FAMCICLOVIR- famciclovir_tablet

Famciclovir is an orally administered prodrug of the antiviral agent penciclovir [see Microbiology ( 12. Famciclovir is the diacetyl 6-deoxy analog of the active antiviral compound penciclovir. Following oral administration famciclovir undergoes rapid and extensive metabolism to penciclovir and little or no famciclovir is detected in plasma or urine. Penciclovir is predominantly eliminated unchanged by the kidney. Therefore, the dose of famciclovir needs to be adjusted in patients with different degrees of renal impairment [see Dosage and Administration ( 2. 3 Pharmacokinetics in adults Absorption and Bioavailability: Penciclovir concentrations increased in proportion to dose over a famciclovir dose range of 125 mg to 1000 mg administered as a single dose. Table 5 shows the mean pharmacokinetic parameters of penciclovir after single administration of famciclovir to healthy male volunteers. Table 5 Mean Pharmacokinetic Parameters of Penciclovir in Healthy Adult Subjects* *Based on pharmacokinetic data from 17 studies dagger double dagger max section max max Dose AUC (0-inf) dagger C max double dagger t max section 125 mg 2. 9 1000 mg 17. 9 Following oral single-dose administration of 500 mg famciclovir to 7 patients with herpes zoster, the AUC (mean +/- SD), C max max There is no accumulation of penciclovir after the administration of 500 mg famciclovir three times daily for 7 days. Penciclovir C max max max max Distribution Metabolism: in vitro in vitro in vivo Drug Interactions ( 7. 2 Elimination: Following the oral administration of a single 500 mg dose of radiolabeled famciclovir to 3 healthy male volunteers, 73% and 27% of administered radioactivity were recovered in urine and feces over 72 hours, respectively. Penciclovir accounted for 82% and 6-deoxy penciclovir accounted for 7% of the radioactivity excreted in the urine. Approximately 60% of the administered radiolabeled dose was collected in urine in the first 6 hours. After intravenous administration of penciclovir in 48 healthy male volunteers, mean +/- SD total plasma clearance of penciclovir was 36. 09 L/hr/kg). Penciclovir renal clearance accounted for 74. 8% of total plasma clearance. Renal clearance of penciclovir following the oral administration of a single 500 mg dose of famciclovir to 109 healthy male volunteers was 27. Active tubular secretion contributes to the renal elimination of penciclovir. The plasma elimination half-life of penciclovir was 2. 3 hours after intravenous administration of penciclovir to 48 healthy male volunteers and 2. 4 hours after oral administration of 500 mg famciclovir to 124 healthy male volunteers. The half-life in 17 patients with herpes zoster was 2. 0 hours and 2. 0 hours after single and repeated doses, respectively. Special populations: Geriatric patients: Dosage and Administration ( 2. 5 Patients with renal impairment: Use in Specific Populations ( 8. Dosage and Administration ( 2. Patients with hepatic impairment: Use in Specific Populations ( 8. 7 HIV-infected patients: Gender: Race: A retrospective evaluation was performed to compare the pharmacokinetic parameters obtained in black and Caucasian subjects after single and repeat once-daily, twice-daily, or three times-daily administration of famciclovir 500 mg. Data from a study in healthy volunteers (single dose), a study in subjects with varying degrees of renal impairment (single and repeat dose) and a study in subjects with hepatic impairment (single dose) did not indicate any significant differences in the pharmacokinetics of penciclovir between black and Caucasian subjects. Mechanism of action: Antiviral activity: 50 Resistance: 50 Cross-resistance.

