Medication info

Tao Long Oral Dissolving Film 10 mg (Tadalafil)

Prescription medicationOral
Ingredient · strength
Tadalafil›10mg / 1 sheet
Manufacturer / importer
Kolon Pharmaceutical Co., Ltd.
Appearance
Rectangular yellow oral dissolving film
Packaging
10 sheets/pack (1 sheet/ pouch x 10)
Approval status
Active

MFDS item code 202104339 · Approved 2021.06.02

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 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 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 of this medicine is strongly discouraged. [See sections 1. Warnings and 11.1) 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 11.2) Pharmacokinetic properties]. Use in men with hepatic impairment The recommended dose is 10mg, taken with or without food before anticipated sexual activity. Clinical data on the safety of this medicine in patients with severe hepatic impairment (Child-Pugh Class C) are limited; if prescribing it, the physician should carefully evaluate the individual benefit/risk. There are no data on administration of doses higher than 10mg in patients with hepatic impairment. [See section 3. Administration with caution in the following patients and 11.2) Pharmacokinetic properties]. Use in men with diabetes No dose adjustment is required in patients with diabetes.
Child dose
Use in children and adolescents This medicine should not be used in people under 18 years of age.

Ingredients

Manufacturer
Kolon Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of erectile dysfunction

  • Erectile dysfunction
View approved original text

This drug is used for the treatment of erectile dysfunction. However, sexual stimulation is necessary to see the effects of this drug, and it is not used for women. Please take this into account to help improve erectile dysfunction.

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 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 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 of this medicine is strongly discouraged. [See sections 1. Warnings and 11.1) 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 11.2) Pharmacokinetic properties]. Use in men with hepatic impairment The recommended dose is 10mg, taken with or without food before anticipated sexual activity. Clinical data on the safety of this medicine in patients with severe hepatic impairment (Child-Pugh Class C) are limited; if prescribing it, the physician should carefully evaluate the individual benefit/risk. There are no data on administration of doses higher than 10mg in patients with hepatic impairment. [See section 3. Administration with caution in the following patients and 11.2) Pharmacokinetic properties]. Use in men with diabetes No dose adjustment is required in patients with diabetes.

Child dose

Use in children and adolescents This medicine should not be used in people under 18 years of age.

Precautions

This drug is used for the treatment of erectile dysfunction, and before use, the physician must carefully evaluate the patient's overall health and heart condition. Sexual activity can put stress on the heart, so patients with cardiovascular diseases should be particularly cautious, and if chest pain or heart-related symptoms occur during sexual activity, they should stop immediately and consult a doctor. This drug can rarely cause an erection lasting more than 4 hours (priapism), in which case immediate medical attention is required, as untreated priapism can lead to damage to penile tissues and permanent loss of erectile function. Taking this drug with nitrates or nitric oxide donors can cause dangerously low blood pressure, so patients who are taking these medications should not use this drug. Patients who have recently experienced serious cardiovascular conditions such as myocardial infarction, cardiac arrest, unstable angina, or stroke should not take this drug. Patients with genetic retinal diseases or hypersensitivity to this drug or its components should also avoid its use. Combining with other erectile dysfunction medications is not recommended as safety and efficacy have not been established. Patients with penile deformities or specific blood disorders should use this drug cautiously, and those with severely impaired kidney or liver function should also take precaution. Combining with alpha-blockers or certain antifungals, antivirals, etc., can increase side effects; therefore, consultation with a physician is necessary. This drug should not be used by pregnant women, nursing mothers, or children. This drug can cause side effects such as headaches, dyspepsia, back pain, muscle pain, flushing, etc., and rarely serious cardiovascular adverse reactions or vision and hearing impairment have been reported. If sudden loss of vision or hearing occurs, the use should be stopped immediately, and medical attention should be sought. When taken with alcohol, the lowering of blood pressure and dizziness may worsen; therefore, caution is advised. In case of overdose, as there is no specific antidote, appropriate treatment according to symptoms should be received, and hematodialysis has little effect on this drug's elimination. Store this medication in a container that is sealed to protect it from air or moisture, and keep it at room temperature between 1 and 30 degrees Celsius. Storing in this way will help maintain the drug's efficacy for a longer time.

Side effects

  • Headache
  • indigestion
  • low back pain
  • muscle pain
  • congestion
  • flushing
  • limb pain
  • nasopharyngitis
  • upper respiratory infection
  • cough
Show 137 more
  • 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 loss
  • retinal vein occlusion
  • retinal artery occlusion
  • decreased vision
  • hearing loss or impairment
  • tinnitus
  • priapism
  • angioedema
  • abnormal electrocardiogram
  • primary sinus tachycardia
  • muscle weakness
  • facial swelling
  • fatigue
  • pain
  • peripheral edema
  • angina
  • chest pain
  • hypotension
  • myocardial infarction
  • orthostatic hypotension
  • palpitations
  • syncope
  • tachycardia
  • abnormal liver function tests
  • dry mouth
  • dysphagia
  • esophagitis
  • gastritis
  • increased GGTP
  • loose stools
  • nausea
  • upper abdominal pain
  • vomiting
  • gastroesophageal reflux
  • hemorrhoidal bleeding
  • rectal bleeding
  • joint pain
  • neck pain
  • sensory loss
  • insomnia
  • paresthesia
  • drowsiness
  • dizziness
  • kidney impairment
  • dyspnea
  • epistaxis
  • pharyngitis
  • itching
  • rash
  • sweating
  • blurred vision
  • conjunctivitis
  • eye pain
  • increased tear production
  • eyelid edema
  • sudden hearing loss or impairment
  • penile enlargement
  • spontaneous penile erection
  • urticaria
  • Stevens-Johnson syndrome
  • exfoliative dermatitis
  • migraine
  • seizures
  • transient global amnesia
  • visual field loss
  • retinal vein occlusion
  • retinal artery occlusion
  • decreased vision
  • hearing loss or impairment
  • tinnitus
  • priapism
  • angioedema
  • abnormal electrocardiogram
  • primary sinus tachycardia
  • muscle weakness
  • facial swelling
  • fatigue
  • pain
  • peripheral edema
  • angina
  • chest pain
  • hypotension
  • myocardial infarction
  • orthostatic hypotension
  • palpitations
  • syncope
  • tachycardia
  • abnormal liver function tests
  • dry mouth
  • dysphagia
  • esophagitis
  • gastritis
  • increased GGTP
  • loose stools
  • nausea
  • upper abdominal pain
  • vomiting
  • gastroesophageal reflux
  • hemorrhoidal bleeding
  • rectal bleeding
  • joint pain
  • neck pain
  • sensory loss
  • insomnia
  • paresthesia
  • drowsiness
  • dizziness
  • kidney impairment
  • dyspnea
  • epistaxis
  • pharyngitis
  • itching
  • rash
  • sweating
  • blurred vision
  • conjunctivitis
  • eye pain
  • increased tear production
  • eyelid edema
  • sudden hearing loss or impairment
  • penile enlargement
  • spontaneous penile erection

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

Storage

This drug should be stored in a sealed container to avoid exposure to air or moisture and kept at room temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain the drug's efficacy for a longer time.

Appearance and packaging

Appearance

Rectangular yellow oral dissolving film

Package unit

10 sheets/pack (1 sheet/ pouch 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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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.