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ZOVIRAX 5% W/W CREAM

Active substance(s): ACICLOVIR

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S1542 LEAFLET Zovirax 20140731

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.

3. HOW TO USE ZOVIRAX
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.



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



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

Adults and children





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

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.



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



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.



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.

In this leaflet:
1. What Zovirax is and what it is used for
2. What you need to know before you use Zovirax

If you use more Zovirax than you should

4. Possible side effects

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.

5. How to store Zovirax
6. Contents of the pack and other information

If you forget to use Zovirax

3. How 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.

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.

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

Warnings and precautions



shortness of breath, wheezing or having trouble breathing

Talk to your doctor or pharmacist before using Zovirax if:



unexplained fever and feeling faint, especially when standing
up.



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.

Other side effects include:
Uncommon (affects less than 1 in 100 people)

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



a burning or stinging feeling after applying the cream that goes
away

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



mild drying or flaking of your skin



itching.

Other medicines and Zovirax

Rare (affects less than 1 in 1,000 people)

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.



redness of your skin



skin rash.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before using any
medicine.

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: 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

S1542 LEAFLET Aciclovir 20140731

PACKAGE LEAFLET: INFORMATION FOR USER

ACICLOVIR 5% w/w CREAM
(aciclovir)

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.

Your medicine is known as Aciclovir 5% w/w Cream but will be
referred to as Aciclovir throughout the following leaflet.

Applying the cream


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

Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.



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



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



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



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

Adults and children



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.



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 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.



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.



In this leaflet:
1. What Aciclovir is and what it is used for
2. What you need to know before you use Aciclovir

If you use more Aciclovir than you should

3. How to use Aciclovir

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.

4. Possible side effects
5. How to store Aciclovir
6. Contents of the pack and other information

If you forget to use Aciclovir
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.



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.

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

Warnings and precautions



shortness of breath, wheezing or having trouble breathing

Talk to your doctor or pharmacist before using Aciclovir if:



unexplained fever and feeling faint, especially when standing
up.



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.

Other side effects include:
Uncommon (affects less than 1 in 100 people)

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



a burning or stinging feeling after applying the cream that goes
away

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



mild drying or flaking of your skin



itching.

Other medicines and Aciclovir

Rare (affects less than 1 in 1,000 people)

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.



redness of your skin



skin rash.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before using any
medicine.

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: 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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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