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CALPOL INFANT SUGAR FREE COLOUR FREE 120 MG/5 ML ORAL SUSPENSION SACHETS

Active substance(s): PARACETAMOL

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2 Before giving the
medicine to your child
Infant Sugar Free
Colour Free
120 mg/5 ml
Oral Suspension Sachets
Contains 120 mg Paracetamol per 5 ml

This medicine brings down high temperatures (also
called fever) and relieves pain.
■ The medicine is OK for most babies over 2 months and
children up to 6 years.
■ Do not give it to children on this list:
■ Not to babies or children taking some other
medicines. See section 2
■ Not to anyone who is allergic to the ingredients.
See section 6
■ Follow the dosage instructions carefully. Children of
different ages need different amounts. These are shown
in the tables. See section 3
■ Speak to your doctor if anything in this list applies:
■ If a child is not getting better, or needs more
medicine than shown in the table. See section 3
■ If a child gets a rash, breathing problems, diarrhoea or
gets very tired. See section 3


Now read this whole leaflet carefully before you use
this medicine. Keep the leaflet: you might need it again.

1 What the medicine is for
The paracetamol in Calpol Infant Sugar Free Colour Free
120 mg/5 ml Oral Suspension Sachets is used to relieve
pain and/or bring down fever (high temperature) in many
conditions including post-immunisation fever, teething,
headache, cold and flu, toothache, earache, sore throat and
other aches and pains.

This medicine is suitable for most people but a few people
should not use it. If you are in any doubt, talk to your doctor or
pharmacist.

Do not give your child this medicine…

If adults take this medicine:
The following additional warnings are included in case an
adult takes this product:
■ You can use this medicine while you are taking oral
contraceptives (‘the pill’), but it may not work so well on
your pain or fever.
■ If you drink large amounts of alcohol, you may be more
open to the side-effects of paracetamol.
■ Ask your doctor or pharmacist for advice before taking
this medicine if you might be pregnant or breast-feeding.

If s/he has ever had a bad reaction to any of
the ingredients.
■ If s/he is taking anything else with
paracetamol in it.
■ If s/he is between 2-3 months old and is taking
this medicine for other causes of pain and fever
and:
■ Weighs less than 4 kg
or
■ Was born before 37 weeks


Some of the ingredients can cause
problems
Methyl (E218), propyl (E216) and ethyl (E214)
parahydroxybenzoate may cause allergic
reactions which could possibly be delayed.
■ The sorbitol liquid (E420) and maltitol liquid (E965)
content of this product means that this product is
unsuitable for people with inherited intolerance to
fructose.
■ Maltitol liquid may have a mild laxative effect. It has
a calorific value of 2.3kcal/g.


If any of these applies, get advice from a doctor or
pharmacist without using Calpol.

3 How to use this medicine
Talk to your doctor or pharmacist…
If your child has serious kidney or liver
problems.
■ If your child has an inherited intolerance
to fructose or been diagnosed with an
intolerance to some other sugars.
■ If your child is taking any other medicines
including:
■ metoclopramide or domperidone (used to treat
nausea and vomiting)
■ colestyramine (used to treat high cholesterol)
■ anticoagulants (drugs that thin the blood, such
as warfarin)
■ anticonvulsants (drugs to treat epilepsy)
If you are not sure about the medicine your child is
taking, show the bottle or pack to your pharmacist.
If any of these bullet points apply, talk to a doctor
or pharmacist.


Check the tables to see how much medicine
to use.
For oral use only.
Each sachet contains 5 ml of this medicine.
Any unused contents of the open sachet should
be discarded.
■ Do not give more medicine than the label tells you to.
If your child does not get better, talk to your doctor.
■ Do not overfill the spoon.
■ Always use the spoon supplied with the pack.
■ It is important to massage the sachet before use.
■ Do not give anything else containing paracetamol
while giving this medicine.
There is a double-ended
spoon in the pack.



Babies up to 2 months
Do not give to babies under 2 months old. Consult
your doctor.

