Aciclovir 200 Mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
£
Read all of this leaflet carefully before you start taking this medicine because It contains important informationforyou.
•Keep this leaflet. You may need to read it again.
•Ifyou have further questions, askyour doctor, pharmacist ornurse.
•This medicine has been prescribed foryou only. Do not pass it onto others. It may harm them, even iftheirsigns of illness arethesame as yours.
• If you get any side effects, talktoyourdoctor, pharmacist ornurse. This includes any possible side effects not listed inthisleaflet.See section 4.
What is in this leaflet
1. WhatAciclovir200mgTablets are and whatthey are used for
2. What you need to know beforeyoutake Aciclovir200 mg Tablets
3. How to takeAciclovir 200 mg Tablets
4. Possibleside effects
5. How to store Aciclovir200 mg Tablets
6. Contents ofthe pack and other information
1.WhatAciclovir200mgTablets are and whatthey are used for
Aciclovir 200 mg Tablets contain aciclovir, one of a group of medicines called antivirals. It works by killing or stopping the growth of viruses.
Aciclovir can be used to
•treat or prevent herpes simplex infections ofthe skin and 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 immunesystem is networking properly).
•prevent herpes simplex infections in patients whose immune system is not working properly •treat chickenpox (varicella) and shingles (herpes zoster) infections.
2.Whatyouneedto know before youtakeAciclovir200 mg Tablets
Elderly:
Doses should be asforadults unless kidney problems are present. Doses should then be reduced and calculated with reference to kidney function.
Elderly patients taking high doses of aciclovir orally should ensure sufficient fluid intake.
Patients with kidney problems:
Caution should betaken ifyou have kidney problems and taking aciclovir.
ForTreatment of heroes simplex infection
If kidney function is severely impaired, the dose of aciclovirshould not exceed 200 mg, twice daily, every twelve hours.
ForTreatment of heroes zoster infection
If kidney function is severely impaired, the dose of aciclovirshould not exceed 800 mg, twice daily, every twelve hours.
If kidney function is moderately impaired, the dose of aciclovirshould not exceed 800 mg, three times daily, every 8 hours.
If you have impaired kidney function, you must make sure that your intake of fluids is sufficient.
If you have the impression thatthe effect of Aciclovir Tablets is too strong ortooweak, talkto your doctor or pharmacist.
Ifyou take more AciclovirTabletsthanyou should
Goto 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 have taken. Signs of an overdose include feeling orbeingsickand headache and confusion.
IfyouforgettotakeAciclovir Tablets
Take one as soon as you can, then go on as before. Ifyou miss several doses, tell your Doctor.
Do not take a double dose to make up for a forgotten dose. Try to space the doses as evenly as possible through the day.
Ifyou stop taking Aciclovir Tablets
Take yourtablets as directed andforas long as directed; do notstop them, evenifyoufeel better, as symptomsmay return.
Ifyou have any further questions on the use ofthis medicine, askyour doctor, pharmacist ornurse. 4. Possible side effects
DonottakeAciclovir200mgTablets;
• ifyouareallergictoaciclovirorvalacicloviroranyoftheotheringredients of this medicine (listed in section 6).
Warnings and precautions
Talkto yourdoctor, pharmacist ornurse before takingAciclovir200 mgTablets •ifyou have kidney problems •ifyou are elderly
•ifyou have previously had treatment with aciclovir, which did not work.
Please inform your doctoror pharmacist, ifyou are not sure if the above applies toyou.
Children
Aciclovirtablets can be used mainly forthe treatment of non-severe skin and mucous membranes herpes simplex virus (HSV) infections. Your child's doctor will recommend IV aciclovir for the treatment of neonatal HSV and severe HSV infection, if your child's immunesystem is networking properly.
Other medicines and Aciclovir200 mgTablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particulartell your doctor or pharmacist if you are taking any ofthefollowing medicines. •Probenecid (used for treating gout as well as used along with other antibiotics for treating severe infections)
•Cimetidine(usedforhealingpepticulcer)
•Mycofenolatemofetil (medicine used intransplant patients which suppresses immunity). •Theophylline (used in asthma and other breathing problems).
AciclovirTablets with food and drink
Aciclovir Tablets can be taken without regards to meal. Ifyou 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 risk of kidney damage.
Pregnancy and breast-feeding
Ifyou are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, askyourdoctororpharmacistforadvice 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 as drowsiness orsleepiness and dizziness may impairyourabilityto concentrate and react. Makesureyou knowhow you reaetto this medicine before you drive oruse machines.
3. HowtotakeAciclovir200 mg tablets
Always take this medicine exactly asyourdoctororpharmacist has told you. Checkwithyourdoctororpharmacistifyouarenotsure.
The tablets maybe dissolved in 50 ml of water before taking or swallowed with a little water ifyou prefer.
Dosage
The recommended doses are as follows, but your doctor may decide to adjust the dose and the treatment period according to your condition, especially if your body's natural ability to fight infection is weakened.
Ifyou have a new outbreak of herpes virus infection while you are taking aciclovir200 mg tablets, tell yourdoctor.
