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Active substance(s): PARACETAMOL

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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 you should contact
your doctor or pharmacist.

If you drink large amounts of alcohol, talk to your doctor
before you take this medicine. You may be more susceptible
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


parahydroxybenzoate (E218) may cause allergic
reactions which could possibly be delayed.
■ The sucrose and sorbitol (E420) content of this product
means that this product is unsuitable for people with
inherited intolerance to fructose. This medicine contains
2.1 g of sucrose per 5 ml dose. This should be taken
into account in patients with diabetes mellitus.
■ Sorbitol may have a mild laxative effect. Each 5 ml of this
product contains 1.895 g of sorbitol. It has a calorific value
of 2.6 kcal/g sorbitol.
■ Sunset Yellow (E110) may cause allergic reactions.

Do not give your child this medicine…
If s/he is allergic to paracetamol or any of the other
ingredients of this medicine (listed in section 6).
■ 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 any of these applies, get advice from a doctor or
pharmacist without using CALPOL®.

T his medicine brings down high temperature (also called
fever) and relieves pain.
■ This medicine is intended for most children over 6 years.
■ Do not give to children on this list:
■ Not to 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.
What is in this leaflet
1. What this medicine is used for
2. What you need to know before you use this medicine
3. How to use this medicine
4. Possible side-effects
5. How to store this medicine
6. Contents of the pack and other information

1 What the medicine is for
The paracetamol in CALPOL SIXPLUS® Suspension is used
to relieve mild/moderate pain and / or bring down fever
(high temperature) in many conditions including cold and flu,
headache, toothache, earache, post immunisation fever, sore
throat and other aches and pains.

LN502702-PIL CALPOL 6+ ORIGINAL 200MLv12.3.indd 1

 arnings and precautions...
Talk to your doctor or pharmacist giving your child this
medicine if:
■ Your child has serious kidney or liver problems.
■ Your child has an inherited intolerance
to fructose or been diagnosed with an
intolerance to some other sugars.
 ther medicines and CALPOL

 etoclopramide or domperidone (used to treat
nausea and vomiting)
■ colestyramine (used to treat high cholesterol)
■ anticoagulants (drugs that thin the blood, such as
■ 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 table to see how much medicine to use.
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.
■ 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

the bottle for at least 10 seconds and
remove the cap.
 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.


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).

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.

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

turn over

22/12/2016 10:47


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

too much paracetamol can cause delayed, serious
liver damage. The symptoms of overdose may include
pale skin, nausea, sweating, feeling of discomfort or
uneasiness, vomiting, loss of appetite and abdominal pain.

By reporting side-effects you can help provide more
information on the safety of this medicine.

If you forget to give the medicine

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Store in the original package.
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.

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

Children under 6 years

4 Possible side-effects

Not recommended for children under 6 years old.
Ask your pharmacist to recommend a suitable product.

CALPOL SIXPLUS® Suspension can have side-effects, like all
medicines, although these don’t affect everyone and are
usually mild.

Children from 6 years
Child’s Age

How much - up to 4 times a day

6-8 years

5 ml

8-10 years

7.5 ml (5 ml + 2.5 ml)

10-12 years

10 ml (5 ml + 5 ml)

12-16 years

10 - 15 ml (Two to three 5 ml
10 - 20 ml (Two to four 5 ml

Adults and children
over 16 years

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.

Speak to your doctor:
If your child 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

LN502702-PIL CALPOL 6+ ORIGINAL 200MLv12.3.indd 2

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 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.
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:

5 Storing this medicine

6 Further Information
What’s in this medicine?

The active ingredient is: Paracetamol 250 mg per 5 ml.
Other ingredients are: Sucrose, sorbitol solution (E420),
glycerol, dispersible cellulose, polysorbate 80, methyl
parahydroxybenzoate (E218), sunset yellow (E110) and purified
water. The flavouring is orange and imitation white sugar.

What this medicine looks like and contents of
the pack
CALPOL SIXPLUS® Suspension is an orange coloured and
flavoured liquid, available in 100 ml and 200 ml bottles. It
contains 250 mg of the active ingredient Paracetamol in every
5 ml of medicine. Not all pack sizes may be marketed.
The Marketing Authorisation 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 December 2016.
CALPOL® and CALPOL SIXPLUS® are registered trade marks.

LN502702 - 16-0397

Component: LN502702, 16-0397
Version: 12.3
Dimension: 160x210mm
Date: 22/12/2016
22/12/2016 10:47

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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.