Medication info
Tadalafil Oral Dissolving Film 20 mg

Tadalafil Oral Dissolving Film 20 mg

Prescription medicationOral
Ingredient · strength
Tadalafil›20mg / 1 sheet
Manufacturer / importer
Daewoong Pharmaceutical Co., Ltd.
Appearance
White rectangular oral dissolving film
Packaging
10 films/case
Approval status
Active

MFDS item code 201503183 · Approved 2015.05.27

Summary

Main use
Treatment of erectile dysfunction
Who takes it
Adults · Children
Adult dose
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] No dosage adjustments are 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 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]. 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 used for the treatment of erectile dysfunction. It is important to take it with sexual stimulation, as the effect appears when there is sexual arousal. This medication is intended for the treatment of erectile dysfunction in men and is not to be used by women. When taken safely, it can help improve erectile function.

How to take

Adult dose

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] No dosage adjustments are 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 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]. 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 medication is for the treatment of erectile dysfunction, and before use, it is essential to confirm the underlying cause through a doctor's diagnosis and physical examination. Sexual activity can place strain on the heart, so it is important to use it while considering cardiovascular health conditions. If an erection lasts more than 4 hours, seek medical assistance immediately, as neglecting this may lead to damage to penile tissue and permanent loss of erectile function. During the use of this medication, it should never be combined with nitrate medications or NO donors, as this can result in dangerously low blood pressure. Patients with recent cardiovascular events such as myocardial infarction, angina, stroke, or uncontrolled high blood pressure or low blood pressure should not use this medication. Patients with genetic retinal disorders or hypersensitivity to any ingredient of this medicine should also not be treated with it. Use with other erectile dysfunction medications is not recommended, and it should not be used by patients who have experienced vision loss. Patients with penile deformities or specific blood disorders should be administered with caution, and it is not recommended for patients with severely impaired kidney or liver function. Careful dosage adjustment and monitoring are required when used with alpha-blockers or potent CYP3A4 inhibitors. This medication may cause side effects such as headaches, indigestion, back pain, muscle pain, nasal congestion, flushing, limb pain, nasopharyngitis, upper respiratory infections, cough, diarrhea, gastroesophageal reflux disease, abdominal pain, dizziness, urinary tract infections, gastroenteritis, hypertension, dizziness, vomiting, insomnia, drowsiness, vertigo, renal dysfunction, respiratory distress, itching, rash, sweating, blurred vision, color vision abnormalities, conjunctivitis, eye pain, increased tear production, eyelid swelling, tinnitus, increased erections, spontaneous

Side effects

  • Headache
  • indigestion
  • low back pain
  • muscle pain
  • 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
  • gastroesophageal reflux disease
  • gastroenteritis
  • hypertension
  • dizziness
  • urticaria
  • Stevens-Johnson syndrome
  • exfoliative dermatitis
  • migraine
  • seizure
  • transient global amnesia
  • visual field defect
  • retinal vein occlusion
  • retinal artery occlusion
  • decreased vision
  • decreased hearing
  • hearing loss
  • tinnitus
  • increased erection
  • spontaneous penile erection
  • angioedema
  • myocardial infarction
  • sudden cardiac death
  • stroke
  • chest pain
  • palpitations
  • ventricular arrhythmia
  • tachycardia
  • increased blood urea nitrogen
  • eye congestion
  • increased SGPT
  • chest pressure
  • vomiting
  • nausea
  • increased alkaline phosphatase
  • fatigue
  • neck stiffness
  • urethral pain
  • kidney pain
  • dry mouth
  • heartburn
  • gastrointestinal disease
  • drowsiness
  • increased white blood cell count
  • thrombocytopenia
  • anxiety
  • sleep disorders
  • decreased hemoglobin
  • eye pain
  • chest pain
  • joint pain
  • hyperventilation
  • eye bleeding
  • eyelid swelling
  • conjunctival hemorrhage
  • dry eye syndrome
  • abdominal cramping
  • increased bilirubin
  • ejaculation disorders
  • pain in the external genitalia
  • erythema
  • itching
  • penile disorders
  • nasal dryness
  • increased serum creatinine
  • hiccups
  • weakness
  • abdominal discomfort
  • abdominal pain
  • allergic reaction
  • facial swelling
  • fever
  • increased SGOT
  • 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 protect it from air and moisture. It is recommended to maintain storage temperatures between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

White rectangular oral dissolving film

Package unit

10 films/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.

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.