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PARACETAMOL 250 MG/5 ML ORAL SUSPENSION

Active substance(s): PARACETAMOL

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PATIENT INFORMATION LEAFLET
PARACETAMOL 250 mg/5 ml ORAL SUSPENSION
Paracetamol 250 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 250 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 250 mg/5 ml Oral Suspension (“Paracetamol Oral Suspension”) contains paracetamol to relieve pain and reduce
high temperatures. Paracetamol Oral Suspension can be used in children and adults for the treatment of mild or moderate pain
and feverishness associated with teething, toothache, headache, colds and flu. It is suitable for adults who have difficulty
swallowing tablets.
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)

are used to prevent pregnancy (e.g. oral steroidal contraceptives)
The effects of alcohol may be increased whilst taking Paracetamol Oral Suspension
Avoid alcohol when taking this medicine.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicines during pregnancy or breast-feeding.
Driving and using machines
Paracetamol Oral Suspension is not expected to affect your 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 up to 0.15 g per 5 ml dose of ethanol (alcohol), equivalent to 3.6 ml beer
or 1.5 ml wine per 5 ml dose. Harmful for those suffering from alcoholism. To be taken into account in pregnant or
breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.

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 table 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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Child’s Age
6 - 8 years
8 - 10 years

How Much
How often (in 24 hours)
One 5 ml spoonful (large end)
4 times
One 5 ml spoonful (large end) and
4 times
one 2.5 ml spoonful (small end)
10 - 12 years
Two 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 your child does not get better, talk to your doctor
• Do not give to children under the age of 6 years.

Children aged 12-16 years: Two - three 5 ml spoonfuls (large end) up to 4 times a day
Adults and children over 16 years: Two - four 5 ml spoonfuls (large end) up to 4 times a day.
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 250 mg.

The other ingredients are: ethanol, sorbitan monooleate, glycerol (E422), magnesium aluminium silicate, liquid
maltitol (E965), saccharin sodium (E954), xanthan gum, orange 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 orange 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 04917/0029
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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Further information

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