
Pink almond-shaped film-coated tablets
Packaging
30 tablets (10 tablets/PTP package x 3)
Approval status
Active

MFDS item code 201501996 · Approved 2015.04.13

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 drug. 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 appropriateness of continuous daily dosing should be reassessed periodically. 2. Once-daily treatment for benign prostatic hyperplasia The recommended dose of this drug for once-daily use is 5mg, taken at approximately the same time each day. 3. Once-daily treatment for erectile dysfunction and benign prostatic hyperplasia The recommended dose of this drug 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 necessary in elderly patients. ● Use in men with renal impairment - Erectile dysfunction No dosage adjustment is necessary 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 Section 11.2) Pharmacokinetic properties]. - Benign prostatic hyperplasia No dosage adjustment is necessary 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 Section 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 it, the physician should carefully assess the individual benefit/risk. (See Section 11. <Special Populations>) ● Use in men with diabetes No dosage adjustment is necessary in patients with diabetes.
Child dose
Under 18 years of age: This drug should not be used in persons under 18 years of age.

Ingredients

Manufacturer
Yuhan Corporation

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 primarily used for the treatment of erectile dysfunction and requires sexual stimulation to be effective. It is also not to be used in women. The medication helps alleviate signs and symptoms caused by benign prostatic hyperplasia in men. Particularly, it is effective in improving both erectile dysfunction and benign prostatic hyperplasia when both conditions are present. Therefore, this medication treats the signs and symptoms of erectile dysfunction and benign prostatic hyperplasia.

How to take

Adult dose

Do not crush this drug. 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 appropriateness of continuous daily dosing should be reassessed periodically. 2. Once-daily treatment for benign prostatic hyperplasia The recommended dose of this drug for once-daily use is 5mg, taken at approximately the same time each day. 3. Once-daily treatment for erectile dysfunction and benign prostatic hyperplasia The recommended dose of this drug 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 necessary in elderly patients. ● Use in men with renal impairment - Erectile dysfunction No dosage adjustment is necessary 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 Section 11.2) Pharmacokinetic properties]. - Benign prostatic hyperplasia No dosage adjustment is necessary 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 Section 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 it, the physician should carefully assess the individual benefit/risk. (See Section 11. <Special Populations>) ● Use in men with diabetes No dosage adjustment is necessary in patients with diabetes.

Child dose

Under 18 years of age: This drug should not be used in persons under 18 years of age.

Precautions

This medicine is used to treat erectile dysfunction and benign prostatic hyperplasia. Before taking this medication, it is essential to check heart health, and those with cardiovascular disease must be cautious of the risks associated with sexual activity. If symptoms such as chest pain, dizziness, or difficulty breathing occur during or after sexual activity, sexual activity must be stopped immediately and a doctor consulted. Rarely, prolonged erections lasting more than 4 hours or painful erections may occur; if such symptoms arise, immediate medical assistance should be sought. Patients taking nitrate compounds or NO donors must not use this medication, as it may dangerously lower blood pressure. Patients who have recently experienced major cardiovascular events such as myocardial infarction, stroke, or unstable angina should not take this medication. If a patient has severe liver or kidney dysfunction, careful consideration should be given before administering the medication, and caution is necessary when combined with alpha-blockers or antihypertensives due to the risk of lowered blood pressure. This medication should not be administered to those using erectile dysfunction treatments or those with genetically induced lactose intolerance. During treatment, side effects such as headaches, dyspepsia, back pain, muscle pain, flushing, and other symptoms may occur; if symptoms are severe or persistent, a doctor should be consulted. Additionally, if there is a sudden decrease in vision or hearing loss, the medication should be stopped immediately and healthcare providers should be informed. This medication is not to be used by pregnant women or children. Caution is needed when taking this medicine with alcohol, as it may cause decreased blood pressure and dizziness. In case of overdose, immediate medical action is necessary, and blood dialysis has little effect on the removal of this medication. Store this medication out of reach of children and maintain it in its original packaging.

Side effects

Headache, dyspepsia, low back pain, muscle pain, nasal congestion, flushing, limb pain, nasopharyngitis, upper respiratory 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 loss, retinal vein occlusion, retinal artery occlusion, vision reduction, non-arteritic anterior ischemic optic neuropathy, hearing reduction, tinnitus, increased erection, spontaneous penile erection, angioedema, angina, chest pain, hypotension, myocardial infarction, orthostatic hypotension, palpitations, fainting, tachycardia, nausea, vomiting, upper abdominal pain, dry mouth, dysphagia, esophagitis, gastritis, increased GGTP, loose stools, hemorrhoidal bleeding, rectal bleeding, arthralgia, neck pain, dizziness, sensory loss, insomnia, paresthesia, drowsiness, vertigo, renal impairment, dyspnea, nosebleed, pharyngitis, itching, rash, sweating, blurred vision, conjunctivitis, eye pain, increased tear secretion, eyelid edema, sudden hearing loss or decrease, tinnitus, priapism, increased blood urea nitrogen, tachycardia, eye congestion, increased SGPT, chest pressure, vomiting, nausea, increased alkaline phosphatase, fatigue, neck stiffness, urethral pain, kidney pain, heartburn, drowsiness, leukocytosis, thrombocytopenia, anxiety, sleep disorder, decreased hemoglobin, eye pain, chest pain, arthralgia, hyperventilation, eye hemorrhage, eyelid swelling, conjunctival hemorrhage, dry eye syndrome, abdominal cramps, increased bilirubin, ejaculation disorder, pain in external genitalia, erythema, itching, penile disorders, flushing, myocardial infarction, ear ringing, nosebleed, dry nose, increased serum creatinine, hiccups, weakness, abdominal discomfort, abdominal pain, allergic reactions, facial edema, fever, increased SGOT, increased hemoglobin, no effect, chills, skeletal pain

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 tightly sealed container. It is recommended to keep the storage temperature between 1°C and 30°C at room temperature. This will help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Pink almond-shaped film-coated tablets

Package unit

30 tablets (10 tablets/PTP package 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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.