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ASDA INFANT PARACETAMOL ORAL SUSPENSION 120MG/5ML

Active substance(s): PARACETAMOL

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DUMMY

DUMMY

PATIENT INFORMATION LEAFLET
ASDA INFANT PARACETAMOL ORAL SUSPENSION 120 mg/5 ml
Paracetamol 120 mg/5 ml

Babies over 2 months in age
For the relief of fever after vaccination at 2, 3 and 4 months
2.5 ml. This dose may be given up to 4 times a day at the time of vaccination. Do not give more than 4 doses in any 24 hour period.
Leave at least 4 hours between doses. If your baby still needs this medicine two days after receiving the vaccine talk to your doctor
or pharmacist.

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 Asda Infant Paracetamol Oral Suspension 120 mg/5 ml
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 Suspension is and what it is used for
2.
Before you give Paracetamol Suspension to your child
3.
How to give Paracetamol Suspension to your child
4.
Possible side effects
5.
How to store Paracetamol Suspension
6.
Further information
1.

WHAT PARACETAMOL SUSPENSION IS AND WHAT IT IS USED FOR

Pain and other causes of fever - if your baby weighs over 4 kg
and was born after 37 weeks




DO NOT give Paracetamol Suspension to your child if he/she:

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

has kidney or liver problems

has a rare hereditary problem of fructose intolerance.
If you are not sure about any of the above, please consult your doctor.
Take special care with Paracetamol 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 Suspension.
Avoid alcohol when taking this medicine.





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

Ethanol: This medicinal product contains small amounts of ethanol (alcohol) less than 100 mg per dose. (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).

Hydrogenated glucose syrup (E965): if your child has an intolerance to some sugars, contact your doctor before giving this
medicine.

Amaranth (E123) (colouring): may cause allergic reactions.
HOW TO GIVE PARACETAMOL SUSPENSION TO YOUR CHILD

DUMMY

How Much
2.5 ml
5 ml
7.5 ml (5 ml + 2.5 ml)
10 ml (5 ml + 5 ml)

How often (in 24 hours)
4 times
4 times
4 times
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 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 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 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 SUSPENSION

Keep all medicines out of the sight and reach 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.

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.

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

2.5 ml
If necessary, after 4-6 hours, give a second 2.5 ml dose

Do not give to babies less than 2 months of age
Leave at least 4 hours between doses
Do not give more than 2 doses. This is to ensure that fever that may be due to a serious infection is quickly diagnosed. If your
child is still feverish after two doses, talk to your doctor or pharmacist.

Child’s Age
3 - 6 months
6 - 24 months
2 - 4 years
4 - 6 years

BEFORE YOU GIVE PARACETAMOL SUSPENSION TO YOUR CHILD

DO NOT give Paracetamol Suspension if your child is taking any other paracetamol containing products, other flu, cold,
cough or decongestant products, or alcohol.

3.

Dose

Children aged 3 months - 6 years:

Your medicine is called Asda Infant Paracetamol Oral Suspension 120 mg/5 ml. It will be referred to throughout this leaflet as ‘Paracetamol
Suspension’. Paracetamol Suspension contains paracetamol to relieve pain and reduce high temperatures. Paracetamol 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.

Age 2-3 months

6.

FURTHER INFORMATION

What Paracetamol Suspension contains
Each 5 ml of Paracetamol Suspension contains:

The active ingredient: paracetamol 120 mg.

The other ingredients are: ethanol, sorbitan monooleate, glycerol (E422), magnesium aluminium silicate, hydrogenated glucose
syrup (E965), saccharin sodium (E954), xanthan gum, amaranth (E123), cherry flavour, sodium benzoate (E211), citric acid
monohydrate, polysorbate 80 and purified water (see end of Section 2 for further information).
What Paracetamol Suspension looks like and contents of the pack:
Paracetamol Suspension is a pink 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.
Marketing Authorisation Holder:
Pinewood Laboratories Limited, Ballymacarbry, Clonmel, Co. Tipperary, Ireland.
Product Licence Number: PL 04917/0009
Manufacturers:
Pinewood Laboratories Limited, Ballymacarbry, Clonmel, Co. Tipperary, Ireland or
CP Pharmaceuticals Ltd., Ash Road North, Wrexham, LL13 9UF.
Date of revision:

June 2016

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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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