APO-FAMCICLOVIR 125mg are white, round, biconvex film-coated tablets engraved "APO" on one side and "FAM" over "125" on the other side. Each tablet typically weighs 138mg. APO-FAMCICLOVIR 250mg are white, round, biconvex film-coated tablets engraved "APO" on one side and "FAM" over "250" on the other side. Each tablet typically weighs 275mg. APO-FAMCICLOVIR 500mg are white, oval, biconvex film-coated tablets engraved "APO" on one side and "FAM500" on the other side. Each tablet typically weighs 549mg.
Apo-Famciclovir is indicated:
for the treatment of acute herpes zoster, including ophthalmic zoster and decreases the duration of associated post-herpetic neuralgia (PHN).
for the acute treatment of first episode and recurrences of genital herpes infections, and for the suppression of recurrent genital herpes.
for the treatment of recurrent herpes labialis (cold sores).
in immunocompromised patients with herpes zoster or herpes simplex infections.
250mg three times a day or 500mg twice a day or 750mg once a day for seven days for the treatment of the acute phase of herpes zoster. 500mg three times a day for seven days for the treatment of ophthalmic zoster. Treatment yields better results if initiated as soon as possible after rash onset. For those at risk of PHN, 250-500mg three times a day for seven days, taken during the acute phase of the disease, to decrease the duration and incidence of PHN.
500mg three times daily for ten days. Initiation of treatment is recommended as soon as possible after rash onset.
250mg three times daily for five days. Initiation of treatment is recommended as soon as possible after onset of lesions.
1000mg twice daily for one day or 125mg twice daily for five days. Initiation of treatment is recommended during the prodromal period or as soon as possible after onset of lesions.
1500mg as a single dose for one day. Initiation of treatment is recommended at the earliest sign or symptom of a cold sore (e.g. tingling, itching or burning).
500mg twice daily for seven days. Initiation of treatment is recommended as soon as possible after rash onset.
250mg 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. A dose of 500 mg b.i.d has been shown to be efficacious in HIV patients.
Because reduced clearance of penciclovir, the antivirally active metabolite of famciclovir (see Pharmacokinetic properties), is related to reduced renal function, as measured by creatinine clearance, special attention should be given to dosages in patients with impaired renal function. The following modifications in dosage are recommended:
Herpes zoster infections in immunocompetent and immunocompromised patients
| Creatinine Clearance (mL/min/1.73m 2 ) | Dosage | |
| > 40 30-39 | 250mg/500mg t.i.d 250mg t.i.d. | or 500mg b.i.d. for 7 or 10 days * or 250mg b.i.d. for 7 or 10 days * |
| 10-29 | 125mg t.i.d. | or 125mg b.i.d. for 7 or 10 days * |
* 7 days in immunocompetent patients, 10 days in immunocompromised patients.
Creatinine Clearance (mL/min/1.73m2) Dosage
>
30 250mg t.i.d. for 5 days
10-29
125mg t.i.d. for 5 days
Adjustments for single-day regimen
Creatinine Clearance (mL/min/1.73m2) Dosage
>
60 1000mg b.i.d for 1 day
40-59 500mg b.i.d for 1 day 20-39 500mg single dose
<20
250mg single dose
Adjustments for 5-day regimen
Creatinine Clearance (mL/min/1.73m2) Dosage
>
10 125mg b.i.d for 5 days
Creatinine Clearance (mL/min/1.73m2) Dosage
>
60 1500mg single dose
40-59 750mg single dose 20-39 500mg single dose
<20
250mg single dose
Creatinine Clearance (mL/min/1.73m2) Dosage
>
40 500mg b.i.d for 7 days
30-39 250mg b.i.d for 7 days 10-29 125mg b.i.d for 7 days
Creatinine Clearance (mL/min/1.73m2) Dosage
>
30 250mg b.i.d.
10-29
125mg b.i.d.
Since 4h haemodialysis results in approximately 75% reduction in plasma penciclovir concentrations, famciclovir should be administered immediately following dialysis. For patients with herpes zoster, the recommended dose is 250mg after each dialysis. For patients with recurrent genital herpes, famciclovir should be administered either in a single dose of 250mg following dialysis (single-day regimen), or 125mg following each dialysis (multiple-day regimen). For patients with recurrent herpes labialis (cold sores), famciclovir should be administered in a single dose of 250mg following dialysis (single-day regimen).
No dosage adjustment is required in patients with well-compensated hepatic impairment. No data are available for patients with severe uncompensated hepatic impairment (see Pharmacokinetic properties). Conversion of famciclovir to the active metabolite penciclvoir may be impaired in these patients, resulting in lower penciclovir plasma concentrations and thus possibly a decrease of efficacy of famciclovir (see Pharmacokinetics).
Dosage modification is not required unless renal function is impaired.
The efficacy and safety of famciclovir has not been investigated in paediatric patients. Famciclovir should therefore not be used in children unless the potential benefits are considered to justify the potential risks associated with treatment.
A placebo-controlled study in immunocompetent Black patients with recurrent genital herpes showed no difference in efficacy between patients receiving famciclovir 1000mg twice daily for one day and placebo. There were no unexpected or new safety findings in this trial in Black patients. This lack of efficacy in the one-day treatment regimen cannot be extrapolated to the five-day treatment regimen for recurrent genital herpes (125mg twice daily for five days) or other indications in Black patients (see sections Pharmacodynamic properties and Pharmacokinetic properties).
Because the systemic availability (AUC) of penciclovir was not altered when famciclovir was administered with food, it appears that famciclovir can be taken without regard to meals (see Pharmacokinetic properties). For some patients i.v penciclovir may be more appropriate than famciclovir, the oral prodrug of penciclovir. While the decision on the best patient management and mode of administration should rest with the physician, in severely ill patients initiation of therapy with i.v penciclovir should be considered.
Herpes zoster patients receiving 750mg three times daily for seven days tolerated the famciclovir therapy well. Genital herpes patients receiving up to 750mg three times daily for 5 days, and up to 500mg three times daily for 10 days also tolerated the product well. Good tolerance was also seen in two reported 12 month studies, in which genital herpes patients received doses of up to 250mg three times daily. Similar tolerance was experienced in immunocompromised herpes zoster patients receiving up to 500mg three times daily for 10 days and herpes simplex patients receiving up to 500mg twice daily for 7 days and 500mg twice daily for 8 weeks.
Apo-Famciclovir is contraindicated in patients with known hypersensitivity to famciclovir or other constituents of Apo-Famciclovir. It is also contraindicated in those patients who have shown hypersensitivity to penciclovir, the active metabolite of famciclovir.
Impaired renal function
Special attention should be paid to patients with impaired renal function and dosage adjustment is necessary (see Dosage and method of administration and Overdosage).
No special precautions are required for elderly patients with normal renal function and patients with mild or moderate hepatic impairment.
Famciclovir has not been studied in patients with severe hepatic impairment. Conversion of famciclovir to the active metabolite penciclovir may be impaired in these patients resulting in lower penciclovir plasma concentrations, and thus possibly a decrease of efficacy of famciclovir (see Pharmacokinetic properties).
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, the risk of transmission is still possible. Therefore, in addition to therapy with APO-FAMCICLOVIR, it is recommended that patients use "safer sex" practices.
Category B1
Although animal studies have not shown any embryotoxic or teratogenic effects with famciclovir or penciclovir (the active metabolite of famciclovir), the safety of famciclovir in human pregnancy has not been established. APO-FAMCICLOVIR should therefore not be used during pregnancy unless the potential benefits are considered to outweigh the potential risks associated with treatment.
Studies in rats show that penciclovir is excreted in the breast milk of lactating females given oral famciclovir. There is no information on excretion in human milk. APO-FAMCICLOVIR should not be used in nursing mothers unless the potential benefits are considered to outweigh the potential risks associated with treatment.
APO-FAMCICLOVIR is presumed to be safe or unlikely to produce and effect on the ability to drive or use machinery. There is no evidence that famciclovir will affect the ability of a patient to drive or to use machines. However, patients who experience dizziness, somnolence, confusion or other central nervous system disturbances while taking APO-FAMCICLOVIR should refrain from driving or operating machinery.
