Acyclovir Tablets USP 400mg Taj Pharma

1. Name of the medicinal product

Acyclovir Tablets USP 200mg Taj Pharma
Acyclovir Tablets USP 400mg Taj Pharma
Acyclovir Tablets USP 800mg Taj Pharma

2. Qualitative and quantitative composition

a)Acyclovir Tablets USP 200mg Taj Pharma
Each uncoated tablet contains:
Acyclovir USP 200mg
Excipients: Q.S.

b)Acyclovir Tablets USP 400mg Taj Pharma
Each uncoated tablet contains:
Acyclovir USP 400mg
Excipients: Q.S.

c) Acyclovir Tablets USP 800mg Taj Pharma
Each uncoated tablet contains:
Acyclovir USP 800mg
Excipients: Q.S.

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Uncoated Tablet
Capsule shaped biconvex uncoated white to off-white tablets.

4. Clinical particulars

• Therapeutic indications

Acyclovir Taj Pharma Tablets are indicated for the treatment of herpes simplex virus infections of the skin and mucous membranes including initial and recurrent genital herpes (excluding neonatal HSV and severe HSV infections in immunocompromised children).

Acyclovir Taj Pharma Tablets are indicated for the suppression (prevention of recurrences) of recurrent herpes simplex infections in immunocompetent patients.

Acyclovir Taj Pharma Tablets are indicated for the prophylaxis of herpes simplex infections in immunocompromised patients.

Acyclovir Taj Pharma Tablets are indicated for the treatment of varicella (chickenpox) and herpes zoster (shingles) infections.

• Posology and method of administration

Posology

Dosage in adults

Treatment of herpes simplex infections: 200mg Acyclovir Taj Pharma should be taken five times daily at approximately four hourly intervals omitting the night time dose. Treatment should continue for 5 days, but in severe initial infections this may have to be extended.

In severely immunocompromised patients (e.g. after marrow transplant) or in patients with impaired absorption from the gut the dose can be doubled to 200mg/400mg/800mg Acyclovir Taj Pharma, or alternatively, intravenous dosing could be considered.

Dosing should begin as early as possible after the start of an infection; for recurrent episodes this should preferably be during the prodromal period or when lesions first appear.

Suppression of herpes simplex infections in immunocompetent patients: 200mg Acyclovir Taj Pharma should be taken four times daily at approximately six-hourly intervals.

Many patients may be conveniently managed on a regimen of 200mg/400mg/800mg Acyclovir Taj Pharma twice daily at approximately twelve-hourly intervals.

Dosage titration down to 200mg Acyclovir Taj Pharma taken thrice daily at approximately eight-hourly intervals or even twice daily at approximately twelve-hourly intervals may prove effective.

Some patients may experience break-through infection on total daily doses of 800mg Acyclovir Taj Pharma.

Therapy should be interrupted periodically at intervals of six to twelve months, in order to observe possible changes in the natural history of the disease.

Prophylaxis of herpes simplex infections in immunocompromised patients: 200mg Acyclovir Taj Pharma should be taken four times daily at approximately six-hourly intervals.

In severely immunocompromised patients (e.g. after marrow transplant) or in patients with impaired absorption from the gut, the dose can be doubled to 200mg/400mg/800mg Acyclovir Taj Pharma, or alternatively, intravenous dosing could be considered.

The duration of prophylactic administration is determined by the duration of the period at risk.

Treatment of varicella and herpes zoster infections: 800mg Acyclovir Taj Pharma should be taken five times daily at approximately four-hourly intervals, omitting the night time dose. Treatment should continue for seven days.

In severely immunocompromised patients (e.g. after marrow transplant) or in patients with impaired absorption from the gut, consideration should be given to intravenous dosing.

Dosing should begin as early as possible after the start of an infection: Treatment of herpes zoster yields better results if initiated as soon as possible after the onset of the rash. Treatment of chickenpox in immunocompetent patients should begin within 24 hours after onset of the rash.

Paediatric population

Treatment of herpes simplex infections, and prophylaxis of herpes simplex infections in the immunocompromised: Children aged two years and over should be given adult dosages and children below the age of two years should be given half the adult dose.

