Famciclovir Tablets USP 250mg Taj Pharma

1. Name of the medicinal product

Famciclovir Tablets USP 125mg Taj Pharma
Famciclovir Tablets USP 250mg Taj Pharma
Famciclovir Tablets USP 500mg Taj Pharma

2. Qualitative and quantitative composition

a) Famciclovir Tablets USP 125mg Taj Pharma
Each film coated tablet contains:
Famciclovir USP 125mg
Excipients: Q.S.

b) Famciclovir Tablets USP 250mg Taj Pharma
Each film-coated tablet contains:
Famciclovir USP 250mg
Excipients: Q.S.

c) Famciclovir Tablets USP 500mg Taj Pharma
Each film-coated tablet contains:
Famciclovir USP 500mg
Excipients: Q.S.

Excipients with known effect

This medicinal product contains less than 1mmol sodium (23mg) per tablet.

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Film-coated tablet.

White, round, biconvex, film-coated tablets

4. Clinical particulars

• Therapeutic indications

Varicella-zoster virus (VZV) infections – herpes zoster

Famciclovir Taj Pharma is indicated for

• the treatment of herpes zoster and ophthalmic zoster in immunocompetent adults (see section 4.4)
• the treatment of herpes zoster in immunocompromised adults (see section 4.4)

Herpes simplex virus (HSV) infections – genital herpes

Famciclovir Taj Pharma is indicated for

• the treatment of first and recurrent episodes of genital herpes in immunocompetent adults
• the treatment of recurrent episodes of genital herpes in immunocompromised adults
• the suppression of recurrent genital herpes in immunocompetent and immunocompromised adults.

Clinical studies have not been conducted in HSV-infected patients immunocompromised for other causes than HIV-infection (see section 5.1).

• Posology and method of administration

Posology

Herpes zoster and ophthalmic zoster in immunocompetent adults

500mg three times daily for seven days.

Treatment should be initiated as soon as possible after a diagnosis of herpes zoster or ophthalmic zoster.

Herpes zoster in immunocompromised adults

500mg three times daily for ten days.

Treatment should be initiated as soon as possible after a diagnosis of herpes zoster.

Genital herpes in immunocompetent adults

First episode of genital herpes: 250mg three times daily for five days. Initiation of treatment is recommended as soon as possible after a diagnosis of first episode of genital herpes.

Episodic treatment of recurrent genital herpes: 125mg twice daily for five days. Initiation of treatment is recommended as soon as possible after onset of prodromal symptoms (e.g. tingling, itching, burning, pain) or lesions.

Recurrent genital herpes in immunocompromised adults

Episodic treatment of recurrent genital herpes: 500mg twice daily for seven days. Initiation of treatment is recommended as soon as possible after onset of prodromal symptoms (e.g. tingling, itching, burning, pain) or lesions.

Suppression of recurrent genital herpes in immunocompetent adults

250mg twice daily. Suppressive therapy should be discontinued after a maximum of 12 months of continuous antiviral therapy to reassess recurrence frequency and severity. The minimum period of reassessment should include two recurrences. Patients who continue to have significant disease may restart suppressive therapy.

Suppression of recurrent genital herpes in immunocompromised adults

500mg twice daily.

Patients with renal impairment

Because reduced clearance of penciclovir is related to reduced renal function, as measured by creatinine clearance, special attention should be given to doses in patients with impaired renal function. Dose recommendations for adult patients with renal impairment are provided in Table 1.

Table 1 Dose recommendations for adult patients with renal impairment

Patients with renal impairment on haemodialysis

Since 4 h haemodialysis resulted in up to 75% reduction in plasma penciclovir concentrations, famciclovir should be administered immediately following dialysis. The recommended dose regimens for haemodialysis patients are included in Table 1.

Patients with hepatic impairment

No dose adjustment is required in patients with mild or moderate hepatic impairment. No data are available for patients with severe hepatic impairment (see sections 4.4 and 5.2).

Elderly patients (>65 years)

Dose modification is not required unless renal function is impaired.

Paediatric population

The safety and efficacy of Famciclovir Taj Pharma in children and adolescents aged less than 18 years have not been established. Currently available data are described in sections 5.1 and 5.2.