In 2 year studies there were no changes seen at 200mg/kg/d. At the maximally tolerated dose of 600mg/kg/d in female rats there was an increased incidence of mammary adenocarcinoma, a common tumour in this strain of rats used in the studies. There was no effect on the incidence of neoplasia in male rats or in mice of either sex.
Famciclovir was not found to be genotoxic in a comprehensive battery of in vivo and in vitro tests designed to detect gene mutation, chromosomal damage and repairable damage to DNA. Penciclovir, (the active metabolite of famciclovir) in common with other drugs of this class, has been shown to cause chromosomal damage, but did not induce gene mutation in bacterial or mammalian cell systems, nor was there evidence of increased DNA repair in vitro.
Famciclovir is well tolerated in laboratory animals. In common with other drugs of this class, degenerative changes of the testicular epithelium were noted. Famciclovir has been shown to have no significant effects on sperm count, morphology, or motility in man. Clinical data do not indicate an impact of famciclovir on male fertility following long-term treatment at an oral dose of 250mg twice daily. Impaired fertility was observed in male rats given 500mg/kg. There were no significant effects on fertility in female rats given famciclovir.
In juvenile rats, famciclovir was administered daily at doses of 0, 40, 125, or 400mg/kg/day for 10 weeks beginning on post-partum Day 4. There were no treatment related deaths or clinical observations. The toxicity of famciclovir was not enhanced in juvenile rats compared to that in the adult animals.
Famciclovir has been well tolerated in human studies. Headache and nausea were reported in clinical trials. These were generally mild or moderate in nature and occurred at a similar incidence in patients receiving placebo treatment. All other adverse reactions have been added due to postmarketing reporting. Reported pooled global placebo or active controlled clinical trials (n=2326 for famciclovir arm) were retrospectively reviewed and reported to obtain a frequency category for all adverse reactions mentioned below. Adverse drug reactions (Table 1) are listed according to system organ classes in MedDRA. Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first. Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category using the following convention (CIOMS III) is also provided for each adverse drug reaction: very common (>= 1/10); common (>= 1/100, < 1/10); uncommon (>= 1/1,000, < 1/100); rare (>= 1/10,000, < 1/1,000); very rare (<1/10,000), not known (cannot be estimated from available data).
Table 1
Blood and lymphatic system disorders
Rare:Thrombocytopenia
Psychiatric disorders
Uncommon:Confusion (predominantly in the elderly) Rare:Hallucinations
Nervous system disorders
Very common:Headache Common:Dizziness Uncommon:Somnolence (predominantly in the elderly)
Gastrointestinal disorders
Common:Vomiting, nausea
Hepatobiliary disorders
Common:Abnormal liver function tests Rare:Cholestatic jaundice
Skin and subcutaneous tissue disorders
Common:Rash, pruritus Uncommon:Angioedema (e.g. face edema, eyelid edema, periorbital edema, pharyngeal edema), urticaria Not known:Serious skin reactions *(e.g. erythema multiforme, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis). *Adverse drug reactions reported from post-marketing experience with famciclovir via spontaneous case reports and literature cases which have not been reported in clinical trials. Because these adverse drug reactions have been reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency. Frequency is therefore listed as "not known" Famciclovir has also been well tolerated in immunocompromised patients. Undesirable effects reported from clinical studies were similar to those reported in the immunocompetent population.
Post-marketing Experience
See table above
Concurrent use of Probenecid and other drugs that affect renal physiology could affect plasma levels of penciclovir (active metabolite of famciclovir, see Pharmacokinetic properties). No clinically significant alterations in penciclovir pharmacokinetics were observed following single-dose administration of 500mg famciclovir after pre-treatment with multiple doses of allopurinol, cimetidine, theophylline, zidovudine, or promethazine or when given shortly after an antacid (magnesium and aluminium hydroxide), or concomitantly with emtricitabine. No clinically significant effect on penciclovir pharmacokinetics was observed following multiple-dose (t.i.d.) administration of famciclovir (500mg) with multiple doses of digoxin. The conversion of the inactive metabolite 6-deoxy penciclovir (formed by deacetylation of famciclovir) to penciclovir is catalysed 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 inhibitors of aldehyde oxidase, did not show relevant effects on the formation of penciclovir. However. raloxifene, the most potent aldehyde oxidase inhibitor observed in vitro, could affect the formation of penciclovir.