For treatment on neonatal herpes virus infections, intravenous Acyclovir Taj Pharma is recommended.

Treatment of varicella infection

6 years and over: 800mg Acyclovir Taj Pharma four times daily

2 – 5 years: 400mg/800mg Acyclovir Taj Pharma four times daily

Under 2 years: 200mg Acyclovir Taj Pharma four times daily

Treatment should continue for five days.

Dosing may be more accurately calculated as 20mg/kg bodyweight (not to exceed 800mg) Acyclovir Taj Pharma four times daily.

No specific data are available on the suppression of herpes simplex infections or the treatment of herpes zoster infections in immunocompetent children.

Dosage in the elderly

The possibility of renal impairment in the elderly must be considered and the dosage should be adjusted accordingly (see Dosage in renal impairment below). Adequate hydration of elderly patients taking high oral doses of Acyclovir Taj Pharma should be maintained.

Dosage in renal impairment

Caution is advised when administering Acyclovir Taj Pharma to patients with impaired renal function. Adequate hydration should be maintained.

In the management of herpes simplex infections in patients with impaired renal function, the recommended oral doses will not lead to accumulation of Acyclovir Taj Pharma above levels that have been established safe by intravenous infusion. However for patients with severe renal impairment (creatinine clearance less than 10 ml/minute) an adjustment of dosage to 200mg Acyclovir Taj Pharma twice daily at approximately twelve-hourly intervals is recommended.

In the treatment of herpes zoster infections it is recommended to adjust the dosage to 800mg Acyclovir Taj Pharma twice daily at approximately twelve hourly intervals for patients with severe renal impairment (creatinine clearance less than 10 ml/minute), and to 800mg Acyclovir Taj Pharma three times daily at intervals of approximately eight hours for patients with moderate renal impairment (creatinine clearance in the range 10 – 25 ml/minute).

Method of administration:

Oral.

Acyclovir Taj Pharma tablets may be dispersed in a minimum of 50 ml of water or swallowed whole with a little water. Ensure that patients on high doses of Acyclovir Taj Pharma are adequately hydrated.

• Contraindications

Hypersensitivity to Acyclovir Taj Pharma or valAcyclovir Taj Pharma, or to any of the excipients listed in section 6.1.

• Special warnings and precautions for use

Use in patients with renal impairment and in elderly patients:

Acyclovir Taj Pharma is eliminated by renal clearance, therefore the dose must be adjusted in patients with renal impairment (see 4.2 Posology and Method of Administration).

Elderly patients are likely to have reduced renal function and therefore the need for dose adjustment must be considered in this group of patients. Both elderly patients and patients with renal impairment are at increased risk of developing neurological side effects and should be closely monitored for evidence of these effects. In the reported cases, these reactions were generally reversible on discontinuation of treatment (see 4.8 Undesirable Effects).

Prolonged or repeated courses of Acyclovir Taj Pharma in severely immune-compromised individuals may result in the selection of virus strains with reduced sensitivity, which may not respond to continued Acyclovir Taj Pharma treatment (see section 5.1).

Hydration status: Care should be taken to maintain adequate hydration in patients receiving high oral doses of Acyclovir Taj Pharma.

The risk of renal impairment is increased by use with other nephrotoxic drugs.

The data currently available from clinical studies is not sufficient to conclude that treatment with Acyclovir Taj Pharma reduces the incidence of chickenpox-associated complications in immunocompetent patients.

Paediatric population:

Oral Acyclovir Taj Pharma should be used in paediatric population mainly for the treatment of non-severe skin and mucosa HSV infections. For the treatment of neonatal HSV and severe HSV infections in immunocompromised children IV Acyclovir Taj Pharma should be used.

• Interaction with other medicinal products and other forms of interaction

Acyclovir Taj Pharma is eliminated primarily unchanged in the urine via active renal tubular secretion. Any drugs administered concurrently that compete with this mechanism may increase Acyclovir Taj Pharma plasma concentrations.

