Medication info
JK Oral Dissolving Film 20 mg (Tadalafil)

JK Oral Dissolving Film 20 mg (Tadalafil)

Prescription medicationOral
Ingredient · strength
Tadalafil›20mg / 1 sheet
Manufacturer / importer
Hana Pharmaceutical Co., Ltd.
Appearance
Rectangular yellow oral dissolving film
Packaging
10 sheets/pack [(1 sheet/foil) × 10]
Approval status
Active

MFDS item code 202204394 · Approved 2022.12.06

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 an adequate effect, 20mg 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, allow it to dissolve, and 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 one day, continuous daily administration is strongly discouraged. [See 1. Warnings and 11.1) Pharmacodynamic properties] Use in older men Dosage adjustments are not 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 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 assess the individual benefit/risk. There are no data on doses higher than 10mg in patients with hepatic impairment. [See 3. Patients requiring caution and 11.2) Pharmacokinetic properties]. Use in men with diabetes No dosage adjustment is required in patients with diabetes.
Child dose
Do not use in people under 18 years of age.

Ingredients

Manufacturer
Hana 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 understand that sexual stimulation is necessary for the drug to take effect. Additionally, this medication is solely intended for the treatment of erectile dysfunction in men and is not used for women. Therefore, if necessary, taking it under a doctor's guidance will help improve erectile function.

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 an adequate effect, 20mg 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, allow it to dissolve, and 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 one day, continuous daily administration is strongly discouraged. [See 1. Warnings and 11.1) Pharmacodynamic properties] Use in older men Dosage adjustments are not 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 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 assess the individual benefit/risk. There are no data on doses higher than 10mg in patients with hepatic impairment. [See 3. Patients requiring caution and 11.2) Pharmacokinetic properties]. Use in men with diabetes No dosage adjustment is required in patients with diabetes.

Child dose

Do not use in people under 18 years of age.

Precautions

This medication is used as a treatment for erectile dysfunction, and before taking it, you must evaluate your cardiac and cardiovascular condition through a doctor's examination. Sexual activity can put stress on the heart, so patients with cardiovascular diseases should exercise caution, and if symptoms occur, sexual activity should be stopped immediately, and a doctor should be consulted. If an erection persists for more than 4 hours, you should seek medical attention immediately, as neglecting this can result in damage to penile tissue or loss of erectile function. This medication can dangerously lower blood pressure if taken with nitrate preparations or NO donors, thus patients taking such medications should not use this drug. Patients who have had significant cardiovascular diseases in the recent past, such as myocardial infarction, acute cardiac arrest, unstable angina, or stroke, should not be administered this drug. Patients with hereditary retinal diseases or hypersensitivity to any component of this medication should also avoid use. Combining this medication with other erectile dysfunction therapies is not recommended as safety and effectiveness have not been confirmed. Patients with severely decreased kidney or liver function should use this medication cautiously, and symptoms of hypotension may arise when used in conjunction with certain antihypertensive medications. During the use of this medication, side effects such as headache, dyspepsia, back pain, myalgia, congestion, flushing, limb pain, pharyngitis, upper respiratory infection, coughing, diarrhea, gastroesophageal reflux disease, abdominal pain, dizziness, overall weakness, fatigue, pain, itching, rash, sweating, eye pain, increased tear secretion, eyelid swelling, tinnitus, increased erection, spontaneous penile erections, facial flushing, facial swelling, abnormal sensations, visual disturbances, palpitations, dry mouth, hypochromia, and drowsiness may occur, most of which are mild to moderate. Rarely, serious side effects such as cardiovascular abnormalities, vision or hearing loss, and priapism have been reported, and if these symptoms occur, medical staff should be consulted immediately. This medication is not to be used by pregnant women, nursing mothers, women, or children, and caution should be taken when driving or operating machinery after confirming one's condition. In case of overdose, standard emergency treatment should be received, and blood dialysis has little effect on the removal of this medication. This medication should be kept out of reach of children, and it is safest to maintain its original packaging.

Side effects

  • Headache
  • dyspepsia
  • low back pain
  • muscle pain
  • congestion
  • flushing
  • limb pain
  • nasopharyngitis
  • upper respiratory tract infection
  • cough
Show 118 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
  • epigastric pain
  • vomiting
  • hemorrhoidal bleeding
  • rectal bleeding
  • arthralgia
  • neck pain
  • sensory loss
  • insomnia
  • paresthesia
  • drowsiness
  • vertigo
  • renal impairment
  • dyspnea
  • epistaxis
  • pharyngitis
  • itching
  • rash
  • sweating
  • blurred vision
  • color vision deficiency
  • conjunctivitis
  • eye pain
  • increased tear secretion
  • eyelid edema
  • sudden decrease or loss of hearing
  • tinnitus
  • increased erection
  • spontaneous penile erection
  • priapism
  • urticaria
  • Stevens-Johnson syndrome
  • exfoliative dermatitis
  • hypersensitivity reaction
  • migraine
  • seizures and seizure recurrence
  • transient global amnesia
  • visual field defect
  • retinal vein occlusion
  • retinal artery occlusion
  • permanent vision loss
  • angioedema
  • electrocardiogram abnormality
  • primary bradycardia
  • increased blood urea nitrogen
  • eye congestion
  • increased SGPT
  • chest tightness
  • vomiting
  • nausea
  • increased alkaline phosphatase
  • fatigue
  • neck stiffness
  • urethral pain
  • kidney pain
  • heartburn
  • gastrointestinal disease
  • drowsiness
  • increased white blood cell count
  • thrombocytopenia
  • anxiety
  • sleep disorders
  • decreased hemoglobin
  • eye pain
  • chest pain
  • arthralgia
  • hyperventilation
  • eye hemorrhage
  • eyelid swelling
  • conjunctival hemorrhage
  • dry eye syndrome
  • abdominal cramps
  • increased bilirubin
  • ejaculatory dysfunction
  • pain in external genitalia
  • erythema
  • penile dysfunction
  • somnolence
  • myocardial ischemia
  • tinnitus
  • epistaxis
  • dry nose
  • increased serum creatinine
  • hiccups
  • myopathy
  • abdominal discomfort
  • abdominal pain
  • allergic reactions
  • facial edema
  • fever
  • increased SGOT
  • increased hemoglobin
  • ineffective
  • chills
  • skeletal pain

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a sealed container. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius to help preserve the drug's effectiveness.

Appearance and packaging

Appearance

Rectangular yellow oral dissolving film

Package unit

10 sheets/pack [(1 sheet/foil) × 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.