Famciclovir, a prodrug of penciclovir, is a nucleoside analog DNA polymerase inhibitor indicated for: Immunocompetent Adult Patients 1. 1 Herpes labialis (cold sores) ᴏ Treatment of recurrent episodes Genital herpes ᴏ Treatment of recurrent episodes ᴏ Suppressive therapy of recurrent episodes Herpes zoster (shingles) HIV-Infected Adult Patients 1. 2 Treatment of recurrent episodes of orolabial or genital herpes Limitation of Use 1. 3 The efficacy and safety of famciclovir have not been established for: Patients <18 years of age Immunocompromised patients other than for the treatment of recurrent episodes of orolabial or genital herpes in HIV-infected patients Black and African American patients with recurrent genital herpes Herpes labialis (cold sores): Genital herpes: Recurrent episodes: Suppressive therapy: Herpes zoster (shingles): Famciclovir tablets are indicated for the treatment of herpes zoster. The efficacy of famciclovir tablets when initiated more than 72 hours after onset of rash has not been established. Recurrent orolabial or genital herpes: The efficacy and safety of famciclovir tablets have not been established for: Patients <18 years of age Patients with first episode of genital herpes Patients with ophthalmic zoster Immunocompromised patients other than for the treatment of recurrent orolabial or genital herpes in HIV-infected patients Black and African American patients with recurrent genital herpes.

Immunocompetent Adult Patients ( 2. 1 Herpes labialis (cold sores) 1500 mg as a single dose Genital herpes 1000 mg twice daily for 1 day 250 mg twice daily Herpes zoster (shingles) 500 mg every 8 hours for 7 days HIV-Infected Adult Patients ( 2. 2 Recurrent episodes of orolabial or genital herpes 500 mg twice daily for 7 days Patients with renal impairment: Adjust dose based on creatinine clearance. 3 Famciclovir tablets may be taken with or without food. Herpes labialis (cold sores): Genital herpes: Recurrent episodes: Suppressive therapy: Herpes zoster (shingles): The recommended dosage of famciclovir tablets for the treatment of herpes zoster is 500 mg every 8 hours for 7 days. Therapy should be initiated as soon as herpes zoster is diagnosed. Recurrent orolabial or genital herpes: Dosage recommendations for adult patients with renal impairment are provided in Table 1 [see Use in Specific Populations ( 8. Table 1 Dosage Recommendations for Adult Patients with Renal Impairment * Indication and Normal Dosage Regimen Creatinine Clearance (mL/min) Adjusted Dosage Regimen Dose (mg) Dosing Interval Single-Day Dosing Regimens Recurrent Genital Herpes1000 mg every 12 hours for 1 day >=60 1000 every 12 hours for 1 day 40-59 500 every 12 hours for 1 day 20-39 500 single dose <20 250 single dose HD* 250 single dose following dialysis Recurrent Herpes Labialis1500 mg single dose >=60 1500 single dose 40-59 750 single dose 20-39 500 single dose <20 250 single dose HD* 250 single dose following dialysis Multiple-Day Dosing Regimens Herpes zoster >=60 500 every 8 hours 40-59 500 every 12 hours 20-39 500 every 24 hours <20 250 every 24 hours HD* 250 following each dialysis Suppression of Recurrent >=40 250 every 12 hours 20-39 125 every 12 hours <20 125 every 24 hours HD* 125 following each dialysis Recurrent Orolabial or Genital Herpes in HIV-Infected Patients 500 mg every 12 hours >=40 500 every 12 hours 20-39 500 every 24 hours <20 250 every 24 hours HD* 250 following each dialysis.

The most common adverse events reported in at least 1 indication by >10% of adult patients are headache and nausea. 1 To report SUSPECTED ADVERSE REACTIONS, contact Cipla Limited, at 1-866-604-3268 or FDA at 1-800-FDA-1088 or www. gov/medwatch. Acute renal failure is discussed in greater detail in other sections of the label [see Warnings and Precautions ( 5 The most common adverse events reported in at least 1 indication by >10% of adult patients treated with famciclovir are headache and nausea. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Immunocompetent patients: Table 2 Selected Adverse Events (all grades and without regard to causality) Reported by >=2% of Patients in Placebo-Controlled Famciclovir Tablets Trials * * dagger double dagger section Incidence Events Herpes Zoster dagger Recurrent Genital Herpes double dagger Genital Herpes- Suppression section Herpes Labialis double dagger Famciclovir (n=273) % Placebo (n=146) % Famciclovir (n=163) % Placebo (n=166) % Famciclovir (n=458) % Placebo (n=63) % Famciclovir (n=447) % Placebo (n=254) % Nervous System Headache 22. 