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SOOTHEZE SIX PLUS PARACETAMOL 250MG/5ML ORAL SUSPENSION

Active substance(s): PARACETAMOL

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Aspar Sootheze PIL 6+(UT)5a.qxp

10/6/11

11:53

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Patient Information Leaflet for

Sootheze Six Plus
Paracetamol 250mg/5ml Oral Suspension
Read this leaflet carefully before taking this medicine.
It does not contain all the information about your medicine that you may need to know, so please ask your
doctor or pharmacist if you have any questions.
This leaflet only applies to Sootheze Six Plus Oral Suspension.

1. WHAT THIS MEDICINE DOES
Sootheze contains paracetamol and is used for the relief of mild to moderate pain, the symptoms of colds and fever. It is
strawberry flavoured and sugar and colour free.

2. CHECK BEFORE YOU TAKE
Do not use this medicine if you:
• Are allergic to Paracetamol or any of the other ingredients in section 6
• Are taking any other medicines containing paracetamol
Take special care and tell your doctor if you:
• Suffer from liver or kidney problems
• Suffer from alcohol dependency or alcoholic liver disease
• Are pregnant or breast feeding
• Are intolerant to some sugars
Tell your doctor or pharmacist if you are already taking any of the following medicines:
• Metoclopramide and Domperidone (for sickness and digestive disorders)
• Blood thinning medicines such as Warfarin
• Antidepressants or sedatives
• Colestyramine (to help control cholesterol levels)
• Anticonvulsants (for epilepsy)
• Oral steroid contraceptives
This medicine contains the E numbers E219 and E217 which can cause allergic reactions (possibly delayed) in some people.

3. HOW TO TAKE THE MEDICINE
• 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 5.0 mL spoonful (large end) and

10 – 12 years





one 2.5 mL spoonful (small end)

4 times

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 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.

Aspar Sootheze PIL 6+(UT)5a.qxp

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When 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
• If you accidentally take too much, seek medical attention IMMEDIATELY, even if you feel well because of the risk of
delayed serious liver damage.
• If you miss a dose, do not take a double dose to make up for the missed dose
• Do not drink alcohol or take other Paracetamol containing products whilst taking this medicine
• If symptoms persist for more then 3 days consult your doctor

4. POSSIBLE SIDE EFFECTS
Paracetamol can cause side effects but not everybody gets them.
Serious side effects
• Pancreatitis or Hepatitis (symptoms include abdominal pain, tiredness, fever, nausea, yellowing of skin or eyes)
• Skin rashes and itching
• Difficulty breathing
• Swollen face
• Unusual bruising or bleeding, accompanied by tiredness and flu like symptoms
If you experience any of the above symptoms after taking this medicine go to the nearest hospital IMMEDIATELY.
Other side effects
• Blood problems including anaemia
• Pain in the lower back and groin
• Changes in your urine
If you experience any of these or any other side effects and they get serious, contact your doctor or pharmacist.

5. STORING YOUR MEDICINE
Keep your medicine in a safe place where children cannot see or reach it. Do not store above 25°C. Store the container in
its original outer carton to protect from light. Do not use after the expiry date printed on the carton. Wipe the neck of the
bottle clean and do not over tighten on replacing the cap.

6. MORE ABOUT YOUR MEDICINE
The active ingredient in this medicine is paracetamol 250mg/5ml. The medicine is a strawberry flavoured off-white
suspension. A double-ended spoon with a 2.5ml and 5ml measure is supplied with this medicine. The inactive
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).
Marketing Authorisation Holder:
Aspar Pharmaceuticals Ltd, Capitol Way, Colindale London NW9 0EQ.
PL 08977/0027
Manufacturer:
Orbis Comsumer Products Ltd, Northfield Industrial Estate, Middlesex, HA0 1NW
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).
Text Revised June 2011
Sootheze Six Plus Suspension is a registered trade mark

Barcode/pharmacode: To be inserted

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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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