Medication info
Tadalafil 20 mg Tablets

Tadalafil 20 mg Tablets

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

MFDS item code 201503288 · Approved 2015.05.29

Summary

Main use
Treatment of erectile dysfunction
Who takes it
Adults · Children
Adult dose
For oral administration. The recommended dose of this medicine is 10mg, taken with or without food before anticipated sexual activity. For patients in whom tadalafil 10mg does not provide an adequate effect, 20 mg may be tried. This medicine may be administered starting at least 30 minutes before sexual activity. The maximum recommended dosing frequency is once daily. Long-term safety following extended daily dosing has not been established, and because the effect of this medicine usually lasts for more than one day, continuous daily administration is strongly discouraged. [See section 1. Warnings and section 11.1) Pharmacodynamic Properties] Dosage adjustments are not required in elderly patients. No dosage 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 11.2) Pharmacokinetic Properties]. 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 individual benefit/risk when prescribing it. There are no data on administering doses higher than 10mg to patients with hepatic impairment. [See section 3. Use with Caution in the Following Patients and section 11.2) Pharmacokinetic Properties]. No dosage adjustment is required in patients with diabetes.
Child dose
Must not be used in persons under 18 years of age.

Ingredients

Manufacturer
Alvogen Korea Co., Ltd.

Efficacy & effects

Treatment of erectile dysfunction

  • Erectile dysfunction
View approved original text

This medication is used for the treatment of erectile dysfunction. However, sexual stimulation is required for effectiveness, and it is not used in women. It is a therapeutic agent that helps individuals struggling with erectile dysfunction.

How to take

Adult dose

For oral administration. The recommended dose of this medicine is 10mg, taken with or without food before anticipated sexual activity. For patients in whom tadalafil 10mg does not provide an adequate effect, 20 mg may be tried. This medicine may be administered starting at least 30 minutes before sexual activity. The maximum recommended dosing frequency is once daily. Long-term safety following extended daily dosing has not been established, and because the effect of this medicine usually lasts for more than one day, continuous daily administration is strongly discouraged. [See section 1. Warnings and section 11.1) Pharmacodynamic Properties] Dosage adjustments are not required in elderly patients. No dosage 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 11.2) Pharmacokinetic Properties]. 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 individual benefit/risk when prescribing it. There are no data on administering doses higher than 10mg to patients with hepatic impairment. [See section 3. Use with Caution in the Following Patients and section 11.2) Pharmacokinetic Properties]. No dosage adjustment is required in patients with diabetes.

Child dose

Must not be used in persons under 18 years of age.

Precautions

This medication is used for the treatment of erectile dysfunction and requires a doctor's diagnosis and physical examination before use. There may be cardiovascular risks associated with sexual activity, so cardiovascular status must be checked. If an erection persists for more than 4 hours, immediate medical help should be sought, as neglecting this can result in penile tissue damage and permanent loss of erectile function. Taking alongside nitrate or NO donors can lead to dangerously low blood pressure, so this medication should not be used by individuals on such medications. Patients who have had recent cardiovascular conditions such as myocardial infarction, angina pectoris, heart failure, or stroke should not take this medication. Patients with genetic retinal diseases or certain eye conditions are also advised against using this medication. The use of other erectile dysfunction treatments in conjunction with this medication is not recommended. It should be administered with caution in patients with severe renal or liver impairment, as symptoms of hypotension may occur when combined with certain antihypertensives. Severe side effects include headache, dyspepsia, back pain, muscle pain, flushing, and rarely reported serious cardiovascular adverse reactions or vision and hearing loss. Caution should be exercised when taking this medication with alcohol, as it may exacerbate blood pressure lowering and dizziness. In case of overdose, immediate medical attention should be sought, and blood dialysis is not effective. Keep out of reach of children, and it is advisable to maintain the original packaging state. This medication cannot be used by women, newborns, or children, and the safety of use during pregnancy has not been established. There is no special influence when driving or operating machinery, but individual differences may warrant caution.

Side effects

  • prolonged erection
  • priapism
  • headache
  • dyspepsia
  • back pain
  • muscle pain
  • congestion
  • flushing
  • limb pain
  • nasopharyngitis
Show 98 more
  • upper respiratory infection
  • cough
  • diarrhea
  • gastroenteritis
  • hypertension
  • dizziness
  • urinary tract infection
  • gastroesophageal reflux disease
  • abdominal pain
  • dizziness
  • sensory impairment
  • insomnia
  • paresthesia
  • drowsiness
  • vertigo
  • renal impairment
  • dyspnea
  • epistaxis
  • pharyngitis
  • itching
  • rash
  • sweating
  • blurred vision
  • color vision deficiency
  • conjunctivitis
  • eye pain
  • increased tear production
  • eyelid edema
  • sudden decrease or loss of hearing
  • tinnitus
  • increased erection
  • spontaneous penile erection
  • urticaria
  • Stevens-Johnson syndrome
  • exfoliative dermatitis
  • migraine
  • seizure
  • transient global amnesia
  • visual field defect
  • retinal vein occlusion
  • retinal artery occlusion
  • decreased vision
  • angioedema
  • myocardial infarction
  • sudden cardiac death
  • stroke
  • chest pain
  • palpitations
  • ventricular arrhythmia
  • tachycardia
  • elevated blood urea nitrogen
  • chest tightness
  • vomiting
  • nausea
  • alkaline phosphatase elevation
  • fatigue
  • neck rigidity
  • urethral pain
  • kidney pain
  • dry mouth
  • heartburn
  • gastrointestinal disease
  • drowsiness
  • leukocytosis
  • thrombocytopenia
  • anxiety
  • sleep disorder
  • decreased hemoglobin
  • eye pain
  • chest pain
  • arthralgia
  • hyperventilation
  • ocular hemorrhage
  • eyelid swelling
  • conjunctival hemorrhage
  • dry eye syndrome
  • abdominal cramps
  • elevated bilirubin
  • ejaculation disorder
  • pain in external genitals
  • erythema
  • penile disorder
  • asthenia
  • tinnitus
  • epistaxis
  • nasal dryness
  • elevated serum creatinine
  • hiccups
  • weakness
  • abdominal discomfort
  • abdominal pain
  • allergic reaction
  • facial swelling
  • fever
  • SGOT elevation
  • increased hemoglobin
  • chills
  • skeletal pain

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

Storage

This medication should be stored in a tightly closed container to prevent air or moisture ingress, at temperatures between 1 and 30 degrees Celsius. This will help maintain the medication's efficacy.

Appearance and packaging

Appearance

Film-coated tablet in a yellow color with a rounded triangular shape and a score line.

Package unit

8 tablets (8 tablets/PTP packaging 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.

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.