CALPOL SUGAR FREE INFANT SUSPENSION SACHETS

Active substance: PARACETAMOL

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2 Before giving the
medicine to your child
Sugar Free
Infant 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 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.

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 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


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 breastfeeding.

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 (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. Each
5 ml spoonful of this product contains 2.72 g of
maltitol liquid. Calorific value 2.3 kcal/g maltitol.
■ Carmoisine (E122) may cause allergic reactions.


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

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.


3 How to use this medicine
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.
■ Never give more medicine than shown in the tables.
■ 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 this medicine with any other paracetamolcontaining product.



There is a double-ended
spoon in the pack.

i

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

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3 How to use this medicine
(continued)
Babies 2 - 3 months
Child's age - 2-3 months

If anyone has too much
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.

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.


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 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.


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, 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 packs of 12 or 20 x 5 ml sachets. It contains
120 mg of the active ingredient paracetamol in every
5 ml of medicine.



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.

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.
If you notice any side-effects not included in this leaflet
please tell your doctor or pharmacist.

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 March 2011.
Calpol is a registered trade mark.



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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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