Famciclovir Tablets

Adult dose

1. Treatment of herpes zoster infection Adults: Take 250 mg of famciclovir orally 3 times daily for 7 days. It is preferable to start treatment as soon as symptoms appear after infection. 2. Treatment of initial genital herpes infection Adults: Take 250 mg of this medicine 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: Take 125 mg of this medicine orally 2 times 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: Take 250 mg of this medicine orally 2 times 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 creatinine clearance of this medicine is reduced in patients with renal impairment, dosage adjustments should be made with care. The dosage and administration for these patients are as follows. 1) Treatment of herpes zoster and initial genital herpes infection: Creatinine clearance (mL/min/1.73㎡) Dosage 30～59 250 mg per dose 2 times daily 10～29 250 mg per dose once daily 2) Treatment of acute recurrent genital herpes infection: Creatinine clearance (mL/min/1.73㎡) Dosage 30～59 125 mg per dose 2 times daily 10～29 125 mg per dose once daily 3) Suppression of recurrent genital herpes infection: Creatinine clearance (mL/min/1.73㎡) Dosage 30～59 250 mg per dose 2 times daily 10～29 125 mg per dose 2 times daily 4) If only serum creatinine is known, creatinine clearance can be calculated using the following formulas. 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 preferable, taking the dialysis interval into account. Since 4 hours of hemodialysis reduces the plasma concentration of this medicine by approximately 75%, administer this medicine 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 required in patients with chronic compensated liver disease. There is insufficient treatment experience in patients with overt chronic decompensated liver disease; therefore, a clear recommended dose has not been established.

This drug should not be administered to patients who are allergic to this drug or its components, including the active substance, penciclovir. Additionally, since this drug contains lactose, it should not be used in patients with lactose intolerance or specific genetic issues. Patients with impaired kidney function should use this drug with caution. In clinical trials, headaches and nausea have been commonly reported, mostly as mild or moderate symptoms. Hematological side effects may rarely include thrombocytopenia, and leukopenia has also been observed. Neurological symptoms such as headache, dizziness, confusion, drowsiness, and hallucinations have been reported, particularly with drowsiness being more prevalent in the elderly. Gastrointestinal symptoms can commonly include nausea, vomiting, abdominal pain, and diarrhea. Liver function abnormalities are also common, and jaundice may rarely occur. Dermatological side effects such as rash, itching, urticaria, and angioedema have been reported, with severe skin reactions occurring rarely. In patients with decreased kidney function, acute renal failure has been rarely reported, so dose adjustments must be considered according to renal function. This drug does not cure genital herpes, and sexual contact should be avoided during treatment to prevent transmission of the infection. Safe sex practices are recommended. There is little likelihood of affecting driving or operating machinery; however, caution should be exercised if symptoms such as dizziness or drowsiness occur. Patients with mild to moderate liver dysfunction do not require special dose adjustments, but in cases of severe liver impairment, efficacy may be reduced. This drug has little interaction potential with other medications, but caution is required as changes in drug concentration or toxicity risks may occur when combined with some drugs. Safety during pregnancy is uncertain, so it should only be used in pregnant women or those who may become pregnant when the benefits outweigh the risks. In breastfeeding mothers, this drug may be passed into breast milk, so it should only be administered when the need for treatment is significant. Safety and effectiveness in children under 18 have not been established, so administration is not recommended for this age group. In the elderly, dosage adjustment is generally not required; however, dose adjustments may be necessary in cases of impaired kidney function. In case of overdose, appropriate supportive care should be provided, and hemodialysis can reduce drug concentration.

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

This drug may be sensitive to air or moisture, so it should be stored in a tightly closed container. It is recommended to store it in a cool and dry place below 30 degrees Celsius.

Appearance

White round film-coated tablets

Package unit

21 tablets (7 tablets/PTP x 3)