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Aciclovir 200mg-5ml Suspension

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Document: leaflet MAH BRAND_PLPI 10383-1973 change

Zovirax® 200mg/5ml Suspension Aciclovir 200mg/5ml Suspension

(aciclovir)

This product is available using either of the above names but will be referred to as Zovirax throughout the following:

Patient Information Leaflet

Read all of this leaflet carefully before you start taking 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 take Zovirax

3)    How to take 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 Suspension (called ‘Zovirax' in this leaflet) contains a medicine called aciclovir. This belongs to a group of medicines called antivirals. It works by killing or stopping the growth of viruses.

Zovirax can be used to:

•    treat chickenpox and shingles

•    treat cold sores, genitals herpes and other herpes simplex infections

•    stop these problems returning after you have had them

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

2)    What you need to know before you take Zovirax Do not use Zovirax:

•    if you are allergic to aciclovir or valaciclovir or any of the other ingredients of this medicine (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.

Warnings and precautions

Talk to 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.

Other medicines and Zovirax

Tell your doctor or pharmacist if you are taking, have recently taken or might take 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.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Some side effects such as feeling drowsy or sleepy may impair your ability to concentrate and react. Make sure you are not affected before you drive or operate machinery.

Zoivirax contains methyl parahydroxybenzoate, propyl parahydroxybenzoate and sorbital

Zovirax contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed). Zovirax also contains sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3) How to take Zovirax

Always take this medicine exactly as your doctor has told you. 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 that 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 four 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 5 ml spoonful 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 five days, or longer if your doctor tells you to.

Suppressing cold sores and genital herpes returning after you have had them

•    The usual dose is one 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.

Suppressing cold sores and genital herpes in people whose immune systems work less well and whose bodies are less able to fight infections

•    The usual dose is one 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.

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 everybody gets them. The following side effects may happen with this medicine:

Allergic reactions (may affect up to 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, tongue or other parts of your body

•    shortness of breath, wheezing or trouble breathing

•    collapse

Other side effects include:

Common (may affect up to 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

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

Uncommon (may affect up to 1 in 100 people)

•    itchy, hive-like rash

•    hair loss.

Rare (may affect up to 1 in 1,000 people)

•    effects on some blood and urine tests

•    increases in the enzymes that work in the liver.

Very rare (may affect up to 1 in 10,000 people)

•    reduced numbers of red blood cells (anaemia)

•    reduced numbers of white blood cells (leukopenia)

•    reduced numbers of blood platelets (cells that help blood to clot) (thrombocytopenia)

•    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 behaviour, 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).

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.

•    Keep out of the sight and reach of children.

•    Do not store above 25°C.

•    Once opened, use within 4 weeks

•    Do not use Zovirax after the expiry date which is stated on the carton. 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 contains

•    Each 5ml of oral suspension contains 200mg of aciclovir.

•    The other ingredients are sorbitol solution 70%, glycerol, microcrystalline cellulose, carmellose sodium, vanillin, banana flavour, purified water, methyl parahydroxybenzoate and propyl parahydroxybenzoate.

What Zovirax looks like and contents of the pack

Zovirax is an off-white suspension with a banana odour.

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 available in an amber-coloured bottle of 62.5ml.

PL 10383/1973 Zovirax 200mg/5ml Suspension    |POM|

Aciclovir 200mg/5ml Suspension

Who makes and repackages your medicine?

Your medicine is manufactured by Aspen Bad Oldesloe GmbH, Industriestrape 32-36, 23843 Bad Oldesloe, Germany and is procured from within the EU and repackaged by the Product Licence holder: Primecrown Ltd., 4/5 Northolt Trading Estate, Belvue road, Northolt, Middlesex UB5 5QS.

Leaflet date: 13.07.2015

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

5) How to store Zovirax