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Zovirax Eye Ointment

Document: leaflet MAH BRAND_PLPI 16369-0851 change

1. What Zovirax is and what it is used for


3. How to use Zovirax




4. Possible side effects


PACKAGE LEAFLET: INFORMATION FOR THE USER Zovirax® Eye Ointment (aciclovir)

This product is available as the above name but will be referred to as

Zovirax throughout the remainder of this 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

Zovirax 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.

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. 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.

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 % 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 % 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.

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.

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/vellowcard. 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.

•    Store below 25°C.

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

•    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.

•    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. Contents of the pack and other information

What Zovirax Eye Ointment contains

•    The active substance is aciclovir.

•    The ointment contains 3% w/w aciclovir.

•    The other ingredient is white soft paraffin.

What Zovirax looks like and contents of the pack

Each carton contains a 4.5 g tube of Zovirax.

Zovirax eye ointment is a sterile, off-white ointment contained in a tube with a white screw cap.

Manufacturer

Glaxo Wellcome Operations UK Ltd - Harmire Road - Barnard Castle - UK.

Procured from within the EU. Parallel Import Product Licence holder:

G Pharma Ltd, Dakota Ave, Salford m50 2PU.

PL 16369/0851 Zovirax® Eye Ointment

Zovirax® is a registered trademark of the Wellcome Foundation

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24/03/2014