Active substance: ACICLOVIR

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Cold Sore Cream ACICLOVIR 5% w/w
Read all of this leaflet carefully before you start using this medicine.
 This medicine is available without prescription to treat minor conditions. However you still need
to use it carefully.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or pharmacist.
 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Cold Sore Cream is and what it is used for
2. Before you use Cold Sore Cream
3. How to use Cold Sore Cream
4. Possible side effects
5. How to store Cold Sore Cream
6. Further information

1. What Cold Sore Cream is and what it is used for
The name of your medicine is Cold Sore Cream ACICLOVIR 5% w/w (called Cold Sore Cream in
this leaflet). It belongs to a group of medicines called “anti-virals”, which act to treat infections
caused by viruses.
Cold Sore Cream is used to treat cold sores; these are infections of the lips and face caused by the
“herpes simplex” virus. Cold Sore Cream should be used as soon as you get the first signs of
infection, when you first see skin blisters or before then if you recognise the tingle sensation that
means a blister will appear soon. If you have already had blisters for more than a day, a different
medicine might be more suitable for you. Ask your doctor or pharmacist for advice.

2. Before you use Cold Sore Cream
Talk to your pharmacist or doctor if:
 You are in any doubt whether your cold sore blister is a cold sore
 You cold sore is severe or becomes severe
 You have a weak immune system. This might be because you have had a transplant,
radiotherapy treatment or an immune deficiency disease
 If you are pregnant and / or breast-feeding
Do not use Cold Sore Cream if:
 You are allergic (hypersensitive) to Aciclovir, another anti-viral medicine called Valaciclovir,
propylene glycol, or any of the other ingredients of this medicine (listed in Section 6)
 The blister is inside the mouth, in the eyes or on the genital area.
Important information about some of the ingredients in Aciclovir Cream
Aciclovir contains an ingredient called “propylene glycol”. This may cause skin irritation.
Aciclovir also contains an ingredient called "cetyl alcohol”. This may cause local skin reactions e.g.
contact dermatitis.

3. How to use Cold Sore Cream
Talk to your pharmacist or doctor if you are not sure about using Cold Sore Cream.
Using this medicine
 Use this medicine on the lips and face only. Do not use it inside your body such as in your
mouth, nose, eyes and in the genital area.
 Continue treatment for 4 days, if your cold sore hasn’t healed after this time, you can use the
cream for up to 10 days in total.
 Apply at the first sign of a cold sore (such as tingling or itching).
 If your skin infection does not get better after a total of 10 days, or gets worse, stop using
Cold Sore Cream and tell your doctor. Do not exceed the stated dose.
 The infection you have can spread to other people. Do not touch the infected skin with your
hands or towels. This will stop the infection from spreading.
 Never give this medicine to others, even if their symptoms are the same as yours.
How to use the cream
1. Wash your hands
2. Use your fingertip to apply a thin layer of Cold Sore Cream to the infected area 5 times each day.
Leave about 4 hours in between each application. Do not rub the infected skin any more than you
need to.
3. Wash your hands again

If you forget to use Cold Sore Cream
 If you forget a dose, use it as soon as you remember. However, if it is almost time for the next
dose, skip the missed dose
 Do not use a double dose to make up for a forgotten dose
If you swallow Cold Sore Cream or get it in your eyes
 Do not swallow Cold Sore Cream. If it is accidentally swallowed, tell your doctor straight away
 Do not use Cold Sore Cream in your eyes. If it gets into your eyes, wash it out with plenty of clean
water. If your eyes get sore, tell your doctor straight away
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Cold Sore Cream can cause side effects, although not everybody gets them. The
following side effects have been reported with this medicine:
Stop taking Cold Sore Cream and see a doctor or go to a hospital immediately if you notice
any of the following very rare serious side effects:
Very rare (affects less than 1 in 10,000 people)
 Allergic reactions. Symptoms can include swelling of the face or throat, or red, swollen skin.
The following side effects can occur;
Uncommon (affects less than 1 in 100 people)
 Short burning or stinging sensations after application
 Skin becomes itchy, dry or scaly
Rare (affects less than 1 in 1,000 people)
 Skin becomes red. Skin rash
If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store Cold Sore Cream
 Keep out of the sight and reach of children, store in its original container.
 Use by the expiry date displayed on the end of the tube after EXP. The expiry date refers to the
last day of that month
 Once opened use within 6 weeks. Write the date of opening on the end of the carton
 Do not store above 25°C. Do not refrigerate or freeze the cream
 Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines safely

6. Further information
What Cold Sore Cream contains
 The active substance is aciclovir. Each gram of the cream contains 50 milligrams of aciclovir
 The other ingredients are PEG-5-glycerol stearate, dimeticone, cetyl alcohol, liquid paraffin, white
soft paraffin, propylene glycol and purified water
What Cold Sore Cream looks like and contents of the pack
Cold Sore Cream is a white to off-white cream that comes in a tube. It is available in packs of 2g.
Marketing Authorisation Holder: Zanza Laboratories (Holdings) Ltd, Unit 2A, Olympic Way,
Sefton Business Park, Liverpool, L30 IRD, UK.
Distributed by: Zanza Laboratories Ltd, Liverpool, UK
Date of last revision: July 2012


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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.