Medication info

Tadalafil Orally Disintegrating Film 20mg

Prescription medicationOralExpired
Ingredient · strength
Tadalafil›20mg / 1 sheet
Manufacturer / importer
Korea Pharma Co., Ltd.
Appearance
White square orally disintegrating film
Packaging
10 sheets/case (1 sheet x 60mg)
Approval status
Expired

MFDS item code 201907877 · Approved 2019.11.12

This product's status changed to Expired on 2024.11.12. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of erectile dysfunction
Who takes it
Adults · Children
Adult dose
Use in adult men 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 produce a sufficient effect, 20 mg may be tried. This medicine may be administered at least 30 minutes before sexual activity. The maximum recommended frequency of administration is once daily. Immediately after removing this medicine from its individual package, place it on the tongue and allow it to dissolve; take without water. Long-term safety after extended daily administration has not been established, and because the effect of this medicine usually lasts for more than one day, continuous daily administration of this medicine is strongly discouraged. [See section 1. Warnings and section 12.1) Pharmacodynamic Properties] Use in elderly men Dose adjustments are 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 12.2) Pharmacokinetic Properties]. Use in men with hepatic impairment The recommended dose is 10mg, taken with or without food before anticipated sexual activity. Since clinical data on the safety of this medicine in patients with severe hepatic impairment (Child-Pugh Class C) are limited, the physician should carefully assess the individual benefit/risk if prescribing it. There are no data on administration of doses higher than 10mg to patients with hepatic impairment. [See section 3. Patients Requiring Cautious Administration and section 12.2) Pharmacokinetic Properties]. Use in men with diabetes No dose adjustment is required in patients with diabetes.
Child dose
Do not use in persons under 18 years of age.

Ingredients

Manufacturer
Korea 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 and requires sexual stimulation to be effective. It is not for use in women and is suitable for male patients. It is used to improve erectile function and assist in normal sexual activity.

How to take

Adult dose

Use in adult men 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 produce a sufficient effect, 20 mg may be tried. This medicine may be administered at least 30 minutes before sexual activity. The maximum recommended frequency of administration is once daily. Immediately after removing this medicine from its individual package, place it on the tongue and allow it to dissolve; take without water. Long-term safety after extended daily administration has not been established, and because the effect of this medicine usually lasts for more than one day, continuous daily administration of this medicine is strongly discouraged. [See section 1. Warnings and section 12.1) Pharmacodynamic Properties] Use in elderly men Dose adjustments are 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 12.2) Pharmacokinetic Properties]. Use in men with hepatic impairment The recommended dose is 10mg, taken with or without food before anticipated sexual activity. Since clinical data on the safety of this medicine in patients with severe hepatic impairment (Child-Pugh Class C) are limited, the physician should carefully assess the individual benefit/risk if prescribing it. There are no data on administration of doses higher than 10mg to patients with hepatic impairment. [See section 3. Patients Requiring Cautious Administration and section 12.2) Pharmacokinetic Properties]. Use in men with diabetes No dose adjustment is required in patients with diabetes.

Child dose

Do not use in persons under 18 years of age.

Precautions

This medication is used for treating erectile dysfunction, and the cause must be determined through a doctor's diagnosis and physical examination before taking it. Sexual activity may put stress on the heart, so caution is advised for patients with cardiovascular diseases. If an erection lasts longer than 4 hours, immediate medical assistance is required, as untreated cases may lead to penile tissue damage and permanent erectile dysfunction. Taking nitrates together with this medication can result in dangerously low blood pressure, so nitrates should not be used while taking this medication. Patients with serious cardiovascular conditions such as myocardial infarction, unstable angina, and heart failure should not take this medication. Patients with penile deformities or blood disorders, and those with severe renal or liver impairment should use this medication with caution. It is not recommended to take this medication together with other erectile dysfunction treatments. Common side effects may include headache, dyspepsia, back pain, muscle pain, flushing, and others; if adverse reactions are severe, discontinue use and consult a doctor. This medication should not be used by women, children, or newborns. Caution should be exercised when consuming alcohol with this medication as it may cause blood pressure lowering or dizziness. In case of overdose, standard supportive treatment should be administered, and this medication is not removed by dialysis. When storing, keep it out of reach of children and in its original packaging. There is a minimal effect on driving or operating machinery, but caution is needed due to individual differences.

Side effects

  • Headache
  • dyspepsia
  • low back pain
  • myalgia
  • congestion
  • flushing
  • limb pain
  • nasopharyngitis
  • upper respiratory tract infection
  • cough
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  • diarrhea
  • gastroesophageal reflux disease
  • abdominal pain
  • hypertension
  • dizziness
  • urinary tract infection
  • gastroenteritis
  • hypertension
  • dizziness
  • urticaria
  • Stevens-Johnson syndrome
  • exfoliative dermatitis
  • migraine
  • seizures
  • transient global amnesia
  • visual field defects
  • retinal vein occlusion
  • retinal artery occlusion
  • vision loss
  • hearing loss or impairment
  • tinnitus
  • priapism
  • angioedema
  • electrocardiogram abnormalities
  • primary sinus tachycardia
  • angina pectoris
  • chest pain
  • hypotension
  • myocardial infarction
  • orthostatic hypotension
  • palpitations
  • syncope
  • tachycardia
  • abnormal liver function test results
  • dry mouth
  • dysphagia
  • esophagitis
  • gastritis
  • increased GGTP
  • loose stools
  • nausea
  • epigastric pain
  • vomiting
  • hemorrhoidal bleeding
  • rectal bleeding
  • arthralgia
  • neck pain
  • sensory loss
  • insomnia
  • paresthesia
  • drowsiness
  • dizziness
  • renal impairment
  • dyspnea
  • epistaxis
  • pharyngitis
  • itching
  • rash
  • sweating
  • blurred vision
  • color vision abnormalities
  • conjunctivitis
  • eye pain
  • increased tear secretion
  • eyelid swelling
  • sudden hearing loss or impairment
  • penile enlargement
  • spontaneous penile erection
  • myasthenia
  • facial edema
  • fatigue
  • pain
  • peripheral edema
  • chills
  • skeletal pain

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is also advised to store the medication at room temperature, ideally between 1 to 30 degrees Celsius, avoiding extreme hot or cold conditions.

Appearance and packaging

Appearance

White square orally disintegrating film

Package unit

10 sheets/case (1 sheet x 60mg)

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

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

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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.