7 Paresthesia 2. 0 Migraine 0. 0 Gastrointestinal Nausea 12. 9 Diarrhea 7. 8 Vomiting 4. 0 Flatulence 1. 0 Abdominal Pain 1. 4 Body as a Whole Fatigue 4. 4 Skin and Appendages Pruritus 3. 0 Reproductive (Female) Dysmenorrhea 0. 0 Table 3 lists selected laboratory abnormalities in genital herpes suppression trials. Table 3 Selected Laboratory Abnormalities in Genital Herpes Suppression Studies * *Percentage of patients with laboratory abnormalities that were increased or decreased from baseline and were outside of specified ranges. daggern values represent the minimum number of patients assessed for each laboratory parameter. NRH=Normal Range High. NRL=Normal Range Low. Parameter Famciclovir (n=660) dagger Placebo (n=210) dagger Anemia (<0. 0 Leukopenia (<0. 75 x NRL) 1. 9 Neutropenia (<0. 5 AST (SGOT) (>2 x NRH) 2. 2 ALT (SGPT) (>2 x NRH) 3. 5 Total Bilirubin (>1. 2 Serum Creatinine (>1. 3 Amylase (>1. 9 Lipase (>1. 7 HIV-infected patients The adverse events listed below have been reported during post approval use of famciclovir. 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: Blood and lymphatic system disorders: Hepatobiliary disorders Immune system disorders: Nervous system disorders Psychiatric disorders Skin and subcutaneous tissue disorders Cardiac disorders:.

Known hypersensitivity to the product, its components, or penciclovir cream. ( 4 Famciclovir tablets are contraindicated in patients with known hypersensitivity to the product, its components, or penciclovir cream.

Nursing mothers: Famciclovir should not be used in nursing mothers unless the potential benefits outweigh the potential risks associated with treatment. 3 Pregnancy category B. In animal reproduction studies, pregnant rats and rabbits received oral famciclovir at doses (up to 1000 mg/kg/day) that provided 2. 8 times (rats) and 1. 4 times (rabbits) the human systemic exposure based on AUC. No adverse effects were observed on embryo-fetal development. In other studies, pregnant rats and rabbits received intravenous famciclovir at doses (360 mg/kg/day) 1. 5 to 6 times (rats) and (120 mg/kg/day) 1. 5 times (rabbits) or penciclovir at doses (80 mg/kg/day) 0. 3 times (rats) and (60 mg/kg/day) 0. 1 times (rabbits) the MRHD based on body surface area comparisons. It is not known whether famciclovir (prodrug) or penciclovir (active drug) are excreted in human milk. Following oral administration of famciclovir to lactating rats, penciclovir was excreted in breast milk at concentrations higher than those seen in the plasma. There are no data on the safety of famciclovir in infants. Famciclovir should not be used in nursing mothers unless the potential benefits are considered to outweigh the potential risks associated with treatment. The efficacy of famciclovir have not been established in pediatric patients. The pharmacokinetic profile and safety of famciclovir (experimental granules mixed with OraSweet registered Study 1 was a single-dose pharmacokinetic and safety study in infants 1 month to < 1 year of age who had an active herpes simplex virus (HSV) infection or who were at risk for HSV infection. Eighteen subjects were enrolled and received a single dose of famciclovir experimental granules mixed with OraSweet based on the patient's body weight (doses ranged from 25 mg to 175 mg). These doses were selected to provide penciclovir systemic exposures similar to the penciclovir systemic exposures observed in adults after administration of 500 mg famciclovir. The efficacy and safety of famciclovir have not been established as suppressive therapy in infants following neonatal HSV infections. In addition, the efficacy cannot be extrapolated from adults to infants because there is no similar disease in adults. Therefore, famciclovir is not recommended in infants. Study 2 was an open-label, single-dose pharmacokinetic, multiple-dose safety study of famciclovir experimental granules mixed with OraSweet in children 1 to < 12 years of age with clinically suspected HSV or varicella zoster virus (VZV) infection. Fifty-one subjects were enrolled in the pharmacokinetic part of the study and received a single body weight adjusted dose of famciclovir (doses ranged from 125 mg to 500 mg). Based on the pharmacokinetic data observed with these doses in children, a new weight-based dosing algorithm was designed and used in the multiple-dose safety part of the study. Pharmacokinetic data were not obtained with the revised weight-based dosing algorithm. A total of 100 