White circular shape film coated tablet

1 tablet contains;
Famciclovir--------250mg

1. Shingles virus infection
2. treatment of genital herpes infection and suppression of recurrent genital herpes

1. Treatment of Shingles virus infection
Adult: Intake 250mg of Famciclovir/take 3 times a day for 7 days. Preferable to start treatment when symptom appears after infection.

2. Treatment of early stage genital herpes infection:
Adult: Intake 250mg of Famciclovir/take 3 times a day for 5 days. Preferable to start treatment when symptom appears after infection.

3. Treatment of acute recurrent genital herpes infection:
Adult: Intake 125mg of Famciclovir/take 2 times a day for 5 days. Preferable to start treatment at Prodromal stage or when symptom appears after infection.

4. Suppression of recurrent genital herpes
Adult: Intake 250mg of Famciclovir/take 2 times a day. To check the change of natural progress of disease, stop treatment periodically in every 6~12 months.

5. Nephropathy patient: In the case of Nephropathy patient, the clearance of this drug reduces, therefore the dosage should be carefully controlled. The usage and dosage should be consulted in the table.

6. Hepatopathy patient
In the case of chronic compensated liver disease patient, a specific dosage control is not necessary. For definite uncompensated liver disease patient, there is no sufficient treatment experience, therefore a definite suggested dosage has not been established.

PRECAUTIONS

1. Do NOT use famciclovir if:

 1) you are allergic to any ingredient in famciclovir or to penciclovir.

 

2. Do not use this medication if:

 1)  you have kidney problems.

 

3. side effects

1) Adverse reactions are ranked under headings of frequency, using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from available data).

2) Blood and lymphatic system disorders:  In rare cases, Thrombocytopenia can occur.  In clinical trial, the decline of whiteblood cell and Neutropenia appears more often than placebo in this medication group prescribed.

3) Psychiatric Disorders :  headache are very common, dizziness are common, confusional state and sleepiness (predominantly in the elderly) are uncommon, In rare cases, hallucinations can occur.

4) Cardiac Disorders :  In rare cases, Palpitations can occur.

5) Gastrointestinal system : nausea, vomiting, stomach pain and diarrhea are common .

6) Hepatobiliary disorders  : Abnormal liver function tests are common, In rare cases,  Cholestatic jaundice can occur.

7) Skin and Subcutaneous Tissue Disorders : rash and Pruritus are common, Uncomnon side effects include urticaria and Angioedema (e.g. face oedema, eyelid oedema, periorbital oedema, pharyngeal oedema). Serious skin reactions (e.g. erythema multiforme, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis) and leukocytoclastic vasculitis . Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

8) Renal : Acute renal failure has been reported rarely in patients with underlying renal disease where the famciclovir dose has not been appropriately reduced for the level of renal function. 9) KOREA Postmarketing Experience (famciclovir-treated patients : 4,304 patients) : The adverse events listed below have been reported during post-approval use of FAMVIR. it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: stomach pain, Constipation, Abnormal liver function, diarrhea, abdominal distension, Dyspepsia, face oedema, Fatigue, Abdominal Pain, leukopenia, insomnia, a short menstruation period, Dysuria.

 

4. General information

1) Patients with genital herpes should be advised to avoid intercourse when symptoms are present even if treatment has been initiated. It is recommended that patients use safer sex practice. Call your doctor or get medical help right away if you have any of these signs or symptoms.

2) No studies on the effects on the ability to drive and use machines have been performed. However, patients who experience dizziness, somnolence, confusion or other central nervous system disturbances while taking Famvir should refrain from driving or operating machinery.

3) No dosage adjustment is recommended for patients with mild or moderate hepatic impairment. Famciclovir has not been studied in patients with severe hepatic impairment. Conversion of famciclovir to its active metabolite penciclovir may be impaired in these patients resulting in lower penciclovir plasma concentrations, and thus a decrease of efficacy of famciclovir may occur.

 

5. Drug Interactions

1) Evidence from preclinical studies has shown no potential for induction of cytochrome P450 enzymes and inhibition of CYP3A4.

