Patient leaflet - Sootheze Six Plus Paracetamol 250 mg / 5 ml oral suspension
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 if she/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 • Have severe illnesses, including severe renal impairment or sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), or you suffer from malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (a blood and fluid abnormality) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: serious breathing difficulties with deep rapid breathing, drowsiness, feeling sick (nausea) and being sick (vomiting).
- 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)
- Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that must have urgent treatment (see section 2).
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:
- 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.
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 | How often (in 24 hours)* |
|---|---|---|
| 6 – 8 years | One 5 mL spoonful (large end) | 4 times |
| 8 – 10 years | One 5 mL spoonful (large end) and one 2.5 mL spoonful (small end) | 4 times |
| 10 – 12 years | Two 5 mL spoonfuls (large end) | 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 5 mL spoonful (large end) up to 4 times a day.
Adults and children over 16 years: Two - four 5 mL spoonful (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.
Frequency “Not known’’ (frequency cannot be estimated from the available data):
A serious condition that can make blood more acidic (called metabolic acidosis), in patients with severe illness using paracetamol (see section 2).
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:
If you get any side effects, talk to your doctor or pharmacist. 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 or search for MHRA Yellow Card in the Google Play or Apple App store. 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.
Store below 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 2.5 ml and 5 ml measure is supplied with this medicine.
The product is available in an amber glass bottle packed into a cardboard carton containing 100 ml, 140 ml, 200 ml, 250 ml or 500 ml 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
This leaflet was last revised in February 2025