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PATIENT INFORMATION LEAFLET
PAEDIATRIC PARACETAMOL ELIXIR BP
Paracetamol 120 mg/5 ml
Read all of this leaflet carefully because it contains important information for you and your child.
This medicine is available without prescription; however, you still need to give Paediatric Paracetamol Elixir carefully to get
the best results from it.
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Keep this leaflet. You may need to read it again.
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Ask your pharmacist if you need more information or advice.
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You must see a doctor if your child’s symptoms worsen or do not improve after 3 days.
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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.
In this leaflet:
1.
What Paracetamol Elixir is and what it is used for
2.
Before you give Paracetamol Elixir to your child
3.
How to give Paracetamol Elixir to your child
4.
Possible side effects
5.
How to store Paracetamol Elixir
6.
Further information
1.
WHAT PARACETAMOL ELIXIR IS AND WHAT IT IS USED FOR
Paediatric Paracetamol Elixir (“Paracetamol Elixir”) contains paracetamol to relieve pain and reduce high temperatures.
Paracetamol Elixir can be used in babies and children for the treatment of mild or moderate pain and feverishness, and also
in babies who develop fever after vaccination.
2.
BEFORE YOU GIVE PARACETAMOL ELIXIR TO YOUR CHILD
DO NOT give Paracetamol Elixir if your child is taking any other paracetamol containing products, other flu, cold,
cough or decongestant products, or alcohol.
DO NOT give Paracetamol Elixir to your child if he/she:
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is allergic (hypersensitive) to paracetamol, or any of the other ingredients of Paracetamol Elixir (see Section 6 and
end of Section 2).
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has kidney or liver problems
If you are not sure about any of the above, please consult your doctor.
Take special care with Paracetamol Elixir
Seek advice from your doctor or pharmacist:
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if your child is under 2 months of age
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if the symptoms persist.
Taking other medicines
Tell your doctor or pharmacist if your child is taking, or has recently taken, any other medicine, even those obtained without a
prescription, but especially medicines which:
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are to treat ‘flu’ or a cold, containing paracetamol and/or a decongestant
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thin the blood (e.g. warfarin)
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control nausea and vomiting (e.g. domperidone or metoclopramide)
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reduce levels of cholesterol and other fats in the blood (e.g. colestyramine).
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treat epilepsy (e.g. anti-convulsants)
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have been prescribed by your doctor to improve sleep (e.g. barbiturates), or for anxiety or depression
(e.g. tricyclic antidepressants)
The effects of alcohol may be increased whilst taking Paracetamol Elixir.
Avoid alcohol when taking this medicine.
Pregnancy and breast-feeding
This medicine is intended for use in children.
Ask your doctor or pharmacist for advice before taking any medicines during pregnancy or breastfeeding.
Driving and using machines
This medicine is intended for use in children. However, it should be noted that Paracetamol Elixir is not expected to affect
ability to drive or operate machinery.
Important information about some of the ingredients of Paracetamol Elixir
Paracetamol Elixir contains:
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Ethanol: This medicinal product contains 0.5 g of ethanol (alcohol) per 5 ml dose, equivalent to 12 ml beer or 5 ml
wine per 5 ml dose. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breastfeeding women, children and high-risk groups such as patients with liver disease, or epilepsy.
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Sorbitol: if your child has an intolerance to some sugars, contact your doctor before giving this medicine.
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Propylene glycol: may cause alcohol-like symptoms, so you should supervise your child after giving this medicine.
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3.
HOW TO GIVE PARACETAMOL ELIXIR TO YOUR CHILD
Check the tables below to see how much of the medicine to use
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For oral use only
It is important to shake the bottle for at least 10 seconds before use
Never give more medicine than shown in the table
Do not overfill the spoon
Always use the spoon supplied with the pack
Do not give this medicine with any other paracetamol-containing product
Age
Dose
For post-vaccination fever for
One 2.5 ml spoonful (small end)
babies aged between 2 - 3 months If necessary, after 4-6 hours, give a second 2.5 ml dose
• Do not give to babies less than 2 months of age
• Do not give more than 2 doses
• Leave at least 4 hours between doses
• If further doses are needed, talk to your doctor or pharmacist
Child’s Age
3 - 6 months
6 - 24 months
2 - 4 years
How Much
How often (in 24 hours)
One 2.5 ml spoonful (small end)
4 times
One 5 ml spoonful (large end)
4 times
One 5.0 ml spoonful (large end) and one 2.5 ml
4 times
spoonful (small end)
4 - 8 years
Two 5 ml spoonfuls (large end)
4 times
8 - 10 years
Three 5 ml spoonfuls (large end)
4 times
10 - 12 years
Four 5 ml spoonfuls (large end)
4 times
• Do not give more than 4 doses in any 24 hour period
• Leave at least 4 hours between doses
• Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist
• If symptoms persist, please consult your doctor
If your child takes more of this medicine than they should: