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FENISTIL COLD SORE CREAM

Active substance(s): PENCICLOVIR

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

AWF 22514 – OTDC 369887
FEN COLD SORE CREAM GB_932973_PIL
120 x 210 mm – Recto/Verso
227
Black
Helvetica Neue LT Pro
Text body: 7 pts

Novartis Pharma Wehr – DE
2174334

Pre-press

Ducommun SA – DO-14-E0758 – 09.06.2015

Recto

12 mm

10 mm

12 mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.
Always use this medicine exactly as described in this leaflet or as your pharmacist has told you.
–– Keep this leaflet. You may need to read it again.
–– Ask your pharmacist if you need more information or advice.
–– If you get any side effects, talk to your pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
–– You must talk to a doctor if you do not feel better or if you feel worse after 4 days.
What is in this leaflet
1. What Fenistil Cold Sore Cream is and what it is used for
2. What you need to know 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. Contents of the pack and other 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.
You must talk to a doctor if you do not feel better or if you feel worse after 4 days.

83,6 mm

Do not use Fenistil Cold Sore Cream
• If you are allergic to penciclovir, famciclovir or any of the other ingredients of Fenistil Cold Sore
Cream (listed in section 6.)
Warnings and Precautions
Talk to your doctor or pharmacist before using Fenistil Cold Sore Cream.
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.
Please check with your doctor or pharmacist before using Fenistil Cold Sore Cream:
• if you are unsure that your sore is a cold sore,
• if 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 or 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.
Children
Fenistil Cold Sore Cream is not recommended for the treatment of children under 12 years of age.
Other medicines and Fenistil Cold Sore Cream
There are no known interactions with other medicines.
However tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before using this medicine.
Driving and using machines
Adverse effects on the ability to drive or operate machinery have not been observed.
Take special care
To prevent transferring the infection or making it worse do not touch your cold sore (See also
­Section 3, “What general precautions should you take when you have a cold sore”).
Important information about some of the ingredients of Fenistil 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.

3. How to use Fenistil Cold Sore Cream

10 mm

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
Start treatment at the earliest sign of a cold sore (symptoms such as, tingling, redness and itching).

120 mm

210 mm

2. What you need to know before you use Fenistil Cold Sore Cream

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

AWF 22514 – OTDC 369887
FEN COLD SORE CREAM GB_932973_PIL
120 x 210 mm – Recto/Verso
227
Black
Helvetica Neue LT Pro
Text body: 7 pts

Novartis Pharma Wehr – DE
2174334

Pre-press

Ducommun SA – DO-14-E0758 – 09.06.2015

Verso

12 mm

10 mm

12 mm

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.
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.
Use in children
Fenistil Cold Sore Cream is not recommended for the treatment of children under 12 years of age.
If you use more Fenistil Cold Sore Cream than you should
There are unlikely to be any harmful effects if you have used a large amount of cream on your skin all
at once, although some irritation of the skin may occur.
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 Fenistil Cold Sore Cream
Fenistil is not harmful if accidentally swallowed and no treatment is necessary but it may cause irritation in the mouth. Please contact your doctor or pharmacist if you are concerned.
What general precautions should you take 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 when you have a cold sore to:
• Avoid kissing, especially children.
• Avoid oral sex.
• Use only your own towel and face cloth and do not share cutlery, cups, glasses, 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 if it gets into the eyes.
Do not give this cream to other people, even if their symptoms are the same as yours.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, Fenistil Cold Sore Cream can cause side effects, although not everybody gets
them. The side effects caused by Fenistil are usually mild in intensity.
Some common side effects are: initial itching, burning, stinging or numbness where the cream has
been applied (may affect up to 1 in 10 people). Some people have also reported allergic-type reactions such as allergic dermatitis, 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.
Reporting side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report any side effects directly 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. By reporting
side effects you can help provide more information on the safety of this medicine.

5. How to store Fenistil Cold Sore Cream
Keep this medicine out of the sight and reach of children.
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.
Do not store above 30 °C. Store in the original pack. Do not freeze.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.

86 mm

6. Contents of the pack and other information
What Fenistil Cold Sore Cream contains
The active substance is penciclovir. One gram of Fenistil contains 10 mg Penciclovir.
The other ingredients are white soft paraffin, liquid paraffin, cetostearyl alcohol, propylene glycol,
cetomacrogol 1000 and 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.
This leaflet was last revised in May 2015.

10 mm

GB 932973 – 2174334

120 mm

210 mm

Pharma code 227

4. Possible side effects

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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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