2) Potential for Famciclovir to Affect Other Drugs

- No clinically significant alterations in penciclovir pharmacokinetics were observed following single-dose administration of 500 mg Famciclovir after pretreatment with multiple doses of allopurinol, cimetidine, theophylline, zidovudine, promethazine, when given shortly after an antacid (magnesium and aluminum hydroxide), or concomitantly with emtricitabine.

- No clinically significant effect on penciclovir pharmacokinetics was observed following multiple-dose (three-times-daily) administration of Famciclovir (500 mg) with multiple doses of digoxin.

- Concurrent use of probenecid may result in increased plasma concentrations of penciclovir, the active metabolite of famciclovir, by competing for elimination. Therefore, patients receiving famciclovir at a dose of 500 mg three times daily co-administered with probenecid, should be monitored for toxicity.

- Famciclovir needs aldehyde oxidase to be converted into penciclovir, its active metabolite. Raloxifen has been shown to be a potent inhibitor of this enzyme in vitro. Co-administration of raloxifene could affect the formation of penciclovir and thus the efficacy of famciclovir. When raloxifen is co-administered with famciclovir the clinical efficacy of the antiviral therapy should be monitored.

3) Potential for Other Drugs to Affect Penciclovir

- No clinically significant effect on penciclovir pharmacokinetics was observed following multiple-dose (three-times-daily) administration of Famciclovir (500 mg) with multiple doses of digoxin.

- No clinically significant effect on the pharmacokinetics of zidovudine, its metabolite zidovudine glucuronide, or emtricitabine was observed following a single oral dose of 500 mg famciclovir coadministered with zidovudine or emtricitabine.

- This medication in vitro inhibitors of aldehyde oxidase, did not show relevant effects on the formation of penciclovir .

 

6. PREGNANCY, BREAST-FEEDING and women planning to become pregnant:

 1) Testicular toxicity was observed in rats, mice, and dogs following repeated administration of famciclovir or penciclovir. Testicular changes included atrophy of the seminiferous tubules, reduction in sperm count, and/or increased incidence of sperm with abnormal morphology or reduced motility.

The degree of toxicity to male reproduction was related to dose and duration of exposure. In male rats, decreased fertility was observed of dosing at 500 mg/kg/day. Famciclovir had no effect on general reproductive performance or fertility in female rats and male persons’s(dosing at 250 mg twice daily) sperm count , morphology, motility .

Impaired fertility (including histopathological changes in the testis, altered sperm morphology, reduced sperm concentration and motility, and reduced fertility) was observed in male rats after 10 weeks of dosing at 500 mg/kg/day. But Famciclovir had no effect on general reproductive performance or fertility in female rats.

2) The safety and effectiveness of  this medication in pregnancy  has not been established.   You will need to discuss the benefits and risks of using famciclovir while you are pregnant.

 

3) Breast-feeding:  Animal studies have shown excretion of penciclovir in breast milk.but It is unknown whether famciclovir is excreted in human breast milk Famciclovir should only be used during Breast-feeding when the potential benefits of treatment outweigh the potential risks. 

4) Pregnancy:  if you are planning to become pregnant. It is not known if Famciclovir tablets will harm your unborn baby. 

 

7. Children

 The safety and effectiveness of this medication for children and adolescents under the age of 18 years have not been established.

 

8. older adults

No dose adjustment based on age is recommended unless renal function is impaired.

 

9. OVER DOSE

 Overdose experience with famciclovir is limited. In the event of an overdose supportive and symptomatic therapy should be given as appropriate. Acute renal failure has been reported rarely in patients with underlying renal disease where the famciclovir dose has not been appropriately reduced for the level of renal function. Penciclovir is dialysable; plasma concentrations are reduced by approximately 75% following 4 h haemodialysis.

 

10. Storage       

1) Store famciclovir at room temperature, 30°C. 

2) Keep famciclovir and all medicines out of reach of children.

3) Keep famciclovir in the original container. Do not store or place capsules in any other container.

 

11. others information

 An increase in the incidence of mammary adenocarcinoma was seen in female rats receiving the high dose of 600 mg/kg/day(50-fold human exposure).  In juvenile rats, famciclovir was administered daily at doses of 0, 40, 125, or 400 mg/kg/day for10 weeks beginning on post-partum Day 4. There were no treatment related deaths clinicalobservations or adverse developmental effects. The toxicity of famciclovir was not enhanced injuvenile rats compared to that in the adult animals.