Adults:
Fortreatment of active herpessimplex infection
Take one aciclovir200 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 be given an injection (into avein).
To prevent herpes simplex infections from retuminaTake one aciclovir 200 mg tablet, four times a day, every sixhours
Or
Take one aciclovir400 mg tablet, twice daily, every 12 hours. You should not use this medicine for longerthansixto twelve months at a time without discussing with your doctor whether you still need to take it.
Prevention of heroes simplex infection in patients with weakened body defence
Take one aciclovir200 mgtablet, 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 is a risk of infection.
Alternatively, you may be given an injection (into a vein).
Treatment of chicken pox (varicella) andshinales (herpes zoster)
The usual dose is 800 mg taken five times a day, every four hours except during the night. Start treatment as soon as the rash orothersymptoms appear. Treatmentshould be continued forseven days.
Patients with a very weak defence reactions, e.g. after a bone marrow transplant or patients who have poorabsorption, may begiven an injection (into a vein).
Use in children and adolescents
For treatment of active heroes simplex infections and prevention of heroes simplex infections in patients with weakened body defence
Children aged two years and oldermayreceivethe adult doses described above.
Children belowthe age of two years should begiven halfthe dose.
Treatment of chicken pox (varicella infection)
6 years and over: 800 mg aciclovir four times daily 2-5 years: 400 mg aciclovirfourtimes daily Under2 years: 200 mg aciclovirfourtimes daily Treatmentshould continue forfive days.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Serious side effects
If any of the following happen, stoptaking AciclovirTablets and tell yourdoctorimmediately or go to the casualty department atyournearest hospital.
Severe allergic reaction such as rash, itching or hives on your skin, swelling of your face, lips, tongue orotherpartsofyourbody. These are very serious side effects and are rare (may affect up to 1 in 1,000 people).
Otherside effects
Common(mayaffectupto 1 in 10 people)
•skin rashes including increased sensitivity ofthe skin tosun (photosensitivity)
•itching
•fever
•headache
•feelingsick (nausea), being sick (vomiting)
• diarrhoea, pain inthe abdomen
• dizziness •feeling very tired
Uncommon (may affect up to 1 in 100 people)
•hive-like rash, hairloss
Rare (may affect up to 1 in 1,000 people)
•difficulty in breathing
Very rare (may affect up to 1 in 10,000 people)
•feeling agitated orconfused •shaking ortremors
•hallucinations (seeing orhearing things that are not real)
• fits (convulsions)
•feeling unusually sleepy or drowsy •unsteadiness when walking and lack of coordination •difficulty speaking
•mental illness with strange or disturbing thoughts ormoods •unconsciousness (coma)
• paralysis of part or all ofyourbody, disturbance ofbehaviour, speech and eye movements, stiff neckandsensitivityto light
The above side effects are temporary and usually occurin patient with kidney problems.
• changes in the number of different type of blood cells may cause increased bruising, sore throat, nose bleeds, infections, excessive tiredness, breathlessness on exertion, or abnormal paleness ofthe skin
• inflammation ofthe liver, yellowing ofyourskin and whites ofyoureyes (jaundice)
• kidney problems where you pass little or no urine, kidney pain which may be associated with kidney failure orcrystalluria (presence of crystals inthe urine)
Laboratory tests
Rarely, tests have shown increases in blood urea and creatinine level and temporary changes in liverfunction and components of the blood like bilirubin.
Reporting ofside effects
If you get any side effects, talkto 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: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety ofthis medicine
5. How to store Aciclovir 200 mg tablets
• Keep this medicine out ofthesight and reach of children.
• Do not use this medicine afterthe 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 longeruse. These measures will help protect the environment.
6. Contents ofthe pack and other information
AciclovirTabletsare available in three different strengths:
However, this leaflet applies onlyto 200 mg strength.
What Aciclovir 200 mgTablets contain
The active substance isAciclovir. Each tablet contains 200 mg of Aciclovir.
The other ingredients are: magnesium stearate, microcrystalline cellulose, sodium starch glycollate, pregelatinised starch and colloidal anhydrous silica.
What Aciclovir200 mgTablets look like and contents ofthe pack
Aciclovir200mg tablets are capsuleshaped biconvex uncoated white to off-white tablets with “200" debossed on one side and “ACV" on the otherside.
AciclovirTabletsare available in packs of25,60 and 100 tablets.
Not all packsizes maybe marketed.
Marketing Authorisation Holderand Manufacturer
MarketingAuthorisation Holder:
Ranbaxy (UK) Limited 5thfloor, Hyde Park, Hayes 3 11 Millington Road Hayes, UB34A2 United Kingdom
Manufacturer:
TerapiaS.A.
124 Fabricii Street 400632 Cluj-Napoca Cluj, Romania
Sun Pharmaceutical Industries Europe BV S
Polarisavenue87
2132JHHoofddorp 5
The Netherlands
This leaflet was last revised in June 2016.
5130693 - LIT ACICLOVIRTAB 200MG, MARKET - UK-R