Aciclovir 400mg/5ml Oral Suspension
Thame Laboratories
Thame Laboratories
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1. What Aciclovir Oral Suspension is and what it is used for
► You are allergic (hypersensitive) to
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
400mg/5ml Oral Suspension but it will
be referr ed to as Aciclovir Oral
Suspension throughout this leaflet.
What is in this leaflet
1. What Aciclovir Oral Suspension is and what it is used for
2. What you need to know before you take Aciclovir Oral Suspension
3. How to take Aciclovir Oral Suspension
4. Possible side effects
5. How to store Aciclovir Oral Suspension
6. Contents of the pack and other information
Aciclovir oral suspension contains the active substance aciclovir. This belongs to a group of medicines called antivirals. It works by killing or stopping the growth of viruses.
Aciclovir Oral Suspension can be used to:
► Treat chickenpox and shingles.
► Treat cold sores and genital 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.
aciclovir or valaciclovir or any of the other ingredients of this medicine (listed in section 6).
Do not take Aciclovir Oral Suspension if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Aciclovir Oral Suspension.
Warnings and precautions
Talk to your doctor or pharmacist before taking Aciclovir Oral Suspension if:
► You have kidney problems.
► You are over 65 years of age.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Aciclovir Oral Suspension.
It is important that you drink plenty of water while taking Aciclovir Oral Suspension.
Other medicines and Aciclovir Oral Suspension
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine. This includes medicines obtained without a prescription and 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 transplant organs.
Pregnancy, breastfeeding 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.
Aciclovir Oral Suspension contains
Aciclovir oral suspension contains Sorbitol liquid (non-crystallising) (E420). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. You may have a mild laxative effect after taking this medicine. Calorific value 2.6 kcal/g sorbitol.
Aciclovir oral suspension contains
methyl parahydroxybenzoate (E218), which may cause an allergic reaction (possibly delayed).
3. How to take Aciclovir Oral Suspension
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The dose that you should take will depend on what you have been given Aciclovir Oral Suspension 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 Aciclovir Oral Suspension for seven days.
Treatment of cold sores and genital herpes
► The usual dose is one 2.5 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 Oral Suspension 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 2.5 ml spoonful four times a day.
► You should try to space each dose by 6 hours.
► You should take Aciclovir Oral Suspension 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 2.5 ml spoonful four times a day.
► You should try to space each dose by 6 hours.
► You should take Aciclovir Oral Suspension until your doctor tells you to stop.
Your doctor may adjust the dose of Aciclovir Oral Suspension 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 Oral Suspension.
Talk to your doctor before taking Aciclovir Oral Suspension if any of the above apply.
Taking this medicine
► Take this medicine by mouth.
► Use the spoon provided to carefully measure the dose needed.
► Start to take Aciclovir Oral Suspension as soon as possible.
Method of administration
► Take this medicine by mouth.
► Use the spoon provided to carefully measure the dose needed (see figure below).
► Start to take Aciclovir Oral Suspension as soon as possible.
► Shake the bottle well before use.
► Swallow the suspension.
► Wash the spoon with clean water after taking every dose.
TURN OVER
PIL/UK/MFG108/03/v1
2.5ml 5ml
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(Small end) (Large end)
4. Possible side effects
5. How to store Aciclovir Oral Suspension
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POM
2.5-5ml double-ended spoon
If you take more Aciclovir Oral Suspension than you should
Aciclovir Oral Suspension is not usually harmful, unless you take too much over several days. Talk to your doctor or pharmacist if you take too much Aciclovir Oral Suspension. Take the medicine pack with you.
If you forget to take Aciclovir Oral Suspension
► If you forget a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose.
► Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine 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 Aciclovir Oral Suspension and see a doctor straight away. The
signs may include:
► Rash, itching or hives on your skin.
► Swelling of the face, lips, tongue or throat 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.
► Itching.
► Skin reaction after exposure to light (photosensitivity).
► 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 are not there).
► Fits.
► Feeling unusually sleepy or drowsy.
► Unsteadiness when walking and lack of coordination.
► Difficulty speaking.
► Inability to think orjudge 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 or whites of the eyes (jaundice).
► Kidney problems where you pass little or no urine.
► Pain in your lower back, the kidney area of your back or above your hip (renal pain).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 this medicine out of the sight and reach of children.
► Do not use after the expiry date which is printed on the carton and bottle label after 'Exp'. The expiry date refers to the last day of that month.
► Do not store above 25°C.
► Do not refrigerate or freeze.
► Discard 30 days after first opening.
► Do not use this medicine if you notice that the suspension becomes discoloured or shows any signs of deterioration. Seek the advice of your pharmacist.
► Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
/■ \ ■6. Contents of the pack and other “information
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What Aciclovir Oral Suspension contains
The active substance is aciclovir.
Each 5ml of oral suspension contains 400mg aciclovir.
The other ingredients are xanthan gum (E415), sorbitol liquid (noncrystallising) (E420), methyl parahydroxybenzoate (E218), orange flavour (containing propylene glycol (E1520)), vanilla flavour (containing propylene glycol (E1520)) and purified water.
What Aciclovir Oral Suspension looks like and contents of the pack
A white to off-white uniform oral suspension with orange and vanilla odour. It comes in an amber glass bottle with a child-resistant plastic cap. The pack also contains a 2.5-5ml double ended measuring spoon.
This medicine is available in a bottle containing 100ml of oral suspension.
Marketing Authorisation Holder and Manufacturer:
Syri Limited t/a Thame Laboratories, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
This leaflet was last revised in 04/2016.
PIL/UK/MFG108/03/v1