Medication info

Tadalafil Tablets 5 mg (Tadalafil)

Prescription medicationTabletOralExpired
Ingredient · strength
Tadalafil›5mg / 1 tablet
Manufacturer / importer
Kwangdong Pharmaceutical Co., Ltd.
Appearance
Yellow film-coated tablets with a rounded triangular shape
Packaging
30 tablets (10 tablets/PTPX3)
Approval status
Expired

MFDS item code 201503485 · Approved 2015.05.29

This product's status changed to Expired on 2025.05.29. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of symptoms of erectile dysfunction, benign prostatic hyperplasia, and coexisting erectile dysfunction and benign prostatic hyperplasia
Who takes it
Adults · Children
Adult dose
Do not crush this product. Take one tablet whole. For oral administration. 1. Erectile dysfunction Use in adult men For patients who anticipate frequent use of tadalafil (at least 2 times per week), the recommended dose is up to 5mg once daily, preferably taken at the same time each day. The appropriateness of continuous daily dosing should be reassessed periodically. 2. Once-daily use for benign prostatic hyperplasia The recommended dose of this product for once-daily use is 5mg, taken at approximately the same time each day. 3. Once-daily use for erectile dysfunction and benign prostatic hyperplasia The recommended dose of this product 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 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 Precautions for Use, 3.2) 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 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 this product, the physician should carefully assess the individual benefit/risk. (See 11. Special Populations.) ● Use in men with diabetes No dosage adjustment is required in patients with diabetes.
Child dose
This product should not be used in persons under 18 years of age.

Ingredients

Manufacturer
Kwangdong Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of symptoms of erectile dysfunction, benign prostatic hyperplasia, and coexisting erectile dysfunction and benign prostatic hyperplasia

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

This medication is primarily used for the treatment of erectile dysfunction in men, and sexual stimulation is required to achieve an effect. It also helps to improve symptoms associated with benign prostatic hyperplasia. This medication is effective in treating both symptoms when erectile dysfunction and benign prostatic hyperplasia occur together. It is not used by women and focuses on treatment for men with the respective symptoms. This medication improves the symptoms of erectile dysfunction and prostatic enlargement.

How to take

Adult dose

Do not crush this product. Take one tablet whole. For oral administration. 1. Erectile dysfunction Use in adult men For patients who anticipate frequent use of tadalafil (at least 2 times per week), the recommended dose is up to 5mg once daily, preferably taken at the same time each day. The appropriateness of continuous daily dosing should be reassessed periodically. 2. Once-daily use for benign prostatic hyperplasia The recommended dose of this product for once-daily use is 5mg, taken at approximately the same time each day. 3. Once-daily use for erectile dysfunction and benign prostatic hyperplasia The recommended dose of this product 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 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 Precautions for Use, 3.2) 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 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 this product, the physician should carefully assess the individual benefit/risk. (See 11. Special Populations.) ● Use in men with diabetes No dosage adjustment is required in patients with diabetes.

Child dose

This product should not be used in persons under 18 years of age.

Precautions

This medication is used for the treatment of erectile dysfunction and benign prostatic hyperplasia, and a proper medical evaluation by a physician is required before taking it. Sexual activity can put stress on the heart, so patients with cardiovascular disease should check their heart condition before taking this medication. If heart-related symptoms occur during or after sexual activity, sexual activity should be stopped immediately and medical attention should be sought. If an erection lasts more than 4 hours after taking this medication, immediate medical assistance is required, as untreated cases can lead to penile tissue damage and permanent erectile dysfunction. This medication should not be taken with nitrate-containing products, as it can significantly lower blood pressure; therefore, patients taking nitrates should never use this medication. Patients with severe cardiovascular diseases such as recent myocardial infarction, unstable angina, heart failure, or stroke should not take this medication. Patients with hereditary retinal diseases or allergies to this medication or its components should also refrain from using it. This medication is not recommended to be taken with other erectile dysfunction medications, and caution is needed for patients with lactose intolerance. Patients with anatomical abnormalities of the penis or certain blood disorders should use this medication cautiously. Patients with severe kidney or liver impairment should consult a physician before use, and especially for those with severe liver impairment, the dose must be limited. When used with alpha-blockers or antihypertensive medications that lower blood pressure, caution is needed due to the risk of dizziness or fainting from blood pressure reduction. When taken with potent CYP3A4 inhibitors, the concentration of this medication in the blood may increase, requiring dose adjustments. It is not to be used by pregnant or breastfeeding women or children. This medication does not significantly affect driving or operating machinery, but dizziness may occur in some individuals, requiring caution. In case of overdose, standard treatment should be administered, and dialysis is not effective in removing this medication. This medication should be stored out of reach of children and preferably kept in its original packaging.

Side effects

Headache, indigestion, low back pain, muscle pain, nasal congestion, flushing, limb pain, nasopharyngitis, upper respiratory tract infection, cough, diarrhea, urinary tract infection, gastroesophageal reflux disease, abdominal pain, dizziness, hypertension, priapism, increased blood urea nitrogen, tachycardia, palpitations, eye congestion, increased SGPT, chest pressure, vomiting, nausea, increased alkaline phosphatase, fatigue, neck stiffness, urethral pain, kidney pain, dry mouth, heartburn, gastrointestinal disease, drowsiness, leukocytosis, thrombocytopenia, decreased hemoglobin, eye pain, chest pain, joint pain, hyperventilation, eye hemorrhage, eyelid swelling, conjunctival hemorrhage, dry eye syndrome, abdominal cramps, increased bilirubin, ejaculatory dysfunction, pain in external genitalia, erythema, itching, penile disorder, myocardial infarction, tinnitus, nosebleed, dry nose, increased serum creatinine, hiccups, weakness, abdominal discomfort, abdominal pain, allergic reaction, facial swelling, fever, increased SGOT, increased hemoglobin, angina, chest pain, hypotension, myocardial infarction, orthostatic hypotension, palpitations, syncope, tachycardia, 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 loss or reduction, tinnitus, angioedema, angioedema

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture, and it is recommended to keep it at room temperature between 1 and 30 degrees Celsius. This storage method helps maintain the effectiveness of the medication for a longer period.

Appearance and packaging

Appearance

Yellow film-coated tablets with a rounded triangular shape

Package unit

30 tablets (10 tablets/PTPX3)

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.