Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Aciclovir may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for Zovirax Cream (called 'Zovirax' in this leaflet) contains a medicine called aciclovir. This belongs to a group of medicines called antivirals. It is used to treat cold sores and genital infections caused by the Herpes simplex virus. It works by killing or stopping the growth of viruses that cause cold sores or genital herpes.
e Zovirax Do not use Zovirax if:
Propylene glycol may cause skin irritation. Do not use this medicine in babies less than 4 weeks old with open wounds or large areas of broken or damaged skin (such as burns) without talking to your doctor or pharmacist. Sodium laurilsulfate; this medicine contains 7.5 mg of sodium laurilsulfate per gram of product. Sodium laurilsulfate may cause local skin reactions (such as stinging or burning sensation) or increase skin reactions caused by other products when applied on the same area.
Zovirax Always use Zovirax exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Applying the cream
4 Possible side effects Like all medicines, Zovirax can cause side effects, although not everybody gets them. The following
may happen with this medicine: Allergic reactions (affects less than 1 in 10,000 people) If you have an allergic reaction, stop taking Zovirax and see a doctor straight away. The signs may include:
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. 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.
Zovirax • • • • • •
6
Keep this medicine out of the sight and reach of children. Store below 25°C. Do not store in a refrigerator. Do not use Zovirax if more than one month has passed since you first opened the tube. Do not use Zovirax after the expiry date which is stated on the carton and tube. The expiry date (Exp.) refers to the last day of that month. 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.
What Zovirax Cream contains
0800 198 5000 (UK Only). Please be ready to give the following information: Product name Reference number
Zovirax Cream 00003/0180
This is a service provided by the Royal National Institute of Blind People. Leaflet date: January 2025 Zovirax is a registered trademark of the GlaxoSmithKline group of companies. 2025 GlaxoSmithKline group of companies. All rights reserved. (GlaxoSmithKline logo)
Zovirax Cream comes as cream. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Zovirax Cream is aciclovir.
Medicines with the same active substance, strength and form include: Boots Antiviral Cold Sore 5% w/w Cream, Pinewood Cold Sore Cream, Virasorb Cold Sore Cream. In total there are 4 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Zovirax Cream, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Zovirax Cream is indicated for the treatment of Herpes Simplex virus infections of the skin including initial and recurrent genital herpes and herpes labialis.
Route of administration: topical.
Do not use in eyes.
Adults and Children: Zovirax Cream should be applied five times daily at approximately four hourly intervals, omitting the night time application.
Zovirax Cream should be applied to the lesions or impending lesions as soon as possible, preferably during the early stages (prodrome or erythema). Treatment can also be started during the later (papule or blister) stages.
Treatment should be continued for at least 4 days for herpes labialis and for 5 days for genital herpes. If healing has not occurred then treatment may be continued for up to an additional 5 days.
Use in the elderly: No special comment
Zovirax Cream is contraindicated in patients known to be hypersensitive to aciclovir, valaciclovir, propylene glycol or any of the excipients of Zovirax Cream listed in section 6.1.
Zovirax Cream is not recommended for application to mucous membranes such as in the mouth, eye or vagina, as it may be irritant.
Particular care should be taken to avoid accidental introduction into the eye.
In severely immunocompromised patients (eg AIDS patients or bone marrow transplant recipients) oral Zovirax dosing should be considered. Such patients should be encouraged to consult a physician concerning the treatment of any infection.
Zovirax Cream contains a specially formulated base and should not be diluted or used as a base for the incorporation of other medicaments.
Excipients
The excipient cetostearyl alcohol can cause local skin reactions (e.g. contact dermatitis).
This medicine contains 400 mg of propylene glycol per gram of product. Propylene glycol may cause skin irritation.
Do not use this medicine in neonates with open wounds or large areas of broken or damaged skin (such as burns).
This medicine contains 7.5 mg of sodium laurilsulfate per gram of product. Sodium laurilsulfate may cause local skin reactions (such as stinging or burning sensation) or increase skin reactions caused by other products when applied on the same area.
No clinically significant interactions have been identified.
Pregnancy:
A post-marketing aciclovir pregnancy registry has documented pregnancy outcomes in women exposed to any formulation of Zovirax. The registry findings have not shown an increase in the number of birth defects amongst aciclovir exposed subjects compared with the general population, and any birth defects showed no uniqueness or consistent pattern to suggest a common cause. Systemic administration of aciclovir in internationally accepted standard tests did not produce embryotoxic or teratogenic effects in rabbits, rats or mice.
In a non-standard test in rats, foetal abnormalities were observed but only following such high subcutaneous doses that maternal toxicity was produced. The clinical relevance of these findings is uncertain.
The use of Zovirax Cream should be considered only when the potential benefits outweigh the possibility of unknown risks however the systemic exposure to aciclovir from topical application of Zovirax Cream is very low.
Teratogenicity:
Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure to indicate little relevance to clinical use (see section 5.3)
Breast-feeding:
Limited human data show that the drug does pass into breast milk following systemic administration. However, the dosage received by a nursing infant following maternal use of Zovirax Cream would be insignificant.
Fertility:
There is no information on the effect of aciclovir on human female fertility.
In a study of 20 male patients with normal sperm count, oral aciclovir administered at doses of up to 1g per day for up to six months has been shown to have no clinically significant effect on sperm count, motility or morphology.
See Clinical Studies in section 5.2
Not applicable
The following convention has been used for the classification of undesirable effects in terms of frequency: very common ≥1/10, common ≥1/100 and <1/10, uncommon ≥1/1000 and <1/100, rare ≥1/10,000 and <1/1000, very rare <1/10,000.
Immune system disorders:
Very rare
• Immediate hypersensitivity reactions including angioedema and urticaria.
Skin and subcutaneous tissue disorders:
Uncommon
• Transient burning or stinging following application of Zovirax Cream
• Mild drying or flaking of the skin
• Itching
Rare
• Erythema
• Contact dermatitis following application. Where sensitivity tests have been conducted, the reactive substances have most often been shown to be components of the cream rather than aciclovir.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions 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.
No untoward effects would be expected if the entire contents of a 10 gram tube of Zovirax Cream containing 500 mg of aciclovir were ingested orally. However the accidental, repeated overdose of oral aciclovir, over several days has resulted in gastrointestinal effects (nausea and vomiting) and neurological effects (headache and confusion). Aciclovir is dialysable by haemodialysis.
Ask anything about Zovirax Cream. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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