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CALPOL SUGAR FREE INFANT SUSPENSION

Active substance(s): PARACETAMOL / PARACETAMOL / PARACETAMOL

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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 any of these applies, get advice from a pharmacist
or doctor 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.



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 post-immunisation
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.

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.


LN50XX01-PIL CALPOL INFANT SF 100ML UKv11.3.indd 1

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.

S
 ome of the ingredients can cause
problems
 ethyl (E218), propyl (E216) and ethyl (E214)
M
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. If you
have been told by your doctor that your child has an
intolerance to some sugars, contact your doctor before
giving this medicinal product.
■ Maltitol may have a mild laxative effect. It has a
calorific value of 2.3 kcal/g.
■ Carmoisine (E122) may cause allergic reactions.


3 How to use this medicine

Check the tables to see how much medicine to
use.
For oral use only.
Always use the syringe supplied with the pack.
■ Do not give more medicine than the label tells you to.
If your child does not get better, talk to your doctor.
■ Do not give anything else containing paracetamol while
giving this medicine.



How to use the syringe

Shake
the bottle for at least 10 seconds and
remove the cap.
■T
 here 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.
■H
 old the syringe in place and turn the
bottle upside down and gently pull down
the plunger to either 2.5 ml or 5 ml 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.
■P
 lace the syringe inside the child's mouth against the cheek
and press the plunger slowly to gently release the medicine.
■A
 fter use, the plug should remain in the neck of the bottle. Wipe
the plug and neck clean and rinse the cap before replacing.
■T
 he syringe should be washed and dried after use. It can be
cleaned by hand or in a dishwasher.



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

Babies 2 - 3 months
For the relief of fever after vaccinations at 2, 3 and 4
months - 2.5 ml. This dose may be given up to 4 times a
day starting 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.
Pain and other causes of fever - refer to the tables below.

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(continued)



Child's age

How Much

2-3 months

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.
Only give if your baby weighs over 4 kg and was born
after 37 weeks.
■ 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.



Children from 3 months to 6 years
How often

Child's age

How much

(in 24 hours)

3-6 months

2.5 ml

Up to 4 times

6-24 months 5 ml

Up to 4 times

2-4 years

7.5 ml (5 ml + 2.5 ml) Up to 4 times

4-6 years

10 ml (5 ml + 5 ml)

Up to 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.



It is important to shake the bottle for at least 10 seconds
before use.

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.

I f 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.

I f 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:

a llergic 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 your 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.

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 Storing this medicine

Keep this medicine out of the sight and reach 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.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
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 100 ml and 200 ml bottles. It contains 120 mg of
the active ingredient paracetamol in every 5 ml of medicine.
The Marketing Authorisation 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 December 2016.
CALPOL® is a registered trade mark.

LN50XX01 - 16-0372
Component: LN50XX01,
16-0372
Version: 11.3
Dimension: 160x210mm
Date: 22/12/2016
LN50XX01-PIL CALPOL INFANT SF 100ML UKv11.3.indd 2

22/12/2016 14:33

Expand Transcript

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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