Ref: 0306/140214/1/F

Zovirax® Cream 2g / Aciclovir 5% Cream 2g Zovirax® Cream 10g / Aciclovir 5% Cream 10g

(aciclovir)

Patient Information Leaflet

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 any further questions, ask your doctor 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. This includes any possible side effects not listed in this leaflet, see section 4.

Your medicine is called Zovirax Cream 2g/Aciclovir 5% Cream 2g/Zovirax Cream 10g/Aciclovir 5% Cream 10g but will be referred to as Zovirax throughout the leaflet.

In this leaflet:

^ What Zovirax is and what it is used for 3 What you need to know before you use Zovirax

How to use Zovirax ^ Possible side effects [5 How to store Zovirax ^ Contents of the pack and other information

• you have a condition where your immune system works less well and your body is less able to fight infections (e.g. if you have HIV or AIDS or if you have had a bone marrow transplant).

If you are not sure, talk to your doctor or pharmacist before using Zovirax.

Zovirax Cream is not for use in the mouth, eyes or the vagina. Zovirax Cream may cause skin irritation.

If you are not sure, talk to your doctor or pharmacist before using Zovirax.

Other medicines and Zovirax

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without prescription, including herbal medicines.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before using any medicine.

What Zovirax is and what it is used 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.

^2) What you need to know before you use Zovirax

Do not use Zovirax if:

• you are allergic (hypersensitive) to aciclovir, valaciclovir, propylene glycol or any of the other ingredients (listed in Section 6).

If you are not sure, talk to your doctor or pharmacist before using Zovirax.

Warnings and precautions

Talk to your doctor or pharmacist before using Zovirax if:

How to use 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

•    Zovirax Cream is not for use in your mouth, eyes or the vagina.

•    You should not mix Zovirax with anything before you use it, not even water.

•    Always wash your hands before and after you use the cream.

Adults and children

•    Apply a thin layer of cream to the affected area five times a day.

•    You should space each application of Zovirax by four hours. Suggested times are: 7am, 11am, 3pm, 7pm and 11pm.

•    If your cold sore has not healed after 4 days, or your genital herpes sore has not healed after 5 days, you may use the cream for 5 more days.

•    If the affected area has still not healed after this, stop using the cream and tell your doctor.

If you use more Zovirax than you should

Talk to your doctor or pharmacist if you use too much Zovirax. Zovirax Cream is for use on the skin, if you swallow any talk to your doctor or pharmacist.

If you forget to use Zovirax

•    If you forget to use Zovirax, use it as soon as you remember. However, if it is nearly time for your next application, skip the missed application.

•    Do not use a double application to make up for a forgotten application.

[4 Possible side effects

Like all medicines, Zovirax can cause side effects, although not everybody gets them. The following side effects 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:

•    rash, itching or hives on your skin

•    swelling of your face, lips, tongue or other parts of your body

•    shortness of breath, wheezing or having trouble breathing

•    unexplained fever and feeling faint, especially when standing up.

Other side effects include:

Uncommon (affects less than 1 in 100 people)

•    a burning or stinging feeling after applying the cream that goes away

•    mild drying or flaking of your skin

•    itching.

Rare (affects less than 1 in 1,000 people)

•    redness of your skin

•    skin rash.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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.

By reporting side effects, you can help provide more information on the safety of this medicine.

Storing your medicine

•    KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN.

•    Do not store above 25°C.

•    Do not refrigerate.

_•    Put the lid back on the tube after each time that you have used it.

•    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

Important

This leaflet does not tell you everything about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist (chemist). He/she will have additional information about this medicine and will be able to advise you.

Contents of the pack and other Information

What Zovirax contains

Each tube contains 5% w/w of Aciclovir as the active ingredient.

Inactive ingredients: Poloxamer 407, cetostearyl alcohol, sodium lauryl sulphate, white soft paraffin, arlacel 165, dimeticone 20, propylene glycol, purified water and liquid paraffin.

What Zovrax looks like and contents of the pack

Zovirax is a topical cream in a collapsible aluminium tube in a cardboard carton.

Available in tubes of 2g and 10g.

Manufacturer and Licence Holder

Zovirax is manufactured by Glaxo Operations U.K.

Ltd, Ware, Hertfordshire, England and is

procured from within the EU and repackaged by the

Product Licence Holder: Lexon (UK) Limited, Unit

18, Oxleasow Road, East Moons Moat, Redditch,

Worcestershire. B98 0RE.

Zovirax is a registered trademark of the GlaxoSmithKline Group of Companies.

^ How to store Zovirax Expiry date

Do not use this medicine after the expiry date shown on the carton label or tube.

If your doctor tells you to stop taking this medicine, return any unused cream to your pharmacist (chemist) for safe disposal. Only keep this medicine, if your doctor tells you to.

If your cream become discoloured or show any other signs of deterioration, consult your pharmacist (chemist) who will tell you what to do.

I POM PL 15184/0306 Leaflet revision date: 14/02/14

Blind or partially sighted?

Is this leaflet hard to see or read? Phone Lexon (UK) Limited,

Tel: 01527 505414 for help.

Ref: 0306/140214/1/B