patients were enrolled in the multiple-dose safety part of the study; 47 subjects with active or latent HSV infection and 53 subjects with chickenpox. Patients with active or latent HSV infection received famciclovir twice a day for 7 days. The daily dose of famciclovir ranged from 150 mg to 500 mg twice daily depending on the patient's body weight. Patients with chickenpox received famciclovir three times daily for 7 days. The daily dose of famciclovir ranged from 150 mg to 500 mg three times daily depending on the patient's body weight. The clinical adverse events and laboratory test abnormalities observed in this study were similar to these seen in adults. The available data are insufficient to support the use of famciclovir for the treatment of children 1 to <12 years of age with chickenpox or infections due to HSV for the following reasons: Chickenpox: Genital herpes: Herpes labialis: Study 3 was an open-label, single-arm study to evaluate the pharmacokinetics, safety, and antiviral activity of a single 1500 mg dose (three 500 mg tablets) of famciclovir in children 12 to <18 years of age with recurrent herpes labialis. A total of 53 subjects were enrolled in the study; 10 subjects in the pharmacokinetic part of the study and 43 subjects in the non-pharmacokinetic part of the study. All enrolled subjects weighed >=40 kg. The 43 subjects enrolled in the non‑pharmacokinetic part of the study had active recurrent herpes labialis and received a single 1500 mg dose of famciclovir within 24 hours after the onset of symptoms (median time to treatment initiation was 21 hours). The safety profile of famciclovir observed in this study was similar to that seen in adults. The median time to healing of patients with non-aborted lesions was 5. In a phase 3 trial in adults in which patients received a single 1500 mg dose of famciclovir or placebo, the median time to healing among patients with non-aborted lesions was 4. 4 days in the famciclovir 1500 mg single-dose group and 6. 2 days in the placebo group. Of note, in the adult study treatment was initiated by patients within 1 hour after the onset of symptoms [see Clinical Studies (14. 1) Of 816 patients with herpes zoster in clinical studies who were treated with famciclovir, 248 (30. 4%) were >=65 years of age and 103 (13%) were >=75 years of age. No overall differences were observed in the incidence or types of adverse events between younger and older patients. Of 610 patients with recurrent herpes simplex (type 1 or type 2) in clinical studies who were treated with famciclovir, 26 (4. 3%) were >65 years of age and 7 (1. 1%) were >75 years of age. Clinical studies of famciclovir in patients with recurrent genital herpes did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently compared to younger subjects. Apparent plasma clearance, renal clearance, and the plasma-elimination rate constant of penciclovir decreased linearly with reductions in renal function. After the administration of a single 500 mg famciclovir oral dose (n=27) to healthy volunteers and to volunteers with varying degrees of renal impairment (CL CR Table 4 Pharmacokinetic Parameters of Penciclovir in Subjects with Different Degrees of Renal Impairment dagger CR double dagger section Parameter (mean +/- S. ) CL CR dagger (mL/min) (n=15) CL CR (mL/min) (n=5) CL CR (mL/min) (n=4) CL CR (mL/min) (n=3) CL CR 88. 3 double dagger 4. 0 CL/F section 66. 8 Half-life (hr) 2. 2 In a multiple-dose study of famciclovir conducted in subjects with varying degrees of renal impairment (n=18), the pharmacokinetics of penciclovir were comparable to those after single doses. A dosage adjustment is recommended for patients with renal impairment [see Dosage and Administration 2. 3 Mild or moderate hepatic impairment (chronic hepatitis [n=6], chronic ethanol abuse [n=8], or primary biliary cirrhosis [n=1]) had no effect on the extent of availability (AUC) of penciclovir following a single dose of 500 mg famciclovir. However, there was a 44% decrease in penciclovir mean maximum plasma concentration (C max max Clinical Pharmacology In a randomized, double-blind, placebo-controlled trial conducted in 304 immunocompetent black and African American adults with recurrent genital herpes there was no difference in median time to healing between patients receiving famciclovir or placebo. In general, the adverse reaction profile was similar to that observed in other famciclovir clinical trials for adult patients [see Adverse Reactions (6. 1) Clinical Studies (14.