Black patients

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.

Method of administration

For oral use.

Famciclovir Taj Pharma can be taken without regard to meals (see section 5.2).

• Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Hypersensitivity to penciclovir.

• Special warnings and precautions for use

Use in patients with renal impairment

In patients with impaired renal function dose adjustment is necessary (see sections 4.2 and 4.9).

Use in patients with hepatic impairment

Famciclovir Taj Pharma 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.

Use for zoster treatment

Clinical response should be closely monitored, particularly in immunocompromised patients. Consideration should be given to intravenous antiviral therapy when response to oral therapy is considered insufficient.

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.

Moreover, 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

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, in addition to therapy with famciclovir, it is recommended that patients use safer sex practices.

Sodium

This medicinal product contains less than 1 mmol sodium (23mg) per tablet, that is to say essentially ‘sodium-free’.

• Interaction with other medicinal products and other forms of interaction

Effects of other medicinal products on famciclovir

No clinically significant interactions have been identified.

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 500mg three times daily co-administered with probenecid, should be monitored for toxicity. If patients experience severe dizziness, somnolence, confusion or other central nervous system disturbances, a dose reduction of famciclovir to 250mg three times daily may be considered.

Famciclovir Taj Pharma 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 coadministered with famciclovir the clinical efficacy of the antiviral therapy should be monitored.

• Fertility pregnancy and lactation

Women of childbearing potential

There are no data supporting any special recommendations in women of child-bearing potential.

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 (see section 4.4).

Pregnancy

There is a limited amount of data (less than 300 pregnancy outcomes) from the use of famciclovir in pregnant women. Based on these limited amounts of information, the cumulative analysis of both prospective and retrospective pregnancy cases did not provide evidence indicating that the product causes any specific foetal defect or congenital anomaly. Animal studies have not shown any embryotoxic or teratogenic effects with famciclovir or penciclovir (the active metabolite of famciclovir). Famciclovir Taj Pharma should only be used during pregnancy when the potential benefits of treatment outweigh the potential risks.

Breast-feeding

It is unknown whether famciclovir is excreted in human breast milk. Animal studies have shown excretion of penciclovir in breast milk. If the woman’s condition mandates treatment with famciclovir, discontinuation of breast-feeding may be considered.

Fertility

Clinical data do not indicate an impact of famciclovir on male fertility following long-term treatment at an oral dose of 250mg twice daily (see section 5.3).

• Effects on ability to drive and use machines

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 Famciclovir Taj Pharma should refrain from driving or operating machinery.

• Undesirable effects

Headache and nausea have been reported in clinical studies. These were generally mild or moderate in nature and occurred at a similar incidence in patients receiving placebo treatment. All other adverse reactions were added during post-marketing.

The pooled global placebo or active controlled clinical trials (n=2326 for famciclovir arm) were retrospectively reviewed to obtain a frequency category for all adverse reactions mentioned below. The following table specifies the estimated frequency of adverse reactions based on all the spontaneous reports and literature cases that have been reported for famciclovir since its introduction to the market.

Adverse reactions (Table 2) 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 the available data).

Table 2: Adverse reactions from clinical trials and post-marketing spontaneous reports

*Adverse drug reactions reported from post-marketing experience with Famciclovir Taj Pharma 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”.

Overall, adverse reactions reported from clinical studies with immunocompromised patients were similar to those reported in the immunocompetent population. Nausea, vomiting and abnormal liver function tests were reported more frequently, especially at higher doses.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

• Overdose

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 hours of haemodialysis.

5. Pharmacological properties
   • Pharmacodynamic properties

Pharmacotherapeutic group: Antivirals for systemic use. Nucleosides and nucleotides excluding reverse transcriptase inhibitors

Mechanism of action

Famciclovir Taj Pharma is the oral prodrug of penciclovir. Famciclovir Taj Pharma is rapidly converted in vivo into penciclovir, which has in vitro activity against herpes simplex (HSV) (types 1 and 2), varicella zoster (VZV), 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 the viral thymidine kinase (TK) phosphorylates penciclovir to a monophosphate form that, in turn, is converted to penciclovir triphosphate by cellular kinases. This triphosphate inhibits viral DNA chain elongation by competitive inhibition with deoxyguanosine triphosphate for incorporation into the growing viral DNA, thus halting virus replication of viral DNA. Penciclovir triphosphate has an intracellular half-life of 10 hours in HSV-1-, 20 hours in HSV-2- and 7 hours in VZV-infected cells grown in culture. 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.

Resistance

Like aciclovir, penciclovir resistance is associated with mutations principally in the thymidine kinase (TK) gene resulting in deficiency or altered substrate specificity of this enzyme, and to a much lesser extent in the DNA polymerase gene. Most aciclovir resistant HSV and VZV clinical isolates are also resistant to penciclovir, but cross resistance is not universal.

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.

Clinical efficacy and safety

In placebo-controlled and active-controlled studies both in immunocompetent and immunocompromised patients with uncomplicated herpes zoster, famciclovir was effective in the resolution of lesions. In an active-controlled clinical study, famciclovir was shown to be effective in the treatment of ophthalmic zoster in immunocompetent patients.

Efficacy of famciclovir in immunocompetent patients with first episode of genital herpes was shown in three active-controlled studies. Two placebo-controlled studies in immunocompetent patients and one-active controlled study in HIV-infected patients with recurrent genital herpes showed that famciclovir was effective.

Two placebo-controlled 12-month studies in immunocompetent patients with recurrent genital herpes showed that famciclovir-treated patients had a significant reduction of recurrences as compared to placebo-treated patients. Placebo-controlled and uncontrolled studies of up to 16 weeks duration showed that famciclovir was effective 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.

Paediatric population

Famciclovir Taj Pharma experimental oral granules were 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). Famciclovir Taj Pharma weight-based doses were selected to provide penciclovir systemic exposures similar to the penciclovir systemic exposures observed in adults after administration of 500mg famciclovir. None of these studies comprised a control group; therefore a conclusion on the efficacy of the investigated regimens is not possible. The safety profile was similar to that seen in adults. However, systemic drug exposure in infants < 6 months of age was low, thus precluding any assessment of famciclovir’s safety in this age group.

• Pharmacokinetic properties

General characteristics

Absorption

Famciclovir Taj Pharma 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 was 77%. Mean peak plasma concentration of penciclovir, following a 125mg, 250mg, 500mg and 750mg oral dose of famciclovir, was 0.8 microgram/ml, 1.6 micrograms/ml, 3.3 micrograms/ml and 5.1 micrograms/ml, respectively, and occurred at a median time of 45 minutes post-dose.

Plasma concentration-time curves of penciclovir are similar following single and repeat (t.i.d. and b.i.d.) dosing, indicating that there is no accumulation of penciclovir on repeated dosing with famciclovir.

The extent of systemic availability (AUC) of penciclovir from oral famciclovir is unaffected by food.

Distribution

Penciclovir and its 6-deoxy precursor are poorly (< 20%) bound to plasma proteins.

Biotransformation and elimination

Famciclovir Taj Pharma is eliminated principally as penciclovir and its 6-deoxy precursor, which are excreted in urine. No unchanged famciclovir has been detected in urine. Tubular secretion contributes to the renal elimination of penciclovir.

The terminal plasma half-life of penciclovir after both single and repeat dosing with famciclovir was approximately 2 hours.

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

Characteristics in special populations

Patients with herpes zoster infection

Uncomplicated herpes zoster infection 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 dosing of famciclovir.

Subjects with renal impairment

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 impairment (see section 4.2).

Subjects with hepatic impairment Mild and moderate hepatic impairment had no effect on the extent of systemic availability of penciclovir following oral administration of famciclovir. No dose adjustment is recommended for patients with mild and moderate hepatic impairment (see sections 4.2 and 4.4). The pharmacokinetics of penciclovir have not been evaluated 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.

Paediatric population

Repeated oral dosing of famciclovir (250 or 500mg three times daily) to paediatric patients (6-11 years) infected with hepatitis B did not have a notable effect on the pharmacokinetics of penciclovir compared to single dose data. There was no accumulation of penciclovir. In children (1-12 years) with herpes simplex virus infection or chickenpox given single oral doses of famciclovir (see section 5.1), the apparent clearance of penciclovir increased with body weight in a nonlinear manner. The plasma elimination half-life of penciclovir tended to decrease with decreasing age, from an average of 1.6 hours in the patients aged 6-12 years to 1.2 hours in patients aged 1-<2 years.

