Macleods Famciclovir 125 mg, 250 mg FC tablet

MACLEODS FAMCICLOVIR TABLETS is indicated for the treatment of herpes zoster (shingles) infection.

MACLEODS FAMCICLOVIR TABLETS is indicated for the treatment of first episode herpes genitalis within 72 hours of appearance of symptoms and recurrent genital herpes infections within 6 hours of appearance of symptoms.

MACLEODS FAMCICLOVIR TABLETS is indicated for the suppression of recurrent genital herpes in immunocompetent patients.

Posology

Dosage in adults:

• Herpes zoster (shingles) infections: 250 mg three times daily for seven days. Treatment should be initiated within 72 hours after rash onset.
• First episode genital herpes infection: Within 72 hours of appearance of symptoms 250 mg three times daily for 5 days.
• Recurrent genital herpes infections: Within 6 hours of appearance of symptoms 125 mg twice a day for five days.
• Suppression of recurrent genital herpes infections in immunocompetent patients: 125 to 250 mg twice daily. The length of treatment depends on the severity of the disease. Therapy should be re-evaluated after 12 months in order to observe possible changes in the natural history of the disease.

Dosage in elderly: Dosage modification is not required unless renal function is impaired.

Dosage in children: There are currently insufficient data on the safety and efficacy of MACLEODS FAMCICLOVIR TABLETS in children, and therefore its use in children is not recommended.

Dosage in renal impairment: Because reduced clearance of penciclovir is related to reduced renal function, as measured by creatinine clearance, special attention should be given to patients with impaired renal function.

The dose of MACLEODS FAMCICLOVIR TABLETS should be modified as follows in patients with significantly impaired renal function:

For the treatment of herpes zoster infections:

• Creatinine Clearance (ml/min/1,73 m2) Dosage
• > 40 250 mg 8 hourly
• 30 to 39 250 mg 8 or 12 hourly
• 10 to 29 125 mg 8 or 12 hourly

For the treatment of first episode genital herpes infections:

• Creatinine Clearance (ml/min/1,73 m2) Dosage
• > 30 250 mg 8 hourly
• 10 to 29 125 mg 8 hourly

For the treatment of recurrent genital herpes infections:

• Creatinine Clearance (ml/min/1,73 m2) Dosage
• > 10 125 mg 12 hourly

For the suppression of recurrent genital herpes infections in immunocompetent patients:

• Creatinine Clearance (ml/min/1,73 m2) Dosage
• > 30 250 mg 12 hourly
• 10 to 29 125 mg 12 hourly

When only serum creatine is available, a nomogram or the following formula (Cockcroft and Gault) should be used to estimate creatine clearance:

Formula to estimate creatine clearance (ml/min/1,73 m2): [140 u2013 age in years] x weight (kg) (72 x serum creatinine u03bcmol/l)

x either 88,5 (for males) or 75,2 (for females)

Renally impaired patients on haemodialysis: Since 4 hours haemodialysis results in approximately 75 % reduction in plasma concentrations of penciclovir, MACLEODS FAMCICLOVIR TABLETS should be administered immediately following haemodialysis. The recommended dose is 250 mg (herpes zoster patients) and 125 mg (genital herpes patients).

Dosage in hepatically impaired patients: No dosage modification is required for patients with well-compensated chronic liver disease. There is no information on patients with overtly decompensated chronic liver disease, accordingly no precise dose recommendations can be made for this group of patients.

Maximum tolerated daily dose and duration: Herpes zoster patients receiving 750 mg three times daily for seven days tolerated MACLEODS FAMCICLOVIR TABLETS well. Genital herpes patients receiving up to 750 mg three times daily for 5 days and up to 500 mg three times daily for 10 days also tolerated the product well. Good tolerance was seen in two 12 month studies, in which genital herpes patients received doses of up to 250 mg three times daily.

Method of administration: Oral use

• Hypersensitivity to famciclovir, penciclovir or any of the components of MACLEODS FAMCICLOVIR TABLETS excipients listed in section 6.1.
• Pregnancy and lactation (see section 4.6).

