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Aciclovir 3%W/W Eye Ointment

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Document: leaflet MAH BRAND_PLPI 19488-0414 change

S0414 LEAFLET Zovirax 20141111

PACKAGE LEAFLET: INFORMATION FOR THE USER ZOVIRAX EYE OINTMENT

Pregnancy and breast-feeding

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

(aciclovir)


Your medicine is known by Zovirax Eye Ointment 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 Eye Ointment (called ‘Zovirax' in this leaflet) contains a medicine called aciclovir. This belongs to a group of medicines called antivirals. It is used to treat eye infections caused by the Herpes simplex virus. It works by killing or stopping the growth of viruses on the front of your eyeball (cornea).

2 WHAT YOU NEED TO KNOW BEFORE YOU USE ZOVIRAX

Do not use Zovirax if:

• you are allergic (hypersensitive) to aciclovir or valaciclovir 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 wear contact lenses. Stop wearing them while using Zovirax.

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

Driving and Using Machines

You may experience blurred vision after using Zovirax Eye Ointment. Do not drive or use any machines unless your vision is clear.

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.

Adults and children

•    The usual dose is 1cm (about 1/2 an inch) of Zovirax applied to the infected eye five times a day.

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

•    You should carry on using Zovirax for at least 3 days after your eye has got better.

•    Your vision may be blurred for 5 to 10 minutes after applying Zovirax. Wait until you can see clearly again before driving or using any tools or machines.

How to apply Zovirax to your eye

1    Wash your hands.

2    Use your finger to gently pull down the lower eyelid of your infected eye.

3    Tilt your head slightly backwards and look up.

4    Apply 1cm (about 1/2 an inch) of Zovirax to the inside of your lower eyelid. Try to avoid the tip of the tube touching any part of your eye.

5 Close your eye for 30 seconds.

6 Wash your hands after applying Zovirax.

If you use more Zovirax than you should

Talk to your doctor or pharmacist if you use too much Zovirax. Zovirax eye ointment is for use in the eye, if you swallow any talk to your doctor or pharmacist.

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.

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.

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 using 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 trouble breathing

•    unexplained fever (high temperature) and feeling faint, especially when standing up.

Other side effects include:

Very common (affects more than 1 in 10 people)

•    irritation or feeling as if there is something in your eye.

Common (affects less than 1 in 100 people)

•    mild stinging in your eye straight after using Zovirax

•    swollen, runny eyes (conjunctivitis).

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

•    swollen eyelids.

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, pharmacist or nurse. 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.

What Zovirax contains

•    It contains 3% w/w of the active ingredient, aciclovir.

•    Zovirax also contains the following inactive ingredients: white soft paraffin.

What Zovirax looks like and contents of the pack

•    It is a sterile off white ointment

•    Zovirax is available in tubes containing 4.5g of ointment. 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 either:

•    Jubilant HollisterStier General Partnership, Kirkland, Quebec, Canada or

•    Glaxo Wellcome Operations, Barnard Castle, UK.

[POMl PL No. 19488/0414

Leaflet revision date: 11 November 2014

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

S0414 LEAFLET Zovirax 20141111

5 HOW TO STORE ZOVI RAX


   KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

• Do not store above 25°C.

• Do not refrigerate.

•    Keep the tube tightly closed when you are not using the ointment.

•    Do not use the ointment if more than one month has passed since the tube was opened.

•    Do not use after the expiry date printed on the carton label or tube.

•    If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.

•    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

•    Do not dispose of medicines in household rubbish. Any unused medicines should be returned to a pharmacist (chemist) who will dispose of them properly. This helps the environment.


S0414 LEAFLET Aciclovir 20141111

PACKAGE LEAFLET: INFORMATION FOR THE USER ACICLOVIR 3% W/W EYE OINTMENT

Pregnancy and breast-feeding

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

Your medicine is known by Aciclovir 3% W/W Eye Ointment but will

be referred to as Aciclovir Eye Ointment 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 Eye Ointment is and what it is used for

2    What you need to know before you use Aciclovir Eye Ointment

3    How to use Aciclovir Eye Ointment

4    Possible side effects

5    How to store Aciclovir Eye Ointment

6    Contents of the pack and other information

Driving and Using Machines

You may experience blurred vision after using Aciclovir Eye Ointment. Do not drive or use any machines unless your vision is clear.

