Aciclovir 250mg Powder for Solution for Infusion

• 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).

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

• if you are allergic to aciclovir, valaciclovir or to any of the other ingredients of this medicine (listed in section 6).

Talk to your doctor or pharmacist or nurse before using Aciclovir for Infusion if you:

• have kidney problems as the dose may need to be modified according to how your kidneys are working.
• have a low resistance to disease (are immune compromised)
• are elderly
• are dehydrated (extremely thirsty)
• are on a low sodium diet (see ‘Important information for patients on a controlled sodium diet’ section below).

Taking another medicine while you are being given aciclovir for infusion can affect how it or the other medicine works.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, even those you may have bought yourself without a prescription.

Please check with your doctor if you are taking any of the following or any other medication:

• Probenecid, a drug used to prevent gout (arthritis in the joints).
• Cimetidine, an anti-stomach ulcer drug.
• Drugs used in transplant patients (i.e. mycophenolate mofetil, ciclosporin and tacrolimus).

It is not certain if the use of Aciclovir during pregnancy causes birth defects. You should let your doctor know if you think you may be pregnant or are trying for a baby.

Aciclovir can get into human breast milk. You should let your doctor know if you are breast-feeding or want to start breast-feeding while you are having treatment with aciclovir for infusion.

Aciclovir for Infusion can cause confusion, hallucinations (seeing or hearing things that are not there), agitation, tremor and drowsiness which may affect your ability to drive or use machines. If you are affected, do not drive or operate machinery.

Each vial contains 26mg of sodium. You should tell your doctor or pharmacist if you are on a controlled sodium diet.

• The recommended adult dose of Aciclovir for Infusion is 5mg per kg bodyweight every eight hours for five days.
• This dose is doubled to 10mg per kg every eight hours for:
  • patients with low resistance to disease who have chicken pox or shingles
  • patients with herpes inflammation of the brain (these patients may need ten days treatment).

For the treatment of herpes infections in newborn and babies up to 3 months old

• In the newborn and babies up to three months old, the dose is 20mg per kg of bodyweight every eight hours, usually for 14 days for skin, eye and mouth infections, or 21 days if the disease is widely spread or has affected the central nervous system.

For the treatment of chickenpox or herpes infections in children aged 3 months to 12 years

• For children aged 3 months to 12 years, the dose is 250mg per m² of body surface area, every eight hours, usually for five days.
• This can be doubled to 500mg per m² of body surface area every eight hours for:
  • children with low resistance to disease who have chickenpox
  • children with herpes inflammation of the brain

Your dosage may need to be reduced if you have kidney problems, are obese or are elderly.

Your doctor will decide the dose which is best for you. If you do not understand, or are in any doubt, ask your doctor or nurse.

A doctor or a nurse will usually give you this medicine. If you are given too much Aciclovir for Infusion you may feel confused or agitated, or suffer from hallucinations (imagining things) or seizures. Too much Aciclovir for Infusion can also cause changes in blood chemicals, kidney failure and loss of consciousness. If you have been given too much medicine, you may be put on a kidney machine to reduce the amount of Aciclovir for Infusion in your blood.

If you think you may have received too much aciclovir for infusion, please tell your doctor or nurse at once.

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.

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

• severe allergy, breathing problems or swelling of the face

Uncommon: may affect up to 1 in 100 people

• a fall in the number of blood cells may cause unexplained bleeding or bruising, sore throats, mouth ulcers, or a low resistance to infections.

Other side effects include:

Common: may affect up to 1 in 10 people

• nausea and vomiting
• allergic reactions such as rashes, sensitivity to light and itching
• swelling, redness and tenderness at the site of injection.

Uncommon: may affect up to 1 in 100 people

• anaemia

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

• headache or feeling dizzy
• diarrhoea or stomach pains
• feeling tired
• fever
• drowsiness, confusion, hallucinations (imagining things), feeling agitated, difficulty in controlling movements, difficulty in speaking, personality changes and inability to concentrate, shaking, fits and loss of consciousness, particularly in patients with other medical problems
• severe local inflammation leading to a breakdown of the skin at the site of injection if aciclovir leaks out of the vein
• liver and kidney problems. These may cause increases in the levels of various chemicals in the blood and yellowing of the skin
• pain in your lower back, the kidney area of your back or just above your hip (renal pain).

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.

Each vial contains 250mg of the active ingredient, aciclovir (as the sodium salt), as a powder.

The other ingredient is sodium hydroxide.

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:

Manufacturer: