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Aciclovir 25 mg/ml Concentrate for solution for infusion

Active Ingredient:
aciclovir sodium
Company:  
Baxter Healthcare Ltd See contact details
ATC code: 
J05AB01
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About Medicine
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Prescription only medicine
Healthcare Professionals (SmPC) Patient Leaflet (PIL) HCP Med Info
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The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 03 Aug 2023
{pdf} View or print the patient leaflet as PDF

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 {phone} 0800 198 5000. The product code(s) for this leaflet is: PL 00116/0678.

{printer} Print patient leaflet as text only

Aciclovir 25 mg/ml Concentrate for solution for infusion

Package leaflet: Information for the user

Aciclovir 25 mg/ml Concentrate for solution for infusion

Aciclovir

The name of your medicine is Aciclovir 25 mg/ml Concentrate for solution for infusion, which will be referred to as Aciclovir throughout this leaflet.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist or nurse.
  • 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See Section 4.

What is in this leaflet

1. What Aciclovir is and what it is used for
2. What you need to know before you use Aciclovir
3. How to use Aciclovir
4. Possible side effects
5. How to store Aciclovir
6. Contents of the pack and other information

1. What Aciclovir is and what it is used for

Aciclovir contains a medicine called aciclovir,This belongs to a group of medicines called antivirals. It works by killing or stopping the growth of viruses.

Aciclovir can be used to:

  • treat severe cases of genital herpes
  • treat chickenpox
  • 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
Do not use Aciclovir :

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 if the above applies to you. If you are not sure, talk to your doctor or pharmacist or nurse before taking Aciclovir.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Aciclovir if:

  • you have kidney problems
  • you are over 65 years of age
  • you are suffering from dehydration

If you are not sure if the above apply to you, talk to your doctor, pharmacist or nurse before taking Aciclovir.

It is important that you drink plenty of water while taking Aciclovir

Other medicines and Aciclovir

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
  • tracrolimus, ciclosporin or 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

No studies on the effects on the ability to drive and use machines have been performed.

Aciclovir Contains Sodium

Aciclovir contains 0.116 mmol (or 2.67 mg) sodium per ml, 1.16 mmol (or 26.7 mg) sodium per 10 ml vial & 2.32 mmol (or 53.4 mg) sodium per 20 ml vial to be taken into consideration by patients on a controlled sodium diet.

3. How to use Aciclovir
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 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 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 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.

Talk to your doctor before having Aciclovir if any of the above apply.

If you are given too much Aciclovir

If you think you have been given too much Aciclovir, talk to your doctor or nurse straight away.

If you have been given too much Aciclovir you may:

  • feel confused or agitated
  • have hallucinations (seeing or hearing things that aren't there)
  • have fits
  • become unconscious (coma).

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:

Allergic reactions (may affect up to 1 in 10,000 people)

If you have an allergic reaction, stop taking Aciclovir 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.

Other side effects include:

Common (may affect up to 1 in 10 people)

  • feeling or being sick
  • itchy, hive-like rash
  • skin reaction 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 numbers of red blood cells (anaemia)
  • reduced numbers 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).

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

Ireland

HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: [email protected]

5. How to store Aciclovir

Keep this medicine out of the sight and reach of children.

Store below 25°C. Do not refrigerate.

Store in the original carton in order to protect from light.

Do not use Aciclovir after the expiry date which is stated on the label and carton after Exp. The expiry date refers to the last day of that month.

Discard unused solution.

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 protect the environment.

Chemical and physical in-use stability has been demonstrated for 12 hours at 25 °C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

Do not use Aciclovir if you notice any visible turbidity or crystallisation in the solution before or during infusion.

6. Contents of the pack and other information
What Aciclovir contains:

The active substance is Aciclovir.

Each 1 ml contains 25 mg of aciclovir as aciclovir sodium.

Each 10 ml vial contains 250 mg of aciclovir (sodium salt formed in situ)

Each 20 ml vial contains 500 mg of aciclovir (sodium salt formed in situ)

A clear, colourless solution, free from visible particles

The other ingredients are:

Water for Injections, Sodium hydroxide (for pH adjustment) and Hydrochloric acid (for pH adjustment)

For further information or if you have any questions about the use of this product, please contact on, telephone +44 (0)1270 582 255.

What Aciclovir looks like and contents of the pack

A clear, colourless solution, free from visible particles

Aciclovir comes in 10 ml and 20 ml clear glass vials.

Each pack contains 5, 10 and 20 vials of 10ml and 5, 10, 20 vials of 20ml.

Marketing Authorisation Holder

United Kingdom:

Baxter Healthcare Limited
Caxton Way
Thetford
Norfolk
IP24 3SE

Ireland:

Baxter Holding B.V.
Kobaltweg 49
3542CE Utrecht
Netherlands

Manufacturer
UAB Norameda
Meistru 8a
02189
Vilnius
Lithuania

Or

Bieffe Medital S.P.A.
Via Nuova Provinciale 23034
Grosotto (SO)
Italy

This medicinal product is authorised in the Member States of the EEA under the following names:

UK Aciclovir 25mg/ml Concentrate for solution for infusion

Estonia Aciclovir Baxter

Ireland Aciclovir 25mg/ml Concentrate for solution for infusion

Lithuania Aciclovir Baxter 25mg/ml Koncentratas Infuziniam tirpalui

Netherlands Aciclovir Baxter 25mg/ml Concentraat voor oplossing voor intraveneuze infusie

This leaflet was last revised in September 2021

1400008219

Baxter Healthcare Ltd
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Address
Caxton Way, Thetford, Norfolk, IP24 3SE, UK
Fax
+44 (0)1635 206071
Medical Information e-mail
[email protected]
Medical Information Direct Line
+44 (0)1635 206345
Medical Information Fax
+44 (0)1635 206071
WWW
http://www.baxterhealthcare.co.uk