Medication info
Tadalafil 20 mg (Tadalafil)

Tadalafil 20 mg (Tadalafil)

Prescription medicationTabletOral
Ingredient · strength
Tadalafil›20mg / 1 tablet
Manufacturer / importer
QL Pharma Co., Ltd.
Appearance
Film-coated tablet in a yellow, rounded triangular shape with a score line
Packaging
PTP - 8 tablets/PTP [(8 tablets/PTP) x 1]
Approval status
Active

MFDS item code 201907020 · Approved 2019.10.02

Summary

Main use
Treatment of erectile dysfunction
Who takes it
Adults · Children
Adult dose
Use in adult men The recommended dose of this drug is 10mg, taken with or without food before anticipated sexual activity. For patients in whom tadalafil 10mg does not provide a sufficient effect, 20 mg may be tried. This drug may be taken starting at least 30 minutes before sexual activity. The maximum recommended dosing frequency is once daily. Long-term safety after extended daily dosing has not been established, and because the effect of this drug usually lasts for more than one day, continuous daily administration of this drug is strongly discouraged. [See section 1. Warnings and section 12.1) Pharmacodynamic Properties] Use in elderly men Dose adjustment is not required in elderly patients. Use in men with renal impairment No dose adjustment is required in patients with mild to moderate renal impairment. The maximum recommended dose in patients with severe renal impairment is 10mg. [See section 12.2) Pharmacokinetic Properties]. Use in men with hepatic impairment The recommended dose of this product is 10mg, taken with or without food before anticipated sexual activity. Since clinical data on the safety of this product in patients with severe hepatic impairment (Child-Pugh Class C) are limited, the physician should carefully assess the benefit/risk for each patient when prescribing it. There are no data on the administration of doses higher than 10mg to patients with hepatic impairment. [See section 3. Patients Requiring Caution and section 12.2) Pharmacokinetic Properties]. Use in men with diabetes No dose adjustment is required in patients with diabetes.
Child dose
This drug should not be used in people under 18 years of age.

Ingredients

Manufacturer
QL Pharma Co., Ltd.

Efficacy & effects

Treatment of erectile dysfunction

  • Erectile dysfunction
View approved original text

This medication is used for the treatment of erectile dysfunction. Sexual stimulation is required for the desired effect, so it should be taken with this in mind. Additionally, this medication is not indicated for women and is recommended for use only in male patients. It helps improve the symptoms of individuals experiencing difficulties due to erectile dysfunction.

How to take

Adult dose

Use in adult men The recommended dose of this drug is 10mg, taken with or without food before anticipated sexual activity. For patients in whom tadalafil 10mg does not provide a sufficient effect, 20 mg may be tried. This drug may be taken starting at least 30 minutes before sexual activity. The maximum recommended dosing frequency is once daily. Long-term safety after extended daily dosing has not been established, and because the effect of this drug usually lasts for more than one day, continuous daily administration of this drug is strongly discouraged. [See section 1. Warnings and section 12.1) Pharmacodynamic Properties] Use in elderly men Dose adjustment is not required in elderly patients. Use in men with renal impairment No dose adjustment is required in patients with mild to moderate renal impairment. The maximum recommended dose in patients with severe renal impairment is 10mg. [See section 12.2) Pharmacokinetic Properties]. Use in men with hepatic impairment The recommended dose of this product is 10mg, taken with or without food before anticipated sexual activity. Since clinical data on the safety of this product in patients with severe hepatic impairment (Child-Pugh Class C) are limited, the physician should carefully assess the benefit/risk for each patient when prescribing it. There are no data on the administration of doses higher than 10mg to patients with hepatic impairment. [See section 3. Patients Requiring Caution and section 12.2) Pharmacokinetic Properties]. Use in men with diabetes No dose adjustment is required in patients with diabetes.

Child dose

This drug should not be used in people under 18 years of age.

