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Active substance(s): ACICLOVIR

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Information for the user

P How to use this medicine
Wash your hands before and after using the cream.

Uncommon (less than 1 in 100,
but more than 1 in 1,000 people treated) Burning, stinging, mild drying or flaking of the skin Itching

Adults and children

How much to use
A thin layer on the affected area making sure the whole cold sore is covered

Rare (less than 1 in 1,000, but more
than 1 in 10,000 people treated) Sudden outbreak of red spots, bumps, and lesions on the skin

Read all of this leaflet carefully because it contains important information for you. This medicine is available without prescription to treat minor conditions. However, you still need to use it carefully to get the best results from it. Keep this leaflet, you may need to read it again Ask your pharmacist if you need more information or advice

Very rare (less than 1 in 10,000
people treated) Raised, red, itchy skin (symptoms of urticaria, which is often known as hives or nettle rash)

How often to use it
Every 4 hours, 5 times a day, for 5 days If after 5 days the cold sore has not healed you can continue to apply the cream for a further 5 days if necessary. For use on the skin only. Apply only to the lips and face. Do not apply the cream to the inside of the mouth, the eyes or inside the vagina as it might cause irritation. Do not use more than the amount recommended above. If your cold sore has not healed after 10 days stop using the cream and talk to your doctor. If your symptoms worsen at any time stop using the cream and talk to your doctor.

Other potential side effects include:
Redness, tense skin Painful sensation of the skin where the cream has been applied

What this medicine is for
This medicine contains Aciclovir which belongs to a group of medicines called antivirals, which act to treat infections caused by viruses. It can be used to treat cold sores of the lips and face.

Other important information
Cold sores are infectious and you should try not to pass the infection on to other people. Taking the following precautions may help to reduce the risk of passing the infection: Do not touch the cold sore with your hands or towel, if possible Wash your hands immediately if you do touch the cold sore Do not share your towels with other people Do not share eating or drinking utensils with other people Try not to kiss other people, especially children, until your cold sore has healed

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

How to store this medicine
Do not store above 30C. Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard. Use by the date on the end flap of the carton. Throw away any medicine left 4 weeks after you first open the cream.

Before you use this medicine
This medicine can be used by adults and children. However, some people should not use this medicine or should seek the advice of their pharmacist or doctor first.

X Do not use: If you are allergic to aciclovir,
propylene glycol, any of the other ingredients of this medicine or if you are allergic to valaclovir.

What is in this medicine
Each gram of cream contains Aciclovir 50 mg, which is the active ingredient. As well as the active ingredient, the cream also contains propylene glycol, liquid paraffin, white soft paraffin, cetyl alcohol, dimeticone, arlatone 983S, purified water. The pack contains 2 g of cream.

To treat herpes infections
(which may appear as ulcers or blisters) on your eye or in the genital area

Information about some of the ingredients in this medicine:
Propylene glycol may cause skin irritation and cetyl alcohol could cause skin reactions (e.g. contact dermatitis).

! If anyone accidentally swallows
some of the medicine:
Talk to a pharmacist or doctor.

Possible side effects
Like all medicines, Aciclovir can cause side effects, although not everybody gets them.

! Talk to your pharmacist or doctor:
If you suffer from problems with your immune system which may make you more prone to infections (this problem may be caused by an illness, some medicines or radiotherapy) If your cold sore is severe If you are in any doubt whether the sore is a cold sore If you are pregnant, planning to become pregnant or breast-feeding

If you take other medicines
This medicine is not expected to affect any other medicines that you may be using. If you are unsure about interactions with any medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.

Stop using the cream and tell your doctor immediately or go to the casualty department at your nearest hospital if the following happens: an allergic reaction causing swelling of the lips, face or neck leading to severe difficulty in breathing, or severe skin rash or hives. This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.

Who makes this medicine
Manufactured by Merckle GmbH, Ludwig-Merckle-Str. 3, D-89143 Blaubeuren, Germany. Marketing Authorisation held by ratiopharm GmBH Graf-Arco-Str 3 d-89079 Ulm Germany. Leaflet prepared: July 2011.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.