Tadalafil Oral Dissolving Film 10 milligrams (Tadalafil)

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, 20 mg may be tried. This medicine may be administered starting 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 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 medicine 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 elderly men Dosage adjustments are not required in elderly 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 section 11.2) 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 when prescribing it. There are no data on administering doses higher than 10mg to patients with hepatic impairment. [See section 3. Use with Caution in the Following Patients and section 11.2) Pharmacokinetic Properties]. Use in men with diabetes No dosage adjustment is required in patients with diabetes.

Child dose

This medicine must not be used in persons under 18 years of age.

This drug is used for the treatment of erectile dysfunction, and it is essential to confirm the underlying cause through a doctor's diagnosis and physical examination before taking it. Sexual activity may pose a burden on the heart; therefore, patients with cardiovascular diseases should consult their physician to assess safety. If an erection lasts longer than 4 hours or is accompanied by pain, seek medical assistance immediately, as untreated conditions can lead to penile tissue damage and loss of erectile ability. Do not take nitrate compounds or NO donors during or after taking this drug, and be sure to inform your doctor of any such medications. Patients with severe cardiovascular diseases such as myocardial infarction, angina, or stroke should not use this drug. This drug may affect sperm production; therefore, caution is needed with long-term use. Patients with specific heart conditions may be sensitive to vasodilators and should take care. Patients who regularly take organic nitrate preparations, those with severe heart disease, those who have recently experienced myocardial infarction or stroke, and patients with hereditary retinal diseases should not take this drug. The concurrent use of this drug with other erectile dysfunction treatments is not recommended. Patients with penile deformities or specific blood disorders, and those with severe kidney or liver dysfunction should consult a physician before taking this drug, as some antihypertensive medications may lead to symptoms of hypotension when used in combination. Concurrent use with strong CYP3A4 inhibitors may lead to increased drug concentration, requiring dose adjustment. This medication is not to be used in women, children, or neonates. Side effects such as headaches, dyspepsia, back pain, muscle pain, flushing, and limb pain may occur; while rarer cardiovascular abnormalities, visual and hearing impairments have been reported. If sudden vision loss or hearing loss occurs, stop taking immediately and consult medical personnel. Caution is necessary when taking with alcohol, as it may cause blood pressure drops and dizziness. In case of overdose, standard treatment should be received; however, dialysis is not effective in removing the drug. Store this medication out of the reach of children and maintain it in its original packaged state. There may be potential drug interactions before and after taking; therefore, inform your doctor of any medications being taken. Driving or operating machinery is unlikely to be significantly affected, but individual reactions should be assessed.

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

This drug must be stored in a tightly sealed container to protect it from air and moisture. The recommended storage temperature is room temperature between 1 to 30 degrees Celsius. This will help ensure the drug's effectiveness is preserved securely.

Appearance

Yellow rectangular oral dissolving film

Package unit

1 sheet, 10 sheets (1 sheet x 10)