S1542 LEAFLET Zovirax 20140731 3. HOW TO USE ZOVIRAX

PACKAGE LEAFLET: INFORMATION FOR USER ZOVIRAX® 5% w/w CREAM (aciclovir)

Your medicine is known as Zovirax 5% w/w Cream but will be

referred to as Zovirax throughout the following leaflet

Read all of this leaflet carefully before you start using this

medicine because it contains important information for you.

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

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

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet, see section 4.

In this leaflet:

1.    What Zovirax is and what it is used for

2.    What you need to know before you use Zovirax

3.    How to use Zovirax

4.    Possible side effects

5.    How to store Zovirax

6.    Contents of the pack and other information

1. WHAT ZOVIRAX IS AND WHAT IT IS USED FOR

Zovirax Cream (called ‘Zovirax' in this leaflet) contains a medicine called aciclovir. This belongs to a group of medicines called antivirals. It is used to treat cold sores and genital infections caused by the Herpes simplex virus. It works by killing or stopping the growth of viruses that cause cold sores or genital herpes.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE ZOVIRAX

Do not use Zovirax if:

•    you are allergic (hypersensitive) to aciclovir, valaciclovir, propylene glycol or any of the other ingredients (listed in Section 6).

If you are not sure, talk to your doctor or pharmacist before using Zovirax.

Warnings and precautions

Talk to your doctor or pharmacist before using Zovirax if:

•    you have a condition where your immune system works less well and your body is less able to fight infections (e.g. if you have HIV or AIDS or if you have had a bone marrow transplant).

If you are not sure, talk to your doctor or pharmacist before using Zovirax.

Zovirax Cream is not for use in the mouth, eyes or the vagina. Zovirax Cream may cause skin irritation.

If you are not sure, talk to your doctor or pharmacist before using Zovirax.

Other medicines and Zovirax

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

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before using any medicine.

Always use Zovirax exactly as your doctor has told you. You should

check with your doctor or pharmacist if you are not sure.

Applying the cream

•    Zovirax Cream is not for use in your mouth, eyes or the vagina.

•    You should not mix Zovirax with anything before you use it, not even water.

•    Always wash your hands before and after you use the cream.

Adults and children

•    Apply a thin layer of cream to the affected area five times a day.

•    You should space each application of Zovirax by four hours. Suggested times are: 7am, 11am, 3pm, 7pm and 11pm.

•    If your cold sore has not healed after 4 days, or your genital herpes sore has not healed after 5 days, you may use the cream for 5 more days.

•    If the affected area has still not healed after this, stop using the cream and tell your doctor.

If you use more Zovirax than you should

Talk to your doctor or pharmacist if you use too much Zovirax.

Zovirax Cream is for use on the skin, if you swallow any talk to your

doctor or pharmacist.

If you forget to use Zovirax

•    If you forget to use Zovirax, use it as soon as you remember. However, if it is nearly time for your next application, skip the missed application.

•    Do not use a double application to make up for a forgotten application.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Zovirax 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 Zovirax 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

•    itching.

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.

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: www.mhra.gov.uk/yellowcard.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ZOVIRAX

•    KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

•    Do not store above 25°C. Do not refrigerate.

•    Do not use Zovirax if more than one month has passed since you first opened the tube.

•    Do not use Zovirax after the expiry date which is stated on the carton and tube. The expiry date (Exp.) refers to the last day of that month.

•    If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

•    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. CONTENTS OF THE PACK AND OTHER INFORMATION

What Zovirax contains

•    The active substance is aciclovir. The topical cream contains 5% w/w aciclovir.

•    The other ingredients are poloxamer 407, cetostearyl alcohol, sodium lauryl sulphate, white soft paraffin, liquid paraffin, propylene glycol, arlacel 165, dimeticone 20, polyethylene glycol 100 stearate and purified water.

What Zovirax looks like and contents of the pack Each carton contains a 10g tube of Zovirax.

The tube has a screw cap and contains a smooth, white to off-white cream.

Product Licence holder

Procured from within the EU and repackaged by the Parallel Import Product Licence holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley, HA0 1DX.

Manufacturer

This product is manufactured by Glaxo Wellcome Operations UK Ltd. Harmire Road Barnard Castle, DL12 8DT County Durham, Barnard Castle - County Durham, UK.

|POM | PL No: 19488/1542 Leaflet revision date: 31 July 2014

Zovirax is a registered trademark of the GlaxoSmithKline group of companies.

