Medication info

Tadalafil Oral Disintegrating Film 10 mg

Prescription medicationOral
Ingredient · strength
Tadalafil›10mg / 1 sheet
Manufacturer / importer
QL Pharma Co., Ltd.
Appearance
Rectangular yellow oral disintegrating film
Packaging
2 pieces/pack[(1 piece/bag x 2)], 10 pieces/pack[(1 piece/bag x 10)]
Approval status
Active

MFDS item code 202107229 · Approved 2021.10.29

Summary

Main use
Treatment of erectile dysfunction
Who takes it
Adults · Children
Adult dose
For oral administration. 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 provide sufficient effect, 20 mg may be tried. This medicine may be taken 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 dosing has not been established, and because the effect of this medicine usually lasts for more than a day, continuous daily administration of this medicine is strongly not recommended. [See section 1. Warnings and section 11.1) Pharmacodynamic Properties] Use in older men No dosage adjustments are required in older patients. Use in men with renal impairment 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]. 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 evaluate the individual benefit/risk when prescribing. There are no data on administration of doses higher than 10mg to patients with hepatic impairment. [See section 3. Patients Requiring Caution and section 11.2) Pharmacokinetic Properties]. Use in men with diabetes No dosage adjustment is required in patients with diabetes.
Child dose
Under 18 years of age: This medicine must not be used in persons 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 and is effective when there is sexual stimulation. It is not indicated for use in women. Understanding these characteristics will help improve erectile dysfunction when taking the medication.

How to take

Adult dose

For oral administration. 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 provide sufficient effect, 20 mg may be tried. This medicine may be taken 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 dosing has not been established, and because the effect of this medicine usually lasts for more than a day, continuous daily administration of this medicine is strongly not recommended. [See section 1. Warnings and section 11.1) Pharmacodynamic Properties] Use in older men No dosage adjustments are required in older patients. Use in men with renal impairment 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]. 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 evaluate the individual benefit/risk when prescribing. There are no data on administration of doses higher than 10mg to patients with hepatic impairment. [See section 3. Patients Requiring Caution and section 11.2) Pharmacokinetic Properties]. Use in men with diabetes No dosage adjustment is required in patients with diabetes.

Child dose

Under 18 years of age: This medicine must not be used in persons under 18 years of age.

Precautions

This medication is for the treatment of erectile dysfunction, and the underlying cause must be confirmed through a doctor's diagnosis and physical examination before use. Sexual activity may put strain on the heart, so patients with unstable cardiovascular status should consult a doctor before using this medication. If an erection lasts more than 4 hours after taking this medication, immediate medical attention should be sought, as failure to treat can result in penile tissue damage or permanent erectile dysfunction. Patients taking nitrates or NO donors should not use this medication together, as blood pressure may drop dangerously low. Patients with recent cardiovascular diseases like myocardial infarction, unstable angina, or stroke should not take this medication. Patients with penile deformities or certain blood disorders should use this medication cautiously, and those with severely impaired liver or kidney function should be careful. Co-administration with other erectile dysfunction treatments is not recommended due to unverified safety. Since this medication is primarily metabolized in the liver, patients with liver dysfunction should adjust the dosage according to medical advice. During use, side effects such as headache, dyspepsia, back pain, muscle pain, flushing, and others may occur, and if these symptoms are severe, consult a doctor. If sudden vision loss or hearing decrease occurs, stop taking this medication immediately and inform medical staff. This medication should not be used by women, children, or newborns, and its safety in pregnant women has not been established. Caution should be exercised when taking this medication with alcohol, as symptoms of blood pressure reduction may be exacerbated. In case of overdose, standard emergency treatment should be administered, and hemodialysis may not help in removing this medication. Keep out of reach of children, and it is recommended to store in the original packaging.

Side effects

  • headache
  • dyspepsia
  • back pain
  • myalgia
  • congestion
  • flushing
  • limb pain
  • nasopharyngitis
  • upper respiratory infection
  • cough
Show 108 more
  • diarrhea
  • gastroesophageal reflux disease
  • abdominal pain
  • hypertension
  • dizziness
  • urinary tract infection
  • gastroenteritis
  • hypertension
  • angina
  • 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
  • upper abdominal pain
  • vomiting
  • hemorrhoidal bleeding
  • rectal bleeding
  • arthralgia
  • neck pain
  • sensory loss
  • insomnia
  • paresthesia
  • drowsiness
  • vertigo
  • kidney impairment
  • dyspnea
  • epistaxis
  • pharyngitis
  • pruritus
  • rash
  • sweating
  • blurred vision
  • color vision deficiency
  • conjunctivitis
  • eye pain
  • increased tear production
  • eyelid edema
  • sudden hearing loss or decrease
  • tinnitus
  • increased erection
  • spontaneous penile erection
  • priapism
  • urticaria
  • Stevens-Johnson syndrome
  • exfoliative dermatitis
  • migraine
  • seizure
  • transient global amnesia
  • visual field loss
  • retinal vein occlusion
  • retinal artery occlusion
  • permanent vision loss
  • angioedema
  • increased blood urea nitrogen
  • thrombocytopenia
  • decreased hemoglobin
  • increased alkaline phosphatase
  • chest pressure
  • nausea
  • fatigue
  • neck stiffness
  • urethral pain
  • kidney pain
  • heartburn
  • drowsiness
  • leukocytosis
  • anxiety
  • sleep disturbances
  • eye pain
  • chest pain
  • arthralgia
  • hyperventilation
  • eye hemorrhage
  • eyelid swelling
  • conjunctival hemorrhage
  • dry eye syndrome
  • abdominal cramps
  • increased bilirubin
  • ejaculation disorder
  • pain in external genitalia
  • erythema
  • penile dysfunction
  • ear ringing
  • epistaxis
  • nasal dryness
  • increased serum creatinine
  • hiccups
  • asthenia
  • abdominal discomfort
  • abdominal pain
  • allergic reaction
  • facial edema
  • fever
  • increased SGOT
  • increased hemoglobin
  • chills
  • skeletal pain

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

Storage

This medication is sensitive to air and moisture, so it must be stored in a tightly sealed container. Avoid extremely hot or cold places, and it is essential to store it at a temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Rectangular yellow oral disintegrating film

Package unit

2 pieces/pack[(1 piece/bag x 2)], 10 pieces/pack[(1 piece/bag x 10)]

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.