Probenecid and cimetidine increase the AUC of Acyclovir Taj Pharma by this mechanism, and reduce Acyclovir Taj Pharma renal clearance. Similarly increases in plasma AUCs of Acyclovir Taj Pharma and of the inactive metabolite of mycophenolate mofetil, an immunosuppresant agent used in transplant patients have been shown when the drugs are co administered. However no dosage adjustment is necessary because of the wide therapeutic index of Acyclovir Taj Pharma

An experimental study on five male subjects indicates that concomitant therapy with Acyclovir Taj Pharma increases AUC of totally administered theophylline with approximately 50%. It is recommended to measure plasma concentrations during concomitant therapy with Acyclovir Taj Pharma.

• Fertility, pregnancy and lactation

Pregnancy

The use of Acyclovir Taj Pharma should be considered only when the potential benefits outweigh the possibility of unknown risks. A post-marketing Acyclovir Taj Pharma pregnancy registry has documented pregnancy outcomes in women exposed to any formulation of Acyclovir Taj Pharma. The registry findings have not shown an increase in the number of birth defects amongst Acyclovir Taj Pharma exposed subjects compared with the general population, and any birth defects showed no uniqueness or consistent pattern to suggest a common cause. Systemic administration of Acyclovir Taj Pharma in internationally accepted standard tests did not produce embryotoxic or teratogenic effects in rabbits, rats or mice. In a non-standard test in rats, foetal abnormalities were observed but only following such high subcutaneous doses that maternal toxicity was produced. The clinical relevance of these findings is uncertain.

Caution should however be exercised by balancing the potential benefits of treatment against any possible hazard. Findings from reproduction toxicology studies are included in Section 5.3.

Breastfeeding

Following oral administration of 200mg Acyclovir Taj Pharma five times a day, Acyclovir Taj Pharma has been detected in breast milk at concentrations ranging from 0.6 to 4.1 times the corresponding plasma levels. These levels would potentially expose nursing infants to Acyclovir Taj Pharma dosages of up to 0.3mg/kg/day. Caution is therefore advised if Acyclovir Taj Pharma is to be administered to a nursing woman.

Fertility

There is no information on the effect of Acyclovir Taj Pharma on human female fertility.

In a study of 20 male patients with normal sperm count, oral Acyclovir Taj Pharma administered at doses of up to 1g per day for up to six months has been shown to have no clinically significant effect on sperm count, motility or morphology.

See clinical studies in section 5.2

• Effects on ability to drive and use machines

There have been no studies to investigate the effect of Acyclovir Taj Pharma on driving performance or the ability to operate machinery. A detrimental effect on such activities cannot be predicted from the pharmacology of the active substance, but the adverse event profile should be borne in mind.

• Undesirable effects

The frequency categories associated with the adverse events below are estimates. For most events, suitable data for estimating incidence were not available. In addition, adverse events may vary in their incidence depending on the indication.

The following convention has been used for the classification of undesirable effects in terms of frequency: very common ≥ 1/10, common ≥ 1/100 and < 1/10, uncommon ≥ 1/1000 and < 1/100, rare ≥ 1/10,000 and < 1/1000, very rare < 1/10,000

Blood and the lymphatic system disorders:

Very rare: Anaemia, leukopenia, thrombocytopenia.

Immune system disorders:

Rare: Anaphylaxis.

Psychiatric and nervous system disorders:

Common: Headache, dizziness.

Very rare: Agitation, confusion, tremor, ataxia, dysarthria, hallucinations, psychotic symptoms, convulsions, somnolence, encephalopathy, coma.

The above events are generally reversible and usually reported in patients with renal impairment or with other predisposing factors (see 4.4 Special Warnings and Precautions for Use).

Respiratory, thoracic and mediastinal disorders:

Rare: Dyspnoea.

Gastrointestinal disorders:

Common: Nausea, vomiting, diarrhoea, abdominal pains.

Hepato-biliary disorders:

Rare: Reversible rises in bilirubin and liver related enzymes.

Very rare: Hepatitis, jaundice.

Skin and subcutaneous tissue disorders:

Common: Pruritus, rashes (including photosensitivity).

Uncommon: Urticaria. Accelerated diffuse hair loss. Accelerated diffuse hair loss has been associated with a wide variety of disease processes and medicines, the relationship of the event to Acyclovir Taj Pharma therapy is uncertain.