3 HOW TO USE ACICLOVIR EYE OINTMENT

Always use Aciclovir Eye Ointment exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Adults and children

•    The usual dose is 1cm (about 1/2 an inch) of Aciclovir Eye Ointment applied to the infected eye five times a day.

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

•    You should carry on using Aciclovir Eye Ointment for at least 3 days after your eye has got better.

•    Your vision may be blurred for 5 to 10 minutes after applying Aciclovir Eye Ointment. Wait until you can see clearly again before driving or using any tools or machines.

How to apply Aciclovir Eye Ointment to your eye

1    Wash your hands.

2    Use your finger to gently pull down the lower eyelid of your infected eye.



1 WHAT ACICLOVIR EYE OINTMENT IS AND WHAT IT IS USED FOR

Aciclovir 3% w/w Eye Ointment (called ‘Aciclovir Eye Ointment' in this leaflet) contains a medicine called aciclovir. This belongs to a group of medicines called antivirals. It is used to treat eye infections caused by the Herpes simplex virus. It works by killing or stopping the growth of viruses on the front of your eyeball (cornea).

2 WHAT YOU NEED TO KNOW BEFORE YOU USE ACICLOVIR EYE OINTMENT

Do not use Aciclovir Eye Ointment if:

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

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

Warnings and precautions

Talk to your doctor or pharmacist before using Aciclovir Eye Ointment if:

• you wear contact lenses. Stop wearing them while using Aciclovir Eye Ointment.

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

Other medicines and Aciclovir Eye Ointment

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.

3    Tilt your head slightly backwards and look up.

4    Apply 1cm (about 1/2 an inch) of Aciclovir Eye Ointment to the inside of your lower eyelid. Try to avoid the tip of the tube touching any part of your eye.

5    Close your eye for 30 seconds.

6    Wash your hands after applying Aciclovir Eye Ointment.

If you use more Aciclovir Eye Ointment than you should

Talk to your doctor or pharmacist if you use too much Aciclovir Eye Ointment. Aciclovir Eye Ointment is for use in the eye, if you swallow any talk to your doctor or pharmacist.

If you forget to use Aciclovir Eye Ointment

•    If you forget to use Aciclovir Eye Ointment, 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.

Like all medicines, Aciclovir Eye Ointment 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 using Aciclovir Eye Ointment 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 trouble breathing

•    unexplained fever (high temperature) and feeling faint, especially when standing up.

Other side effects include:

Very common (affects more than 1 in 10 people)

•    irritation or feeling as if there is something in your eye.

Common (affects less than 1 in 100 people)

•    mild stinging in your eye straight after using Aciclovir Eye Ointment

•    swollen, runny eyes (conjunctivitis).

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

•    swollen eyelids.

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, pharmacist or nurse. 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.

What Aciclovir Eye Ointment contains

•    It contains 3% w/w of the active ingredient, aciclovir.

•    Aciclovir Eye Ointment also contains the following inactive ingredients: white soft paraffin.

What Aciclovir Eye Ointment looks like and contents of the pack

•    It is a sterile off white ointment

•    Aciclovir Eye Ointment is available in tubes containing 4.5g of ointment.

Product License holder

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

Manufacturer

This product is manufactured by either:

•    Jubilant HollisterStier General Partnership, Kirkland, Quebec, Canada or

•    Glaxo Wellcome Operations, Barnard Castle, UK.

|~POMl PL No. 19488/0414

Leaflet revision date: 11 November 2014

S0414 LEAFLET Aciclovir 20141111

5 HOW TO STORE ACICLOVIR EYE OINTMENT

   KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

• Do not store above 25°C.

• Do not refrigerate.

•    Keep the tube tightly closed when you are not using the ointment.

•    Do not use the ointment if more than one month has passed since the tube was opened.

•    Do not use after the expiry date printed on the carton label or tube.

•    If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.

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

•    Do not dispose of medicines in household rubbish. Any unused medicines should be returned to a pharmacist (chemist) who will dispose of them properly. This helps the environment.