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Aciclovir 400mg/5ml Double Strength Suspension

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Ref: LTT0050/191113/1/F

Zovirax® 400mg/5ml Double Strength Suspension/ Aciclovir 400mg/5ml Double Strength Suspension

(aciclovir)

Patient Information Leaflet

Your medicine is called Zovirax 400mg/5ml Double Strength Suspension/ Aciclovir 400mg/5ml Double Strength Suspension but will be referred to as Zovirax throughout this leaflet.

Read all of this leaflet carefully before you start taking this medicine

*    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. 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

What Zovirax is and what it is used for [a Before you take Zovirax How to take Zovirax Possible side effects How to store Zovirax r® Further information

^ What Zovirax is and what it is used for

Zovirax contains a medicine called aciclovir. This belongs to a group of medicines called anti-virals. It works by killing or stopping the growth of viruses.

Zovirax can be used to:

*    treat chickenpox and shingles

*    treat cold sores and genital herpes

*    stop these problems returning after you have had them

*    stop these problems in people whose immune system work less well, which means their bodies are less able to fight infections.

^ Before you take Zovirax

Do not use Zovirax if:

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

Do not take Zovirax if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Zovirax.

Take Special care with Zovirax

Check with your doctor or pharmacist before taking Zovirax if:

*    you have kidney problems

*    you are over 65 years of age.

If you are not sure if the above apply to you, talk to your doctor or pharmacist before taking Zovirax.

It is important that you drink plenty of water while taking Zovirax.

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 a prescription, including herbal medicines.

In particular tell your doctor or pharmacist if you are taking any of the following medicines:

*    Probenecid, used to treat gout

*    cimetidine, used to treat stomach ulcers

*    mycophenolate mofetil, used to stop your body rejecting transplanted organs

Important information about what is in Zovirax

This medicine contains:

*    Methyl and propyl parahydroxybenzoates. These may cause allergic reactions. This allergy may happen some time after starting the medicine.

Pregnancy and breast feeding

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

[4 How to take Zovirax

Always take Zovirax exactly as your doctor has told you.

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

Taking this medicine

*    Take this medicine by mouth

*    Use the spoon provided to carefully measure the dose needed.

*    Start to take Zovirax as soon as possible.

The dose you should take will depend on what you have been given Zovirax for. Your doctor will discuss this with you.

Treatment of chickenpox and shingles

*    The usual dose is two 5 ml spoonfuls five times a day.

*    You should space each dose by 4 hours.

Suggested times are: 7am, 11am, 3pm, 7pm and 11pm.

*    You should take Zovirax for seven days.

Treatment of cold sores and genital herpes

*    The usual dose is one 2.5ml spoonful five times a day.

*    You should space each dose by 4 hours.

Suggested time are: 7am, 11am, 3pm, 7pm, and 11pm.

*    You should take Zovirax for five days, or longer if your doctor tells you to.

Stopping these problems returning after you have had them

*    The usual dose is one 2.5ml spoonful four times a day.

*    You should try to space each dose by 6 hours.

*    You should take Zovirax until your doctor tells you to stop.

Stopping these problems in people whose immune systems work less well and whose bodies are less able to fight infections.

*    The usual dose is one 2.5 ml spoonful four times a day.

*    You should try to space each dose by 6 hours.

*    You should take Zovirax until your doctor tells you to stop.

Your doctor may adjust the dose of Zovirax if:

*    it is for a child

*    you are over 65 years of age

*    you have kidney problems. If you have kidney problems, it is important to drink plenty of water while you are being treated with Zovirax.

Talk to your doctor before taking Zovirax if any of the above apply.

If you take more Zovirax than you should

Zovirax is not usually harmful, unless you take too much over several days. Talk to your doctor or pharmacist if you take too much Zovirax. Take the medicine pack with you.

Zovirax® 400mg/5ml Double Strength Suspension/ Aciclovir 400mg/5ml Double Strength Suspension

(aciclovir)

Further information

What Zovirax contains:

*    The active substance in Zovirax is aciclovir.

*    The other ingredients are: sorbitol solution, glycerol, dispersible cellulose 65 CPS, methyl parahydroxybenzoate (E218), propyl parahydroxbenzoate (E216), orange flavour and purified water.

What Zovirax looks like and contents of the pack

Zovirax comes in an amber coloured glass bottle, containing an off-white, orange flavoured suspension.

The medicine comes with a double-ended measuring spoon. One end of the spoon will give you 5ml of the suspension and the other will give you 2.5ml. Zovirax is supplied in 100ml bottles.

Manufacturer and Licence Holder

This medicine is manufactured by Glaxo Wellcome GmbH & Co. KG, Industriestrasse 32-36 Bad Oldesloe, 23843, Germany and is procured from within the EU. Product Licence Holder: LTT Pharma Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE. Repackaged by Lexon (UK) Limited, Redditch, B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.

[poM PL 33723/0050 Zovirax 400mg/5ml Double Strength Suspension/ Aciclovir 400mg/5ml Double Strength Suspension


Patient Information Leaflet (continued)

If you forget to take Zovirax

*    If you forget to take Zovirax, take it as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose.

*    Do not take a double dose to make up for a forgotten dose.

[4 Possible side effects

Like all medicines, Zovirax can cause side effects, although not everyone gets them. The following side effects may happen with this medicine:

Allergic reactions (affects less than 1 in 1,000 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, tongues 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:

Common (affects less than 1 in 10 people)

*    headache

*    feeling dizzy

*    feeling or being sick

*    diarrhoea

*    stomach pains

*    rash

*    skin reaction after exposure to light (photosensitivity)

*    itching

*    feeling tired

*    fever

Uncommon (affects less than 1 in 100 people)

*    itchy, hive-like rash

*    hair loss

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

*    difficulty breathing

*    effects on some blood and urine tests

*    swelling of your face, lips, mouth, tongue or throat

Vary rare (affects less than 1 in 10,000 people)

*    nosebleeds and bruising more easily than usual

*    feeling weak

*    feeling agitated or confused

*    shaking or tremors

*    hallucinations (seeing or hearing things that aren't there)

*    fits

*    feeling unusually sleepy or drowsy

*    unsteadiness when walking and lack of coordination

*    difficulty speaking

*    inability to think or judge clearly

*    unconsciousness (coma)

*    paralysis of part or all of your body

*    disturbances of behavior, speech and eye movements

*    stiff neck and sensitivity to light

*    inflammation of the liver (hepatitis)

*    yellowing of your skin and whites of your eyes (jaundice)

*    kidney problems where you pass little or no urine

*    pain in your lower back, the kidney area of your back or just above your hip (renal pain).

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 and 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 help provide more information on the safety of this medicine.

How to store Zovirax

*    Keep out of the sight and reach of children.

*    Do not store above 30°C.

*    Store in the original container.

*    Do not use Zovirax after the expiry date which is stated on the carton. The expiry date (Exp.) refers to the last day of the 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.

Zovirax is a registered trademark of Glaxo Group Limited.

Revision date: 19/11/13

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