soothelip

aciclovir 5% cream

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

This medicine is available without prescription. However, you still need to use Soothelip carefully to get the best results from it.

•    Keep this leaflet. You may need to read it again.

•    Ask you pharmacist if you need more information or advice.

•    You must contact a doctor if your symptoms worsen or do not improve.

•    If you have any unusual effects after using this product, tell your doctor or pharmacist.

IN THIS LEAFLET

1.    What is Soothelip and what is it used for?

2.    Before you use Soothelip

3.    How to use Soothelip

4.    Possible side effects

5.    How to store Soothelip

6.    Further information

1.    WHAT IS SOOTHELIP AND WHAT IS IT USED FOR?

Soothelip Aciclovir 5% Cream is used in the treatment of cold cores. Once a cold sore has appeared, treatment with Soothelip Aciclovir 5% Cream can accelerate the healing process.

The active substance in Soothelip Aciclovir 5% Cream is aciclovir. Aciclovir is an antiviral agent that has been shown to be effective in treating infections caused by the herpes simplex virus, such as cold sores.

2.    BEFORE YOU USE SOOTHELIP Do not use Soothelip:

•    If you are allergic (hypersensitive) to aciclovir,

valaciclovir, propylene glycol or any of the other

ingredients of Soothelip (listed in section 6, Further Information).

•    In the eyes, inside the mouth or on the genitals.

Before using Soothelip, consult your doctor if:

•    You are unsure whether your sore is a cold sore.

•    Your cold sore infection is severe.

•    Your immune system is not working properly (for instance you have had a bone marrow transplant or you have AIDS).

•    You know you are sensitive to cetyl alcohol, propylene glycol or sorbic acid, because they may cause local skin reactions or irritation (e.g. contact dermatitis).

Taking other medicines:

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is especially important if you are taking:

•    Probenecid.

Pregnancy and breast-feeding:

As with all medicines, Soothelip should not be used during pregnancy or breastfeeding, unless you ₁ are advised to do so by your doctor.

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

3.    HOW TO USE SOOTHELIP

It is important to start treating the cold sore as soon as it begins. You may be able to tell when you are about to get a cold sore by an itching or tingling feeling in the area. You should use the cream when you first notice this itching or tingling feeling.

Follow the instructions below closely. You should ask your doctor or pharmacist if you are unsure how to use this medicine.

Adults and elderly:

•    Wash your hands before and after applying the cream. This will prevent your cold sore from getting worse or spreading, or you infecting someone else.

•    Apply the cream to the affected area 5 times daily (about every four hours) for 5 days.

•    If your cold sore has not healed after five days of treatment you can continue using the cream for another five days.

You should consult your doctor if your cold sore has not healed after 10 days or gets worse during treatment.

If you forget to use Soothelip:

If you forget to apply the cream, apply it as soon as you remember and then apply the next treatment at the usual time.

If you accidentally swallow Soothelip:

Soothelip is for use on cold sore on the lips and surrounding skin only.

You are very unlikely to suffer any bad effects if you accidentally swallow Soothelip Aciclovir 5% Cream. However, if you notice any unusual effects or are worried tell your doctor or contact the Accident and Emergency Department of your nearest hospital.

4.    POSSIBLE SIDE EFFECTS

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

Some people may experience side effects, particularly when they first start using the product. These side effects may include a burning or stinging where the cream has been applied, mild drying or flaking of the skin, redness of the skin and itching.

If you get a skin rash, swelling of the face or throat, or urticaria, you may be allergic to the cream. Stop using it and tell your doctor immediately.

If any of these side effects become troublesome or you react badly to the cream in any other way, tell your doctor or pharmacist immediately.

5.    HOW TO STORE SOOTHELIP

Keep out of the reach and sight of children.

This product should be stored in the original carton.

Do not store above 25^oC. Do not refrigerate or freeze.

Do not use Soothelip after the expiry date which is stated at one end of the carton and on the tube.

The expiry date refers to the last day of that month.

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

6. FURTHER INFORMATION

What Sootehlip contains:

*    The active substance is aciclovir (5% w/w).

*    The other ingredients are cetyl alcohol, dimethicone, heavy liquid paraffin, polyethylene glycol - 5 glyceryl stearate, propylene glycol, sorbic acid, white soft paraffin and water.

What Sootehlip looks like and content of the pack:

Soothelip is available in tubes containing 2g of a smooth white to off-white cream. The amount of cream in this tube should be enough to treat one cold sore attack.

Marketing Authorisation Holder: Bayer plc, Consumer Care Division, Newbury, Berkshire, RG14 1JA, United Kingdom.

Manufacturer: Kern Pharma S.L., Pollgono Industrial Colon II, Calle Venus 72, 08228 Terrassa, Barcelona, Spain.

Remember: if you have any doubts about using Soothelip correctly, seek the advice of your doctor or pharmacist.

How to avoid further infection:

The virus that causes a cold sore can infect other parts of the body and can easily be passed on to other people. You can help avoid further infection if you follow the advice given below:

✓ Wash your hands before and after touching cold sores.

*    Do not share your towel or allow others to touch your cold sore.

*    Avoid sharing your eating and drinking utensils.

*    Avoid kissing and oral sex.

*    Avoid touching your eyes, as the virus that causes the cold sore can lead to ulceration of the eye.

*    Avoid breaking the blister or picking the scabs.

If you are still worried or have any questions about the symptoms or the treatment of cold sores, ask your doctor or pharmacist for advice.

This leaflet was last revised in May 2011.

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