ACICLOVIR 5% cream Leaflet INFORMATION FOR THE USER Please read this leaflet carefully before you start

to take your medicine. Keep it, as you may want to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. 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 Aciclovir belongs to group of medicines : antivirals. Aciclovir Cream is used to infections caused by the Herpes simplex virus (HSV) 2. Before you use Aciclovir Do not use Aciclovir if: you are allergic to acyclovir or propylene glycol or any of the other ingredients; Take special care with Aciclovir For varicelo-zosterian virus, grave herpes infections and for patients with low resistance is recommended the Aciclovir tablets treatment. Check with your doctor before using Aciclovir if you have a condition where your immune system works less well and your body is less able to fight. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without prescription, although it is not known interactions with other medicine in case of acyclovir treatment. Since it is used on skin and does not get into the circulatory system in great quantities, Aciclovir Cream does not interact with other medicine administrated orally. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before using any medicine. In case of lack of clinic experience Aciclovir Cream is not recommended during pregnancy or breast-feeding , only after the evaluation of maternity benefits/ child risk rate. Driving or operating machinery Aciclovir does not affect the ability to drive or operate machinery.

3. How to use Aciclovir Always use Aciclovir exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. In case of primary infections and relapses, the treatment must be started at first symptoms of infection (pain, burning or stinging sensation). It is recommended to apply a layer of cream to the affected area every 4 hours - approximately 5 times a day. The treatment should be used until the area is healed, this could take 5 up to 10 days. If the affected area has still not healed after this, stop using the cream and tell your doctor. Wash your hands before and after you use the cream. If you use more Aciclovir than you should Talk to your doctor if you use too much Aciclovir. 4. Possible side effects Like all medicines, Aciclovir can cause side effects, although not everybody gets them. There may appear temporary a burning or stinging feeling after applying the cream. Rarely appears skin rash, itching, mild drying or flaking of your skin. In some cases a side effect would be contact dermatitis on your skin. If you have an allergic reaction, stop taking Aciclovir. 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. 5. How to store Aciclovir Store below 25C, in its original carton. Keep out of the reach and sight of children. Do not use Aciclovir after the expiry date which is stated on the carton and tube. The expiry date (Exp.) 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. This will help protect the environment. 6. Further information What Aciclovir Cream contains The active substance is acyclovir 50mg/g. The other ingredients are : dimeticone, cetostearyl alcohol, poloxamer, liquid paraffin, white paraffin, propylene glycol, purified water, glycerol monostearate and polyoxyethylene stearate. What Aciclovir looks like and contents of the pack The tube has a screw cap and contains a smooth, white to off-white cream, with a characteristic smell. The carton contains a 2 g tube of cream. Marketing authorization holder and manufacturer EGIS PHARMACEUTICS PLC Keresztri t 30-38 1106 BUDAPESTA UNGARIA This leaflet was approved in December 2006

EGIS Doc. No. : 16828/R