Probenecid: May increase penciclovir levels. Monitor for evidence of penciclovir toxicity. 2 The steady-state pharmacokinetics of digoxin were not altered by concomitant administration of multiple doses of famciclovir (500 mg three times daily). 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. An in vitro 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 with probenecid or other drugs significantly eliminated by active renal tubular secretion may result in increased plasma concentrations of penciclovir. The conversion of 6-deoxy penciclovir to penciclovir is catalyzed by aldehyde oxidase. Interactions with other drugs metabolized by this enzyme and/or inhibiting this enzyme could potentially occur. Clinical interaction studies of famciclovir with cimetidine and promethazine, in vitro in vitro.

OVERDOSAGE
Appropriate symptomatic and supportive therapy should be given. Penciclovir is removed by hemodialysis.
NONCLINICAL TOXICOLOGY
Carcinogenesis: Mutagenesis: in vitro in vivo in vitro S. typhimurium E. coli in vivo in vitro in vivo Impairment of fertility: Famciclovir had no effect on general reproductive performance or fertility in female rats at doses up to 1000 mg/kg/day (2.7 to 10.8x the human AUC). Two placebo-controlled studies in a total of 130 otherwise healthy men with a normal sperm profile over an 8-week baseline period and recurrent genital herpes receiving oral famciclovir (250 mg twice daily) (n=66) or placebo (n=64) therapy for 18 weeks showed no evidence of significant effects on sperm count, motility or morphology during treatment or during an 8-week follow-up.
CLINICAL STUDIES
A randomized, double-blind, placebo-controlled trial was conducted in 701 immunocompetent adults with recurrent herpes labialis. Patients self-initiated therapy within 1 hour of first onset of signs or symptoms of a recurrent herpes labialis episode with famciclovir 1500 mg as a single dose (n=227), famciclovir 750 mg twice daily (n=220) or placebo (n=254) for 1 day. The median time to healing among patients with non-aborted lesions (progressing beyond the papule stage) was 4. 4 days in the famciclovir 1500 mg single-dose group (n=152) as compared to 6. 2 days in the placebo group (n=168). The median difference in time to healing between the placebo and famciclovir 1500 mg treated groups was 1. 3 days (95% CI: 0. 6 en dash 2. No differences in proportion of patients with aborted lesions (not progressing beyond the papule stage) were observed between patients receiving famciclovir or placebo: 33% for famciclovir 1500 mg single dose and 34% for placebo. The median time to loss of pain and tenderness was 1. 7 days in famciclovir 1500 mg single dose-treated patients vs. 9 days in placebo-treated patients. Recurrent episodes: A randomized (2:1), double-blind, placebo-controlled trial was conducted in 304 immunocompetent black and African American adults with recurrent genital herpes. Patients self-initiated therapy within 6 hours of the first sign or symptom of a recurrent genital herpes episode with either famciclovir 1000 mg twice daily (n=206) or placebo (n=98) for 1 day. The median time to healing among patients with non-aborted lesions was 5. 4 days in famciclovir-treated patients (n=152) as compared to 4. 8 days in placebo-treated patients (n=78). The median difference in time to healing between the placebo and famciclovir-treated groups was -0. 26 days (95% CI: -0. Suppressive therapy: Table 6 Recurrence Rates at 6 and 12 Months in Adults with Recurrent Genital Herpes on Suppressive Therapy dagger double dagger Recurrence Rates at 6 Months Recurrence Rates at 12 Months Famciclovir 250 mg twice daily (n=236) Placebo (n=233 Famciclovir 250 mg twice daily (n=236) Placebo (n=233) Recurrence-free 39% 10% 29% 6% Recurrencesdagger 47% 74% 53% 78% Lost to follow-updouble dagger 14% 16% 17% 16% Famciclovir-treated patients had approximately 1/5 the median number of recurrences as compared to placebo-treated patients. Higher doses of famciclovir were not associated with an increase in efficacy. A randomized, double-blind trial compared famciclovir 500 mg twice daily for 7 days (n=150) with oral acyclovir 400 mg 5 times daily for 7 days (n=143) in HIV-infected patients with recurrent orolabial or genital herpes treated within 48 hours of lesion onset. Approximately 40% of patients had a CD4 + 3 Two randomized, double-blind trials, 1 placebo-controlled and 1 active-controlled, were conducted in 964 immunocompetent adults with uncomplicated herpes zoster. Treatment was initiated within 72 hours of first lesion appearance and was continued for 7 days. In the placebo-controlled trial, 419 patients were treated with either famciclovir 500 mg three times daily (n=138), famciclovir 750 mg three times daily (n=135) or placebo (n=146). The median time to full crusting was 5 days among famciclovir 500 mg-treated patients as compared to 7 days in placebo-treated patients. The times to full crusting, loss of vesicles, loss of ulcers, and loss of crusts were shorter for famciclovir 500 mg-treated patients than for placebo-treated patients in the overall study population. The effects of famciclovir were greater when therapy was initiated within 48 hours of rash onset; it was also more profound in patients 50 years of age or older. Among the 65. 