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Tixylix Toddler Syrup

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Document: leaflet MAH BRAND 3_PL 44673-0173 change

Recto


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9 mm


14 mm

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BLACKCURRANT

Flavour Syrup

G LYC E RO L


210 mm


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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 Blackcurrant Flavour 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 Blackcurrant Flavour Syrup is and what it is used for

2.    Before you give Tixylix Blackcurrant Flavour Syrup

3.    How to give Tixylix Blackcurrant Flavour Syrup

4.    Possible side effects

5.    How to store Tixylix Blackcurrant Flavour Syrup

6.    Further information

1.    WHAT TIXYLIX BLACKCURRANT FLAVOUR SYRUP IS AND WHAT IT IS USED FOR

Tixylix Blackcurrant Flavour Syrup is a soothing cough suppressant which relieves the symptoms of dry tickly coughs. Each 5 ml dose of Tixylix Blackcurrant Flavour 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 BLACKCURRANT FLAVOUR SYRUP

Do not give Tixylix Blackcurrant Flavour Syrup

•    If your child is allergic (hypersensitive) to any of the ingredients of Tixylix Blackcurrant Flavour Syrup (see Section 6).

Take special care with Tixylix Blackcurrant Flavour Syrup

•    Tixylix Blackcurrant Flavour 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 Blackcurrant Flavour Syrup and other medicines.

Taking Tixylix Blackcurrant Flavour Syrup with food and drink

Tixylix Blackcurrant Flavour 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 Blackcurrant Flavour Syrup during pregnancy.

Driving and using machines

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

Important information about some of the ingredients of Tixylix Blackcurrant Flavour Syrup.

Tixylix Blackcurrant Flavour 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 (00010101)



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Verso

14 mm


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3. HOW TO GIVE TIXYLIX BLACKCURRANT FLAVOUR SYRUP

Always give Tixylix Blackcurrant Flavour 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.


Age

Dose

Under 3 months

Do not give Tixylix Blackcurrant Flavour Syrup

3 to 12 months

One 5 ml spoonful

1 to 5 years

Two 5 ml spoonfuls


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 Blackcurrant Flavour Syrup than you should

Giving your child too much Tixylix Blackcurrant Flavour 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 Blackcurrant Flavour 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 Blackcurrant Flavour Syrup can cause side effects, although not everybody gets them. Tixylix Blackcurrant Flavour 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 BLACKCURRANT FLAVOUR 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 Blackcurrant Flavour 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 Blackcurrant Flavour 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 Blackcurrant Flavour Syrup looks like and contents of the pack

Tixylix Blackcurrant Flavour 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 316681 - XXXXX


TB

E

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148 mm