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PARACETAMOL 120 MG/5 ML ORAL SUSPENSION

Active substance(s): PARACETAMOL

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PATIENT INFORMATION LEAFLET
PARACETAMOL 120 mg/5 ml ORAL SUSPENSION
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 Paracetamol 120 mg/5 ml Oral Suspension
carefully to get the best results from it.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

You must see a doctor if your child’s symptoms worsen or do not improve after 3 days.

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 Oral Suspension is and what it is used for
2.
Before you give Paracetamol Oral Suspension to your child
3.
How to give Paracetamol Oral Suspension to your child
4.
Possible side effects
5.
How to store Paracetamol Oral Suspension
6.
Further information
1.

WHAT PARACETAMOL ORAL SUSPENSION IS AND WHAT IT IS USED FOR

Paracetamol 120 mg/5 ml Oral Suspension (“Paracetamol Oral Suspension”) contains paracetamol to relieve pain and reduce
high temperatures. Paracetamol Oral Suspension can be used in babies and children for the treatment of mild or moderate
pain and feverishness associated with teething, toothache, headache, colds and flu. It can also be used in babies who develop
fever after vaccination.
2.

BEFORE YOU GIVE PARACETAMOL ORAL SUSPENSION TO YOUR CHILD

DO NOT give Paracetamol Oral Suspension if your child is taking any other paracetamol-containing products, other
flu, cold, cough or decongestant products, or alcohol.
DO NOT give Paracetamol Oral Suspension to your child if he/she:

is allergic (hypersensitive) to paracetamol, or any of the other ingredients of Paracetamol Oral Suspension (see
Section 6 and end of Section 2).

has kidney or liver problems
If you are not sure about any of the above, please consult your doctor.
Take special care with Paracetamol Oral Suspension
If your child does not get better, talk to your doctor.
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:

are to treat ‘flu’ or a cold, containing paracetamol and/or a decongestant

thin the blood (e.g. warfarin)

control nausea and vomiting (e.g. domperidone or metoclopramide)

reduce levels of cholesterol and other fats in the blood (e.g. colestyramine)

treat epilepsy (e.g. anti-convulsants)

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 Oral Suspension.
Avoid alcohol while 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 breast-feeding.
Driving and using machines
This medicine is intended for use in children. However, it should be noted that Paracetamol Oral Suspension is not expected to
affect ability to drive or operate machinery.
Important information about some of the ingredients of Paracetamol Oral Suspension
Paracetamol Oral Suspension contains:

Ethanol: This medicinal product contains small quantities of ethanol (alcohol), less than 100 mg per 5 ml. (It contains
up to 0.08 g of ethanol (alcohol) per 5 ml dose, equivalent to less than 2 ml beer or 1 ml wine per 5 ml dose).

Liquid Maltitol (E965): if your child has an intolerance to some sugars, contact your doctor before giving this medicine.
3.
HOW TO GIVE PARACETAMOL ORAL SUSPENSION TO YOUR CHILD
Check the tables overleaf to see how much of the medicine to use
• 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 anything else containing paracetamol while giving this medicine

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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
4 times
One 5 ml spoonful (large end)
One 5 ml spoonful (large end) and
4 times
one 2.5 ml spoonful (small end)
Two 5 ml spoonfuls (large end)
4 times
4 - 8 years
Three 5 ml spoonfuls (large end)
4 times
8 - 10 years
Four 5 ml spoonfuls (large end)
4 times
10 - 12 years
• 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 your child does not get better, talk to your doctor

If your child takes more of this medicine than they should:
Talk to a doctor at once if your child takes too much of this medicine even if they seem well. This is because too much
paracetamol can cause delayed, serious liver damage.
If you forget to give this medicine:
If you miss a dose give it as soon as you remember and take any remaining doses for that day at evenly spaced times.
Do not take a double dose to make up for the missed dose.
4.

POSSIBLE SIDE EFFECTS

Like all medicines, Paracetamol Oral Suspension can cause side effects although not everybody gets them.
You or your child may notice the following:

rash, itchy skin, swelling of the lips, eyes, tongue, or difficulty in breathing, which may be signs of an
allergic reaction. STOP giving Paracetamol Oral Suspension to your child immediately.

blood disorders
Very rare cases of serious skin reactions have been reported.
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 PARACETAMOL ORAL SUSPENSION

Keep all medicines out of reach and sight of children. Do not store above 25˚C. Store in the original container. Keep the
container in the outer carton. Do not use this medicine after the expiry date which is stated on the label and/or carton. The
expiry date 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. These measures will help to protect the environment.
6.
FURTHER INFORMATION
What Paracetamol Oral Suspension contains
Each 5 ml of Paracetamol Oral Suspension contains:

The active ingredient: paracetamol 120 mg.

The other ingredients are: ethanol, sorbitan monooleate, glycerol (E422), magnesium aluminium silicate, liquid
maltitol (E965), saccharin sodium (E954), xanthan gum, cherry flavour, sodium benzoate (E211), citric acid
monohydrate, polysorbate 80 and purified water (see end of Section 2 for further information).
What Paracetamol Oral Suspension looks like and contents of the pack:
Paracetamol Oral Suspension is a cream to brown oral suspension with cherry odour and taste presented in 70 ml, 100 ml,
150 ml and 200 ml amber glass bottles with pilfer-proof screw caps. A 2.5 ml/5 ml measuring spoon is provided. This
medicinal product is a colour free and sugar free product.
Marketing Authorisation Holder:
Pinewood Laboratories Limited, Ballymacarbry, Clonmel, Co. Tipperary, Ireland.
Product Licence Number: PL 04917/0028
Manufacturers:
Pinewood Laboratories Limited, Ballymacarbry, Clonmel, Co. Tipperary, Ireland or
CP Pharmaceuticals Ltd., Ash Road North, Wrexham, LL13 9UF.
Date of revision:
June 2014
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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