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Read aOO of this leaflet carefully because it contains important information for you.

Cold Sore Cream Aciclovir 5%

2g Cream


This medicine is available without prescription to treat minor conditions. However, you stiOO 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

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.

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.

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.

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

! 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

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

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 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.

How to use this medicine

Wash your hands before and after using the cream.


Age

How much to us@

Adults and children

A thin layer on the affected area making sure the whole cold sore is covered

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.

! 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.

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

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

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

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

Other potential side effects include:

♦    Redness, tense skin

♦    Painful sensation of the skin where the cream has been applied

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 30°C.

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.

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 2g of cream.

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.

20140-C


Leaflet prepared August 2011