CALCOLD SIX PLUS

Active substance: PARACETAMOL

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Do not give your child this medicine…
If s/he has ever had a bad reaction to any of
the ingredients.
I If s/he is taking anything else with paracetamol in it.
I If s/he suffers from epilepsy.
I If s/he is taking, or has taken in the last two weeks,
drugs for depression known as Monoamine Oxidase
Inhibitors (MAOIs).
I If s/he is aged under 6 years old.
I If s/he is taking any other cough and cold medicine.
If any of these apply, get advice from a doctor or
pharmacist without using CalCold SixPlus.
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®

SixPlus
Contains 120 mg Paracetamol and
12.5 mg Diphenhydramine hydrochloride per 5 ml
This medicine is for the symptoms of flu and feverish colds.
It helps to ease breathing, unblock noses and provide
effective relief of pain including headache, sore throat and
teething pain.
I The medicine is OK for most children aged 6 to 12 years.
I Do not give it to children on this list:
I Not to children taking some other medicines. See section
2c
I Not to anyone who is allergic to the ingredients.
See section 6 c
I Some children should not take this product. Follow the
instructions shown in the table carefully. See section 3 c
I Speak to your doctor if anything in this list applies:
I If a child is not getting better, or needs more medicine
than shown in the table. See section 3 c
I If a child gets a rash, breathing problems, diarrhoea or
gets very tired. See section 3 c
Now read this whole leaflet carefully before you use this
medicine. Keep the leaflet, you might need it again.
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1 What the medicine is for
The paracetamol in CalCold SixPlus is used to relieve
pain and bring down fever (high temperature).
The diphenhydramine in CalCold SixPlus provides relief
from a runny and blocked nose and reduces nasal irritation
associated with colds.

2 Before giving the
medicine to your child
This medicine is suitable for most children, but a few children
should not use it. If you are in any doubt, talk to your doctor or
pharmacist.

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This product may cause drowsiness. It should NOT
be used to sedate a child.

If adults take this medicine:
You can use this product while you are taking oral
contraceptives (‘the pill’), but CalCold SixPlus may not
work so well on your pain or fever.
I If you drink large amounts of alcohol, you may be
more susceptible to the side-effects of paracetamol.
I Ask your doctor or pharmacist for advice before
taking this medicine if you might be pregnant or are
breast-feeding.
I CalCold SixPlus may cause drowsiness, dizziness,
blurred vision or make it difficult for you to
concentrate. If you notice any of these effects do
not drive or use machinery.
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Talk to your doctor or pharmacist…

If your child has kidney or liver problems.
If your child has difficulty passing water (urinary
retention).
I If your child has an inherited intolerance to fructose or
has been diagnosed with an intolerance to some other
sugars.
I If s/he suffers from or has had closed angle glaucoma
(increased pressure in the eye).
I If your child is taking any other medicines including:
I Antimuscarinic drugs e.g.:
I tricyclic antidepressants (drugs to treat mood
disorders).
I atropine (used to treat some eye conditions and
occasionally bowel conditions).
I CNS depressants e.g.:
I hypnotics (sleeping tablets including barbiturates).
I minor tranquillisers (drugs used to relax muscles or
decrease anxiety).
I opioid analgesics (drugs used to relieve pain e.g.
codeine, tramadol, morphine).
I antipsychotics (drugs used to treat mood
disorders).
I metoclopramide or domperidone (used to treat nausea
and vomiting).
I colestyramine (used to treat high cholesterol)
I anticoagulants (drugs that thin the blood, such as
warfarin).
I 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.

Special warnings about this medicine

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Some of the ingredients can cause problems
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The sorbitol (E420) content of this product means
that this product is unsuitable for people with
inherited intolerance to fructose.
Maltitol liquid and sorbitol liquid may have a mild
laxative effect.
Each 5 ml spoonful of this product contains
1.28 g of maltitol and 0.455 g of sorbitol. Calorific
values: 2.3 kcal/g maltitol and 2.6 kcal/g sorbitol.
Propylene glycol may make your child drowsy;
children should be supervised whilst they are taking
CalCold SixPlus.

