Famciclovir 250 mg Tablets

Adult dose

1. Treatment of herpes zoster 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 Adults: Administer this product 250 mg 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 Adults: Administer this product 125 mg 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: Administer this product 250 mg 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 the clearance of this product is reduced in patients with renal impairment, dosage adjustment should be undertaken with caution. The dosage regimen for these patients is as follows. 1) Treatment of herpes zoster and first-episode genital herpes: Creatinine clearance (mL/min/1.73㎡) 30～59: 250 mg per dose, 2 times daily Creatinine clearance (mL/min/1.73㎡) 10～29: 250 mg per dose, 1 time daily 2) Treatment of acute recurrent genital herpes: Creatinine clearance (mL/min/1.73㎡) 30～59: 125 mg per dose, 2 times daily Creatinine clearance (mL/min/1.73㎡) 10～29: 125 mg per dose, 1 time daily 3) Suppression of recurrent genital herpes: Creatinine clearance (mL/min/1.73㎡) 30～59: 250 mg per dose, 2 times daily Creatinine clearance (mL/min/1.73㎡) 10～29: 125 mg per dose, 2 times 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 Hemodialysis patients should preferably receive this product every 48 hours, 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 250 mg for patients with herpes zoster and 125 mg for patients with genital herpes. 6. Patients with hepatic impairment: No dosage adjustment is required in patients with chronic compensated liver disease. There is insufficient treatment experience in patients with overt chronic decompensated liver disease; therefore, no clear recommended dosage has been established.

This medicine should not be administered to certain patients. It should not be used in patients who have had an allergic reaction to this medicine or its components. Additionally, as it contains lactose, it should not be administered to patients with lactose intolerance or certain genetic metabolic disorders. Caution is required when using this medicine in patients with impaired renal function, and dosage adjustment may be necessary. During treatment with this medicine, symptoms such as headache or nausea may occur, most of which are mild to moderate. Rarely, blood-related adverse reactions such as thrombocytopenia or leukopenia have been reported. Symptoms such as dizziness, drowsiness, confusion, or hallucinations may occur, affecting the central nervous system, so caution is warranted. Gastrointestinal disturbances such as nausea, vomiting, abdominal pain, and diarrhea are common. Hepatic function abnormalities or jaundice may appear rarely, so it is advisable to periodically check liver health. Skin reactions such as rashes, itching, hives, and swelling around the face or eyes are also commonly reported. In patients with poor renal function, acute renal failure may rarely occur, so kidney status should be closely monitored. This medicine does not cure genital herpes, and contact should be avoided if symptoms are present during treatment. Caution should be taken when driving or operating machinery if dizziness or drowsiness occurs. Patients with mild to moderate liver impairment typically do not require special dosage adjustments, but patients with severe liver disease may experience decreased efficacy. The potential for interactions with other medications is low, however, caution is needed as co-administered drugs may elevate plasma concentrations of penciclovir. Pregnant or breastfeeding women should only use this medication if its safety is assured, under a physician's judgment. It is better not to use in children under 18 years, as safety and efficacy have not been established. Generally, older adults do not need dosage adjustments, but adjustments are necessary if renal function is compromised. In case of overdose, appropriate treatment should be received, and blood dialysis can decrease the drug concentration. This medicine should be stored in a dry place below 30 degrees Celsius, out of reach of children. Transferring to other containers may not be good for quality retention.

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

This medicine can be sensitive to air or moisture; therefore, it should be stored in a sealed container. It is also advisable to store it in a cool, dry place below 30 degrees Celsius.

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle