Aciclovir 250 mg powder for solution for infusion – patient leaflet, side effects, dosage

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.

Package leaflet: Information for the user Aciclovir 250mg Powder for Solution for Infusion

Qualitative and Quantitative Composition

Each vial contains 250mg of aciclovir as the sodium salt

Pharmaceutical Form

Powder for solution for infusion.

White powder.

Therapeutic indications

Aciclovir for infusion is indicated for the treatment of Herpes simplex infections in immunocompromised patients and severe initial genital herpes in the non-immunocompromised.

Aciclovir for infusion is indicated for the prophylaxis of Herpes simplex infections in immunocompromised patients.

Aciclovir for infusion is indicated for the treatment of Varicella zoster infections.

Aciclovir for infusion is indicated for the treatment of herpes encephalitis.

Aciclovir for infusion is indicated for the treatment of Herpes simplex infections in the neonate and infant up to three months of age.

Posology and method of administration

Route of administration: Slow intravenous infusion over 1 hour.

A course of treatment with aciclovir for infusion usually lasts 5 days, but this may be adjusted according to the patient’s condition and response to therapy. Treatment for herpes encephalitis usually lasts 10 days. Treatment for neonatal herpes usually lasts 14 days for mucocutaneous (skin-eye-mouth) infections and 21 days for disseminated or central nervous system disease.

The duration of prophylactic administration of aciclovir for infusion is determined by the duration of the period at risk.

Dosage in adults:

Patients with Herpes simplex (except herpes encephalitis) or Varicella zoster infections should be given aciclovir for infusion in doses of 5mg/kg bodyweight every 8 hours provided renal function is not impaired (see Dosage in renal impairment).

Immunocompromised patients with Varicella zoster infections or patients with herpes encephalitis should be given aciclovir for infusion in doses of 10mg/kg bodyweight every 8 hours provided renal function is not impaired (see Dosage in renal impairment).

In obese patients who receive aciclovir intravenously based on their actual body weight, increased plasma concentrations may be obtained (see SPC section 5.2 Pharmacokinetic properties). A dose reduction should be therefore considered in obese patients, especially in patients with renal impairment or in elderly patients.

Dosage in children:

The dose of aciclovir for infusion for children aged between 3 months and 12 years is calculated on the basis of body surface area.

Children 3 months of age or older with Herpes simplex (except herpes encephalitis) or Varicella zoster infections should be given aciclovir for infusion in doses of 250 mg per square metre of body surface area every 8 hours if renal function is not impaired.

In immunocompromised children with Varicella zoster infections or children with herpes encephalitis, aciclovir for infusion should be given in doses of 500 mg per square metre body surface area every 8 hours if renal function is not impaired.

The dosage of aciclovir for infusion in neonates and infants up to 3 months of age is calculated on the basis of bodyweight.

The recommended regimen for infants treated for known or suspected neonatal herpes is aciclovir 20 mg/kg body weight IV every 8 hours for 21 days for disseminated and CNS disease, or for 14 days for disease limited to the skin and mucous membranes.

Infants and children with impaired renal function require an appropriately modified dose, according to the degree of impairment (see Dosage in renal impairment).

Dosage in the elderly:

The possibility of renal impairment in the elderly must be considered and dosage should be adjusted accordingly (see Dosage in renal impairment below). Adequate hydration should be maintained.

Dosage in renal impairment:

Caution is advised when administering aciclovir for infusion to patients with impaired renal function. Adequate hydration should be maintained.

Dosage adjustment for patients with renal impairment is based on creatinine clearance, in units of ml/min for adults and adolescents and in units of ml/min/1.73m² for infants and children less than 12 years of age. The following adjustments in dosage are suggested:

Dosage adjustments in adults and adolescents with renal impairment for treatment of Herpes Simplex or Varicella Zoster virus infections:

Creatinine Clearance Dosage for Herpes simplex infection

or Varicella zoster

Dosage for Herpes encephalitis or immune- compromised patients with Varicella zoster 25 to 50 ml/min 5 mg/kg body weight given every

12 hours.

10 mg/kg body weight given every 12 hours.

10 to 25 ml/min 5 mg/kg body weight given every

24 hours.

10 mg/kg body weight given every 24 hours.

0 (anuric) to

10 ml/min

2.5 mg/kg body weight given every 24 hours.

5 mg/kg body weight given every 24 hours.

Patients on

haemodialysis

2.5 mg/kg body weight given every 24 hours after dialysis.

5 mg/kg body weight given every 24 hours after dialysis.

Dosage adjustments in neonates, infants and children with renal impairment for treatment of Herpes Simplex or Varicella Zoster virus infections:

Creatinine Clearance

(mL/min/1.73 m²)

Dosage for Herpes simplex infection or Varicella zoster

Dosage for Herpes encephalitis or immune-compromised patients with Varicella zoster 25 to 50 ml/min 250 mg/m² body surface area given

every 12 hours.

500 mg/m² body surface area given every 12 hours.

10 to 25 ml/min 125 mg/m² body surface area given

every 12 hours.

250 mg/m² body surface area given every 12 hours.

0 (anuric) to

10 ml/min

62.5 mg/m² body surface area given every 12 hours.

125 mg/m² body surface area given every 12 hours.

Patients on

haemodialysis

62.5 mg/m² body surface area given every 12 hours after dialysis.

125 mg/m² body surface area given every 12 hours after dialysis.

Contraindications

Hypersensitivity to aciclovir and valaciclovir, or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

Severe cutaneous adverse reactions:

Cases of severe cutaneous adverse reactions (SCARs), including toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS) and erythema multiforme (EM) have been reported in patients treated with aciclovir. As SCARs can be life-threatening or fatal, if signs and symptoms suggestive of SCARs appear, treatment with aciclovir must be discontinued immediately, and alternative treatment should be given. Patients who have developed SCARs with the use of aciclovir or valaciclovir must not receive aciclovir (see Contraindications and Adverse Reactions).

Use in patients with renal impairment and in elderly patients:

Adequate hydration should be maintained in patients given i.v. or high oral doses of aciclovir. Intravenous doses should be given by infusion over one hour to avoid precipitation of aciclovir in the kidney; rapid or bolus injection should be avoided. The risk of renal impairment is increased by use with other nephrotoxic drugs. Care is required if administering i.v. aciclovir with other nephrotoxic drugs. Aciclovir is eliminated by renal clearance, therefore the dose must be adjusted in patients with renal impairment (see SPC section 4.2 Posology and method of administration). Elderly patients are likely to have reduced renal function and therefore the need for dose adjustment must be considered in this group of patients. Both elderly patients and patients with renal impairment are at increased risk of developing Aciclovir 250mg Powder for Solution for Infusion

The following information is intended for healthcare professionals only:

DOSAGE AND ADMINISTRATION INFORMATION ONLY

Please refer to the Summary of Product Characteristics (SPC) for complete prescribing information 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

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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 02/2026

neurological side effects and should be closely monitored for evidence of these effects. In the reported cases, these reactions were generally reversible on discontinuation of treatment (see SPC section 4.8 Undesirable effects). Prolonged or repeated courses of aciclovir in severely immune-compromised individuals may result in the selection of virus strains with reduced sensitivity, which may not respond to continued aciclovir treatment (see SPC section 5.1).

In patients receiving aciclovir for infusion at higher doses (e.g. for herpes encephalitis), specific care regarding renal function should be taken, particularly when patients are dehydrated or have any renal impairment.

Reconstituted aciclovir for infusion has a pH of approximately 11 and should not be administered by mouth. Product contains sodium (26mg, approx. 1,13mmol). To be taken into consideration by patients on a controlled sodium diet.

Aciclovir for infusion contains no antimicrobial preservative. Reconstitution and dilution should therefore be carried out under full aseptic conditions immediately before use and any unused solution discarded. The reconstituted or diluted solutions should not be refrigerated.

This vial contains approximately 26mg of sodium in total. The sodium content should be taken into consideration when prescribing to patients requiring sodium restriction.

Interaction with other medicinal products and other forms of interaction

Aciclovir is eliminated primarily unchanged in the urine via active renal tubular secretion. Any drugs administered concurrently that compete with this mechanism may increase aciclovir plasma concentrations. Probenecid and cimetidine increase the AUC of aciclovir by this mechanism, and reduce aciclovir renal clearance. However no dosage adjustment is necessary because of the wide therapeutic index of aciclovir.

In patients receiving intravenous aciclovir, caution is required during concurrent administration with drugs which compete with aciclovir for elimination, because of the potential for increased plasma levels of one or both drugs or their metabolites. Increases in plasma AUCs of aciclovir and of the inactive metabolite of mycophenolate mofetil, an immunosuppressant agent used in transplant patients, have been shown when the drugs are co-administered.

If lithium is administered concurrently with high dose aciclovir IV, the lithium serum concentration should be closely monitored because of the risk of lithium toxicity.

Care is also required (with monitoring for changes in renal function) if administering intravenous aciclovir with drugs which affect other aspects of renal physiology (e.g. ciclosporin, tacrolimus). An experimental study on five male subjects indicates that concomitant therapy with aciclovir increases AUC of totally administered theophylline with approximately 50%. It is recommended to measure plasma concentrations during concomitant therapy with aciclovir.

Overdose

Overdosage of intravenous aciclovir has resulted in elevations of serum creatinine, blood urea nitrogen and subsequent renal failure. Neurological effects including confusion, hallucinations, agitation, seizures and coma have been described in association with overdosage.

Patients should be observed closely for signs of toxicity. Haemodialysis significantly enhances the removal of aciclovir from the blood and may, therefore, be considered a management option in the event of symptomatic overdose.

List of excipients

Sodium hydroxide

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

Nature and contents of container

Packs* of one, five or ten Type II colourless glass 10ml vials stoppered with a chlorobutyl stopper and an aluminium and polypropylene flip-off cap.

*Not all pack sizes may be marketed

Special precautions for disposal and other handling

Reconstitution:

Aciclovir 250mg for infusion should be reconstituted using 10ml of either Water for Injections PhEur or Sodium Chloride Intravenous Infusion BP (0.9% w/v) to provide a solution containing 25mg aciclovir per ml. From the calculated dose, determine the appropriate number and strength of vials to be used. To reconstitute each vial add the recommended volume of infusion fluid and shake gently until the contents of the vial have dissolved completely.

The reconstituted solution appears light yellow and slightly opalescent.

After reconstitution aciclovir powder for solution for infusion may be administered by a controlled-rate infusion pump.

Alternatively, the reconstituted solution may be further diluted to give an aciclovir concentration of not greater than 5 mg/ml (0.5% w/v) for administration by infusion:

For further dilution, add the required volume of reconstituted solution to the chosen infusion solution, as recommended below, and shake well to ensure adequate mixing occurs.

For children and neonates, where it is advisable to keep the volume of infusion fluid to a minimum, it is recommended that dilution is on the basis of 4ml reconstituted solution (100mg aciclovir) added to 20 ml of infusion fluid.

For adults, it is recommended that infusion bags containing 100ml of infusion fluid are used, even when this would give an aciclovir concentration substantially below 0.5% w/v. Thus, one 100 ml infusion bag may be used for any dose between 250mg and 500mg aciclovir (10 and 20 ml of reconstituted solution) but a second bag must be used for doses between 500 and 1000mg.

When diluted in accordance with the recommended schedules, aciclovir for infusion is known to be compatible with the following infusion fluids:

• sodium chloride intravenous infusion BP (0.45% and 0.9% w/v);
• sodium chloride (0.18% w/v) and glucose (4% w/v) intravenous infusion BP
• sodium chloride (0.45% w/v) and glucose (2.5% w/v) intravenous infusion BP
• compound sodium lactate intravenous infusion BP (Hartmann’s Solution).

Aciclovir for infusion, when diluted in accordance with the above schedule will give an aciclovir concentration not greater than 0.5% w/v.

Since no antimicrobial preservative is included, reconstitution and dilution must be carried out under full aseptic conditions, immediately before use, and any unused solution discarded. Should any visible turbidity or crystallisation appear in the solution before or during infusion, the preparation should be discarded.

Marketing Authorisation Holder

Wockhardt UK Limited

Ash Road North

Wrexham LL13 9UF

United Kingdom

Marketing Authorisation Number

PL 29831/0320

Information for the Healthcare Professional Leaflet date