Elderly patients (≥65 years)

Based on cross-study comparisons, the mean penciclovir AUC was about 30% higher and penciclovir renal clearance about 20% lower after oral administration of famciclovir in elderly volunteers (65-79 years) compared to younger volunteers. Partly 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 section 4.2).

Gender

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.

• Preclinical safety data

General toxicity

Studies on safety pharmacology and repeated dose toxicity reveal no special hazard for humans.

Genotoxicity

Famciclovir Taj Pharma 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, in common with other substances of this class, has been shown to cause mutations/chromosomal aberrations in human lymphocytes and in the L5178Y mouse lymphoma assay at concentrations at least 25-fold to 100-fold, respectively higher than the maximum concentration reached in human plasma after a single oral famciclovir dose of 1500mg. Penciclovir was negative in the bacterial Ames test and there was no evidence of increased DNA repair in vitro.

Penciclovir caused an increased incidence of micronuclei in mouse bone marrow in vivo when administered intravenously at doses highly toxic to bone marrow (≥ 500mg/kg corresponding to ≥ 810 times the maximum human dose based on body surface area conversion).

Carcinogenicity

At high doses in female rats, there was an increased incidence of mammary adenocarcinoma, a tumour commonly observed in the strain of rats used in the carcinogenicity study. There was no effect on the incidence of neoplasia in male rats treated at doses up to 240mg/kg/day (corresponding to a 38.4mg/kg human equivalent dose or 1.3-fold of the highest recommended total daily dose of 1500mg famciclovir or a patient of 50 kg body weight) or in mice of either sex at doses up to 600mg/kg/day (corresponding to a 48mg/kg human equivalent dose or 1.6-fold of the highest recommended total daily dose).

Reproductive toxicity

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 500mg/kg/day (corresponding to a 80mg/kg human equivalent dose or 2.7-fold of the highest recommended total daily dose). Furthermore, testicular toxicity was noted in the general toxicity studies. This finding was reversible and has also been observed with other substances of this class. Animal studies did not indicate any negative effect on female fertility at doses up to 1000mg/kg/day (corresponding to a 160mg/kg human equivalent dose or 5.3-fold of the highest recommended total daily dose).

Embryofetal development studies showed no evidence of adverse effects at oral doses of famciclovir and intravenous doses of penciclovir corresponding to 0.7- to 5.3- fold of the highest recommended total daily dose of famciclovir.

6. Pharmaceutical particulars
   • List of excipients

Tablet core:

Starch, pregelatinised

Sodium laurilsulfate

Cellulose, microcrystalline

Croscarmellose sodium

Silica, colloidal anhydrous

Stearic acid

Film-coating:

Hypromellose

Titanium dioxide

Macrogol 4000

Macrogol 6000

• Incompatibilities

Not applicable

• Shelf life

2 years

• Special precautions for storage

Do not store above 30°C.

Store in the original package in order to protect from moisture.

• Nature and contents of container

Tablets are provided in blister packs (PVC/PE/PVDC / Aluminium blisters)

Pack sizes:

Each pack contains: 10, 15, 21, 56, 60 film coated tablets

Each container contains: 60, 100, 120, 240, 360, 400 and 500 film coated tablets.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements

Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

Famciclovir Tablets USP 250mg Taj Pharma

Package Leaflet: Information for The Patient

Famciclovir Taj Pharma

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Famciclovir Taj Pharma is and what it is used for
2. What you need to know before you take Famciclovir Taj Pharma
3. How to take Famciclovir Taj Pharma
4. Possible side effects
5. How to store Famciclovir Taj Pharma
6. Contents of the pack and other information

1.What Famciclovir Taj Pharma is and what it is used for

Famciclovir Taj Pharma contains the active substance famciclovir and is an antiviral medicine. It stops the infecting virus from reproducing. Since the virus reproduces very early in the infection, you will benefit most from treatment if you take Famciclovir Taj Pharma as soon as the first symptoms appear.

