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 29831/0320.
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have further questions, please ask your doctor, nurse 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
The name of your medicine is Aciclovir 250mg Powder for Solution for Infusion. In the rest of this leaflet it is called Aciclovir for Infusion (Infusion is a slow injection).
What is in this leaflet
1. What Aciclovir for Infusion is and what it is used for 2. What you need to know before you use Aciclovir for Infusion 3. How to use Aciclovir for Infusion 4. Possible side effects 5. How to store Aciclovir for Infusion 6. Contents of the pack and other information
1. What Aciclovir for Infusion is and what it is used for
Aciclovir belongs to a group of medicines called antivirals. It works by killing or stopping the growth of viruses.
Aciclovir for Infusion can be used to:
treat chickenpox
treat severe cases of genital herpes
treat and stop cold sores and genital herpes in people whose immune systems work less well, which means their bodies are less able to fight infections
treat serious virus infections in children up to 3 months of age. This can rarely be caused by the virus responsible for cold sore infection and genital herpes.
treat inflammation of the brain. This can rarely be caused by the virus responsible for cold sore infection and genital herpes.
2. What you need to know before you use Aciclovir for Infusion
Do not take aciclovir for infusion:
if you are allergic to aciclovir or valaciclovir or to any of the other ingredients of this medicine (listed in section 6).
Do not take Aciclovir for Infusion if the above applies to you. If you are not sure, talk to your doctor or pharmacist before having Aciclovir for Infusion.
Warnings and precautions
Talk to your doctor or pharmacist or nurse before using Aciclovir for Infusion if you:
have had severe skin reactions with aciclovir or valaciclovir
have kidney problems
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 for Infusion. It is important that you drink plenty of water while taking Aciclovir for Infusion.
Conditions you need to look out for
Aciclovir for Infusion can cause severe skin reactions. You must look out for certain symptoms while you are taking Aciclovir for Infusion, to reduce the risk of any problems. If you experience any signs or symptoms of severe skin reactions, stop taking Aciclovir for Infusion and contact your doctor immediately (see ‘Possible side effects’).
Other medicines and Aciclovir for Infusion
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
tacrolimus, ciclosporin or mycophenolate mofetil, used to stop your body rejecting transplanted organs.
Pregnancy 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 for Infusion contains sodium
Each vial contains 26mg of sodium. You should tell your doctor or pharmacist if you are on a controlled sodium diet.
3. How to use Aciclovir for Infusion
How your medicine is given
You will never be expected to give yourself this medicine. It will always be given to you by a person who is trained to do so.
Before the medicine is given to you it will be diluted.
Aciclovir for Infusion will be given to you as a continuous infusion into your vein. This is where the drug is slowly given to you over a period of time.
The dose you will be given, the frequency and the duration of the dose will depend on:
the type of infection you have
your weight
your age.
Your doctor may adjust the dose of Aciclovir for Infusion if:
you have kidney problems. If you have kidney problems, it is important you receive plenty of fluids while you are being treated with Aciclovir for Infusion.
Talk to your doctor before having Aciclovir for Infusion if any of the above apply.
If you use more aciclovir for infusion than you should
If you think you have been given too much Aciclovir for Infusion, talk to your doctor or nurse straight away.
If you have been given too much Aciclovir for Infusion you may:
feel confused or agitated
have hallucinations (seeing or hearing things that aren’t there)
have fits
become unconscious (coma).
If you forget to use aciclovir for infusion
A doctor or a nurse will usually give you this medicine. If you think you have missed a dose, please tell your doctor or nurse.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse.
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 1 in 10,000 people)
If you have an allergic reaction, stop taking Aciclovir for Injection 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
unexplained fever (high temperature) and feeling faint, especially when standing up.
Severe skin reactions: These are very rare (these may affect up to 1 in 10,000 people) taking Aciclovir for Injection. Signs include:
widespread red or scaly rash with blisters (that may contain pus), bumps under the skin or peeling of the skin. Flu-like symptoms with rash, fever swollen glands, and abnormal blood test results.
Contact a doctor immediately if you get these symptoms. Stop taking Aciclovir for Injection.
Other side effects include:
Common (may affect up to 1 in 10 people)
feeling or being sick
Itchy, hive like rash
skin reactions after exposure to light (photosensitivity)
itching
swelling, redness and tenderness at the site of injection
increase in the liver enzymes.
Uncommon (may affect up to 1 in 100 people)
reduced number of red blood cells (anaemia)
reduced number of white blood cells (leukopenia)
reduced number of blood platelets (cells that help the blood to clot) (thrombocytopenia).
Very rare (may affect up to 1 in 10,000 people)
headache or feeling dizzy
diarrhoea or stomach pains
feeling tired
fever
effects on some blood urine tests
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 or scaly rash with blisters (that may contain pus), bumps under the skin or peeling of skin. Flu-like symptoms with a rash, 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, website: www.mhra.gov.uk/yellowcard or search for the 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 for Infusion
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 carton and the label on the small glass container (vial). The expiry date refers to the last day of that month.
Your doctor, nurse or pharmacist will be responsible for storing and preparing aciclovir before use and for checking that the vials have not passed their expiry date.
Do not store above 25°C. The vials should be kept in their outer carton, in order to protect from light.
Once the powder has been made into a solution the product should be used immediately. If this is not possible it would generally not be stored for more than 24 hours at 2-8°C.
Do not throw away 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 Aciclovir for Infusion contains
Each vial contains 250mg of the active ingredient, aciclovir (as the sodium salt), as a powder. The other ingredient is sodium hydroxide.
What Aciclovir for Infusion looks like and contents of the pack
The white powder comes in a glass vial with a rubber cap and metal/plastic seal. It is available in packs of 1, 5 or 10 vials. 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 250mg Powder for Solution for Infusion 29831/0320
This is a service provided by the Royal National Institute of Blind People.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Wockhardt UK Ltd Ash Road North Wrexham LL13 9UF UK
Manufacturer:
CP Pharmaceuticals Ltd Ash Road North Wrexham LL13 9UF UK