FENISTIL COLD SORE CREAM

Active substance: PENCICLOVIR

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Penciclovir

Cold Sore Cream 1% w/w

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 Savlon 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 Savlon Cold Sore Cream is and what it is used for
2. Before you use Savlon Cold Sore Cream
3. How to use Savlon Cold Sore Cream
4. Possible side effects
5. How to store Savlon Cold Sore Cream
6. Further information
1. WHAT SAVLON COLD SORE CREAM IS AND WHAT IT IS USED FOR
Savlon Cold Sore Cream is for the treatment of cold sores on the lips and face caused by the
herpes simplex virus.
Savlon Cold Sore Cream is intended for use in adults and children over 12 years of age.
The active ingredient in Savlon Cold Sore Cream is Penciclovir 1%.



2. BEFORE YOU USE SAVLON COLD SORE CREAM
Do not use Savlon Cold Sore Cream if you have:
• an allergy (hypersensitivity) to any of the ingredients of Savlon Cold Sore Cream (see Section 6),
• a condition, or other medical treatment, which weakens your immune system (i.e. the way
your body fights infection) – for example:
• HIV infection,
• a bone marrow transplant
• cancer treatment.
Do not apply the cream to the inside of your mouth, your eyes or genital area. It is not intended
for the treatment of ocular or genital herpes.
Savlon Cold Sore Cream is not recommended for children aged under 12 years.
Take special care with Savlon Cold Sore Cream if you:
• are pregnant, or planning to become pregnant, or are breast-feeding,
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.
There are no known interactions between Savlon Cold Sore Cream and other medicines.
Using Savlon Cold Sore Cream with food and drink
This cream is intended for external use only.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
The safety of penciclovir in human pregnancy has not been established, nor is it known whether
penciclovir passes into human breast milk. If you are pregnant, intending to become pregnant,
or breast-feeding, Savlon Cold Sore Cream should only be used on the advice of your doctor.
Driving and using machines
There is no evidence that Savlon Cold Sore Cream can affect your ability to drive or operate
machinery.
Important information about some of the ingredients of Savlon Cold Sore Cream.
The cream contains:
• cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis)
• propylene glycol which may cause skin irritation.

Penciclovir

Cold Sore Cream 1% w/w

3. HOW TO USE SAVLON COLD SORE CREAM
Adults, elderly and children over 12 years: Start treatment as early as possible after the first sign
of an infection. Apply Savlon Cold Sore Cream every 2 hours during waking hours (approximately
8 times a day). Continue the treatment for 4 days. If the cold sore gets worse or does not
improve after 4 days, seek medical advice.
Children under 12 years: not recommended.
Savlon Cold Sore Cream should not be used for more than 4 days without seeking medical
advice.
If you use more Savlon Cold Sore Cream than you should
No untoward effects are expected. If you accidentally swallow some of the cream you may
experience slight irritation in the mouth.
If you forget to use Savlon 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 have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Savlon Cold Sore Cream can cause side effects, although not everybody gets them.
You may experience initial burning, stinging or numbness after applying the cream.
Very rarely, hypersensitivity reactions, such as local skin reactions (allergic dermatitis), rash,
itching of raised bumps of the skin (urticaria), intense itching (pruritis) and swelling (oedema),
have been reported.
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.
5. HOW TO STORE SAVLON 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 Savlon 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 Savlon 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 Savlon Cold Sore Cream”).
What Savlon Cold Sore Cream looks like and contents of the pack
Savlon Cold Sore Cream is a smooth white cream.
Savlon Cold Sore Cream is available in 2g aluminium tubes.
Marketing Authorisation Holder and Manufacturer
Novartis Consumer Health UK Limited
Wimblehurst Road
Horsham
West Sussex
RH12 5AB
For any information about this medicinal product, please contact the Marketing Authorisation
Holder.
This leaflet was last approved in 11/2009.

GB 301245 - XXXXXX


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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.

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