Aciclovir 800 Mg Tablets

Document: leaflet MAH GENERIC_PL 14894-0009 change


Aciclovir 800mg Tablets

Read all of this leaflet carefully before you starttaking this medicine because it contains important information foryou.

•    Keep this leaflet. You may need to read it again.

•    Ifyou have further questions, ask yourdoctor, pharmacisfor nurse.

•This medicine has been prescribedforyou only. Do not pass ifonfoothers. If may harm them,even if theirsigns of illness are the same as yours.

•    Ifyou gefany side effects, falkfo your doctor, pharmacist ornurse. This includesany ited in this leaflet. See section 4.



Doses should be as foradults unless kidney problems are present. Doses should then be reducedand calculated with reference to kidney function.

Elderly patients taking high doses ofAciclovir orally should ensure sufficient fluid intake. Patients with kidney problems:

Caution should be takenif you have kidney problems and taking aciclovir. ForTreatmentofherpessimplexinfection

If kidney function is severely impaired, the dose of aciclovir should not exceed 200 mg, twice daily, every twelve hours.

What is in this leaflet:

1.    What Aciclovir 800 mg Tablets are and what they are used fo r

2. WhatyouneedtoknowbeforeyoutakeAciclovir800mgTablets

3.    How to take Aciclovir 800 mg Tablets

4.    Possible side effects

5.    Howto store Aciclovir 800 mg Tablets

6.    Contentsofthepackandother information

1.WhatAciclovir800 mg Tablets are and what they are usedfor

Aciclovir 800 mg labiets contain aciclovir, one of a group of medicines called antivirals. It works by killing orstopplng the growth of viruses.

Aciclovircanbe used to

■    treat or prevent herpes simplex infections of the skinand mucous membranes e.g. cold sores and genital herpes (excluding herpes simplex virus infection in neonates and severe herpes simplex virus infections in children whose immune system is notworking properly).

■    prevent herpes simplex infections in patients whose immune system is notworking properly.

■    treat chicken pox (varicella) and shingles (herpes zoster) infections.

2. What you need to know before you take Aciclovir800 mg Tablets

Warningsand precautions

Talk to your doctor, pharmacist or nurse before taking Aciclovi r 800 mg Tablets

■    ifyou have kidney problems

■    ifyou are elderly

■    ifyou have previouslyhadtreatmentwith aciclovir, whichdid not work.

Please inform yourdoctoror pharmacist, ifyou arenotsure ifthe above applies to you. Children

Aciclovir tablets can be used mainly for the treatment of non-severe skin and mucous membranes herpes simplex virus (HSV) infections. Your child's doctorwill recommend IV aciclovir for the treatment of neonatal HSV and severe HSV infection, if your child's immune system is notworking properly.

Other medicines and Aciclovir800 mg Tablets

Tell yourdoctoror pharmacist ifyou are taking, have recently taken or mighttake any other medicines.

In particulartell yourdoctoror pharmacist if you are taking any of the following medicines

■    Probenecid (used for treating gout as well as used along with other antibiotics for treating severe infections)

■    Cimetidine (usedfor healing peptic ulcer)

■    Mycofenolate mofetil (medicine used in transplant patients which suppresses immunity).

■    Theophylline (used in asthma and other breathing problems).

AciclovirTablets with foodand drink

Aciclovir Tablets can be taken without regards to meal. If you are taking high doses of aciclovir or if you are an elderly or you have problems with your kidney, you should drink plenty of water to prevent the nskof kidney damage.

Pregnancy and breast-feeding

Ifyouare pregnantor breast-feeding, thinkyou may be pregnant orare planning to have baby, askyourdoctoror pharmacist for advice before taking this medicine.

Driving and using machines

There is no available information on effect of aciclovir on driving and using machines. Some side effects such asdrowsinessorsleepiness and dizziness mayimpairyourability to concentrate and react. Make sure you know how you react to this medicine before you driveoruse machines.

3. Howto takeAciclovir 800 mg Tablets

Always take this medicine exactly as yourdoctoror pharmacist has told you.

Check with your doctor or pharmacist if you arenotsure.

may bedissolved in 50 ml of water before taking orswallowed with a little water

ifyou prefer

The recommended doses areas follows, butyourdoctor maydecideto adjust the dose and the treatment period according to your condition, especially if your body's natural ability to fight infection is weakened.

Ifyou havea newoutbreak of herpes virus infection while youare taking aciclovir 800 mg tablets, tell your doctor.



Take one aciclovir 200 mg tablet, five times a day, every four hours, except during the night. Start treatment as soon as signs of infection are present. Treatment is usually for 5 days. This may be longerwhen infection is severe.

In patients with very weak defence reactions, e.g. after a bone marrow transplant or patients who have poor absorption, the dose can be increased to 400 mg or alternatively you may begivenan injection (intoavein).

To prevent herpes simplex infections from returning

Take one aciclovir 200 mg tablet, fourtimes a day, every six hours

Take one aciclovir 400 mg tablet, twice daily, every 12 hours. You should not use this medicine for longer than six to twelve months at a time without discussing with your doctor whetheryou still need to take it

Prevention of heroes simplex infection in patients with weakened body defence

Take one aciclovir200 mg tablet, fourtimes a day, every six hours.

