Aspar Sootheze PIL 6+(UT)5a.qxp 10/6/11 1	1:53 Page 1
Patient Informs Sootheze	J tion Leaflet for 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 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 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 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