Rare: Angioedema.

Renal and urinary disorders:

Rare: Increases in blood urea and creatinine.

Very rare: Acute renal failure, renal pain. Renal pain may be associated with renal failure and crystalluria.

General disorders and administration site conditions:

Common: fatigue, fever.

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

Symptoms and signs

Acyclovir Taj Pharma is only partly absorbed in the gastrointestinal tract. Patients have ingested overdoses of up to 20g Acyclovir Taj Pharma on a single occasion, usually without toxic effects. Accidental, repeated overdoses of oral Acyclovir Taj Pharma over several days have been associated with gastrointestinal effects (such as nausea and vomiting) and neurological effects (headache and confusion).

Overdosage of intravenous Acyclovir Taj Pharma has resulted in elevations of serum creatinine, blood urea nitrogen and subsequent renal failure. Neurological effects including confusion, hallucinations, agitation, seizures and coma have been described in association with intravenous overdosage.

Management

Patients should be observed closely for signs of toxicity. Haemodialysis significantly enhances the removal of Acyclovir Taj Pharma from the blood and may, therefore, be considered a management option in the event of symptomatic overdose.

5. Pharmacological properties

• Pharmacodynamic properties

Pharmacotherapeutic group: Direct acting antivirals, Nucleosides and nucleotides excl. reverse transcriptase inhibitors.

Acyclovir Taj Pharma is a synthetic purine nucleoside analogue with in vitro and in vivo inhibitory activity against human herpes viruses, including herpes simplex virus (HSV) types I and II and varicella zoster virus (VZV).

The inhibitory activity of Acyclovir Taj Pharma for HSV I, HSV II and VZV is highly selective. The enzyme thymidine kinase (TK) of normal, uninfected cells does not use Acyclovir Taj Pharma effectively as a substrate, hence toxicity of mammalian host cells is low; however, TK encoded by HSV and VZV converts Acyclovir Taj Pharma to Acyclovir Taj Pharma monophosphate, a nucleoside analogue which is further converted to the diphosphate and finally to the triphosphate by cellular enzymes. Acyclovir Taj Pharma triphosphate interferes with the viral DNA polymerase and inhibits viral DNA replication with resultant chain termination following its incorporation into the viral DNA.

Prolonged or repeated courses of Acyclovir Taj Pharma in severely immuno-compromised individuals may result in the selection of virus strains with reduced sensitivity, which may not respond to continued Acyclovir Taj Pharma treatment. Most of the clinical isolates with reduced sensitivity have been relatively deficient in viral TK, however, strains with altered viral TK or viral DNA polymerase have also been reported. In vitro exposure of HSV isolates to Acyclovir Taj Pharma can also lead to the emergence of less sensitive strains. The relationship between the in vitro-determined sensitivity of HSV isolates and clinical response to Acyclovir Taj Pharma therapy is not clear.

• Pharmacokinetic properties

Acyclovir Taj Pharma is only partially absorbed from the gut. Mean steady state peak plasma concentrations (C^ssmax) following doses of 200mg administered four-hourly were 3.1 microMol (0.7 micrograms/ml) and equivalent trough plasma levels (C^ssmin) were 1.8 microMol (0.4 micrograms/ml). Corresponding C^ssmax levels following doses of 200mg/400mg and 800mg administered four-hourly were 5.3 microMol (1.2 micrograms/ml) and 8 microMol (1.8 micrograms/ml) respectively and equivalent C^ssmin levels were 2.7 microMol (0.6 micrograms/ml) and 4 microMol (0.9 micrograms/ml).

In adults the terminal plasma half-life of Acyclovir Taj Pharma after administration of intravenous Acyclovir Taj Pharma is about 2.9 hours. Most of the drug is excreted unchanged by the kidney. Renal clearance of Acyclovir Taj Pharma is substantially greater than creatinine clearance, indicating that tubular secretion, in addition to glomerular filtration contributes to the renal elimination of the drug. 9-carboxymethoxymethylguanine is the only significant metabolite of Acyclovir Taj Pharma, and accounts for approximately 10 – 15% of the administered dose recovered from the urine. When Acyclovir Taj Pharma is given one hour after 1 gram of probenecid the terminal half-life and the area under the plasma concentration time curve is extended by 18% and 40% respectively.