3 How to use this medicine
Check the table that follows to see how much
medicine to use.
It is important to shake the bottle for at least 10
seconds before use.
Never give more medicine than shown in the table.
I Do not overfill the spoon.
I For oral use only.
I Always use the spoon supplied with the pack.
I Do not give this medicine with any other paracetamolcontaining product.
There is a double ended spoon in the pack.
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2.5 ml

5 ml

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3 How to use this medicine
(continued)
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Children under 6 years
Do not give to children under 6 years, consult
your doctor.

Children from 6 to 12 years

CHILD'S AGE

HOW MUCH - Up to 3 times a day

6-8 years

Two 5 ml spoonfuls

8-10 years

Three 5 ml spoonfuls

10-12 years

Four 5 ml spoonfuls

Do not give more than 3 doses in any 24 hour period.
I Leave at least 4 hours between doses.
I Do not give your child this medicine for more than
3 days without speaking to your doctor or pharmacist.
I Parents or carers should seek medical attention if the
child's condition deteriorates during treatment.
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Speak to your doctor:
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If your child needs more than the doses shown in the
table, or if the fever doesn't go away or they become
worse, 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 CalCold SixPlus
until you get medical advice.

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.

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CalCold SixPlus can have side-effects, like all medicines,
although these don’t affect everyone and are usually mild.

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.

If your child experiences any of the following stop
using the medicine and seek immediate help:

6 Further information

4 Possible side-effects

Allergic reactions including skin rashes (which may be
severe and include blistering and peeling of the skin),
itching, swelling of the face, tongue and throat.
I 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.
I Rarely people can experience fits.
I Rarely people can have abnormal blood test results for
liver function.
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If your child experiences any of the following, stop
using the medicine and talk to your doctor:
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Rarely people can have an irregular heartbeat or an
increased awareness of the heartbeat (palpitations).

Other effects that may occur include:
Commonly
I drowsiness including some difficulty performing tasks.
I headache, upset stomach, difficulty in passing urine,
stimulation, blurred vision, dry mouth, thickened
mucus.
Rarely
I low blood pressure, tremor, shakiness, slurred speech,
dizziness, confusion, depression, sleep disturbances.
I blood disorders.
If your child experiences any side-effects not included in this
leaflet or you are not sure about anything talk to your doctor
or pharmacist.
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 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.
Keep the bottle in the outer carton.
Do not use after the end of the month shown as an expiry
date on the packaging.

What’s in this medicine?
The active ingredients are: 120 mg Paracetamol
and 12.5 mg Diphenhydramine hydrochloride per 5 ml
of medicine.
Other ingredients are: Propylene glycol,
polyethylene glycol, benzoic acid (E210), glycerol,
sorbitol liquid (E420), maltitol liquid, sodium cyclamate,
saccharin sodium and purified water. The flavourings are base
sugar and strawberry.

What the medicine looks like
CalCold SixPlus is a clear liquid available in 100 ml bottles.
Product Licence holder: McNeil Products Ltd, Maidenhead,
Berkshire, SL6 3UG, UK.
The manufacturer is Pinewood Laboratories Limited,
Ballymacarbry, Clonmel, Co Tipperary, Ireland.
This leaflet was revised February 2011.
CalCold SixPlus is a registered trade mark.

7 Information about treating
cough and cold in children
It's normal for children to get 8 or more colds in a year.
Because colds are caused by viruses, not bacteria, antibiotics
don't help. Here are simple steps to help your child who has
a cough or cold.
I If they are hot/feverish: Increase the amount of fluid your
child normally drinks. Lower their temperature with a
paracetamol or ibuprofen medicine which has doses for
children.
I For coughs: Coughing serves a purpose, it helps clear
phlegm and mucus. Give the child plenty of warm clear
fluids to drink.
I To help with breathing: Plain saline nose drops / sprays
can help with blocked noses.

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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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