Below is a text only representation of the Patient Information Leaflet (ePIL).
The text only version may be available in large print, Braille or audio CD.
For further information call emc accessibility on
0800 198 5000.
The product code(s) for this leaflet is: PL 29831/0002.
Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or your pharmacist.
This medicine has been prescribed only for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet
1. What Aciclovir Tablets are and what they are used for 2. What you need to know before you take Aciclovir Tablets 3. How to take Aciclovir Tablets 4. Possible side effects 5. How to store Aciclovir Tablets 6. Contents of the pack and other information
1. What Aciclovir Tablets are and what they are used for
The name of your medicine is Aciclovir Tablets. This belongs to a group of medicines called antivirals. It works by killing or stopping the growth of viruses.
Aciclovir Tablets can be used to:
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 systems work less well, which means their bodies
are less able to fight infections.
2. What you need to know before you take Aciclovir Tablets
Do not take Aciclovir Tablets if:
you are allergic to aciclovir or valaciclovir or any of the other ingredients of this medicine (listed in section 6)
Do not take Aciclovir Tablets if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Aciclovir Tablets.
Warning and precautions
Talk to your doctor of pharmacist before taking Aciclovir Tablets if:
if you have had severe skin reactions with aciclovir or valaciclovir
you have kidney problems
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 Aciclovir Tablets. It is important that you drink plenty of water while taking Aciclovir Tablets.
Conditions you need to look out for
Aciclovir can cause severe skin reactions. You must look out for certain symptoms while taking Aciclovir Tablets, to reduce the risk of any problems. If you experience any signs or symptoms of severe skin reactions, stop taking Aciclovir Tablets and contact your doctor immediately (see possible side effects’).
Other medicines and Aciclovir Tablets
Tell your doctor or pharmacist if you are taking or have recently taken 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 and fertility
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.
Aciclovir Tablets contain lactose and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine contains less than 1mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free’.
3. How to take Aciclovir Tablets
Always take this medicine 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
Unless told otherwise, swallow your tablets whole with plenty of water
Start to take Aciclovir Tablets as soon as possible.
The dose that you should take will depend on what you have been given Aciclovir Tablets for. Your doctor will discuss this with you.
Treatment of chickenpox and shingles
The usual dose is 800 mg taken five times a day
You should space each dose by 4 hours Suggested times are: 7am, 11am, 3pm, 7pm and 11pm
You should take Aciclovir Tablets for seven days.
Treatment of cold sores and genital herpes
The usual dose is one 200 mg tablet taken five times a day
You should space each dose by 4 hours Suggested times are: 7am, 11am, 3pm, 7pm and 11pm
You should take Aciclovir 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 200 mg tablet taken four times a day
You should try to space each dose by 6 hours
You should take Aciclovir 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 200 mg tablet taken four times a day
You should try to space each dose by 6 hours
You should take Aciclovir Tablets until your doctor tells you to stop.
Your doctor may adjust the dose of Aciclovir 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 Aciclovir Tablets.
Talk to your doctor before taking Aciclovir Tablets if any of the above apply.
If you take more Aciclovir Tablets than you should
Aciclovir Tablets are not usually harmful, unless you take too much over several days. Talk to your doctor or pharmacist if you take too much Aciclovir Tablets. Take the medicine pack with you.
If you forget to take Aciclovir Tablets
Do not take a double dose (two doses at the same time) to make up for a forgotten dose. Take your next dose as soon as you remember, then go on as before. However, if it is nearly time for the next dose, skip the missed 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 following side effects may happen with this medicine:
Conditions you need to look out for
Allergic reactions (may affect up to 1 in 1,000 people)
If you have an allergic reaction, stop taking Aciclovir 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
Severe skin reactions: These are very rare (these may affect up to 1 in 10,000 people) taking Aciclovir Tablets. Signs include:
widespread red or scaly rash with blisters (that may contain pus), bumps under the skin or peeling of skin. Flu-like symptoms with a rash, fever, swollen glands, and abnormal blood test results.
Contact a doctor immediately if you get these symptoms.
Stop taking Aciclovir Tablets.
Other side effects include:
Common (may affect up to 1 in 10 people)
feeling or being sick
diarrhoea
stomach pains
rash
headache
feeling dizzy
feeling tired
itching
skin reaction after exposure to light (photosensitivity) 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)
severe skin reactions, such as widespread red or scaly rash with blisters (that may contain pus), bumps under the skin or peeling of skin. Flu-like symptoms with a rash, fever, swollen glands, and abnormal blood test results. (see ‘Conditions you need to look out for’).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Aciclovir Tablets
Keep this medicine out of the sight and reach of children
Do not store above 25°C
Do not use after the expiry date (month, year) stated on the label and carton
If it is out of date or you no longer want it, take it back to the pharmacy
Do not use Aciclovir Tablets if you notice anything wrong with the medicine. Talk to your pharmacist.
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 to protect the environment.
6. Contents of the pack and other information
What Aciclovir Tablets contain
The tablets come in three strengths, 200mg, 400mg and 800mg.
The active ingredient is aciclovir
The other ingredients are gelatin, lactose, maize starch, microcrystalline cellulose, sodium starch glycollate and magnesium stearate.
What Aciclovir Tablets look like and contents of the pack
Aciclovir 200mg Tablets are white, circular tablets marked ACV 200 on one face and CP on the reverse.
Aciclovir 400mg Tablets are white, oval tablets marked with ACV 400 and a breakline on one face and CP on the reverse.
Aciclovir 800mg Tablets are white, oval tablets marked with ACV 800 and a breakline on one face and CP on the reverse.
Aciclovir 200mg Tablets are available in blister packs of 25 and 100 tablets.
Aciclovir 400mg Tablets are available in blister packs of 25, 30, 56, 60, 70 and 100 tablets.
Aciclovir 800mg Tablets are available in blister packs of 35 tablets.
Not all pack sizes may be marketed.
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following information:
Product name Reference number
Aciclovir 200mg Tablets 29831/0002
Aciclovir 400mg Tablets 29831/0001
Aciclovir 800mg Tablets 29831/0003
This is a service provided by the Royal National Institute of Blind People.
Marketing Authorisation Holder:
Wockhardt UK Ltd Ash Road North Wrexham LL13 9UF UK
Manufacturer:
CP Pharmaceuticals Ltd Ash Road North Wrexham LL13 9UF UK