Aciclovir 5%W/W Cream

Document: leaflet ACTAVIS_PL 20395-0002 change

Aciclovir 5% w/w Cream

Active ingredient: Aciclovir

Read all of this leaflet carefully before you start using this medicine.

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

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

•    Your doctor has prescribed this cream for ou. Do not pass it on to others. It may arm them even if their symptoms are

the same as yours.

• If any of the side effects get serious, or if you notice any side effects not listed in the leaflet, please tell your doctor or pharmacist.

In this leaflet:

j What Aciclovir 5% w/w Cream is and what is it used for 3) Before you use Aciclovir 5% w/w Cream

31 How to use Aciclovir 5% w/w Cream

Possible side effects 3| How to store Aciclovir 5% w/w Cream

3| Further information

j What Aciclovir 5% w/w Cream is and what it is used for

Aciclovir belongs to a group of medicines called antivirals. Aciclovir works in cells that are infected by certain viruses, including the herpes simplex virus. It interferes with virus DNA, slowing down virus growth. Aciclovir is not harmful to human DNA.

What is Aciclovir 5% w/w Cream used for?

Aciclovir 5% w/w Cream is used to treat infections of the skin caused by the herpes simplex virus, including cold sores, genital herpes and herpes labialis.

31 Before you use Aciclovir 5% w/w Cream

Do not use Aciclovir 5% w/w Cream:

If you are allergic to Aciclovir or any other ingredients of the preparation.

Do not use Aciclovir 5% w/w cream inside your mouth, to treat mouth ulcers and in the eyes or genital areas.

Take special care with Aciclovir 5% w/w Cream:

Tell your doctor before you start using the cream:

If you pregnant, plan to become pregnant or are breast feeding.

If you have a weak immune system for example due to immune deficiency disease or following transplant surgery.

Consult your doctor first if you have an infection.

Taking other medicines:

Please tell your doctor if you are taking any of the following medicines:


Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without prescription.

Pregnancy and Breastfeeding:

Tell your doctor if you are pregnant or are planning to become pregnant. Your doctor will advise you to discontinue using this cream.

Tell your doctor if you are breast-feeding or are planning to breast-feed your baby. A small amount of this drug does pass in to breast milk.

Driving and using machines:

This medicine should not affect your ability to drive or operate machinery.

Important information about some of the ingredients of Aciclovir:

Aciclovir 5% w/w cream contains cetyl alcohol and propylene glycol which may cause local skin reactions (skin irritation and redness).

31 How to use Aciclovir 5% w/w Cream

Always use Aciclovir 5% w/w Cream exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Aciclovir 5% w/w Cream is for use on the skin only. It is not to be taken internally.

To work at its best, Aciclovir 5% w/w Cream should be started as soon as possible after the first symptoms of infection appear.

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People who suffer from cold sores can often tell when they are about to get a cold sore by a tingling or itching sensation. Aciclovir 5% w/w Cream should be used at this tingling stage or just after skin blisters appear. However do not use Aciclovir 5% w/w cream unless your doctor tells you to.

The following instructions will tell how to use Aciclovir 5% w/w Cream:-

1.    Wash your hands.

2.    Apply a thin film of Aciclovir 5% w/w Cream to the infected skin, and the skin immediately next to it, using your fingertip. Take care not to rub the infected skin any more than you need to.

3.    You should apply Aciclovir 5% w/w Cream to the infected area 5 times each day, at intervals of about 4 hours. Night time application can omitted. Do not use the cream any more than this unless you are told to by a doctor.

4.    Wash your hands again. Herpes simplex is infectious and you should try to avoid touching the infected skin with your hands or with towels, etc. to prevent spreading the infection.

Never apply Aciclovir 5% w/w Cream to area of the body called the mucous membranes, as the cream can cause irritation. These areas to avoid include the inside of the mouth and nose and the inside of the vagina. Never apply Aciclovir 5% w/w cream to the eyes.

For herpes labialis treatment should be continued for at least 4 days and for 5 days for genital herpes. If the infection has not healed after this time, treatment can be continued for up to 5 days more.

If you use more Aciclovir 5% w/w Cream than you should:

Aciclovir 5% w/w Cream is not to be used in the mouth or vagina as it may irritate the skin in these areas. If it is accidentally swallowed, do not worry, but contact your doctor or pharmacist for advice.

Aciclovir 5% w/w Cream should not be used in the eyes. If it gets into the eyes, wash it out with plenty of water. If your eye gets sore tell your doctor or pharmacist.

If you forget to use Aciclovir 5% w/w Cream:

If you forget to use your cream, apply some as soon as you remember, then go on as before.

If you have any further questions on the use of Aciclovir 5% w/w Cream ask your doctor or pharmacist.

Possible side Effects

Like all medicines, Aciclovir cream can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

Allergic reactions (affects less than 1 in 10,000 people)

If you have an allergic reaction, stop taking Aciclovir cream and see a doctor straight

away. The signs may include: rash, itching or hives on your skin, swelling of your face, lips, tongue or other parts of your body, shortness of breath, wheezing or having trouble breathing, unexplained fever and feeling faint, especially when standing up. Other side effects include:

Uncommon (affects less than 1 in 100 people)

a burning or stinging feeling after applying the

cream that goes away,

mild drying or flaking of your skin,


Rare (affects less than 1 in 1,000 people) redness of your skin, skin rash.

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. Reporting of 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 side effects directly via the Yellow Card Scheme at: By reporting side effects you can help provide more information on the safety of this medicine.

T| How to store Aciclovir 5% w/w Cream

Keep out of the sight and reach of children.

Do not use Aciclovir 5% w/w Cream after the expiry or 'use by' date shown on the container. Use within 6 weeks of opening.

Keep Aciclovir 5% w/w Cream in its original container and store at a temperature below 25°C but do not refrigerate or freeze.

Further information What the cream contains:

The active ingredient is Aciclovir. Each gram of the cream contains 50mg of Aciclovir.

The other ingredients are stearoyl macrogolglycerides, dimeticone, cetyl alcohol, liquid paraffin, white soft paraffin, propylene glycol and purified water.

What Aciclovir 5% w/w Cream looks like and contents of the pack

Aciclovir 5% w/w cream is available from your pharmacist with a prescription in 2g and 10g tubes.

Marketing Authorisation Holder and Manufacturer

Relonchem Limited, Cheshire House,

Gorsey Lane, Widnes, Cheshire, WA8 0RP, UK. Date leaflet last revised: December 2013 (Version 2)


PL 20395/0002

Actavis, Barnstaple, EX32 8NS, UK

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