Pojin Clover Tablet 250 mg (Famciclovir)

Adult dose

1. Treatment of herpes zoster infection Adults: Administer famciclovir 250 mg orally 3 times daily for 7 days. It is preferable to start treatment as soon as symptoms appear after infection. 2. Treatment of first-episode genital herpes infection Adults: Administer 250 mg of this product orally 3 times daily for 5 days. It is preferable to start treatment as soon as symptoms appear after infection. 3. Treatment of acute recurrent genital herpes infection Adults: Administer 125 mg of this product orally twice daily for 5 days. It is preferable to start treatment during the prodromal period or as soon as symptoms appear after infection. 4. Suppression of recurrent genital herpes Adults: Administer 250 mg of this product orally twice daily. Discontinue treatment periodically every 6～12 months to assess whether the natural course of the disease has changed. 5. Patients with renal impairment: Because the creatinine clearance of this product is reduced in patients with renal impairment, dose adjustment should be made with care. The dosage and administration for these patients are as follows. 1) Treatment of herpes zoster and first-episode genital herpes infection: Creatinine clearance (mL/min/1.73㎡) 30～59: 250 mg per dose twice daily Creatinine clearance (mL/min/1.73㎡) 10～29: 250 mg per dose once daily 2) Treatment of acute recurrent genital herpes infection: Creatinine clearance (mL/min/1.73㎡) 30～59: 125 mg per dose twice daily Creatinine clearance (mL/min/1.73㎡) 10～29: 125 mg per dose once daily 3) Suppression of recurrent genital herpes infection: Creatinine clearance (mL/min/1.73㎡) 30～59: 250 mg per dose twice daily Creatinine clearance (mL/min/1.73㎡) 10～29: 125 mg per dose twice daily 4) If only serum creatinine is known, creatinine clearance can be calculated using the following formula. Men: {body weight (kg) × (140-age)}/ {72 × serum creatinine (mg/dL)} Women: 0.85 × the value calculated for men 5) Patients with renal impairment undergoing hemodialysis For patients on hemodialysis, administration every 48 hours is preferred, taking the dialysis interval into consideration. A 4-hour hemodialysis session reduces the plasma concentration of this product by approximately 75%; therefore, administer this product immediately after dialysis. The recommended dose is 250mg for patients with herpes zoster and 125mg for patients with genital herpes. 6. Patients with hepatic impairment: No dose adjustment is necessary in patients with chronic compensated liver disease. There is insufficient treatment experience in patients with overt chronic decompensated liver disease; therefore, no clear recommended dose has been established.

This medication should not be used in certain patients. It should not be administered to patients who have had allergic reactions to this medication, its components, or the active substance, penciclovir. Additionally, this medication contains lactose, so it should not be used by patients with lactose intolerance or certain genetic metabolic disorders. Patients with allergies to soybean oil, soy, or peanuts should also avoid this medication. Patients with impaired kidney function or abnormalities in fat metabolism, such as hyperlipidemia, diabetic dyslipidemia, or pancreatitis, should use this medication with caution. During treatment, side effects such as headaches, dizziness, nausea, vomiting, skin rash, and itching may occur, and, rarely, rapid heartbeat or kidney function problems may arise. If any unusual symptoms appear, patients should consult a healthcare provider immediately. This medication does not cure genital herpes, so it is important to avoid sexual contact and maintain safe sexual practices if symptoms are present during treatment. Additionally, if symptoms such as dizziness or drowsiness occur, patients should refrain from driving or operating machinery. Patients with mild to moderate liver dysfunction do not need special dose adjustments, but the safety in patients with severe liver dysfunction has not been established, so caution is required. During administration of this medication, routine blood lipid level checks should be performed to confirm lipid overload and adjust the dose if necessary. Drug interactions must also be taken into consideration. The levels of this medication in the blood may change when combined with certain drugs, so especially when used with probenecid or lamotrigine, therapeutic effects and side effects should be closely monitored. Women who are pregnant or may become pregnant should only use this medication when the benefits outweigh the risks. Nursing mothers should also be cautious with administration. Children under 18 years of age should preferably not use this medication as its safety and efficacy have not been established. For the elderly, dose adjustments are generally not necessary, but if kidney function is impaired, the dose should be adjusted. In the event of overdose, seek immediate medical attention for appropriate treatment, and blood dialysis can be utilized to reduce drug concentration. This medication should be stored in a dry place below 30 degrees Celsius and kept out of reach of children. Care should be taken as transferring to a different container may jeopardize quality.

• headache
• nausea
• thrombocytopenia
• leukopenia
• neutropenia
• dizziness
• confusion
• drowsiness
• hallucinations
• palpitations

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, it is advisable to store it in a cool, dry place below 30 degrees Celsius.

Appearance

White round film-coated tablet

Package unit

21 tablets (7 tablets/PTP X 3)