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Pg. 1

Babies 2 - 3 months
Child's age - 2-3 months

How much

1. Post-vaccination fever

2.5 ml (small end of
spoon).
2. Other causes of pain and fever If necessary, after 4-6
- if your baby weighs over 4 kg hours, give a second
and was born after 37 weeks
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.



Children from 3 months to 6 years
Child's age

How much - up to 4 times a day

3-6 months

One 2.5 ml spoonful (small end)

6-24 months

One 5 ml spoonful (large end)

2-4 years

One 5 ml spoonful (large end) and
one 2.5 ml spoonful (small end)

4-6 years

Two 5 ml spoonfuls (large end)

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.



i

Children over 6 years
Ask a pharmacist to recommend a suitable product.

Speak to your doctor:
If your baby needs more than the doses shown in
the table, or if fever doesn’t go away, speak to your
doctor as soon as possible.
■ If you are not sure of the cause of your child’s
illness or it is accompanied by a rash, breathing
difficulties, diarrhoea or excessive tiredness or
lethargy, speak to your doctor straight away. Do not
give Calpol until you get medical advice.


If anyone has too much
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 the medicine
Give the next dose when needed, provided that the last
dose was given at least 4 hours ago.
Do not give a double dose.

4 Possible side-effects
Calpol Infant Sugar Free Colour Free 120 mg/5 ml Oral
Suspension Sachets can have side-effects, like all medicines,
although these don’t affect everyone and are usually mild.

Tell your doctor as soon as possible if you
notice any of these:
allergic reactions including swelling of the face, tongue
or throat, difficulty swallowing, unexplained wheezing,
shortness of breath which may be accompanied by
skin rash or hives.
■ becoming unusually tired, unexpected bruising or
bleeding and getting more infections (such as colds)
than usual. These are very rare effects in people taking
paracetamol.
■ Very rare cases of serious skin reactions have been
reported. Symptoms may include:
■ Skin reddening
■ Blisters
■ Rash
If skin reactions occur or existing skin symptoms worsen,
stop use and seek medical help right away.
If your child shows any of these signs, stop giving
paracetamol and talk to a doctor right away.


Long term use: People who use medicines containing
paracetamol every day for a long time (several months or
more) could get certain side-effects, including liver and kidney
damage. People taking paracetamol in the usual way for
shorter periods have not had these problems, but liver function
tests may be affected.
If you notice any side-effects not included in this leaflet please
tell your doctor or pharmacist.

If you experience any side-effect not included in this
leaflet or are unsure of anything, talk to your doctor or
pharmacist. Also you can help to make sure medicines
remain as safe as possible by reporting any unwanted
side-effects via the internet at www.mhra.gov.uk/
yellowcard; alternatively you can call Freephone 0808
100 3352 (available between 10am – 2pm Monday to
Friday) or fill in the paper form available from your local
pharmacy.

5 Storing this medicine
Keep the product out of the reach and sight of children.
Do not store above 25°C.
Keep sachets in the outer carton.
Do not use after the end of the month shown as an expiry
date on the packaging.
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’s in this medicine?
The active ingredient is: Paracetamol 120 mg per 5 ml
Other ingredients are: Maltitol liquid (E965),
glycerol, polysorbate 80, sorbitol liquid (E420), methyl
parahydroxybenzoate (E218), propyl parahydroxybenzoate
(E216), ethyl parahydroxybenzoate (E214), dispersible
cellulose, xanthan gum and purified water. The flavouring is
strawberry.

What the medicine looks like
Calpol Infant Sugar Free Colour Free 120 mg/5 ml Oral
Suspension Sachets is an off-white liquid, available in
packs of 12 or 20 x 5 ml sachets. It contains 120 mg
of the active ingredient paracetamol in every 5 ml of
medicine.
The Product Licence holder is McNeil Products Ltd,
Maidenhead, Berkshire, SL6 3UG, UK.
The manufacturer is Famar Orléans, 5 avenue de Concyr,
45071 Orléans, Cedex 2, France.
This leaflet was revised May 2014.
Calpol is a registered trade mark.

F306970-66 / 14-041

3 How to use this medicine
(continued)

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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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