JK Oral Dissolving Film 10 mg (Tadalafil)

Adult dose

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

This medicine should not be used in people under 18 years of age.

This medicine is used for the treatment of erectile dysfunction, and a doctor's diagnosis and cardiovascular assessment are necessary before use. It may put a burden on the heart during sexual activity, so patients with heart disease should be cautious. If an erection lasts longer than 4 hours, immediate medical assistance should be sought, as failure to treat may lead to penile tissue damage or permanent loss of erectile function. This medicine should never be taken in conjunction with nitrate preparations, as it can cause dangerously low blood pressure. Patients with severe cardiovascular conditions such as myocardial infarction, cardiac arrest, unstable angina, or stroke should not be administered this medicine. Patients with hereditary retinal diseases or allergies to any components of this medicine should also avoid using it. Combining with other erectile dysfunction treatment medications is not recommended as safety has not been established. Patients with penile deformities or blood disorders, or those with severely impaired kidney or liver function should use this medicine with caution. There is a risk of low blood pressure when taken with certain medications, such as alpha blockers, so caution is warranted. This medicine may cause side effects such as headache, dyspepsia, back pain, myalgia, flushing, and limb pain; cardiovascular abnormalities, vision, or hearing problems have been reported rarely. If sudden loss of vision or hearing occurs, stop taking the medication immediately and consult a physician. Pregnant women, nursing mothers, and children should not use this medicine, and caution should be taken when driving or operating machinery after determining individual reactions. In case of overdose, standard treatment should be administered as dialysis is not effective. This medicine should be kept out of the reach of children, and maintaining the original packaging is recommended.

• Headache
• dyspepsia
• low back pain
• muscle pain
• congestion
• flushing
• limb pain
• nasopharyngitis
• upper respiratory infection
• cough

This medicine should be stored in a tightly sealed container to protect it from air or moisture. Additionally, it should be stored in a place that avoids extreme heat or cold, ideally between 1 and 30 degrees Celsius.

Appearance

Rectangular yellow oral dissolving film

Package unit

10 sheets/pack [(1 sheet/foil) × 10]