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CALPOL SIX PLUS SUGAR FREE SUSPENSION

Active substance(s): PARACETAMOL

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2 Before giving the
medicine to your child



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



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.

 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.
■ 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.


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 temperatures
(also called fever) and relieves pain.
■ This medicine is intended 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.
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® Sugar Free 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.

LN5028XX-PIL CALPOL 6PLUS SF 100MLv13.3.indd 1

Warnings 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.

Other medicines and CALPOL®



 etoclopramide or domperidone (used to treat
m
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 susceptible
to the side-effects of paracetamol.

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.



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 11:04

(continued)

If anyone has too much



■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

i

Children from 6 years

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. The symptoms of overdose may include
pale skin, nausea, sweating, feeling of discomfort or
uneasiness, vomiting, loss of appetite and abdominal pain.

If you forget to give the medicine



Not recommended for children under 6 years old.

Ask your pharmacist to recommend a suitable product.

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.


LN5028XX-PIL CALPOL 6PLUS SF 100MLv13.3.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® Sugar Free Suspension can have sideeffects, 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 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:
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 this medicine looks like and contents of
the pack
CALPOL SIXPLUS® Sugar Free Suspension is a white 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.
LN502801 - 16-0405

Component: LN502801, 16-0405
Version: 13.3
Dimension: 160x210mm
Date: 22/12/2016
22/12/2016 11:04

+ 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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