In patients with very weak defence reactions, e.g. after a bone marrow transplant or patients who have poor absorption, the dose can be increased to 400 mg. Treatment should continue as long as there isariskof infection.

Alternatively, you may be givenan injection (into a vein).

Treatment of chicken pox 1 varicella! and shingles 1 herpes zosterl

The usual dose is 800 mg taken five timesa day, every four hours except during the night. Start treatment as soon as the rash or other symptoms appear. Treatment should be continued forsevendays.

Use inchildrenandadolescents

For treatment of active herpes simplex infections and prevention of herpes simplex infections in patients with weakened body defence

Children aged two yearsandolder may receive the adult doses described above.

Children below the ageoftwo years should be given half the dose.

Treatment of chicken poxlvaricella infection!

6yearsandover:800mgaciclovirfourtimesdaily 2-5years: 400 mg aciclovir four times daily Under2years: 200 mg aciclovir four times daily



If kidney function is severely impaired, the dose of aciclovir should twice daily, every twelve hours.

If kidney function is moderately impaired, the dose of aciclovir should not exceed 8( threetimesdaily,every8hours.

Ifyou have impaired kidney function, you must make sure that your intake of fluids is sufficient.

If you have the impression that the effect of AciclovirTablets is too strong or too weak, talk to your doctor or pharmacist.

Ifyou take more AciclovirTablets than you should

Go to the nearest hospital casualty department or contact your doctor immediately.

Take this leaflet or the blister pack with you so your doctor will know what you I Signs of an overdose include feeling or beingsickand headacheand confusion.

If you forget to take Aciclovir Tablets

Take one as soon as youcan, then goonas before. If you miss several dose:


Do not take a double dose to make up for a forgotten dose. Try to space the evenlyas possible through the day.

Ifyou stop taking AciclovirTablets

Take your tablets as directed and for as long as better, as symptoms may return.

Ifyou have any further questions on the use of this medicine, askyour doctor, pharmacist ornurse.

I. Possible side effects

although not

Serious side effects

If any of the following happen, stop taking AciclovirTablets and tell your doctor immediately or go to the casualty department at your nearest hospital.

Severe allergic reaction suchasrash, itching or hives onyourskin, swelling of your face, lips,tongueorotherpartsofyourbody.Theseareveryserious- '

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

Other side effects

Common (mayaffectupto 1 in 10 people)

• feeling sick (nausea), being sick (vomiting) ■diarrhoea, pain in the abdomen ■dizziness

Uncommon (mayaffectupto 1 in 100 people) ■hive-likerash.hairloss

Rare (mayaffectupto 1 in 1,000 people)

■difficulty In breathing

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

■    feeling agitated or confused

■    shaking or tremors

■    hallucinations (seeing or hearing things thatare not real)

■    fits (convulsions)

■    feeling unusually sleepy or drowsy

■    unsteadiness when walking and lack of coordination

■    difficultyspeaking

■    mental illness with strange ordisturbing thoughts or moods

■    unconsciousness (coma)

■    paralysis of part or all of your body, disturbance of behaviour, speech and eye movements, stiff neck and sensitivity to light

The above side effects are temporary and usuallyoccurinpatientwith kidney problems.

■    changes in the number of different type of blood cells may cause increased bruising, sore throat, nose bleeds, infections, excessive tiredness, breathlessness onexertion, or abnormal paleness of theskin

■inflammationofthe liver, yellowing ofyourskin and whites of your eyes (jaundice)

■    kidney problems where you pass little or no unne, kidney pain which may be associated with kidney failure or crystalluria (presence of crystals in the urine).

Laboratory tests

Rarely, tests have shown increases in blood urea and creatinine level and temporary changes in liver function and components of the blood like bilirubin.

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.

You can also report side effects directly via the Yellow Card Scheme at: By reporting side effects you can help provide more information on the safety of this medicine

S.Howtostore Aciclovir 800 mg 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 throwaway medicines you no longer use. These measures will help protecttheenvironment.

6. Contents ofthepackand other information


However, this leaflet applies only to 800 mg strength.

What Aciclovir 800 mg Tablets contain

The active substance isAciclovir. Each tablet contains 800 mg ofAciclovir. Theother ingredients are:

Magnesium stearate, microcrystalline cellulose, sodium starch glycollate, starchand colloidal anhydrous sillica.

What Aciclovir 800 mg Tablets look like and contents of the pack

Aciclovir 800 mg tablets are capsule shaped biconvex uncoated white to off-white tablets with "800"debossed ononesideand "ACV"on theotherside.

AciclovirTabletsareavailableinpacksof35,60and 100 tablets. Notall packsizes maybe marketed.

Marketing Authorisation Holderand Manufacturer

Marketing Authorisation Holder:

Ranbaxy(UK) Limited 5th floor, Hyde Park, Hayes 3 11 Millington Road Hayes,UB34AZ United Kingdom



124 Fabncn Street 4 0 0532 Cluj-Napoca Cluj, Romania

Sun Pharmaceutical Industries Europe BV Polarisavenue 87 2132JHHoofddorp The Netherlands

last revised in June 2016.