Recto

9 mm

Verso

yixyiix

TODDLER SYRUP

G LYC E RO L

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 Toddler 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 Toddler Syrup is and what it is used for

2.    Before you give Tixylix Toddler Syrup

3.    How to give Tixylix Toddler Syrup

4.    Possible side effects

5.    How to store Tixylix Toddler Syrup

6.    Further information

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

Tixylix Toddler Syrup is a soothing cough suppressant which relieves the symptoms of dry, tickly coughs. Each 5 ml dose of Tixylix Toddler 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 TODDLER SYRUP

Do not give Tixylix Toddler Syrup

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

Take special care with Tixylix Toddler Syrup

•    Tixylix Toddler 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 Toddler Syrup and other medicines.

Taking Tixylix Toddler Syrup with food and drink

ng    , ,

Tixylix Toddler Syrup may be given with

thout food.

3. HOW TO GIVE TIXYLIX TODDLER SYRUP

Always give Tixylix Toddler 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.

m

>

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 Toddler Syrup during pregnancy.

Driving and using machines

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

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

Tixylix Toddler 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.

°?

O Q)

o g

tn P

£

E

in

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. ff your child's condition does not get better in 3 days, talk to your doctor.

If you give more Tixylix Toddler Syrup than you should

Giving your child too much Tixylix Toddler 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 Toddler 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 Toddler Syrup can cause side effects, although not everybody gets them.

Tixylix Toddler Syrup may cause diarrhoea in overdose.

If your child experiences any side effects, 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.gov.uk/yellowcard¹

www.mhra.gov.uk/yellowcard. Alternatively you can calPFreephone 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 TODDLER 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 Toddler 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 Toddler 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 Toddler Syrup looks like and contents of the pack

Tixylix Toddler 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

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.

148 mm

14mm

Itarus House,

Tenter Road,

Moulton Park,

Northampton NN36PZ

Need help? Contact us:

+44 (0)1604 468100

mail@itarus.com

www.itarus.com

Microsoft-

CERTIFIED

Customer: Novartis Customer Ref: 80432504 ARA No: 1754

Job Description: Tixylix - Toddler Syrup - Leaflet Process: XXXXX Job No: 155648 File No: 72738 Printer: Xxxxxxx Packer: Xxxxxxx File Name: 155648VB_14.ai Rev. Date: 30/04/2013 Rev. Time: 15:15 Barcode: - Size/BWR: 000%/000 Profile ref: Supplied Operator: 7 Output Queue: PDF Spec: - No of Cols: 2 Dispro: N/A DGC: N/A

2

Cool Gray 10 C P 433 C

PROFILE

170

.Illlllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllll

190

200

210

220

230

240

250

260

270

280

PrintSpec™