Aciclovir 250mg Powder for Solution for Infusion

Patient Leaflet Updated 02-Mar-2018 | Wockhardt UK Ltd

Aciclovir 250mg Powder for Solution for Infusion

Package leaflet: Information for the user

Aciclovir 250mg Powder for Solution for Infusion

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. These medicines work by stopping viruses from spreading in the body.

Aciclovir for Infusion is used to treat a variety of infections caused by herpes viruses:

  • herpes infections in newborn infants and babies up to 3 months of age
  • herpes infections in patients with a low resistance to disease
  • inflammation of the brain caused by herpes virus
  • severe infections of the genitals caused by herpes virus
  • chickenpox and shingles

Aciclovir for Infusion is also used to prevent herpes infections in people who have a low resistance to disease.

2. What you need to know before you use Aciclovir for Infusion
Do not take aciclovir for infusion:
  • if you are allergic to aciclovir, valaciclovir or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

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).

Other medicines and Aciclovir for Infusion

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).

Pregnancy and breast-feeding

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.

Driving and using machines

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.

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

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Do not take by mouth.

Your doctor or nurse will prepare your injection by diluting it with water or salt solution, either in the vial or in another container. The mixture is given by a slow injection into a vein (called an infusion) over an hour using a syringe-pump or with a drip.

It is important to drink plenty of water after you have been given aciclovir infusion.

For the treatment of herpes infections, chickenpox or ‘shingles’ in adults
  • 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).

Use in children and adolescents

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.

If you use more aciclovir for infusion than you should

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.

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.

If you experience any of the following symptoms, tell your doctor or nurse immediately:

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).

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 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

This leaflet was last revised in 02/2018

103376/7

Company Contact Details
Wockhardt UK Ltd
Address

Ash Road North, Wrexham Industrial Estate, Wrexham, LL13 9UF

Fax

+44 (0)1978 661 702

Medical Information e-mail
Telephone

+44 (0)1978 661 261

WWW

www.wockhardt.co.uk