Medication info
Jedaeropil Oral Dissolving Film 10mg (Tadalafil)

Jedaeropil Oral Dissolving Film 10mg (Tadalafil)

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

MFDS item code 201504229 · Approved 2015.06.30

Summary

Main use
Treatment of erectile dysfunction
Who takes it
Adults · Children
Adult dose
For oral administration. Use in adult men The recommended dose is 10mg, taken regardless of meals before anticipated sexual activity. For patients in whom tadalafil 10mg does not provide an adequate effect, 20 mg may be tried. This drug may be taken at least 30 minutes before sexual activity. The maximum recommended frequency is once daily. Immediately after removing this drug from its individual package, place it on the tongue and allow it to dissolve; take it without water. Long-term safety following extended daily dosing has not been established, and because the effect of this drug usually lasts for more than one day, continuous daily administration is strongly discouraged. [See section 1, Warnings, and section 11.1) Pharmacodynamic properties] Use in older men Dose adjustments are not required in older 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 section 11.2) Pharmacokinetic properties]. Use in men with hepatic impairment The recommended dose is 10mg, taken regardless of meals before anticipated sexual activity. Because clinical data on the safety of this drug 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 administration of doses greater 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 dose adjustment is required in patients with diabetes.
Child dose
Do not use in persons under 18 years of age.

Ingredients

Manufacturer
CMG Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of erectile dysfunction

  • Erectile dysfunction
View approved original text

This medicine is used for the treatment of erectile dysfunction, and sexual stimulation is required for it to work. It is also recommended not to be used by women. This medication assists individuals struggling with erectile dysfunction.

How to take

Adult dose

For oral administration. Use in adult men The recommended dose is 10mg, taken regardless of meals before anticipated sexual activity. For patients in whom tadalafil 10mg does not provide an adequate effect, 20 mg may be tried. This drug may be taken at least 30 minutes before sexual activity. The maximum recommended frequency is once daily. Immediately after removing this drug from its individual package, place it on the tongue and allow it to dissolve; take it without water. Long-term safety following extended daily dosing has not been established, and because the effect of this drug usually lasts for more than one day, continuous daily administration is strongly discouraged. [See section 1, Warnings, and section 11.1) Pharmacodynamic properties] Use in older men Dose adjustments are not required in older 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 section 11.2) Pharmacokinetic properties]. Use in men with hepatic impairment The recommended dose is 10mg, taken regardless of meals before anticipated sexual activity. Because clinical data on the safety of this drug 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 administration of doses greater 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 dose adjustment is required in patients with diabetes.

Child dose

Do not use in persons under 18 years of age.

Precautions

This medicine is used for the treatment of erectile dysfunction and requires a doctor's diagnosis and evaluation of cardiovascular status prior to use. Sexual activity may put a strain on the heart, so patients with cardiovascular disease should exercise caution, and if symptoms related to the heart occur during or after sexual activity, they should stop immediately and consult a doctor. Rarely, this medication can cause an erection lasting longer than 4 hours (priapism), and if this occurs, immediate medical assistance should be sought. Taking this medicine alongside nitrates or nitric oxide (NO) donor drugs can lead to dangerously low blood pressure, so it should not be administered to patients taking these medications. Patients who have had recent serious cardiovascular conditions such as myocardial infarction, angina, or stroke should not use this medication. Patients with penile deformities or specific blood disorders should use this medication with caution, and patients with severe kidney or liver dysfunction should consult a doctor before taking it. This medication is not recommended to be used in combination with other erectile dysfunction treatments and should not be administered to patients who have previously experienced optic nerve disorders. While taking this medication, side effects such as headaches, dyspepsia, back pain, muscle pain, facial flushing, and limb pain may occur, and if these symptoms are severe or persistent, a doctor should be consulted. Additionally, this medication can rarely cause visual impairment, hearing loss, and cardiovascular adverse reactions, so if symptoms occur, use should be stopped immediately and the healthcare provider should be informed. Caution is needed when taking this medication with alcohol due to possible blood pressure lowering and dizziness. In cases of overdose, standard treatment should be received, and it is difficult to remove the drug by dialysis, so immediate visit to a medical institution is necessary. This medicine should not be used by children and women, and its safety has not been established in pregnant women. When storing, keep out of reach of children and maintain the original packaging.

Side effects

  • Priapism
  • headache
  • dyspepsia
  • low back pain
  • muscle pain
  • congestion
  • flushing
  • limb pain
  • nasopharyngitis
  • upper respiratory infection
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  • cough
  • diarrhea
  • gastroesophageal reflux disease
  • abdominal pain
  • hypertension
  • dizziness
  • urinary tract infection
  • gastroesophageal reflux disease
  • hypertension
  • angina
  • chest pain
  • hypotension
  • myocardial infarction
  • orthostatic hypotension
  • palpitations
  • syncope
  • tachycardia
  • abnormal liver function test values
  • dry mouth
  • dysphagia
  • esophagitis
  • gastritis
  • increased GGTP
  • loose stools
  • nausea
  • epigastric pain
  • vomiting
  • gastroesophageal reflux
  • hemorrhoidal bleeding
  • rectal bleeding
  • arthralgia
  • neck pain
  • sensory loss
  • insomnia
  • paresthesia
  • drowsiness
  • dizziness
  • kidney dysfunction
  • shortness of breath
  • epistaxis
  • pharyngitis
  • itching
  • 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
  • hives
  • Stevens-Johnson syndrome
  • exfoliative dermatitis
  • migraine
  • seizure
  • transient global amnesia
  • visual field defect
  • retinal vein occlusion
  • retinal artery occlusion
  • permanent vision loss
  • angioedema
  • arrhythmia
  • primary bradycardia
  • increased blood urea nitrogen
  • conjunctival injection
  • increased SGPT
  • chest pressure
  • vomiting
  • nausea
  • increased alkaline phosphatase
  • fatigue
  • neck stiffness
  • urethral pain
  • kidney pain
  • heartburn
  • gastrointestinal disease
  • drowsiness
  • increased white blood cell count
  • thrombocytopenia
  • anxiety
  • sleep disturbances
  • decreased hemoglobin
  • eye pain
  • chest pain
  • arthralgia
  • hyperventilation
  • ocular hemorrhage
  • eyelid swelling
  • conjunctival hemorrhage
  • dry eye syndrome
  • abdominal cramps
  • increased bilirubin
  • ejaculation disorder
  • pain in the external genitalia
  • erythema
  • penile dysfunction
  • myocardial infarction
  • tinnitus
  • epistaxis
  • dry nose
  • increased serum creatinine
  • hiccups
  • weakness
  • 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 should be stored in a tightly closed container to prevent air and moisture from entering and kept at room temperature between 1 to 30 degrees Celsius. Storing it this way will help maintain the medication's efficacy for a long time.

Appearance and packaging

Appearance

White square 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.