Tafokcen 60 mg (Dapoxetine Hydrochloride)

Adult dose

To avoid the bitter taste, swallow this medicine whole in one dose with at least 1 cup of water. Patients should avoid driving or operating dangerous machinery if they experience fainting or prodromal symptoms of fainting, such as dizziness or lightheadedness. [See Precautions for Use, Section 4.3] Adult men (18~64 years): Before starting treatment, the physician should obtain a history of orthostatic events and perform an orthostatic test (blood pressure, pulse, lying down, and standing). If the patient has a history of orthostatic events or shows a similar response during the orthostatic test, use of this medicine should be avoided. [See Precautions for Use, Section 4.4] Take the initial recommended dose of 30mg orally approximately 1~3 hours before sexual activity. If the effect of 30mg is insufficient and it is well tolerated, the dose may be increased to the maximum recommended dose of 60mg. Do not take more than 1 dose within 24 hours. If the patient experiences an orthostatic reaction with the initial dose, the dose should not be increased to 60mg. This medicine may be taken with or without food. For patients prescribed this medicine to treat premature ejaculation, the prescribing physician should assess the balance between the risks of this medicine and the benefits reported by the patient after the first 4 weeks of treatment or 6 doses, and determine whether it is appropriate to continue treatment. Elderly patients (65 years and older): The safety and efficacy of this medicine in elderly patients have not been established. Patients with renal impairment: No dosage adjustment is necessary in patients with mild or moderate renal impairment, but administer with caution. Use in patients with severe renal impairment is not recommended. Patients with hepatic impairment: This medicine should not be administered to patients with moderate or severe hepatic impairment (Child-Pugh Class B and C). Patients who are poor CYP2D6 metabolizers or are taking a strong CYP2D6 inhibitor: The dose is limited to 30mg in patients with a genotype associated with poor CYP2D6 metabolism or in patients receiving concomitant treatment with a strong CYP2D6 inhibitor; administer with caution. [See Precautions for Use, Section 5.5)②] Patients taking a moderate or strong CYP3A4 inhibitor: Concomitant use with a strong CYP3A4 inhibitor is contraindicated. The dose is limited to 30mg in patients receiving concomitant treatment with a moderate CYP3A4 inhibitor; administer with caution. [See Precautions for Use, Section 5.5)③]

Child dose

Children and adolescents under 18 years: This medicine should not be administered to children and adolescents under 18 years of age.

This medication should not be used by patients with allergic reactions to the active ingredient or any of the included components. Patients with severely impaired cardiac function or certain heart diseases should also avoid this medication. It should not be administered to patients with moderate to severe liver dysfunction. This medication is contraindicated in patients who are currently taking or have recently discontinued specific types of drugs, particularly MAO inhibitors or thioridazine. Additionally, it should be avoided if taken simultaneously with or within a certain period of taking other drugs affecting serotonin. Patients taking strong CYP3A4 enzyme inhibitors should not use this medication. Patients experiencing symptoms of orthostatic hypotension or with suspected symptoms should use this medication with caution, and avoid taking it if symptomatic. Patients with a history of mania or bipolar disorder should not take this medication, and it should be immediately discontinued if symptoms appear. The use of this medication is not recommended for patients with a history of major psychiatric disorders. Patients with certain genetic metabolic disorders, such as lactose intolerance, should also avoid this medication. This medication should not be used by teenagers under 18 years of age and elderly patients over 65 years, nor by women. Patients with impaired kidney function require dosage adjustment, and patients with certain slow enzyme metabolism may need to limit dosages. Patients with a history of seizures should immediately discontinue use if seizures occur while taking this medication and should avoid it if they have poorly controlled epilepsy. Diabetic patients should exercise caution due to the potential for blood sugar changes. This medication contains Yellow No. 5 dye, and patients allergic to this component should use it with caution. Common side effects during use include headache, dizziness, nausea, diarrhea, insomnia, and fatigue, and in severe cases, fainting or orthostatic hypotension may occur. This medication should only be used by men with premature ejaculation and is not appropriate for other purposes or for women or teenagers. Taking this medication with alcohol may worsen drowsiness or dizziness, so alcohol consumption should be avoided. Caution is necessary when driving or operating dangerous machinery, and those with eye issues or at risk of glaucoma should also exercise caution. This medication interacts with many other drugs, particularly with certain antidepressants, antibiotics, antifungals, and heart medications requiring caution when taken together. Overdose may result in symptoms such as nausea, vomiting, drowsiness, and dizziness, and as no specific antidote exists, immediate medical assistance is required. This medication should be kept out of reach of children and should not be transferred to other containers.

• Syncope
• orthostatic hypotension
• headache
• dizziness
• nausea
• diarrhea
• insomnia
• fatigue
• anxiety
• restlessness

This medication may be sensitive to air and moisture, so it should be stored in a sealed container. It is recommended to keep it at room temperature that is neither too hot nor too cold, ideally between 1 degree and 30 degrees Celsius.

Appearance

Gray round film-coated tablet

Package unit

4 tablets/PTP