Famciclovir Taj Pharma is used to treat two types of viral infections in adults:

• Shingles (herpes zoster), which is a viral infection caused by a virus called varicella zoster (the same virus that causes chickenpox). Famciclovir Taj Pharma stops the virus from spreading in the body so that healing can occur faster.
• Famciclovir Taj Pharma is also used for the treatment of shingles in the area around the eye or of the eye itself (ophthalmic zoster).
• Genital herpes. Genital herpes is a viral infection caused by herpes simplex virus type 1 or 2.

It is normally spread by sexual contact. It causes blisters and burning or itching around the genitals, which may be painful. Famciclovir Taj Pharma is used to treat genital herpes infections in adults.

People who have frequent episodes of genital herpes can also take Famciclovir Taj Pharma to help to prevent the attacks.

2. What you need to know before you take Famciclovir Taj Pharma

Do not take Famciclovir Taj Pharma

• if you are allergic to famciclovir, to any of the other ingredients of this medicine (listed in section 6), or to penciclovir (the active metabolite of famciclovir and an ingredient of some other medicines).

Ask your doctor for advice, if you think you may be allergic.

Warnings and precautions

Talk to your doctor or pharmacist before taking Famciclovir Taj Pharma: 2

• if you have kidney problems (or have had them before). Your doctor may decide to give you a lower dose of Famciclovir Taj Pharma.
• if you have problems with your body’s immune system.
• if you have liver problems.

If any of these applies to you, tell your doctor before you take Famciclovir Taj Pharma.

Children and adolescents

Famciclovir Taj Pharma is not recommended for use in children and adolescents.

Prevent passing genital herpes to others

If you are taking Famciclovir Taj Pharma to treat or to suppress genital herpes, or you have had genital herpes in the past, you should still practise safe sex, including the use of condoms. This is important to prevent you passing the infection on to others. You should not have sex if you have genital sores or blisters.

Other medicines and Famciclovir Taj Pharma

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

It is especially important that you tell your doctor or pharmacist if you are taking any of the following medicines:

• Raloxifene (used to prevent and treat osteoporosis)
• Probenecid (used to treat high blood levels of uric acid associated with gout and to increase blood levels of penicillin-type antibiotics)
• any other medicine that can affect your kidneys.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby,

ask your doctor or pharmacist for advice before taking this medicine.

Famciclovir Taj Pharma is not to be used during pregnancy unless clearly necessary. Your doctor will discuss with you the potential risks of taking Famciclovir Taj Pharma during pregnancy.

Famciclovir Taj Pharma is not to be used during breast-feeding unless clearly necessary as it is not known whether famciclovir can pass into human milk. Your doctor will discuss with you the possible risks of taking Famciclovir Taj Pharma during breast-feeding.

If you are of child-bearing age with genital herpes, you should avoid intercourse when symptoms are present even if treatment has been started.

Driving and using machines

Famciclovir Taj Pharma can cause dizziness, drowsiness or confusion. Do not drive or use machines if you have any of these symptoms while taking Famciclovir Taj Pharma.

This medicine contains sodium

This medicine contains less than 1 mmol sodium (23mg) per tablet, that is to say essentially ‘sodium-free’.

3. How to take Famciclovir Taj Pharma

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• The daily dose and length of treatment will depend on the type of viral infection you have – see below. Your doctor will prescribe the correct dose for you.
• For the best results start the medicine as soon as possible after the first signs and symptoms appear.
• Do not have sexual contact with anyone if you have symptoms of genital herpes – even if you have started treatment with Famciclovir Taj Pharma. This is because you could pass the herpes infection to your partner.
• If you have or have had kidney problems, your doctor may decide to give you a lower dose of Famciclovir Taj Pharma.

Dose for shingles

If you have a normal immune system, the recommended dose is

• One tablet of 500mg, three times a day, for seven days

If you have a reduced immune system, the recommended dose is

• One tablet of 500mg three times a day, for ten days.

Dose for genital herpes

The dose depends on the state of your immune system, and the stage of your infection.

If you have a normal immune system, the doses are as follows:

For the first outbreak, the recommended dose is:

• One tablet of 250mg three times a day, for five days.

To treat further outbreaks, the recommended dose is:

• One tablet of 125mg twice a day, for five days.