In adults, mean steady state peak plasma concentrations (C^ssmax) following a one hour infusion of 2.5mg/kg, 5mg/kg and 10mg/kg were 22.7 microMol (5.1 micrograms/ml), 43.6 microMol (9.8 micrograms/ml) and 92 microMol (20.7 micrograms/ml), respectively. The corresponding trough levels (C^ssmin) 7 hours later were 2.2 microMol (0.5 micrograms/ml), 3.1 microMol (0.7 micrograms/ml), and 10.2 microMol (2.3 micrograms/ml), respectively.

In children over 1 year of age similar mean peak (C^ssmax) and trough (C^ssmin) levels were observed when a dose of 250mg/m² was substituted for 5mg/kg and a dose of 500mg/m² was substituted for 10mg/kg. In neonates and young infants (0 to 3 months of age) treated with doses of 10mg/kg administered by infusion over a one-hour period every 8 hours the C^ssmax was found to be 61.2 microMol (13.8 micrograms/ml) and C^ssmin to be 10.1 microMol (2.3 micrograms/ml). The terminal plasma half-life in these patients was 3.8 hours. A separate group of neonates treated with 15mg/kg every 8 hours showed approximate dose proportional increases, with a Cmax of 83.5 micromolar (18.8 microgram/ml) and Cmin of 14.1 micromolar (3.2 microgram/ml).

In the elderly, total body clearance falls with increasing age associated with decreases in creatinine clearance although there is little change in the terminal plasma half-life.

In patients with chronic renal failure the mean terminal half-life was found to be 19.5 hours. The mean Acyclovir Taj Pharma half-life during haemodialysis was 5.7 hours. Plasma Acyclovir Taj Pharma levels dropped approximately 60% during dialysis.

Cerebrospinal fluid levels are approximately 50% of corresponding plasma levels. Plasma protein binding is relatively low (9 to 33%) and drug interactions involving binding site displacement are not anticipated.

• Preclinical safety data

Mutagenicity:

The results of a wide range of mutagenicity tests in vitro and in vivo indicate that Acyclovir Taj Pharma is unlikely to pose a genetic risk to man.

Carcinogenicity:

Acyclovir Taj Pharma was not found to be carcinogenic in long term studies in the rat and the mouse.

Teratogenicity:

Systemic administration of Acyclovir Taj Pharma in internationally accepted standard tests did not produce embryotoxic or teratogenic effects in rats, rabbits or mice.

In a non-standard test in rats, foetal abnormalities were observed, but only following such high subcutaneous doses that maternal toxicity was produced. The clinical relevance of these findings is uncertain.

Fertility:

Largely reversible adverse effects on spermatogenesis in association with overall toxicity in rats and dogs have been reported only at doses of Acyclovir Taj Pharma greatly in excess of those employed therapeutically. Two generation studies in mice did not reveal any effect of Acyclovir Taj Pharma on fertility.

6. Pharmaceutical particulars

• List of excipients

Magnesium stearate

Microcrystalline cellulose

Sodium starch glycollate

Pregelatinised starch

Colloidal anhydrous silica

• Incompatibilities

Not applicable.

• Shelf life

3 years

• Special precautions for storage

No special storage conditions are required.

• Nature and contents of container

Blister strips comprising of plain aluminium foil and PVdC coated PVC film.

Pack sizes: 56, 60, 70, 80, 100, 200, 300, 500 Tablets per carton

Not all pack sizes may be marketed.

• Special precautions for disposal and other handling

Not applicable.

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

Acyclovir Tablets USP 400mg Taj Pharma

Package leaflet: Information for the user

Acyclovir Taj Pharma 200mg Tablets

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, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Acyclovir Taj Pharma 200mg/400mg/800mg Tablets are and what they are used for
2. What you need to know before you take Acyclovir Taj Pharma 400mg/800mg Tablets
3. How to take Acyclovir Taj Pharma 200mg/400mg/800mg Tablets
4. Possible side effects
5. How to store Acyclovir Taj Pharma 200mg/400mg/800mg Tablets
6. Contents of the pack and other information.