The pharmacokinetics of digoxin were not altered by concomitant administration of single or multiple (t.i.d) doses of famciclovir (500mg). No clinically significant effects on the pharmacokinetics of zidovudine, its metabolite zidovudine glucuronide or emtricitabine were observed following a single oral dose of 500mg famciclovir co-administered with zidovudine or emtricitabine. Although famciclovir is only a weak inhibitor of aldehyde oxidase in vitro, interactions with drugs metabolized by aldehyde oxidase could potentially occur. Evidence from reported preclinical studies has shown no potential for induction of cytochrome P450 enzymes and inhibition of CYP3A4.
Because the systemic availability (AUC) of penciclovir was not altered when famciclovir was administered with food, it appears that famciclovir can be taken without regard to meals (see Pharmacokinetic properties).
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 dosage has not been appropriately reduced for the level of renal function. Penciclovir, the active metabolite, is dialysable; plasma concentrations are reduced by approximately 75% following 4 h haemodialysis.
Pharmacotherapeutic group: Oral antiviral agent, ATC code: JO5A B09 Famciclovir is the oral form of penciclovir. Famciclovir is rapidly converted in vivo into penciclovir, which has demonstrable in vitro activity against herpes simplex viruses (HSV types 1 and 2), varicella zoster virus, Epstein-Barr virus and cytomegalovirus. The antiviral effect of orally administered famciclovir has been demonstrated in several animal models: this effect is due to in vivo conversion to penciclovir. In virus-infected cells penciclovir is rapidly and efficiently converted into a triphosphate (mediated via virus-induced thymidine kinase, the viral thymidine kinase (TK) phosphorylates penciclovir to a monophosphate form that, in turn, is converted to penciclovir triphosphate by cellular kinases). This triphosphate persists in infected cells in excess of 12 hours and inhibits replication of viral DNA. In uninfected cells treated with penciclovir, concentrations of penciclovir- triphosphate are only barely detectable. Hence the probability of toxicity to mammalian host cells is low and uninfected cells are unlikely to be affected by therapeutic concentrations of penciclovir. The most common form of resistance encountered with acyclovir among HSV strains is a deficiency in the production of the thymidine kinase (TK) enzyme. Such TK deficient strains would be expected to be cross-resistant to both penciclovir and acyclovir. However, penciclovir has been shown to be active against a recently isolated acyclovir-resistant herpes simplex virus strain with an altered DNA polymerase. Results from 11 worldwide clinical studies involving penciclovir (topical or intravenous formulations) or famciclovir in immunocompetent or immunocompromised patients, including studies of up to 12 months treatment with famciclovir, have shown a small overall frequency of penciclovir resistant isolates: 0.2% (2/913) in immunocompetent patients and 2.1% (6/288) in immunocompromised patients. The resistant isolates were mostly found at the start of treatment or in a placebo group, with resistance occurring on or after treatment with famciclovir or penciclovir only in two immunocompromised patients
Famciclovir is the oral prodrug of the antivirally active compound penciclovir. Following oral administration, famciclovir is rapidly and extensively absorbed and converted to penciclovir. Bioavailability of penciclovir after oral administration of famciclovir is 77%. Mean peak plasma concentration of penciclovir, following a 125mg, 250mg, 500mg and 750mg oral dose of famciclovir, was 0.8microgram/mL, 1.6micrograms/mL, 3.3micrograms/mL and 5.1micrograms/mL respectively, and occurred at a median time of 45 minutes post-dose. The extent of systemic availability (AUC) of penciclovir from oral famciclovir is unaffected by food. Plasma concentration-time curves of penciclovir are similar following single and repeat (t.i.d. and b.i.d.) dosing. The terminal plasma half-life of penciclovir after both single and repeat dosing with famciclovir, is approximately 2 hours. There is no accumulation of penciclovir on repeated dosing with famciclovir. Penciclovir and its 6-deoxy precursor are poorly (< 20%) bound to plasma proteins. Famciclovir is eliminated principally as penciclovir and its 6-deoxy precursor, which are excreted in urine and no unchanged famciclovir has been detected in urine. Tubular secretion contributes to the renal elimination of penciclovir.