2% of patients with at least 1 positive viral culture, famciclovir treated patients had a shorter median duration of viral shedding than placebo-treated patients (1 day and 2 days, respectively). There were no overall differences in the duration of pain before rash healing between famciclovir- and placebo-treated groups. In addition, there was no difference in the incidence of pain after rash healing (postherpetic neuralgia) between the treatment groups. In the 186 patients (44. 4% of total study population) who developed postherpetic neuralgia, the median duration of postherpetic neuralgia was shorter in patients treated with famciclovir 500 mg than in those treated with placebo (63 days and 119 days, respectively). No additional efficacy was demonstrated with higher dose of famciclovir. In the active-controlled trial, 545 patients were treated with 1 of 3 doses of famciclovir three times daily or with acyclovir 800 mg five times daily. Times to full lesion crusting and times to loss of acute pain were comparable for all groups and there were no statistically significant differences in the time to loss of postherpetic neuralgia between famciclovir and acyclovir-treated groups.
PATIENT INFORMATION
Famciclovir fam sye'' kloe vir) Tablets Rx only Revised 10/2016 Read this Patient Information before you start taking famciclovir tablets and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment. What are famciclovir tablets? Famciclovir tablets are a prescription antiviral medicine used to: It is not known if famciclovir tablets are safe and effective in children younger than 18 years of age. Famciclovir tablets are not a cure for herpes. It is not known if famciclovir tablets can stop the spread of herpes to others. If you are sexually active, you can pass herpes to your partner even if you are taking famciclovir tablets. Herpes can be transmitted even if you do not have active symptoms. You should continue to practice safer sex to lower the chances of spreading genital herpes to others. Do not have sexual contact with your partner during an outbreak of genital herpes or if you have any symptoms of genital herpes. Use a condom made of latex or polyurethane when you have a sexual contact. Ask your healthcare provider for more information about safer sex practices. Who should not take famciclovir tablets? Do not take famciclovir tablets if you are allergic to any of its ingredients or to penciclovir cream. See the end of this Patient Information leaflet for a complete list of ingredients in Famciclovir tablets. What should I tell my healthcare provider before taking famciclovir tablets? Before you start taking famciclovir tablets, tell your healthcare provider if you: Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take: Know the medicines you take. Keep a list of them with you to show to your healthcare provider and pharmacist every time you get a new medicine. How should I take famciclovir tablets? What are the possible side effects of famciclovir tablets? The most common side effects of famciclovir tablets include: Talk to your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of famciclovir tablets. Ask your healthcare provider or pharmacist for more information. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store famciclovir tablets? Store famciclovir tablets at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Keep famciclovir tablets and all medicines out of reach from children. General information about famciclovir tablets Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use famciclovir tablets for a condition for which it was not prescribed. Do not give famciclovir tablets to other people, even if they have the same symptoms you have. It may harm them. This leaflet summarizes the most important information about famciclovir tablets. If you would like more information, talk with your healthcare provider. Your healthcare provider or pharmacist can give you information about famciclovir tablets that is written for health professionals. For more information, call 1-866-604-3268 What are the ingredients in famciclovir tablets? Active ingredient: Inactive ingredients: Disclaimer: Other Brands listed are the registered trademarks of their respective owners and are not trademarks of Cipla Limited. Manufactured by Manufactured for 9100 S. Dadeland Blvd., Suite 1500 Miami, FL 33156 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 Revised: 10/2016

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