1. What Acyclovir Taj Pharma 200mg/400mg/800mg Tablets are and what they are used for

Acyclovir Taj Pharma 200mg/400mg/800mg Tablets contain a medicine called Acyclovir Taj Pharma. This belongs to a group of medicines called antivirals. It works by killing or stopping the growth of viruses.

Acyclovir Taj Pharma can be used to

• treat chickenpox and shingles
• treat cold sores, genital herpes and other herpes simplex infections
• stop these problems returning after you have had them
• stop these problems in people whose immune system works less well, which means their bodies are less able to fight infections

2. What you need to know before you take Acyclovir Taj Pharma 200mg/400mg/800mg Tablets

Do not take Acyclovir Taj Pharma 200mg/400mg/800mg Tablets:

• if you are allergic to Acyclovir Taj Pharma or valAcyclovir Taj Pharma or any of the other ingredients of this medicine (listed in section 6).

Do not take Acyclovir Taj Pharma 200mg/400mg/800mg Tablets if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Acyclovir Taj Pharma 200mg/400mg/800mg Tablets.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Acyclovir Taj Pharma 200mg/400mg/800mg Tablets

• if you have kidney problems
• if you are over 65 years of age

If you are not sure if the above apply to you, talk to your doctor or pharmacist before taking Acyclovir Taj Pharma 200mg/400mg/800mg Tablets.

It is important that you drink plenty of water while taking Acyclovir Taj Pharma 200mg/400mg/800mg Tablets

Children

Acyclovir Taj Pharma tablets can be used mainly for the treatment of non-severe skin and mucous membranes herpes simplex virus (HSV) infections. Your child’s doctor will recommend IV Acyclovir Taj Pharma for the treatment of neonatal HSV and severe HSV infection, if your child’s immune system is not working properly.

Other medicines and Acyclovir Taj Pharma 200mg/400mg/800mg Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines.

In particular tell your doctor or pharmacist if you are taking any of the following medicines.

• probenecid, used to treat gout
• cimetidine, used to treat stomach ulcers
• mycophenolate mofetil, used to stop your body rejecting transplanted organs

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.

Driving and using machines

Some side effects such as feeling drowsy or sleepy may impair your ability to concentrate and react. Make sure you are not affected before you drive or operate machinery.

3. How to take Acyclovir Taj Pharma 200mg/400mg/800mg Tablets

Always take this medicine exactly as your doctor or pharmacist has told you.

Check with your doctor or pharmacist if you are not sure.

Taking this medicine

• Take this medicine by mouth
• Dissolve the tablet in a glass of water and stir before drinking
• If you prefer, the tablet can also be swallowed whole with a little water.
• Start to take Acyclovir Taj Pharma 200mg/400mg/800mg Tablets as soon as possible.

The dose that you should take will depend on what you have been given Acyclovir Taj Pharma 200mg/400mg/800mg Tablets for. Your doctor will discuss this with you. A 200mg tablet is also available.

Treatment of chickenpox and shingles

• The usual dose is two 200mg/400mg/800mg taken five times a day
• You should space your dose by at least four hours
• Suggested times are: 7am, 11am, 3pm, 7pm and 11pm
• You should take Acyclovir Taj Pharma 200mg/400mg/800mg Tablets for seven days.

Treatment of cold sores and genital herpes

• The usual dose is one 200mg tablet taken five times a day
• You should space your dose by at least four hours
• Suggested times are: 7am, 11am, 3pm, 7pm and 11pm
• You should take Acyclovir Taj Pharma 200mg/400mg/800mg Tablets for five days, or longer if your doctor tells you to.

Stopping these problems returning after you have had them

• The usual dose is one 200mg tablet taken four times a day
• You should try to space each dose by 6 hours
• You should take Acyclovir Taj Pharma 200mg/400mg/800mg Tablets until your doctor tells you to stop.

