Tapoxetine Tablet 30 mg (Dapoxetine Hydrochloride)

Adult dose

Adult men (18~64 years): 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. 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.

Child dose

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

This medication should not be taken by individuals who are allergic to the active ingredient or any of the contained ingredients. It is advisable for those with severely impaired cardiac function, certain heart conduction abnormalities, severe ischemic heart disease, or uncontrolled hypertension (cardiovascular diseases) to avoid using this medication. Patients with significantly impaired liver function should also not take this medication. Using this medication may be risky for those who are currently taking or have recently stopped taking certain types of medications, particularly monoamine oxidase inhibitors or thioridazine. Additionally, it should be avoided in combination with other antidepressants that have serotonin effects or herbal medicines. It is also safe not to use this medication in conjunction with strong liver enzyme inhibitors. Patients with postural hypotension (dizziness upon standing) or those suspected of having it should use this medication with caution. Individuals with a history of mania or bipolar disorder should not take this medication, and immediate cessation is required upon symptom occurrence. Use of this medication is not recommended for those with major psychiatric disorders. Those with genetic issues like lactose intolerance should also refrain from using this medication. This medication is not to be used in individuals under 18 years of age, individuals over 65 years, and women. Dosage adjustments may be necessary for those with decreased kidney function or those with slow liver enzyme metabolism. Patients with a history of seizures should use this medication with caution; if seizures occur, it must be stopped immediately. This medication is primarily intended for men with premature ejaculation and should not be used for other purposes. Co-ingestion of this medication with alcohol or certain recreational drugs may lead to severe side effects, so it should be avoided. Dizziness, nausea, sweating, and other symptoms may occur after taking, particularly within 3 hours of the first dose, requiring caution due to the risk of fainting. It is safer to avoid driving or operating hazardous machinery if symptoms are present. Individuals with hypertension or heart disease should consult a physician for careful use, especially if they have postural hypotension. This medication may elevate the risk of bleeding, so caution is advised for individuals with bleeding tendencies or blood coagulation disorders. If adverse symptoms occur during use, immediate consultation with healthcare providers is necessary, particularly for changes in mental state or suicidal thoughts. In cases of overdose, standard emergency treatments should be administered, and since this medication is not easily removed from the body, professional treatment may be required. This medication must be stored out of reach of children, and transferring it to another container should be avoided.

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

This medication should be stored in a tightly closed container to avoid exposure to air or moisture. Maintaining a storage temperature between 1 and 30 degrees Celsius at room temperature is important.

Appearance

Gray round film-coated tablet

Package unit

4 tablets/PTP