Uncomplicated herpes zoster does not significantly alter the pharmacokinetics of penciclovir measured after the oral administration of famciclovir. The terminal plasma half-life of penciclovir in patients with herpes zoster was 2.8 h and 2.7 h, respectively, after single and repeated doses of famciclovir.
The apparent plasma clearance, renal clearance, and plasma elimination rate constant of penciclovir decreased linearly with reductions in renal function, both after single and repeated dosing. Dose adjustment is necessary in patients with renal insufficiency (see Dosage and method of administration).
Well-compensated chronic liver disease had no effect on the extent of systemic availability of penciclovir following oral famciclovir. No dose adjustment is recommended for patients with well-compensated hepatic impairment (see Dosage and method of administration and Special warnings and precautions for use). The pharmacokinetics of penciclovir have not been evaluated in patients with severe uncompensated hepatic impairment. Conversion of famciclovir to the active metabolite penciclvoir may be impaired in these patients, resulting in lower penciclovir plasma concentrations and thus possibly a decrease of efficacy of famciclovir.
Based on cross-study comparisons, the mean penciclovir AUC was about 40% higher and penciclovir renal clearance about 20% lower after oral administration of famciclovir in elderly volunteers (65-79 years) compared to younger volunteers. Some of this difference may be due to differences in renal function between the two age groups. No dose adjustment based on age is recommended unless renal function is impaired (see Dosage and method of administration).
Small differences in renal clearance of penciclovir between females and males have been reported and were attributed to gender differences in renal function. No dose adjustment based on gender is recommended.
In the paediatric studies described in section "Clinical studies", the famciclovir doses were based on the patient's body weight and were selected to provide systemic exposures similar to the penciclovir systemic exposure observed in adults after administration of 500mg famciclovir. 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 studies in patients 1 to <=12 years of age. Pharmacokinetic data were not obtained with the revised weight-based dosing algorithm.
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 500mg. 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 relevant difference in the pharmacokinetics of penciclovir between Black and Caucasian subjects.
In a reported study in suppression of recurrent genital herpes in which immunocompetent patients were treated with famciclovir for 4 months, there was no evidence of resistance to the active metabolite penciclovir when isolates from 71 patients were analysed. Reported results from penciclovir and famciclovir patient studies, including studies of up to four months treatment with famciclovir, have shown a small overall frequency of penciclovir resistant isolates: 0.3% in the 981 total isolates tested to date and 0.19% in the 529 virus isolates from immunocompromised patients. The resistant isolates were found at the start of treatment or in a placebo group, with no resistance occurring on or after treatment with famciclovir or penciclovir. In reported placebo-controlled and active-controlled studies, both in immunocompetent and immunocompromised patients with herpes zoster, famciclovir was effective in the resolution of lesions. A placebo controlled study has demonstrated that famciclovir significantly reduces the duration of post- herpetic neuralgia when administered to patients with herpes zoster. In a large clinical study, famciclovir was shown to be effective and well tolerated in the treatment of ophthalmic zoster. In a reported placebo-controlled study in immunocompetent patients showed that famciclovir 1500mg as a single dose or 750mg twice daily for one day was effective and well tolerated in the treatment of recurrent herpes labialis (cold sores). 701 immunocompetent adults with recurrent herpes labialis self- initiated therapy within 1 hour of first onset of signs or symptoms of a recurrent herpes labialis episode with famciclovir 1500mg as a single dose (n=227), famciclovir 750mg 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 1500mg single-dose group (n=152) as compared to 4.0 days in the famciclovir 750mg twice-daily group (n=157) and 6.2 days in the placebo group (n=168). The median difference in time to healing was 1.8 days (95% CI: 0.9 - 2.7) between placebo and famciclovir 1500mg treated groups and 2.2 days (95% CI: 1.3 - 3.1) between placebo and famciclovir 750mg twice daily groups. 