Renal impairment: Special attention should be paid to patients with impaired renal function and dosage adjustments is necessary (see sections 4.2 and 4.9). No special precautions are required for elderly patients with normal renal function.

Hepatic impairment: No special precautions are required for patients with well compensated liver disease. MACLEODS FAMCICLOVIR TABLETS 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 MACLEODS FAMCICLOVIR TABLETS may occur.

Use for herpes zoster treatment: Patients with complicated herpes zoster, i.e. those with visceral involvement, disseminated zoster, motor neuropathies, encephalitis and cerebrovascular complications should be treated with intravenous antiviral therapy. Immunocompromised patients with ophthalmic zoster or those with a high risk for disease dissemination and visceral organ involvement should be treated with intravenous antiviral therapy.

Transmission of genital herpes: Genital herpes is a sexually transmitted disease. The risk of transmission is increased during acute episodes. Patients should be advised to avoid intercourse when symptoms are present even if treatment with an antiviral has been initiated. During suppressive treatment with antiviral agents, the frequency of viral shedding is significantly reduced. However, transmission is still possible. Therefore, it is recommended that patients take appropriate steps for protected intercourse.

Lactose intolerance: MACLEODS FAMCICLOVIR TABLETS contains lactose. Patients with the rare hereditary conditions of galactose intolerance e.g. galactosaemia, Lapp lactase deficiency, glucose-galactose malabsorption or fructose intolerance should not take MACLEODS FAMCICLOVIR TABLETS. Contains lactose which may have an effect on the glycaemic control of patients with diabetes mellitus.

No clinically significant interactions have been identified. Evidence from preclinical studies has shown no potential for induction of cytochrome P450. Probenecid and other medicines that affect renal physiology could affect plasma levels of penciclovir. In a phase I study no medicine interactions were observed after co-administration with zidovudine and famciclovir. 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 raloxifen could affect the formation of penciclovir and thus the efficacy of MACLEODS FAMCICLOVIR TABLETS. When raloxifen is co-administered with MACLEODS FAMCICLOVIR TABLETS the clinical efficacy of the antiviral therapy should be monitored.

Pregnancy: The use of MACLEODS FAMCICLOVIR TABLETS is contra-indicated during pregnancy (see section 4.3).

Breastfeeding: The use of MACLEODS FAMCICLOVIR TABLETS is contra-indicated during breastfeeding (see section 4.3).

MACLEODS FAMCICLOVIR TABLETS may cause dizziness, somnolence, confusion and hallucinations which could adversely affect the ability of patients to drive and use machinery.

MACLEODS FAMCICLOVIR TABLETS has not been studied in ophthalmic zoster, disseminated zoster or in immunocompromised patients. Headache and nausea have been reported in clinical trials.

The following side effects have been reported:

Tabulated list of adverse reactions

MedDRA System organ class Frequency Adverse reactions

• Blood and lymphatic system disorders Less frequent Thrombocytopenia
• Immune system disorders Less frequent Angiodema
• Psychiatric disorders Less frequent Confusion (predominantly in the elderly), hallucinations
• Nervous system disorders Frequent Headache, dizziness Less frequent Somnolence (predominantly in the elderly)
• Cardiac disorders Less frequent Palpitations
• Gastrointestinal disorders Frequent nausea, vomiting, abdominal pain, diarrhoea
• Hepatobiliary disorders Frequent Abnormal liver function tests Less frequent Cholestatic jaundice
• Skin and subcutaneous tissue disorders Frequent Rash, pruritis Less frequent Urticaria
• Frequency not known Serious skin reactions (e.g. erythema multiforme, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis), leukocytoclastic vasculitis.

Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8.

Symptomatic and supportive therapy should be given as appropriate. Acute renal failure has been reported in patients where the famciclovir dosage has not been appropriately reduced for the level of renal function. Penciclovir is dialysable and plasma concentrations are reduced by ~75 % following 4 hours haemodialysis.