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SOOTHEZE SIX PLUS PARACETAMOL 250MG/5ML ORAL SUSPENSION

Active substance(s): PARACETAMOL / PARACETAMOL

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Package Leaflet: Information for the patient
Sootheze Six Plus
Paracetamol 250mg/5ml Oral Suspension








This 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 any of the ingredients (see section 6)
Follow the dosage instructions carefully. Children of different ages need different
amounts (see section 3)
Speak to your doctor if anything in this list applies:
o If a child is not getting better or needs more medicine than described in section 3
o If a child gets a rash, breathing problems, diarrhoea or gets very tired (see section 3)

Now read this whole leaflet carefully before taking this medicine. Keep this leaflet: you
might need it again
What is in this leaflet
1. What Sootheze Six Plus is and what it is used for
2. What you need to know before your child takes Sootheze Six Plus
3. How to take Sootheze Six Plus
4. Possible side effects
5. How to store Sootheze Six Plus
6. Contents of the pack and other requirements
1.

WHAT SOOTHEZE SIX PLUS IS AND WHAT IT IS USED FOR

Sootheze Six Plus contains paracetamol and is used to relieve mild to 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.
2.

WHAT YOU NEED TO KNOW BEFORE YOUR CHILD TAKES SOOTHEZE
SIX PLUS

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 ifs/he:
• Is allergic to Paracetamol or any of the other ingredients in this medicine (see section 6)
• Has ever had a bad reaction to any of the ingredients
• Is taking any other medicines containing paracetamol
If any of these applies, get advice from a doctor or pharmacist before using Sootheze.
Warnings and Precautions
Take special care and talk to your doctor or pharmacist if your child:
• Suffers from serious liver or kidney problems
• Is intolerant to some sugars such as maltitol

This medicine contains the E numbers E219 and E217 which can cause allergic reactions
(possibly delayed) in some individuals.
Other medicines and Sootheze
Tell your doctor or pharmacist if your child is already taking any of the following
medicines:
• Metoclopramide or Domperidone (used to treat nausea and vomiting)
• Blood thinning medicines such as Warfarin
• Colestyramine (to help control cholesterol levels)
• Anticonvulsants (to treat epilepsy)
If you are not sure about the medicine your child is taking, show the bottle or pack to
your pharmacist.
If adults take this medicine.
The following additional warnings are included in case an adult takes this product:
o 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.
o 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.
o Ask your doctor or pharmacist for advice before taking this medicine if you might be
pregnant or breast-feeding.
3.

HOW TO TAKE SOOTHEZE SIX PLUS




For oral use only
It is important to shake the bottle for at least 10 seconds before use

Check the tables below to see how much of the medicine to use
Child’s Age

How Much

6 – 8 years
8 – 10 years

One 5 mL spoonful (large end)
One 5 mL spoonful (large end) and one 2.5 mL
spoonful (small end)
Two 5 mL spoonfuls (large end)

10 – 12 years





How often
(in 24 hours)*
4 times
4 times
4 times

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
Do not give to children under the age of 6 years.

Children aged 12-16 years: Two - three 5mL spoonfuls (large end) up to 4 times a day.
Adults and children over 16 years: Two - four 5mL spoonfuls (large end) up to 4 times a
day.
When giving or taking this medicine it is important to remember the following:
• Never give more medicine that shown in the table
• Do not overfill the spoon.







Always use the spoon supplied with the pack
Do not give this medicine with any other paracetamol-containing product
Do not exceed the stated dose
Do not drink alcohol or take other Paracetamol containing products whilst taking this
medicine
If symptoms persist for more than 3 days consult your doctor

If you take more Sootheze Six Plus Paracetamol Suspension than you should:
• If your child accidentally takes too much of this medicine, talk to a doctor at once,
even if your child seems well because of the risk of delayed serious liver damage.
If you forget to take Sootheze Six Plus Paracetamol Suspension:
• If you miss a dose, do not take a double dose to make up for the missed dose
If you stop taking Sootheze Six Plus Paracetamol Suspension:
If you have any further questions on the use of this medicine, ask your doctor or
Pharmacist.
4.

POSSIBLE SIDE EFFECTS

Sootheze Six Plus Suspension can cause side effects, like all medicines, but not everybody
gets them, and these 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 experiences any of the above symptoms after taking this medicine, 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 get any side effects talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet.
Reporting of side effects:
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.

HOW TO STORE SOOTHEZE SIX PLUS

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Store the container in its original outer carton to protect from light.
Do not use after the end of the month shown as an expiry date printed 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.

CONTENTS OF THE PACK AND OTHER REQUIREMENTS

What Sootheze Six Plus Suspension contains:
The active ingredient in this medicine is paracetamol 250mg/5ml.
The other ingredients are: glycerol, xanthan gum, avicel, maltitol liquid (E965), polysorbate
80, sodium saccharin (E954), citric acid monohydrate, methyl parahydroxybenzoate sodium
(E219), propyl parahydroxybenzoate sodium (E217) and purified water. The flavouring is
strawberry (contains propylene glycol).
What Sootheze Six Plus Suspension look like and contents of the pack:
The medicine is a strawberry flavoured, sugar-free, off-white suspension. A double-ended
spoon with a 2.5ml and 5ml measure is supplied with this medicine.
The product is available in an amber glass bottle packed into a cardboard carton containing
100ml, 140ml, 200ml, 250ml or 500ml bottles
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Aspar Pharmaceuticals Ltd,
Capitol Way, Colindale
London NW9 0EQ.
Manufacturer:
Orbis Consumer Products Ltd,
Northfield Industrial Estate,
Middlesex, HA0 1NW
PL 08977/0027
Sootheze Six Plus Suspension is a registered trade mark
Text Revised February 2017

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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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