FENISTIL COLD SORE CREAM

Active substance: PENCICLOVIR

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AWF 20707 – OTDC 343821
FEN COLD SORE CRM 2 G GB_926082_PIL
120 x 210 mm – Recto/Verso
194
Black
Helvetica Neue LT Pro
Text body: 8 pts

Novartis Pharma Wehr – DE
2158148

Pre-press

Ducommun SA – DO-14-E2277 – 12.08.2014

12 mm

12 mm

10 mm

Recto

PACKAGE LEAFLET: INFORMATION FOR THE USER

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.

83,6 mm

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

10 mm

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.

120 mm

210 mm

2. BEFORE YOU USE FENISTIL COLD SORE CREAM

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Order – AWF
Reference
Format
Pharma code
Colour
Font
Font min. size
Reference MKT
Production site
Reference SITE

AWF 20707 – OTDC 343821
FEN COLD SORE CRM 2 G GB_926082_PIL
120 x 210 mm – Recto/Verso
194
Black
Helvetica Neue LT Pro
Text body: 8 pts

Novartis Pharma Wehr – DE
2158148

Pre-press

Ducommun SA – DO-14-E2277 – 12.08.2014

12 mm

12 mm

10 mm

Verso

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

86 mm

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.

10 mm

GB 926082 – 2158148

120 mm

210 mm

Pharma code 194

5. HOW TO STORE FENISTIL COLD SORE CREAM

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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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