Stopping these problems in people whose immune systems work less well and whose bodies are less able to fight infections

• The usual dose is one 200mg tablet taken four times a day
• You should try to space each dose by 6 hours
• You should take Acyclovir Taj Pharma 200mg/400mg/800mg Tablets until your doctor tells you to stop.

Your doctor may adjust the dose of Acyclovir Taj Pharma 200mg/400mg/800mg Tablets if:

• it is for a child
• you are over 65 years of age
• you have kidney problems. If you have kidney problems, it is important to drink plenty of water while you are being treated with Acyclovir Taj Pharma 200mg/400mg/800mg Tablets

Talk to your doctor before taking Acyclovir Taj Pharma 200mg/400mg/800mg Tablets if any of the above apply.

If you take more Acyclovir Taj Pharma Tablets than you should

Acyclovir Taj Pharma 200mg/400mg/800mg Tablets are not usually harmful, unless you take too much over several days. Talk to your doctor or pharmacist if you take too much Acyclovir Taj Pharma 200mg/400mg/800mg Tablets. Take the medicine pack with you.

If you forget to take Acyclovir Taj Pharma Tablets

• If you forget to take Acyclovir Taj Pharma 200mg/400mg/800mg Tablets, take it as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose
• Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects:

If any of the following happen, stop taking Acyclovir Taj Pharma 200mg/400mg/800mg Tablets and tell your doctor immediately or go to the casualty department at your nearest hospital.

Allergic reactions (may affect up to 1 in 1,000 people)

If you have an allergic reaction, stop taking Acyclovir Taj Pharma 200mg/400mg/800mg Tablets and see a doctor straight away. The signs may include:

• rash, itching or hives on your skin
• swelling of your face, lips, tongue or other parts of your body
• shortness of breath, wheezing or trouble breathing
• collapse

Other side effects include:

Common (may affect up to 1 in 10 people)

• headache
• feeling dizzy
• feeling or being sick
• diarrhoea
• stomach pains
• rash
• skin reaction after exposure to light (photosensitivity)
• itching
• feeling tired
• unexplained fever (high temperature) and feeling faint, especially when standing up.

Uncommon (may affect up to 1 in 100 people)

• itchy, hive-like rash
• hair loss.

Rare (may affect up to 1 in 1,000 people)

• effects on some blood and urine tests
• increases in the enzymes that work in the liver.

Very rare (may affect up to 1 in 10,000 people)

• reduced numbers of red blood cells (anaemia)
• reduced numbers of white blood cells
  (leukopenia)
• reduced numbers of blood platelets (cells that help blood to clot) (thrombocytopenia)
• feeling weak
• feeling agitated or confused
• shaking or tremors
• hallucinations (seeing or hearing things that aren’t there)
• fits
• feeling unusually sleepy or drowsy
• unsteadiness when walking and lack of coordination
• difficulty speaking
• inability to think or judge clearly
• unconsciousness (coma)
• paralysis of part or all of your body
• disturbances of behaviour, speech and eye movements
• stiff neck and sensitivity to light
• inflammation of the liver (hepatitis)
• yellowing of your skin and whites of your eyes (jaundice)
• kidney problems where you pass little or no urine
• pain in your lower back, the kidney area of your back or just above your hip (renal pain).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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 Acyclovir Taj Pharma 200mg/400mg/800mg Tablets

Keep this medicine out of the sight and reach of children.

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

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

Acyclovir Taj Pharma Tablets are available in three different strengths:

However, this leaflet applies only to 200mg/400mg/800mg strength.

What Acyclovir Taj Pharma 400mg/800mg Tablets contain

The active substance is Acyclovir Taj Pharma. Each tablet contains 200mg/400mg/800mg of Acyclovir Taj Pharma.

The other ingredients are:

Magnesium stearate, microcrystalline cellulose, sodium starch glycollate, pregelatinised starch and colloidal anhydrous silica.

What Acyclovir Taj Pharma 200mg/400mg/800mg Tablets look like and contents of the pack

Acyclovir Taj Pharma 200mg/400mg/800mg tablets are capsule shaped biconvex uncoated white to off-white tablets

Acyclovir Taj Pharma Tablets are available in packs of 56, 60, 70, 100 and 500 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