Prilij 60 mg (Dapoxetine hydrochloride)

Adult dose

This medicine should be swallowed whole to avoid its bitter taste and should be taken with at least 1 cup of water. Adult males (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. The physician prescribing this medicine for the treatment of premature ejaculation should assess the balance between the risks of this medicine 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 with this medicine. Elderly patients (65 years and older): The safety and efficacy of this medicine have not been established in elderly patients. Patients with renal impairment: No dosage adjustment is necessary in patients with mild or moderate renal impairment, but this medicine should be administered with caution. Use in patients with severe renal impairment is not recommended. Patients with hepatic impairment: This medicine must 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 potent CYP2D6 inhibitor: The dose is limited to 30mg in patients with a poor CYP2D6 metabolizer genotype or those receiving concomitant treatment with a potent CYP2D6 inhibitor, and this medicine should be administered with caution. Patients taking a moderate or potent CYP3A4 inhibitor: Concomitant use with a potent CYP3A4 inhibitor is contraindicated. The dose is limited to 30mg in patients receiving concomitant treatment with a moderate CYP3A4 inhibitor, and this medicine should be administered with caution.

Child dose

This medicine must not be administered to children and adolescents under 18 years of age.

This medication should not be used by patients with an allergy to the active ingredient or any of the components. It should not be administered to patients with severely impaired cardiac function, certain cardiac conduction disorders, significant ischemic heart disease, or valvular heart disease. It is also advisable not to use this medication in patients with moderate to severe liver impairment. Patients currently taking or who have recently stopped taking a specific antidepressant called an MAO inhibitor should not use this medication. Those taking or who have recently taken the medication thioridazine should also avoid using this medication. It should not be used in combination with other serotonin-acting medications or herbal products that were recently combined. Patients taking strong CYP3A4 enzyme inhibitors, such as some antifungal or antiviral medications, should also avoid this medication. Patients with symptoms or suspected symptoms of orthostatic hypotension, those with a history of mania or bipolar disorder should not use this medication and should stop immediately if symptoms arise. It is not recommended for patients with a history of major psychiatric disorders, including depression, anxiety disorders, suicidal tendencies, and schizophrenia. Patients with lactose intolerance or related genetic issues, women, individuals under 18, and seniors over 65 should not use this medication. Patients with mild renal impairment or certain genotypes should receive careful dosage adjustments. Patients with a history of seizures should exercise caution as the risk of seizures may increase; if a seizure occurs, use should be discontinued immediately. Caution should be exercised if taking other medications that may interact with this medication. Patients with diabetes should be careful as there may be changes in blood glucose control. Common side effects of this medication may include headaches, dizziness, nausea, diarrhea, insomnia, and fatigue. Serious symptoms such as syncope or orthostatic hypotension have also been reported; if these symptoms occur, immediate consultation with a physician is advised. This medication should only be used by men with premature ejaculation and should not be used in combination with recreational drugs. Post-ingestion symptoms such as dizziness, nausea, and sweating may occur, so caution is advised to avoid driving or operating hazardous machinery. The risk of drowsiness or syncope increases when taken with alcohol; therefore, alcohol should be avoided. Patients with cardiovascular disease may have a heightened risk of syncope, requiring caution. Patients at risk for bleeding or on medications that affect platelet function should be careful when using this medication. It should not be used by pregnant or nursing women, or in children, and appropriate treatment should be administered in case of overdose depending on the symptoms. This medication should be stored out of reach of children and should not be transferred to other containers.

Syncope, orthostatic hypotension, headache, dizziness, nausea, diarrhea, insomnia, fatigue, anxiety, restlessness, agitation, reduced libido, abnormal dreams, depression, feelings of depression, irritability, nightmares, sleep disorders, bruxism, euphoria, apathy, anhedonia, mood changes, early insomnia, mid-insomnia, sexual dysfunction, delirium, hyperarousal, abnormal thoughts, disorientation, loss of libido, drowsiness, attention deficit, tremor, perceptual disturbances, taste disturbances, hypersomnia, cataplexy, sedation, decreased level of consciousness, vasovagal syncope, positionally induced dizziness, perceptual disturbances, dizziness during exercise, sudden sleep, blurred vision, pupil dilation, visual impairment, eye pain, tinnitus, vertigo, cardiac arrhythmia, bradycardia, tachycardia, flushing, facial flushing, hypotension, systolic hypertension, venous congestion, yawning, dry mouth, vomiting, constipation, abdominal pain, upper abdominal pain, dyspepsia, bloating, gastric discomfort, abdominal distension, abdominal discomfort, epigastric discomfort, urgent bowel movement, hyperhidrosis, pruritus, cold sweat, erectile dysfunction, ejaculation failure, sensory abnormalities in male reproductive organs, male pleasure dysfunction, hyperreactivity, weakness, heat sensation, neural hypersensitivity, abnormal sensation, intoxication, increased blood pressure, increased heart rate, elevated diastolic blood pressure, elevated orthostatic blood pressure, muscle stiffness, limb weakness, cystitis, drowsiness, attention deficit, blurred vision

This medication may be sensitive to air and moisture, so it should be stored in a sealed container. It is best to store the medication at room temperature between 1 to 30 degrees Celsius. Avoid storing it in excessively hot or cold places to ensure safe storage.

Appearance

Gray round film-coated tablet

Package unit

6 tablets/PTP