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CALPOL SIX PLUS SUSPENSION SUGAR FREE

Active substance(s): PARACETAMOL

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Transcript


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.


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.


Contains 250 mg Paracetamol per 5 ml
This 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 Six Plus 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.

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.

F308695-PIL-CALPOL6+SF80ml-UKv5.6.indd 1

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.

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.
■ Never give more medicine than shown in the table.
■ 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) and propyl (E216)
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.



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 table for the
correct dose).



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





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3 How to use this
medicine (continued)
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.


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.

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.

5 Storing this medicine
Keep the product out of the reach and sight 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.
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.

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
6-8 years

How much - up to 4 times a day
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)

Adults and children 10 - 20 ml (Two to four 5 ml
over 16 years
doses)
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.


F308695-PIL-CALPOL6+SF80ml-UKv5.6.indd 2

4 Possible side-effects
Calpol Six Plus 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.


If your child shows any of these signs, stop giving
paracetamol and talk to a doctor.
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.
If you notice any side-effects not included in this leaflet
please tell your doctor or pharmacist.

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 Six Plus 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 Product Licence 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 January 2012.
Calpol is a registered trade mark.

F308695
11-0341

15/02/12 13:22

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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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