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Asda Cold Sore 5% W/W Cream

Document: leaflet MAH GENERIC_PL 16431-0202 change

ACICLOVIR 5% w/w CREAM (ACICLOVIR)

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 Aciclovir is and what it is used for

2.    Before you use Aciclovir

3.    How to use Aciclovir

4.    Possible side effects

5.    How to store Aciclovir

6.    Further information

1. What Aciclovir is and what it is used for

The name of your medicine is Aciclovir 5% w/w cream (called Aciclovir in this leaflet). It belongs to a group of medicines called "anti-virals" which act to treat infections caused by viruses.

Aciclovir is used to treat cold sores; these are infections of the lips and face caused by the "herpes simplex" virus. Aciclovir 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 Aciclovir

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 Aciclovir 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 Aciclovir

Talk to your pharmacist or doctor if you are not sure about using Aciclovir.

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 aciclovir 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 Aciclovir 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 Aciclovir

•    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 Aciclovir or get It In your eyes

•    Do not swallow Aciclovir. If it is accidentally swallowed, tell your doctor straight away

•    Do not use Aciclovir 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, Aciclovir can cause side effects, although not everybody gets them. The following side effects have been reported with this medicine:

Stop taking Aciclovir 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 Aciclovir

   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 Aciclovir 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 Aciclovir looks like and contents of the pack

Aciclovir is a white to off-white cream that comes in a tube. It is available in packs of 2g. Marketing Authorisation Holder: Ayrton Saunders Ltd 9, Arkwright Road, Astmoor Industrial Estate, Runcorn, Cheshire. WA7 INU Date of last revision: August 2013