CALPOL SUGAR FREE INFANT SUSPENSION

Active substance: PARACETAMOL

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parahydroxybenzoate may cause allergic reactions
which could possibly be delayed.
■ The sorbitol (E420) and maltitol content of this
product means that this product is unsuitable for
people with inherited intolerance to fructose.
■ Maltitol may have a mild laxative effect. It has a
calorific value of 2.3kcal/g.
■ Carmoisine (E122) may cause allergic reactions.

Do not give your child this medicine…
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



Sugar Free
Infant Suspension
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 c
■ Not to anyone who is allergic to the ingredients.
See section 6 c
■ Follow the dosage instructions carefully. Children of
different ages need different amounts. These are shown in
the tables. See section 3 c
■ 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 c
■ If a child gets a rash, breathing problems, diarrhoea or
gets very tired. See section 3 c

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

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

3 How to use this medicine

If any of these bullet points apply, talk to a doctor or
pharmacist.



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

2 Before giving the
medicine to your child
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.

F308604-PIL-CALPOLSF100200ml-UKv8.6.indd 1

Check the tables to see how much medicine
to use.

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.





For oral use only.
Always use the syringe supplied with the pack.
■ It is important to shake the bottle for
at least 10 seconds before use.
■ Never give more medicine than shown in the tables.
■ Do not give this medicine with any other paracetamolcontaining product.

i

How to use the syringe
Shake the bottle for at least 10 seconds and
remove the cap.
■ There is a plug with a hole in the neck of
the bottle. Insert the end of the syringe in to
the hole and ensure it is secure.


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.

Some of the ingredients can cause
problems


Methyl (E218), propyl (E216) and ethyl (E214)



Hold the syringe in place and turn the
bottle upside down and gently pull down
the plunger to either 2.5 ml or 5ml as
appropriate (see tables for the correct dose).



Turn the bottle the right way up.
Remove the syringe by holding onto the
bottle and twisting out gently.



turn over

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3 How to use this medicine
(continued)

i

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

Speak to your doctor:
Place the syringe inside the child's mouth against the
cheek and press the plunger slowly to gently release the
medicine.
■ After use, the plug should remain in the neck of the bottle.
Wipe the plug and neck clean and rinse the cap before
replacing.
■ The syringe should be washed and dried after use. It can
be cleaned by hand or in a dishwasher.


i

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.


Babies under 2 months

If anyone has too much

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

Immediate medical advice should be sought in
the event of an overdose, even if the child seems
well, because of the risk of delayed, serious liver
damage.

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

How much

1. Post-vaccination fever

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

2.5 ml

6-24 months

5 ml

2-4 years

7.5 ml (5 ml + 2.5 ml)

4-6 years

10 ml (5 ml + 5 ml)

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.



F308604-PIL-CALPOLSF100200ml-UKv8.6.indd 2

kidney damage. People taking paracetamol in the usual
way for shorter periods have not had these problems.
If you notice any side-effects not included in this leaflet
please tell your doctor or pharmacist.

5 Storing this medicine
Keep the product out of the reach and sight of children.
Do not store above 25°C.
Keep bottle 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.

If you forget to give the medicine

6 Further information

Give the next dose when needed, provided that the
last dose was given at least 4 hours ago.
Do not give a double dose.

What’s in this medicine?

4 Possible side effects
Calpol Sugar Free Infant Suspension 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.
If your child shows any of these signs, stop giving
paracetamol and talk to a doctor.


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

The active ingredient is: Paracetamol 120 mg per 5 ml
Other ingredients are: Maltitol liquid, glycerol, polysorbate
80, sorbitol solution (E420), methyl parahydroxybenzoate
(E218), propyl parahydroxybenzoate (E216), ethyl
parahydroxybenzoate (E214), dispersible cellulose,
xanthan gum and purified water. The flavouring is
strawberry and colouring is carmoisine (E122).

What the medicine looks like
Calpol Sugar Free Infant Suspension is a pink liquid,
available in 100 ml and 200 ml bottles. 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 Orleans, 5 avenue de
Concyr, 45071 Orléans, Cedex 2, France.
This leaflet was revised January 2012.
Calpol is a registered trade mark.
F308604
11-0189

30/01/12 12:03

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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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