Tadalafil Oral Disintegrating Film 20 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, 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

Must not be used in persons under 18 years of age.

This medication is used as a treatment for erectile dysfunction and it is essential to confirm the underlying cause through a doctor's diagnosis and physical examination before taking it. Patients with heart conditions may experience strain on the heart during sexual activity, thus careful evaluation of cardiovascular status should be conducted before treatment. If an erection lasts longer than 4 hours, seek medical help immediately, as failure to treat can lead to penile tissue damage or permanent erectile dysfunction. During or after taking this medication, do not use nitrates or nitrogen oxide donors concurrently, and if you are taking such medications, inform your doctor. Patients who have recently experienced serious cardiovascular diseases such as myocardial infarction, angina, heart failure, or stroke should not use this medication. Patients with genetic retinal disorders or hypersensitivity to any component of this medication should also avoid taking it. Combining with other erectile dysfunction treatments is not recommended due to unproven safety and efficacy. Patients with anatomical abnormalities of the penis or blood disorders should take this medication with caution, and those with severely impaired kidney or liver function also need to be careful. If taken with antihypertensives or specific alpha-blockers, symptoms of hypotension may occur, thus caution is required. During treatment, side effects such as headache, dyspepsia, back pain, myalgia, flushing, dizziness may occur. Rarely, serious cardiovascular adverse reactions, vision impairment, or hearing loss have been reported; if such symptoms arise, immediately consult a healthcare professional. Taking alcohol may lower blood pressure or cause dizziness, so avoid excessive drinking. Women who are pregnant or breastfeeding, as well as children and adolescents should not take this medication. Dizziness may occur when driving or operating machinery; thus it is advisable to check your condition after taking the medication. In case of an overdose, visit a medical facility immediately for appropriate treatment; hemodialysis does not significantly affect the elimination of this medication. This medication should be kept out of the reach of children and stored in its original packaging.

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

This medication should be stored in a tightly closed container to avoid exposure to air or moisture, and it is safe to keep it at room temperature between 1 degree and 30 degrees Celsius.

Appearance

Yellow rectangular oral disintegrating film

Package unit

10 pieces (1 piece x 10)