Aciclovir 200mg/5ml Suspension
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Z ovirax ®
Read all of this leaflet carefully before you start
taking this medicine 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 Content of the pack and other information
1. What Zovirax is and what it is used for
Zovirax 200mg/5ml 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 and genital herpes
• 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 (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.
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
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
200mg/5ml Suspension
(aciclovir)
• mycophenolate mofetil, used to stop your body rejecting transplanted organs.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before using any
medicine.
Excipient Warning:
• E216 propyl parahydroxybenzoate, E218 methyl parahydroxybenzoate : 'May cause allergic reactions, possibly delayed.'
3 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 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.
POM
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 (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, 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:
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.
Very 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 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).
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.
5 How to store Zovirax
• Keep out of the sight and reach of children.
• Do not store above 25°C.
• 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.
• If the suspension become discoloured or show any signs of deterioration, you should seek the advice of your pharmacist.
6 Content of the pack and other Information
What Zovirax contains
• Each 5ml contains 200mg of the active ingredient aciclovir.
• The other ingredients are sorbitol, microcrystalline cellulose, sodium carboxymethylcellulose, glycerol, propyl parahydroxybenzoate, methyl parahydroxybenzoate, vanillin, banana flavour and purified water.
What Zovirax looks like and contents of the pack
Zovirax is supplied to you in an amber-coloured glass bottle containing an off-white suspension with a characteristic odour. A measuring cup is supplied with indications for 2.5ml, 5ml and 10ml.
Manufactured by: Glaxo Wellcome GmbH & Co. KG, Industriestrasse 32-36, 23843 Bad Oldesloe, Germany.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield, Ruislip, Middlesex, HA4 0NU, UK
Zovirax® 200mg/5ml Suspension - PL No: 18799/2110
Leaflet date: 18.09.2014
Zovirax is a registered trademark of the GlaxoSmithKline
Aciclovir
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.
The name of your medicine is Aciclovir 200mg/5ml Suspension, but it will be referred to as Aciclovir throughout this leaflet.
In this leaflet:
1 What Aciclovir is and what it is used for
2 What you need to know before you take Aciclovir
3 How to take Aciclovir
4 Possible side effects
5 How to store Aciclovir
6 Content of the pack and other nformation
1 What Aciclovir is and what it is used for
Aciclovir 200mg/5ml Suspension (called 'Aciclovir' 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.
Aciclovir 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 systems work less well, which means their bodies are less able to fight infections.
2 What you need to know Before you take Aciclovir
Do not use Aciclovir if:
• you are allergic (hypersensitive) to aciclovir or valaciclovir or any of the other ingredients (listed in Section 6).
Do not take Aciclovir if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Aciclovir.
Warnings and precautions
Talk to your your doctor or pharmacist before taking Aciclovir 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 Aciclovir.
It is important that you drink plenty of water while taking Aciclovir.
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 a prescription, including herbal medicines.
In particular tell your doctor or pharmacist if you are taking any of the following medicines:
Package leaflet: Information for the user
200mg/5ml Suspension
• probenecid, used to treat gout
• cimetidine, used to treat stomach ulcers
• mycophenolate mofetil, used to stop your body rejecting transplanted organs.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before using any
medicine.
Excipient Warning
• E216 propyl parahydroxybenzoate, E218 methyl parahydroxybenzoate : 'May cause allergic reactions, possibly delayed.'
3 How to take Aciclovir
Always take Aciclovir 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 Aciclovir as soon as possible.
The dose that you should take will depend on what you have been given Aciclovir 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 Aciclovir 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 Aciclovir 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 Aciclovir 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 Aciclovir until your doctor tells you to stop.
Your doctor may adjust the dose of Aciclovir 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 Aciclovir.
Talk to your doctor before taking Aciclovir if any of the above apply.
If you take more Aciclovir than you should
Aciclovir is not usually harmful, unless you take too much over several days. Talk to your doctor or pharmacist if you take too much Aciclovir. Take the medicine pack with you.
If you forget to take Aciclovir
• If you forget to take Aciclovir, 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.
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.
5 How to store Aciclovir
4 Possible side effects
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 1,000 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
• 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.
Very 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 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).
• Keep out of the sight and reach of children.
• Do not store above 25°C.
• Do not use Aciclovir 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.
• If the suspension become discoloured or show any signs of deterioration, you should seek the advice of your pharmacist.
6 Content of the pack and other information
What Aciclovir contains
• Each 5ml contains 200mg of the active ingredient aciclovir.
• The other ingredients are sorbitol, microcrystalline cellulose, sodium carboxymethylcellulose, glycerol, propyl parahydroxybenzoate, methyl parahydroxybenzoate, vanillin, banana flavour and purified water.
What Aciclovir looks like and contents of the pack
Aciclovir is supplied to you in an amber-coloured glass bottle containing an off-white suspension with a characteristic odour. A measuring cup is supplied with indications for 2.5ml, 5ml and 10ml.
Manufactured by: Glaxo Wellcome GmbH & Co. KG, Industriestrasse 32-36, 23843 Bad Oldesloe, Germany.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield, Ruislip, Middlesex, HA4 0NU, UK pom
Aciclovir 200mg/5ml Suspension - PL No: 18799/2110
Leaflet date:18.09.2014