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VECTAVIR COLD SORE CREAM

Active substance(s): PENCICLOVIR

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Novartis Consumer Health SA
Package Leaflet

Confidential

B. PACKAGE LEAFLET

Page 1
Vectavir Cold Sore Cream

Novartis Consumer Health SA
Package Leaflet

Confidential

Page 2
Vectavir Cold Sore Cream

PACKAGE LEAFLET: INFORMATIOM FOR THE USER
Vectavir Cold Sore Cream
Penciclovir
Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.

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

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1.
2.
3.
4.
5.
6.

What Vectavir is and what it is used for
What you need to know before you use Vectavir
How to use Vectavir
Possible side effects
How to store Vectavir
Contents of the pack and other information

1.

What Vectavir is and what it is used for

Vectavir is used for the treatment of cold sores (Herpes labialis). A cold sore is caused by a viral
infection. The virus can remain inactive for extended periods of time, but when triggered the virus
multiplies and a cold sore develops. This can occur, for example when you are run-down, when you
have a cold or flu, or when you have been out in strong sunlight. The virus causes painful blistering of
the lips.
Vectavir contains penciclovir and is an antiviral medicine which stops the virus multiplying. Applying
Vectavir means your cold sore heals faster and the duration of pain will be shorter. The time your cold
sore is infectious will also be shorter, although applying Vectavir will not stop you spreading your
cold sores to another person.
You must talk to a doctor if you do not feel better or if you feel worse after 4 days.

2.

What you need to know before you use Vectavir

Do not use Vectavir:

If you are allergic to penciclovir, famciclovir or any of the other ingredients of Vectavir (listed
in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Vectavir.
Vectavir should only be used on cold sores on the lips and around the mouth. It is not recommended
for application to mucous membranes (i.e. inside the mouth or nose or on genital areas). Avoid
application in or near the eyes.
Please check with your doctor or pharmacist before using Vectavir:

Novartis Consumer Health SA
Package Leaflet



Confidential

Page 3
Vectavir Cold Sore Cream

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

Children
Vectavir is not recommended for the treatment of children under 12 years of age.
Other medicines and Vectavir
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 taking this medicine.
Driving and using machines
Adverse effects on the ability to drive or operate machinery have not been observed.
Important information about some of the ingredients of Vectavir
Vectavir contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis). It
also contains propylene glycol which may cause skin irritation.

3.

How to use Vectavir

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if
you are not sure.
Use the cream as early as possible after early symptoms (tingling and itching) appear. However, the
cream can still be applied at the first sign of a cold sore. Always wash your hands before and after
applying the cream. Squeeze a small amount onto your finger and apply to the affected area.
Optionally, for packs which are supplied with clean, single use applicators, these may be used instead
of your finger, if desired. Apply every 2 hours throughout the day (approximately 8 times a day) for 4
consecutive days.
You should see your doctor if your symptoms persist or worsen at any time, or if your cold sore does
not improve after 4 days of treatment.
Use in children
Vectavir is not recommended for the treatment of children under 12 years of age.
If you use more Vectavir 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 Vectavir
If you forget to use your cream, apply it as soon as you remember, then continue as before.
If you accidentally swallow the cream
Vectavir 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 that cold sores are infectious.

Novartis Consumer Health SA
Package Leaflet

Confidential

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Vectavir Cold Sore Cream

To avoid the virus infecting other parts of the body, and 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 the 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 others, even if their symptoms are the same.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, Vectavir can cause side effects, although not everybody gets them. The side effects
caused by Vectavir are usually mild in intensity.
Some common side effects (may affect up to 1 in 10 people) are: burning, stinging or numbness when
the cream is applied. The effects will usually go away quickly.
Some people have also reported allergic-type reactions such as allergic dermatitis, rash, hives, itching
and swelling.
Reporting side effects
If you get any side effects, talk to you doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report any side effects directly (see details below) to the national
reporting system via the internet at www.mhra.gov.uk/yellowcard. By reporting side effects you can
help to provide more information on the safety of this medicine.

5.






6.

How to store Vectavir
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the “expiry date” which is stated on the tube and the carton. The
expiry date refers to the last day of that month.
Do not store above 30°C.
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.

Contents of the pack and other information

What Vectavir contains
The active substance in your cream is penciclovir. One gram of Vectavir contains 10 mg penciclovir.
The other ingredients are white soft paraffin, liquid paraffin, cetostearyl alcohol, propylene glycol,
cetomacrogol 1000 and purified water.
What Vectavir looks like and contents of the pack
Vectavir is a smooth white cream. It is available in 2g and 5g aluminium tubes.

Novartis Consumer Health SA
Package Leaflet

Confidential

Page 5
Vectavir Cold Sore Cream

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing authorization holder: Novartis Consumer Health, Camberley, GU15 3YL, UK.
Manufacturer: Novartis Consumer Health, Camberley, GU15 3YL, UK.
This medicinal product is authorized in the Member States of the EEA under the following
names:
Austria
Belgium
Bulgaria
Cyprus
Denmark
Finland
Germany
Greece
Hungary
Iceland
Ireland
Italy
Luxembourg
Malta
Norway
Portugal
Slovakia
Spain
Sweden
UK
This leaflet was last revised in June 2015.
Vectavir is a Trade Mark.

Famvir 1% Cream
Vectavir 1% Cream
ФЕНИВИР 1% крем
Fenivir Kρέμα
Vectavir creme 10 mg/g
Vectavir 1% Cream
Pencivir bei Lippenherpes
Fenivir 1% Cream
Fenivir 10 mg/g krém
Vectavir 10 mg/ml krem
Vectavir Cold Sore Cream
Vectavir 1% crema
Vectavir 1% Cream
Fenistil Cold Sore Cream
Vectavir 1% krem
Fenivir 1% Cream
Vectavir
Fenivir 10 mg/g crema
Vectavir 1% kräm
Vectavir 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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