Medication info

Tadalafil 5 mg Tablet

Prescription medicationApproval withdrawn
Ingredient · strength
Tadalafil›Strength being verified
Manufacturer / importer
RP Bio Co., Ltd.
Appearance
Yellow, triangular film-coated tablet with rounded corners
Packaging
30 tablets (10 tablets/PTP*3)
Approval status
Approval withdrawn

MFDS item code 201503596 · Approved 2015.06.04

This product's status changed to Approval withdrawn on 2023.03.15. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of benign prostatic hyperplasia, erectile dysfunction, or symptoms of both conditions
Who uses it
Adults · Children
Adult dosage
For oral administration. 1. Erectile dysfunction Use in adult men For patients expected to use tadalafil frequently (at least twice a 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 periodically reassessed. 2. Once-daily dosing for benign prostatic hyperplasia The recommended dose of this medicine for once-daily use 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 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 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 The once-daily dose has not been evaluated in patients with hepatic impairment. Therefore, if prescribing this medicine, the physician should carefully assess the individual benefit/risk. (See section 11. <Special Populations>) ● Use in men with diabetes No dosage adjustment is required in patients with diabetes.
Children's dosage
This medicine should not be used in persons under 18 years of age.

Ingredients

Manufacturer
RP Bio Co., Ltd.

Efficacy & effects

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

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

This medication is primarily used for the treatment of erectile dysfunction in men. However, sexual stimulation is required for effectiveness, and it is not suitable for women. It also helps alleviate symptoms and signs associated with benign prostatic hyperplasia. This medication is effective in treating symptoms of erectile dysfunction and benign prostatic hyperplasia in men. In other words, this medication is used to improve symptoms of erectile dysfunction and prostatic enlargement in men.

Dosage and Administration

Adult dosage

For oral administration. 1. Erectile dysfunction Use in adult men For patients expected to use tadalafil frequently (at least twice a 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 periodically reassessed. 2. Once-daily dosing for benign prostatic hyperplasia The recommended dose of this medicine for once-daily use 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 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 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 The once-daily dose has not been evaluated in patients with hepatic impairment. Therefore, if prescribing this medicine, the physician should carefully assess the individual benefit/risk. (See section 11. <Special Populations>) ● Use in men with diabetes No dosage adjustment is required in patients with diabetes.

Children's dosage

This medicine 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. Before taking, the physician must thoroughly assess the patient's heart condition and overall health status, especially for patients with cardiovascular diseases. If heart-related symptoms occur during or after sexual activity, sexual activity should be immediately stopped and consult a doctor. This medication may cause prolonged erection lasting more than 4 hours or priapism accompanied by pain, necessitating immediate medical attention. Moreover, taking this medication with nitrate medications can cause a significant drop in blood pressure; therefore, patients taking such medications should not use this drug. Administration is prohibited for patients with serious cardiovascular diseases such as myocardial infarction, stroke, or unstable angina. Furthermore, patients with severely impaired liver or kidney function, certain genetic disorders, and those with hypersensitivity to the ingredients of this medication should not use it. Concurrent use with other erectile dysfunction treatments is also not recommended. There may be a risk of hypotension symptoms when consumed with alcohol; therefore, caution is advised. If sudden vision loss or hearing loss occurs, immediately discontinue the medication and inform medical personnel. This medication is not for use in children or women. In case of overdose, standard emergency management should be sought, as removal of this drug by hemodialysis is difficult. Store out of reach of children and maintain the original packaging. It is very important to strictly follow the doctor's instructions before and after taking, and consult immediately if any side effects occur.

Side effects

  • Headache
  • dyspepsia
  • lumbago
  • myalgia
  • congestion
  • flush
  • limb pain
  • nasopharyngitis
  • upper respiratory infection
  • cough
Show 74 more
  • diarrhea
  • urinary tract infection
  • gastroesophageal reflux disease
  • abdominal pain
  • dizziness
  • hypertension
  • priapism
  • increased blood urea nitrogen
  • tachycardia
  • palpitations
  • conjunctival injection
  • increased SGPT
  • chest pressure
  • vomiting
  • nausea
  • increased alkaline phosphatase
  • fatigue
  • neck stiffness
  • urethral pain
  • kidney pain
  • dry mouth
  • heartburn
  • gastrointestinal disorders
  • drowsiness
  • increased white blood cell count
  • decreased platelet count
  • anxiety
  • sleep disorders
  • decreased hemoglobin
  • eye pain
  • chest pain
  • joint pain
  • hyperventilation
  • eye hemorrhage
  • eyelid swelling
  • conjunctival hemorrhage
  • dry eye syndrome
  • abdominal cramping
  • increased bilirubin
  • ejaculatory dysfunction
  • pain in external genitalia
  • erythema
  • itching
  • penile dysfunction
  • myocardial infarction
  • tinnitus
  • epistaxis
  • dry nose
  • increased serum creatinine
  • hiccup
  • asthenia
  • abdominal discomfort
  • abdominal pain
  • allergic reaction
  • facial edema
  • fever
  • increased SGOT
  • increased hemoglobin
  • urticaria
  • Stevens-Johnson syndrome
  • exfoliative dermatitis
  • migraine
  • seizure
  • transient global amnesia
  • visual field defect
  • retinal vein occlusion
  • retinal artery occlusion
  • permanent vision loss
  • angioedema
  • angioedema
  • sudden hearing loss or decrease
  • tinnitus
  • increased erection
  • spontaneous penile erection

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. It is recommended to store the medication at a cool room temperature, between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow, triangular film-coated tablet with rounded corners

Package unit

30 tablets (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.

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.