Freyazigen 30 mg (Dapoxetine Hydrochloride)

Adult dose

To avoid a bitter taste, swallow this medicine whole with at least 1 cup of water. Adult men (18~64 years): Administer 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 administer more than once within 24 hours. If the patient experiences an orthostatic reaction with the initial dose, do not increase the dose to 60mg. This medicine may be taken with or without food. The physician prescribing this medicine for the treatment of premature ejaculation should assess the balance between its risks and the benefits reported by the patient after the initial 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 with low CYP2D6 metabolism or taking a strong CYP2D6 inhibitor: The dose is limited to 30mg in patients with a poor-metabolizer genotype for CYP2D6 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 under 18 years: This medicine should not be administered to children or adolescents under 18 years of age.

This medication should not be used by patients who are allergic to certain ingredients. Patients with severely impaired heart function or uncontrolled hypertension may be at risk if they take this medication, so caution is advised. It is recommended to avoid administering this medication to patients with moderate to severe liver impairment. Co-administration with certain types of antidepressants or some heart medications may cause severe side effects; thus, such combinations should be avoided. Patients with orthostatic hypotension or arrhythmias should be cautious, as there is a risk of fainting when taking this medication. This medication is not suitable for patients with a history of mania or bipolar disorder. It is not recommended for patients with a history of mental illness as it may exacerbate symptoms. Patients with lactose intolerance or related genetic disorders should avoid taking this medication. Children and adolescents under 18 years and elderly patients over 65 years should use this medication with caution. Patients with kidney impairment or certain genetic metabolic disorders may require dosage adjustments. Patients with a history of seizures should be cautious as the risk of seizures may increase while taking this medication. There may be interactions with other medications, so patients should consult with healthcare professionals. Diabetic patients may be affected in their blood glucose control, so caution is necessary. This medication contains certain colorants that may cause allergic reactions, so it should be used carefully in patients with such allergies. Patients taking this medication may experience symptoms such as fainting, dizziness, or drowsiness, so they should avoid driving or operating dangerous machinery. When taken with alcohol, the risk of side effects may increase, so alcohol consumption should be avoided. This medication is intended only for use in males with premature ejaculation and should not be used for other purposes. Sudden discontinuation of the medication may cause withdrawal symptoms such as discomfort, anxiety, and dizziness, so it should be gradually reduced under medical supervision. This medication should be stored in a secure place out of reach of children, and it is advisable not to change the container.

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

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. The storage temperature should be maintained at room temperature between 1 degree and 30 degrees Celsius. This helps to preserve the medication's efficacy.

Appearance

Gray round film-coated tablet

Package unit

4 tablets (4 tablets/PTP x 1)