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PACKAGE LEAFLET: INFORMATION FOR THE USER

Fenistir^old ^^ore ^^ream Penciclovir

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

This medicine is available without a prescription. However, you still need to use Fenistil Cold Sore Cream 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.

-    You must contact a doctor if your symptoms worsen or do not improve after 4 days.

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

In this leaflet:

1.    What Fenistil Cold Sore Cream is and what it is used for

2.    Before you use Fenistil Cold Sore Cream

3.    How to use Fenistil Cold Sore Cream

4.    Possible side effects

5.    How to store Fenistil Cold Sore Cream

6.    Further information

1.    WHAT FENISTIL COLD SORE CREAM IS AND WHAT IT IS USED FOR

The active ingredient in this medicine is Penciclovir, an antiviral which is used to treat infections caused by viruses. Fenistil Cold Sore Cream can be used to treat cold sores on the lips and around the mouth.

2.    BEFORE YOU USE FENISTIL COLD SORE CREAM

Contact your doctor before using the cream if you are in any doubt that you have a cold sore. Do not use the cream inside your mouth, in or near your eyes, nose or on your genital area. Avoid applying the cream near your eyes.

Do not use and seek further advice from a pharmacist or doctor if:

•    you have an allergy (hypersensitivity) to any of the ingredients of Fenistil Cold Sore Cream (see Section 6),

•    you have a condition, or are receiving treatment, which weakens your immune system (i.e. the way your body fights infection) - for example, HIV infection, a bone marrow transplant, cancer treatment.

•    you need to treat ulcers or blisters which appear around your eyes or genital area. Contact your doctor if your cold sore gets worse or is severe.

Pregnancy and breast-feeding

If you are pregnant, planning to become pregnant or breast-feeding, talk to your doctor or pharmacist before using the cream.

Take special care:

To prevent transferring the infection or making it worse do not touch your cold sore (See also Section 6, Further Information, Precautions to be taken when you have a cold sore). Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those obtained without a prescription. This medicine is not known to affect any other medicines that you may be taking.

Other important information The cream contains:

•    cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis)

•    propylene glycol which may cause skin irritation.

3.    HOW TO USE FENISTIL COLD SORE CREAM

Start treatment at the earliest sign of a cold sore (symptoms such as, tingling, redness and itching).

Adults and children over 12 years: Apply the cream in a thin layer over the cold sore.

Apply the cream every 2 hours during the day, for 4 days. Always wash your hands before and after applying the cream.

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Fenistir^{ColdSoreCream} Penciclovir

If the cold sore gets worse or does not improve after 4 days, talk to your pharmacist or doctor. Use to treat cold sores on the lips and face only. Do not apply this medicine to the inside of your mouth, around the eyes or the genital area.

If you forget to use Fenistil Cold Sore Cream

Apply the next application as soon as you remember and carry on as before. Do not apply more cream to make up for a forgotten dose.

If you accidentally swallow this medicine, talk to a doctor or pharmacist straight away.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Fenistil Cold Sore Cream can cause side effects, although not everybody gets them.

You may experience initial itching, burning, stinging or numbness where the cream has been applied.

Very rarely, some people may experience an allergic reaction to the cream. Symptoms of this include a rash, raised and itchy bumps or swelling of the area where the cream has been applied. If this happens stop using the cream and seek medical advice.

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

You can report any side effects you get to the Medicines and Healthcare products Regulatory Agency (MHRA), through the Yellow Card Scheme; you can make a report by filling in a Yellow Card (available from pharmacies), by phoning freephone 0808 100 3352, or on the web at www.mhra.gov.uk/yellowcard

5.    HOW TO STORE FENISTIL COLD SORE CREAM

Keep out of the reach and sight of children.

Do not store above 30°C. Store in the original pack. Do not freeze.

Do not use Fenistil Cold Sore Cream after the ‘Use By' date which is stated on the tube and carton. The ‘Use By' 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 Fenistil Cold Sore Cream contains

The active ingredient is penciclovir 1% w/w.

The other ingredients are: white soft paraffin, liquid paraffin, cetostearyl alcohol, propylene glycol, cetomacrogol 1000, purified water. (See also Section 2 “Important Information about some of the ingredients of Fenistil Cold Sore Cream”).

What Fenistil Cold Sore Cream looks like and contents of the pack Fenistil Cold Sore Cream is a smooth white cream.

Fenistil Cold Sore Cream is available in 2 g aluminium tubes.

Marketing Authorisation Holder and Manufacturer

Novartis Consumer Health UK Limited, Camberley, Surrey, GU15 3YL, UK.

For any information about this medicinal product, please contact the Marketing Authorisation Holder.

Precautions to be taken when you have a cold sore

Remember cold sores are infectious

To prevent the virus infecting other parts of the body, or passing the virus to other people, it is important to:

•    Avoid kissing, especially children

•    Only use your own towel or face cloth

•    Do not share cups, glasses, cutlery etc

•    Avoid breaking the blisters or picking sores, as this may prolong the healing process

•    Avoid touching your eyes, as the virus can cause a serious condition in the eyes

•    Do not give open cream to other people even if their symptoms are the same as yours. Leaflet approved: June 2014.

GB 926082 - 2158148    lb NOVARTIS

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