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BABY SYRUP

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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 Baby Syrup carefully to get the best results from it.

-    Keep this leaflet. 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 after 3 days.

-    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 Baby Syrup is and what it is used for

2.    Before you give Tixylix Baby Syrup

3.    How to give Tixylix Baby Syrup

4.    Possible side effects

5.    How to store Tixylix Baby Syrup

6.    Further information

1.    WHAT TIXYLIX BABY SYRUP IS AND WHAT IT IS USED FOR

Tixylix Baby Syrup is a soothing cough suppressant which relieves the symptoms of dry, tickly coughs.

Each 5 ml dose of Tixylix Baby Syrup contains 0.75 ml glycerol as the active ingredient.

This medicine is intended for use in children aged 3 months to 5 years.

2.    BEFORE YOU GIVE TIXYLIX BABY SYRUP

Do not give Tixylix Baby Syrup

•    if your child is allergic (hypersensitive) to any of the ingredients of Tixylix Baby Syrup (see Section 6).

Take special care with Tixylix Baby Syrup

•    Tixylix Baby Syrup is not recommended for children under 3 months.

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.

There are no known interactions between Tixylix Baby Syrup and other medicines.

Taking Tixylix Baby Syrup with food and drink Tixylix Baby Syrup 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. No informaton is available on the effect of glycerol taken during pregnancy or use during breast-feeding. Caution is therefore advised if taking Tixylix Baby Syrup during pregnancy.

Driving and using machines

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

Important information about some of the ingredients of Tixylix Baby Syrup.

Tixylix Baby Syrup contains sodium benzoate (E211). Tixylix Baby Syrup contains maltitol. If you have been told by your doctor that your child is intolerant to some sugars, contact your doctor before taking this medicinal product.

Pharma code XXX (010000000)

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3. HOW TO GIVE TIXYLIX BABY SYRUP

Always give Tixylix Baby Syrup exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Using the measuring spoon provided, the following doses may be given 3 to 4 times daily, by mouth, as required. Allow 3 to 4 hours between doses.

210 mm

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

You can help by keeping your child warm and giving plenty of fluids. Make sure the bedroom is well ventilated but not cold. If your child's condition does not get better in 3 days, talk to your doctor.

If you give more Tixylix Baby Syrup than you should

Giving your child too much Tixylix Baby Syrup may cause diarrhoea. 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 Baby Syrup

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 Baby Syrup can cause side effects, although not everybody gets them.

Tixylix Baby Syrup may cause diarrhoea in overdose.

Reporting of side effects

If your child gets any side effects, talk to your doctor, pharmacist or nurse. 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. By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOW TO STORE TIXYLIX BABY SYRUP

Keep out of the reach and sight of children.

Do not store above 25 °C. Keep the container tightly closed.

Do not use Tixylix Baby Syrup 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 Baby Syrup contains

-    The active substance is glycerol (0.75 ml per 5ml dose).

-    The other ingredients are liquid maltitol (Lycasin), hydroxyethylcellulose, sodium benzoate (E211), citric acid monohydrate, sodium citrate, natural flavours (vanilla, blackcurrant), purified water.

What Tixylix Baby Syrup looks like and contents of the pack

Tixylix Baby Syrup is a colour-free syrup.

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

•    Amber-coloured glass bottle with child resistant cap, containing 100 ml or 150 ml. Measuring spoon provided.

•    Amber-coloured polyethylene teraphthalate bottle with child resistant cap, containing 150 ml. Measuring spoon provided.

Marketing Authorisation Holder

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, Brentford, TW8 9GS, U.K.

Manufacturer:

BCM Limited, Beeston, Nottinghamshire, NG90 2PR.

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

This leaflet was last revised in January 2016

GB 316684 - XXXXX

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