S1542 LEAFLET Zovirax 20140731

PACKAGE LEAFLET: INFORMATION FOR USER ACICLOVIR 5% w/w CREAM (aciclovir)

Your medicine is known as Aciclovir 5% w/w Cream but will be

referred to as Aciclovir throughout the following leaflet.

Read all of this leaflet carefully before you start using this

medicine because it contains important information for you.

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

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

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet, see section 4.

In this leaflet:

1.    What Aciclovir is and what it is used for

2.    What you need to know before you use Aciclovir

3.    How to use Aciclovir

4.    Possible side effects

5.    How to store Aciclovir

6.    Contents of the pack and other information

1. WHAT ACICLOVIR IS AND WHAT IT IS USED FOR

Aciclovir Cream (called ‘Aciclovir' in this leaflet) contains a medicine called aciclovir. This belongs to a group of medicines called antivirals. It is used to treat cold sores and genital infections caused by the Herpes simplex virus. It works by killing or stopping the growth of viruses that cause cold sores or genital herpes.

Always use Aciclovir exactly as your doctor has told you. You

should check with your doctor or pharmacist if you are not sure.

Applying the cream

•    Aciclovir Cream is not for use in your mouth, eyes or the vagina.

•    You should not mix Aciclovir with anything before you use it, not even water.

•    Always wash your hands before and after you use the cream.

Adults and children

•    Apply a thin layer of cream to the affected area five times a day.

•    You should space each application of Aciclovir by four hours. Suggested times are: 7am, 11am, 3pm, 7pm and 11pm.

•    If your cold sore has not healed after 4 days, or your genital herpes sore has not healed after 5 days, you may use the cream for 5 more days.

•    If the affected area has still not healed after this, stop using the cream and tell your doctor.

If you use more Aciclovir than you should

Talk to your doctor or pharmacist if you use too much Aciclovir.

Aciclovir Cream is for use on the skin, if you swallow any talk to

your doctor or pharmacist.

If you forget to use Aciclovir

•    If you forget to use Aciclovir, use it as soon as you remember. However, if it is nearly time for your next application, skip the missed application.

•    Do not use a double application to make up for a forgotten application.

4. POSSIBLE SIDE EFFECTS

2. WHAT YOU NEED TO KNOW BEFORE YOU USE ACICLOVIR

Do not use Aciclovir if:

•    you are allergic (hypersensitive) to aciclovir, valaciclovir, propylene glycol or any of the other ingredients (listed in Section 6).

If you are not sure, talk to your doctor or pharmacist before using Aciclovir.

Warnings and precautions

Talk to your doctor or pharmacist before using Aciclovir if:

•    you have a condition where your immune system works less well and your body is less able to fight infections (e.g. if you have HIV or AIDS or if you have had a bone marrow transplant).

If you are not sure, talk to your doctor or pharmacist before using Aciclovir.

Aciclovir Cream is not for use in the mouth, eyes or the vagina. Aciclovir Cream may cause skin irritation.

If you are not sure, talk to your doctor or pharmacist before using Aciclovir.

Other medicines and Aciclovir

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

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before using any medicine.

Like all medicines, Aciclovir 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 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

•    itching.

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.

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: www.mhra.gov.uk/yellowcard.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ACICLOVIR

•    KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

•    Do not store above 25°C. Do not refrigerate.

•    Do not use Aciclovir if more than one month has passed since you first opened the tube.

•    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.

•    If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

•    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. CONTENTS OF THE PACK AND OTHER INFORMATION

What Aciclovir contains

•    The active substance is aciclovir. The topical cream contains 5% w/w aciclovir.

•    The other ingredients are poloxamer 407, cetostearyl alcohol, sodium lauryl sulphate, white soft paraffin, liquid paraffin, propylene glycol, arlacel 165, dimeticone 20, polyethylene glycol 100 stearate and purified water.

What Aciclovir looks like and contents of the pack

Each carton contains a 10g tube of Aciclovir.

The tube has a screw cap and contains a smooth, white to off-white cream.

Product Licence holder

Procured from within the EU and repackaged by the Parallel Import Product Licence holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley, HA0 1DX.

Manufacturer

This product is manufactured by Glaxo Wellcome Operations UK Ltd. Harmire Road Barnard Castle, DL12 8DT County Durham, Barnard Castle - County Durham, UK.

|POM | PL No: 19488/1542 Leaflet revision date: 31 July 2014

S1542 LEAFLET Aciclovir 20140731