Precautions

This medication is used for treating erectile dysfunction. Before taking it, a thorough diagnosis and physical examination by a doctor to determine the underlying cause of erectile dysfunction is essential. Sexual activity may put a strain on the heart, so patients with cardiovascular diseases should be especially careful. If symptoms such as chest pain or palpitations occur during sexual activity, it should be stopped immediately and a doctor should be informed. If an erection lasts longer than four hours after taking this medication, immediate medical attention is required. If not treated, prolonged erections can lead to damage to penile tissue and permanent loss of erectile function. Taking this medication with nitrate-based drugs (such as heart medications) can cause dangerously low blood pressure, so it is crucial to inform the doctor about any such medications. Patients who have recently had a myocardial infarction, angina, or stroke, or those with uncontrolled high or low blood pressure should not use this medication. Patients with hereditary retinal disorders are also advised not to take this medication. Rare side effects reported in clinical trials include headache, dyspepsia, back pain, muscle pain, facial flushing, and others. Severe side effects such as vision changes, hearing loss, and priapism may also occur, so if any abnormal symptoms appear, immediate consultation with a doctor is necessary. Patients with severe liver or kidney impairment should use this medication cautiously, as co-administration with other blood pressure medications or alpha-blockers may increase the risk of hypotension. Caution is advised when taken with alcohol, as it may cause blood pressure decrease and dizziness. This medication is not to be used by women, children, or neonates, and its safety during pregnancy has not been established. While it does not significantly affect driving or machine operation, dizziness can occur in some individuals, so caution is advisable. In cases of overdose, standard treatment should be followed, as dialysis is not very effective in removing this medication from the bloodstream. This medication should be kept out of reach of children and stored in its original packaging to ensure safety.

Side effects

Priapism, headache, dyspepsia, low back pain, myalgia, 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 defect, retinal vein occlusion, retinal artery occlusion, decreased vision, non-arteritic anterior ischemic optic neuropathy, sudden hearing decrease or loss, tinnitus, angioedema, abnormal electrocardiogram, primary sinus bradycardia, myasthenia, facial edema, fatigue, pain, peripheral edema, angina, chest pain, hypotension, myocardial infarction, orthostatic hypotension, palpitations, syncope, tachycardia, abnormal liver function test values, dry mouth, dysphagia, esophagitis, gastritis, increased GGTP, loose stools, nausea, epigastric pain, vomiting, gastroesophageal reflux, hemorrhoidal bleeding, rectal bleeding, arthralgia, neck pain, sensory disturbance, insomnia, paresthesia, drowsiness, dizziness, renal impairment, dyspnea, epistaxis, pharyngitis, itching, rash, sweating, blurred vision, color vision abnormality, conjunctivitis, eye pain, increased tear production, eyelid edema, sudden hearing loss, priapism, angioedema, headache, myalgia, facial flushing, itching, congestion, paresthesia, visual impairment, palpitations, dyspepsia, facial edema, dizziness, abdominal pain, increased blood urea nitrogen, tachycardia, palpitations, eye redness, increased SGPT, chest pressure, vomiting, nausea, increased alkaline phosphatase, fatigue, neck rigidity, urethral pain, kidney pain, dry mouth, heartburn, gastrointestinal disease, drowsiness, increased white blood cell count, thrombocytopenia, anxiety, sleep disturbances, decreased hemoglobin, eye pain, chest pain, arthralgia, hyperventilation, eye hemorrhage, eyelid swelling, conjunctival hemorrhage, dry eyes, abdominal cramps, increased bilirubin, ejaculation disorder, pain in external genitalia, erythema, penile disorder, flushing, myocardial infarction, tinnitus, epistaxis, dry nasal passages, increased serum creatinine, hiccups, weakness, abdominal discomfort, abdominal pain, allergic reaction, facial swelling, fever, increased SGOT, increased hemoglobin, chills, skeletal pain

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

Storage

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. It is recommended to maintain the storage temperature between 1 to 30 degrees Celsius at room temperature. Proper storage will help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Film-coated tablet in a yellow, rounded triangular shape with a score line

Package unit

PTP - 8 tablets/PTP [(8 tablets/PTP) x 1]

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.