To prevent future outbreaks, the recommended dose is:

• One tablet of 250mg twice a day.

Your doctor will tell you how long you need to continue taking your tablets.

If you have a reduced immune system, the doses are as follows:

To treat the current outbreak, the recommended dose is:

• One tablet of 500mg twice a day, for seven days.

To prevent future outbreaks, the dose is

• One tablet of 500mg twice a day.

Your doctor will tell you how long you need to continue taking your tablets.

Method of administration

You can take Famciclovir Taj Pharma with or without food.

If you take more Famciclovir Taj Pharma than you should

If you have taken more tablets than you have been told to take, or if someone else accidentally takes your medicine, go to your doctor or hospital for advice immediately. Show them your pack of tablets.

Taking too much Famciclovir Taj Pharma may affect the kidneys. In people who already have kidney problems it may, rarely, lead to kidney failure if their dose is not correctly lowered.

If you forget to take Famciclovir Taj Pharma

If you forget to take a dose of Famciclovir Taj Pharma, you should take it as soon as you remember. Then take your next dose as scheduled. However, do not take two doses within a time interval of less than 1 hour, in that case you should skip the missed dose. Furthermore, do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects caused by Famciclovir Taj Pharma are usually mild to moderate in intensity.

Contact a doctor or go to the emergency department at your nearest hospital straight away if you get any of the following serious side effects:

• Severe blistering of the skin or mucous membranes of the lips, eyes, mouth, nasal passages or genitals (these could be signs of a serious allergic skin reaction)
• Swelling below the surface of the skin (e.g. facial swelling, swelling around eye, eyelid swelling, throat swelling)
• Unexplained bruising, reddish or purplish patches on the skin or nosebleeds (these could be signs of a decrease in the number of blood platelets)
• Yellowing of the skin and/or eyes (signs of jaundice).

The frequency of the following side effects is not known (cannot be estimated from the available data):

• Inflammation of blood vessels which shows as red or purple discolouration of the skin which doesn’t fade
• Seizures or fits
• Difficulty breathing or swallowing. Rash, itching, hives, wheezing or coughing, light-headedness, dizziness, changes in levels of consciousness. Drop in blood pressure, with or without generalized itching, skin reddening, facial/throat swelling, blue discoloration of the lips, tongue or skin (signs of severe allergic reaction).

Other possible side effects:

Very common (may affect more than 1 in 10 people)

• Headache

Common (may affect up to 1 in 10 people)

• Feeling sick (nausea)
• Vomiting
• Stomach pain
• Diarrhoea
• Dizziness
• Rash
• Itching
• Liver function test giving abnormal results

Uncommon (may affect up to 1 to 100 people)

• Confusion (usually in older people)
• Drowsiness (usually in older people)
• Hives (skin rash with red, raised, itchy bumps)
• Rare (may affect up to 1 in 1,000 people)
• Hallucinations (seeing or hearing things that are not really there)
• Feeling the heart ‘thump’ in the chest (palpitations)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Famciclovir Taj Pharma

Keep out of the sight and reach of children.

Do not store above 30°C. Store in the original package to protect from moisture.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Do not use this medicine if you notice the pack is damaged or shows signs of tampering.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Famciclovir Taj Pharma contains

The active substance is famciclovir.

125mg tablet: Each tablet contains 125mg of famciclovir.

250mg tablet: Each tablet contains 250mg of famciclovir.

500mg tablet: Each tablet contains 500mg of famciclovir.

The other ingredients are:

Tablet core:

Starch pregelatinised, sodium laurilsulfate, cellulose, microcrystalline, croscarmellose sodium, silica colloidal anhydrous, stearic acid.

Film-coating:

Hypromellose, titanium dioxide, macrogol 4000, macrogol 6000.

What Famciclovir Taj Pharma looks like and contents of the pack

125mg/250mg/500mg film-coated tablets: White, round, biconvex, film-coated tablets.

The tablet can be divided into equal halves. Use lower strength tablets where these are available.

Famciclovir Taj Pharma is available in blister packs of:

10, 20, 21, 25, 50, 60, 120, 240, 250, 360, 400 and 500 film coated tablets.

Not all pack sizes may be marketed.

Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com