Tadalafil Orally Disintegrating Film 10 mg

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 produce a sufficient effect, 20 mg may be tried. This medicine may be administered 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 and allow it to dissolve; take without water. Long-term safety after 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 12.1) Pharmacodynamic Properties] Use in elderly men Dose adjustments are not required in elderly 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 12.2) Pharmacokinetic Properties]. Use in men with hepatic impairment The recommended dose is 10mg, taken with or without 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 if prescribing it. There are no data on administration of doses higher than 10mg to patients with hepatic impairment. [See section 3. Patients Requiring Cautious Administration and section 12.2) 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.

This medication is used for the treatment of erectile dysfunction; before taking it, you must confirm the cause of erectile dysfunction through a doctor's diagnosis and physical examination. Sexual activity can place strain on the heart, so patients with cardiovascular diseases should exercise particular caution, and if any heart-related symptoms occur during sexual activity, they should stop immediately and consult a doctor. This medication can rarely cause prolonged erections lasting more than 4 hours (priapism), in which case immediate medical attention is required, as untreated priapism may result in penile tissue damage and permanent loss of erectile function. Do not use this medication with nitrate drugs or NO donors, as it can dangerously lower blood pressure. During treatment with this medication, these substances should never be used. Patients who have recently experienced serious cardiovascular conditions such as myocardial infarction, cardiac arrest, unstable angina, or stroke, or those with uncontrolled hypertension or hypotension should not use this medication. Patients with certain hereditary retinal diseases are also advised against using this medication, and combining it with other erectile dysfunction treatments is not recommended due to uncertainty regarding safety. Patients with specific diseases such as penile deformities or blood disorders should be administered this medication with caution, and patients with severely impaired kidney or liver function should also be wary. Common side effects include headache, dyspepsia, back pain, muscle pain, flushing, and limb pain, while rare but serious cardiovascular adverse reactions or reports of vision and hearing loss have been noted. If sudden vision loss or hearing reduction occurs during use, stop taking the medication immediately and inform medical staff. This medication is metabolized by the enzyme CYP3A4, so dosage adjustments or caution is necessary when taken with drugs that inhibit or induce this enzyme. Taking it with alcohol may cause decreased blood pressure and dizziness; therefore, excessive drinking should be avoided. This medication is not approved for use in pregnant women or children. It does not significantly affect driving or machine operation, but individual differences may exist, so it is advisable to check your condition after taking it. In case of an overdose, standard emergency treatment should be received, and hemodialysis is not effective for removing this medication. Store this medication out of the reach of children and keep it in its original packaging to maintain safety.

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

This medication should be stored in a tightly sealed container to protect it from air and moisture, and it is suitable to keep it at room temperature between 1 and 30 degrees Celsius. Proper storage will maintain the medication's effectiveness and prevent degradation.

Appearance

White square orally disintegrating film

Package unit

10 sheets/case (1 sheet x 30 mg)