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 1500mg single dose, 29% for famciclovir 750mg twice daily and 34% for placebo. The median time to loss of pain and tenderness was 1.7 days in famciclovir 1500mg single dose-treated patients, 2.1 days in famciclovir 750mg twice daily-treated patients and 2.9 days in placebo-treated patients. Three placebo-controlled studies in immunocompetent patients showed that famciclovir administered either as 125mg twice daily for five days (two studies) or 1000mg twice daily for one day (one study) was effective in the treatment of recurrent genital herpes. In an active-controlled study in immunocompetent patients with recurrent genital herpes, famciclovir 1000mg twice daily for one day was non-inferior to valaciclovir 500mg twice daily for three days. A placebo-controlled study in immunocompetent Black patients with recurrent genital herpes showed no difference in efficacy between patients receiving famciclovir 1000mg twice daily for one day or placebo. There were no unexpected or new safety findings in this trial in Black patients. An active-controlled study in HIV-infected patients showed that famciclovir 500mg twice daily for seven days was effective and well tolerated in the episodic treatment of HSV infections. Placebo-controlled and uncontrolled studies showed that famciclovir 500mg twice daily was effective and well tolerated in the suppression of recurrent genital herpes in HIV-infected patients; the placebo-controlled study showed that famciclovir significantly decreased the proportion of days of both symptomatic and asymptomatic HSV shedding.
The efficacy of famciclovir in paediatric patients under the age of 18 years has not been established. The safety of famciclovir experimental oral granules was evaluated in 169 paediatric patients 1 month to <=12 years of age. One hundred of these patients were 1 to <=12 years of age and were treated with famciclovir oral granules (doses ranged from 150mg to 500mg) either twice (47 patients with herpes simplex virus infections) or three times (53 patients with chickenpox) daily for 7 days. The remaining 69 patients (18 patients 1 to <=12 months, 51 patients 1 to <=12 years) participated in single-dose pharmacokinetic and safety studies using famciclovir oral granules (doses ranged from 25mg to 500mg). The frequency, intensity, and nature of adverse events and laboratory abnormalities reported in the clinical trials were similar to those seen in adults. The available data are insufficient to support the use of famciclovir for the treatment of chickenpox or infections due to herpes simplex virus in this patient population (see Method of administration). No efficacy studies have been conducted in paediatric patients and there are no efficacy data in adults with diseases similar to the ones evaluated in the safety and pharmacokinetics paediatric studies (i.e. chickenpox or gingivostomatitis).
Chemical Structure
It is a synthetic acyclic guanine derivative
Chemical name: 2-[2-(2-amino-9H-purin-9-yl)ethyl]-1,3-propanediol diacetate. Molecular formula: C14H19N5O4;
Molecular weight: 321.3.
APO-FAMCICLOVIR Tablets contain famciclovir 125mg, 250mg or 500mg
List of excipients
APO-FAMCICLOVIR tablets contain: Poloxamer 407, Stearic Acid, Hydroxypropyl Methylcellulose, Polyethylene Glycol 8000 and Titanium Dioxide. Each Tablet is: Gluten free. Lactose free
Nil
Nil
Shelf life: 3 years from the date of manufacture.
Store at or below 25degC
| Strength | Container | Number of tablets in pack |
| 125mg Tablets | Bottles | 28, 40 or 56 |
| Blisters | 10, 28, 40 or 56 | |
| 250mg Tablets | Bottles | 14, 20, 21, 28, 40 or 56 |
| Blisters | 5, 14, 20, 21, 28, 30 or 56 | |
| 500mg Tablets | Bottles | 12, 14, 16, 20, 28, 30 or 56 |
| Blisters | 3, 12, 14, 16, 20, 28, 30 or 56 |
Prescription Medicine: 125mg, 250mg & 500mg when the Pharmacist only criteria not met. Pharmacist Only Medicine: Tablets containing 500mg or less for the treatment of recurrent herpes labialis when pack contains up to 3 tablets)
Apotex NZ Ltd 32 Hillside Road Glenfield Private Bag 102-995 North Shore Mail Centre Auckland Telephone: (09) 444 2073 Fax: (09) 444 2951
08 February 2013