Aciclovir cream 5%

Read all of this leaflet carefully because it contains important information for you.

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

•    Ask your doctor or pharmacist if you need more information or advice.

•    You must contact a doctor if your symptoms worsen or do not improve.

•    If you have any unusual effects after using this product, tell your doctor or pharmacist.

In this leaflet:

1.    What is Aciclovir cream is and what is it used for?

2.    Before you use Aciclovir cream

3.    How to use Aciclovir cream

4.    Possible side effects

5.    How to store Aciclovir    cream

6.    Further information

1. What is Aciclovir cream and what is it used for?

Aciclovir cream is used in the treatment of genital herpes and cold sores. Once genital herpes or a cold sore has appeared, treatment with Aciclovir cream can accelerate the healing process.

The active substance in Aciclovir cream is aciclovir. Aciclovir is an antiviral agent that has been shown to be effective in treating infections caused by the herpes simplex virus, such as genital herpes and cold sores.

2.    Before you use Aciclovir cream

Do not use Aciclovir cream and tell your doctor:

•    If you are allergic (hypersensitive) to aciclovir, valaciclovir or any of the other ingredients of Aciclovir cream

(listed in section 6, Further Information). Cetyl alcohol, propylene glycol or sorbic acid may cause local skin reactions or irritation (e.g. contact dermatitis).

•    In the eyes, inside the mouth or genitals.

Check with your doctor or pharmacist before using Aciclovir cream if:

•    Your immune system is not working properly (for instance you have had a bone marrow transplant or you have AIDS).

Taking other medicines:

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is especially important if you are taking:

• Probenecid (used for gout).

Pregnancy and breast-feeding:

As with all medicines, Aciclovir cream should not be used during pregnancy or breast-feeding, unless you are advised to do so by your doctor.

Ask you doctor or pharmacist for advice before taking any medicine.

3.    How to use Aciclovir cream

It is important to start treatment as soon as possible. Always use Aciclovir cream exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure how to use this medicine.

Adults and the elderly:

•    Wash your hands before and after applying the cream. This will prevent your

cold sore or genital herpes from getting worse or spreading, or you infecting someone else.

•    Apply the cream to the affected area 5 times daily (about every four hours)

for 5 days.

If your cold sore or genital herpes has not healed after five days of treatment you can continue using the cream for another five days.

If you forget to use Aciclovir cream:

If you forget to apply the cream, apply it as soon as you remember and then apply the next treatment at the usual time.

If you accidentally swallow Aciclovir cream:

Aciclovir cream is for use on cold sores on the lips and surrounding skin and herpes on the genitals only. You are very unlikely to suffer any bad effects if you accidentally swallow Aciclovir cream. However, if you notice any unusual effects or are worried tell your doctor or contact the Accident and Emergency Department of your nearest hospital.

4.    Possible side effects

Like all medicines, Aciclovir cream can cause side effects, although not everybody gets them.

Some people may experience side effects, particularly when they first start using the product.

Stop using Aciclovir cream and contact your doctor immediately if you have

•    an allergic reaction: urticaria/hives (pale/red raised skin with severe itching) or any swelling of the face, mouth, tongue or airways or difficulty breathing.

Uncommon (affects 1 to 10 users in 1,000):

•    burning or stinging where the cream has been applied, mild dry flaking of the skin, itching.

Rare (affects 1 to 10 users in 10,000):

•    erythema (redness of the skin)

If any of these side effects become troublesome or you react badly to the cream in any other way, tell your doctor or pharmacist immediately.

5.    How to store Aciclovir cream

Keep out of the reach and sight of children.

Store below 25°C. Do not refrigerate or freeze.

Do not use Aciclovir cream after the expiry date which is stated at one end of the carton and on the tube. The expiry 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 Aciclovir cream contains:

•    The active substance is aciclovir (5% w/w).

•    The other ingredients are cetyl alcohol, dimethicone, heavy liquid paraffin, polyethylene glycol - 5 glyceryl stearate, propylene glycol, sorbic acid, white soft paraffin and water.

What Aciclovir cream looks like and contents of the pack:

Aciclovir cream is available in tubes containing 2g or 10g of a smooth white to off-white cream.

Marketing Authorisation Holder: Actavis, Barnstaple, EX32 8NS, UK Manufacturer: Patheon UK Limited, Swindon, SN3 5BZ, England This leaflet was last revised in March 2011