Medication info
Tadalafil Oral Disintegrating Film 10 mg

Tadalafil Oral Disintegrating Film 10 mg

Prescription medicationOral
Ingredient · strength
Tadalafil›10mg / 1 sheet
Manufacturer / importer
Daewoong Pharmaceutical Co., Ltd.
Appearance
White square oral disintegrating film
Packaging
10 pieces/case
Approval status
Active

MFDS item code 201503184 · Approved 2015.05.27

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 regardless of food before anticipated sexual activity. Patients for whom tadalafil 10mg does not provide an adequate effect may try 20 mg. This medicine may be administered at least 30 minutes before sexual activity. The maximum recommended dosing frequency is once daily. Immediately after removing this medicine from its individual package, place it on the tongue, allow it to dissolve, and take it without water. Long-term safety following 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 11.1) Pharmacodynamic properties] Use in elderly men No dosage adjustments are required in elderly 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 regardless of 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 when prescribing it. There are no data on administering doses higher than 10mg to patients with hepatic impairment. [See section 3. Precautions for use in the following patients and section 11.2) Pharmacokinetic properties]. Use in men with diabetes No dosage adjustment is required in patients with diabetes.
Child dose
This medicine must not be used in persons under 18 years of age.

Ingredients

Manufacturer
Daewoong Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of erectile dysfunction

  • Erectile dysfunction
View approved original text

This medication is primarily used for the treatment of erectile dysfunction and requires sexual stimulation to be effective. It is not intended for use in females, thus assisting in the improvement of male erectile dysfunction.

How to take

Adult dose

Use in adult men The recommended dose of this medicine is 10mg, taken regardless of food before anticipated sexual activity. Patients for whom tadalafil 10mg does not provide an adequate effect may try 20 mg. This medicine may be administered at least 30 minutes before sexual activity. The maximum recommended dosing frequency is once daily. Immediately after removing this medicine from its individual package, place it on the tongue, allow it to dissolve, and take it without water. Long-term safety following 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 11.1) Pharmacodynamic properties] Use in elderly men No dosage adjustments are required in elderly 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 regardless of 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 when prescribing it. There are no data on administering doses higher than 10mg to patients with hepatic impairment. [See section 3. Precautions for use in the following patients and section 11.2) Pharmacokinetic properties]. Use in men with diabetes No dosage adjustment is required in patients with diabetes.

Child dose

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

Precautions

This drug is intended for the treatment of erectile dysfunction, and prior diagnosis by a physician and evaluation of cardiovascular condition are essential before use. Sexual activity may place stress on the heart, and patients with heart disease or a history of recent myocardial infarction or stroke should not use this medication. This medication may cause a prolonged erection (priapism) lasting more than 4 hours, therefore if an erection persists for more than 4 hours, immediate medical assistance should be sought. Patients taking nitrate drugs or NO donors should not take this medication concurrently as it could dangerously lower blood pressure. Patients with cardiovascular issues or uncontrolled blood pressure, hereditary retinal diseases, etc., should not be administered this medication. It is considered safe not to use this medication with other erectile dysfunction treatments, and patients who have experienced vision loss due to specific optic nerve diseases should also refrain from use. Patients with penile deformities or blood disorders that may affect erection duration should use this medication with caution. Patients with severe liver or kidney dysfunction should consult a physician before taking this medication, and care should be taken as symptoms of hypotension may occur when combined with certain antihypertensive agents. Common side effects of this medication include headaches, dyspepsia, back pain, muscle pain, flushing, and limb pain, which are mostly mild or transient. Rarely, serious cardiovascular adverse reactions, vision or hearing loss, allergic reactions have been reported, so if any abnormal symptoms appear, immediate consultation with medical personnel is necessary. This medication is not intended for use by women, children, or pregnant individuals, and caution should be exercised during driving or operating machinery until individual reaction is confirmed. In the event of an overdose, standard treatment should be followed, and dialysis does not affect the clearance of this drug. This medication should be stored out of reach of children, and it is advisable to maintain the original packaging state. Before taking this medication, it is crucial to consult with a physician regarding individual health status and any medications currently being taken, especially paying attention to possible interactions with other drugs.

Side effects

  • Headache
  • dyspepsia
  • low back pain
  • muscle pain
  • congestion
  • flushing
  • limb pain
  • nasopharyngitis
  • upper respiratory tract infection
  • cough
Show 126 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
  • urticaria
  • Stevens-Johnson syndrome
  • exfoliative dermatitis
  • migraine
  • seizure
  • transient global amnesia
  • visual field defect
  • retinal vein occlusion
  • retinal artery occlusion
  • decreased vision
  • sudden hearing loss
  • hearing loss
  • tinnitus
  • angioedema
  • abnormal electrocardiogram
  • primary bradycardia
  • facial swelling
  • fatigue
  • pain
  • peripheral edema
  • abnormal liver function tests
  • dry mouth
  • dysphagia
  • esophagitis
  • gastritis
  • increased GGTP
  • loose stools
  • nausea
  • upper abdominal pain
  • vomiting
  • gastroesophageal reflux
  • hemorrhoidal bleeding
  • rectal bleeding
  • arthralgia
  • neck pain
  • sensory impairment
  • insomnia
  • paresthesia
  • drowsiness
  • dizziness
  • renal impairment
  • dyspnea
  • epistaxis
  • pharyngitis
  • itching
  • rash
  • sweating
  • blurred vision
  • color vision deficiency
  • conjunctivitis
  • eye pain
  • increased tear secretion
  • eyelid swelling
  • increased erection
  • spontaneous penile erection
  • chills
  • skeletal pain
  • upper abdominal pain
  • nausea
  • vomiting
  • arthralgia
  • muscle cramps
  • dizziness
  • abdominal pain
  • increased blood urea nitrogen
  • conjunctival injection
  • increased SGPT
  • chest pressure sensation
  • nausea
  • increased alkaline phosphatase
  • fatigue
  • neck stiffness
  • urethral pain
  • kidney pain
  • heartburn
  • gastrointestinal disorders
  • drowsiness
  • leukocytosis
  • thrombocytopenia
  • anxiety
  • sleep disturbance
  • anemia
  • eye pain
  • chest pain
  • arthralgia
  • hyperventilation
  • eye hemorrhage
  • eyelid edema
  • conjunctival hemorrhage
  • dry eye syndrome
  • abdominal cramps
  • increased bilirubin
  • erectile dysfunction
  • external genitalia pain
  • erythema
  • penile dysfunction
  • myocardial infarction
  • tinnitus
  • epistaxis
  • dry nose
  • increased serum creatinine
  • hiccups
  • asthenia
  • abdominal discomfort
  • abdominal pain
  • allergic reaction
  • facial swelling
  • fever
  • increased SGOT
  • increased hemoglobin

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

Storage

This medication must be stored in a tightly closed container to protect it from air and moisture. It is best to keep it at room temperature between 1°C and 30°C.

Appearance and packaging

Appearance

White square oral disintegrating film

Package unit

10 pieces/case

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.

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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.