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CALPOL SIX PLUS SUSPENSION SUGAR FREE

Active substance(s): PARACETAMOL / PARACETAMOL / PARACETAMOL

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2 Before giving the
medicine to your child

Some of the ingredients can cause
problems
 ethyl (E218) and propyl (E216) parahydroxybenzoate
M
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 you have an
intolerance to some sugars, contact your doctor
before taking this medicinal product.
■ Sorbitol and maltitol may have a mild laxative effect.
Each 5 ml of this product contains 1.935 g of sorbitol
and 2.04 g of maltitol. Calorific values: 2.6 kcal/g
sorbitol and 2.3 kcal/g maltitol.


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 any of these applies, get advice from a doctor or
pharmacist without using CALPOL®.


T his medicine brings down high temperatures
(also called fever) and relieves pain.
■ The medicine is OK for most children over 6 years.
■ Do not give it 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.

1 What the medicine is for
The paracetamol in CALPOL SIXPLUS® Suspension Sugar
Free is used to relieve 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.

LN50XX01-PIL CALPOL 6PLUS SF 80MLv7.4.indd 1

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.



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, talk to your doctor
before you take this medicine. 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.

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 anything else containing paracetamol while
giving this medicine.
■ Do not give more medicine than the label tells you to.
If your child does not get better, talk to your doctor.



i

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.

turn over

22/12/2016 11:00

(continued)

If you forget to give the medicine

■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.

i

Children under 6 years

Not recommended for children under 6 years old.

Ask your pharmacist to recommend a suitable product.

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
doses)
10 - 20 ml (Two to four 5 ml
doses)

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
too much paracetamol can cause delayed, serious liver
damage.

LN50XX01-PIL CALPOL 6PLUS SF 80MLv7.4.indd 2

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 SIXPLUS® Suspension Sugar Free 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: CALPOL® is NOT intended for 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.
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.

6 Further Information
What’s in this medicine?

The active ingredient is: Paracetamol 250 mg per 5 ml.
Other ingredients are: Maltitol, sorbitol liquid (E420),
glycerol, dispersible cellulose, xanthan gum, polysorbate
80, methyl parahydroxybenzoate (E218), propyl
parahydroxybenzoate (E216), acesulfame potassium,
saccharin sodium and purified water. The flavouring is
imitation strawberry.

What the medicine looks like
CALPOL SIXPLUS® Suspension Sugar Free is a white liquid,
available in 80 ml bottles. It contains 250 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 Orléans, 5 avenue de Concyr,
45071 Orléans, Cedex 2, France.
This leaflet was revised December 2016.
CALPOL® and CALPOL SIXPLUS® are registered trade marks.

- 16-0400
Component: LN50XX01
LN50XX01,
16-0400
Version: 7.4
Dimension: 160x210mm
Date: 22/12/2016
22/12/2016 11:00

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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