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WARNING: Do not exceed the stated dose. Do not take with any other cough and cold medicine.

3. HOW TO GIVE TIXYLIX CHESTY COUGH

CHESTY COUGH

GUAIFENESIN

PACKAGE LEAFLET: INFORMATION FOR THE USER

Cough and cold in children

It is usual for children to get several colds a year. As they get older, their immunity builds up and they get fewer colds. Most colds will get better within a few days and you may not need to do more than keep your child comfortable until they get over it.

Fever: If they are feverish, give them plenty of fluids to drink. Their temperature may be lowered with a

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suitable medicine which has doses for children. For further advice, talk to your healthcare professional Coughs: Although it can be distressing to hear your child cough, in fact this he' the chest and mucus from the nose. Give your child plenty of warm clear fluids

Always give Tixylix Chesty Cough exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Not to be used in children under 6 years of age. Seek medical advice before use for more than 5 days. Parents or carers should seek medical advice if the child's condition deteriorates during treatment.

Shake well before use. Using the measuring spoon provided, the following doses may be given every 4 hours, by mouth, as required! Do not exceed 6 doses in 24 hours.

After use, wipe the neck of the bottle clean and make sure the safety cap is properly closed.

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Read all of this leaflet carefully because it contains important information for you.

This medicine is available without a prescription. However, you still need to give Tixylix Chesty Cough carefully to get the best results from it.

-    Keep this Teaflet. You may need to read it again.

-    Ask your pharmacist if you need more information or advice.

-    You must contact a doctor if your child's symptoms worsen or do not improve.

-    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Tixylix Chesty Cough is and what it is used for

2.    Before you give Tixylix Chesty Cough

3.    How to give Tixylix Chesty Cough

4.    Possible side effects

5.    How to store Tixylix Chesty Cough

6.    Further information

1.    WHAT TIXYLIX CHESTY COUGH IS AND WHAT IT IS USED FOR

Tixylix Chesty Cough is a linctus for the relief of chesty coughs with associated hoarseness and sore throat. It also helps to loosen mucus (catarrh) to make breathing easier. Each 5 ml dose of Tixylix Chesty Cough contains 50 mg guaifenesin as the active ingredient.

This medicine is intended for use in children aged 6 to 10 years.

2.    BEFORE YOU GIVE TIXYLIX CHESTY COUGH

Do not give Tixylix Chesty Cough

•    if your child is under 6 years of age.

•    if your child is allergic (hypersensitive) to any of the ingredients of Tixylix Chesty Cough (see Section 6). Take special care with Tixylix Chesty Cough

•    Tixylix Chesty Cough is not recommended for use in children with hereditary fructose intolerance.

•    Consult a doctor before use if your child is suffering from an acute asthma attack, a chronic cough or is asthmatic.

• Stop use and consult a healthcare professional if the cough persists after 5 days.

• Stop use and consult a healthcare professional if the cough is accompanied by a fever, rash or persistent headache or is recurrent.

Taking other medicines

Please tell your doctor or pharmacist if your child is taking, or has recently taken, any other medicines, including medicines obtained without a prescription or if any tests are planned for a sample of your child's urine.

Tixylix Chesty Cough should not be given at the same time as a cough suppressant.

Taking Tixylix Chesty Cough with food and drink

Tixylix Chesty Cough may be given with or without food.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

This medicine is intended for use in children. There are no special precautions if Tixylix Chesty Cough is taken during pregnancy or when breast-feeding.

Driving and using machines

This medicine is intended for use in children. Tixylix Chesty Cough does not affect your ability to drive or operate machinery.

Important information about some of the ingredients of Tixylix Chesty Cough.

Tixylix Chesty Cough contains 1 g of sorbitol per 5 ml dose, and is unsuitable for use in children with hereditary fructose intolerance. Tixylix Chesty Cough also contains glycerol, sodium benzoate (E211) and sweeteners (sodium saccharin and acesulfame potassium).

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If you give more Tixylix Chesty Cough than you should

Giving your child too much Tixylix Chesty Cough may cause nausea and vomiting. If you have accidentally given your child more medicine than you should, or if you suspect that your child has taken extra medicine, please contact your doctor. Take along the bottle and the label, and any medicine that is left.

If you forget to give Tixylix Chesty Cough

Do not give your child a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Tixylix Chesty Cough can cause side effects, although not everybody gets them.

If your child has any unwanted effects, such as nausea, vomiting or allergic reactions please tell your doctor or pharmacist.

Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at HYPERLINK "http://www.mhra.qov.uk/yellowcard" www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy

5.    HOW TO STORE TIXYLIX CHESTY COUGH

Keep out of the reach and sight of children.

Store below 25°C. Keep the container tightly closed.

Do not use Tixylix Chesty Cough after the expiry date which is stated on the carton and the bottle label after <EXP>. The expiry date refers to the last day of that month.

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.

6.    FURTHER INFORMATION

What Tixylix Chesty Cough contains

The active substance is guaifenesin.

The other ingredients are sodium benzoate (E211), sodium saccharin, glycerol, sorbitol solution (70%) (non-crystalline), citric acid monohydrate or anhydrous citric acid, blackcurrant flavour, vanilla flavour, acesulfame potassium, hydroxyethylcellulose, purified water.

What Tixylix Chesty Cough looks like and contents of the pack

Tixylix Chesty Cough is a colour-free linctus.

The following pack sizes are available, not all pack sizes may be marketed:

•    100 ml amber-coloured glass bottle with either a tamper-evident cap or a child resistant cap. Measuring spoon provided.

•    150ml amber-coloured glass bottle with either a tamper-evident cap or a child resistant cap. Measuring spoon provided.

Marketing Authorisation Holder

Novartis Consumer Health, Park View, Watchmoor Park, Surrey, GU15 3YL.

Manufacturer:

BCM Limited, Beeston, Nottinghamshire, NG90 2PR.

For any information about this medicinal product, please contact the Marketing Authorisation Holder.

This leaflet was last approved in April 2013.

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