Vardenafil Tablet 10mg (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. Patients in whom tadalafil 10mg does not provide an adequate effect may try 20 mg. This medicine may be administered starting at least 30 minutes before sexual activity. The maximum recommended dosing frequency is once daily. 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 of this medicine is strongly not recommended. [Refer to Section 1. Warnings and Section 11.1) Pharmacodynamic properties] Use in elderly men No dosage adjustments are 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. [Refer to Section 11.2) Pharmacokinetic properties]. Use in men with hepatic impairment The recommended dose of this product is 10mg, taken with or without food before anticipated sexual activity. Since clinical data on the safety of this product 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 administering doses higher than 10mg to patients with hepatic impairment. [Refer to 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 product should not be used in people under 18 years of age.

This drug is used for the treatment of erectile dysfunction, and before use, the doctor must thoroughly check the patient's medical history and cardiovascular status. As sexual activity can be burdensome for the heart, patients with heart disease should exercise caution before using this drug. If an erection lasts longer than 4 hours after taking this drug, immediate medical attention should be sought, as untreated prolonged erections may result in damage to the penile tissue. Taking this medication with nitrate compounds or nitric oxide donors may dangerously lower blood pressure; therefore, patients taking these medications should not use this drug. Use of this medication is prohibited in patients who have recently experienced cardiovascular diseases such as myocardial infarction, angina, heart failure, arrhythmia, or stroke. Patients with hereditary retinal disorders or specific lactase deficiency should also not take this medication. Using this medication in conjunction with other erectile dysfunction treatments is not recommended due to uncertain safety. Patients with severe renal or liver impairment should use this drug with caution, and care should be taken when co-administered with alpha-blockers or strong CYP3A4 inhibitors. In clinical trials, side effects such as headache, dyspepsia, back pain, myalgia, flushing, and dizziness have been reported, and rarely serious cardiovascular adverse reactions or loss of vision and hearing may occur. If sudden loss of vision or hearing occurs during treatment, the use of this medication should be immediately discontinued, and a doctor should be consulted. This drug should not be used in women, children, or neonates, and its safety during pregnancy has not been confirmed. It does not significantly affect driving or operating machinery, but dizziness may occur in some individuals, so caution is advised. In the event of an overdose, standard treatment should be administered, and blood dialysis has little effect on the excretion of this medication. This drug should be stored out of reach of children and it is advisable to keep it in its original packaging.

• Priapism
• headache
• dyspepsia
• lower back pain
• muscle pain
• congestion
• flushing
• limb pain
• nasopharyngitis
• upper respiratory infection

This medication should be stored in a tightly sealed container to protect it from air and moisture, ideally at room temperature between 1 and 30 degrees Celsius. Storing it this way can help maintain its effectiveness and prevent deterioration.

Appearance

Film-coated tablet in the shape of a rounded triangle with a dividing line, yellow in color

Package unit

8 tablets (8 tablets/PTP) x 1