TIXYLIX BABY SYRUP
Active substance(s): GLYCEROL
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Draft Z
Order – AWF
Reference
Format
Pharma code
Colour
Font
Font min. size
Reference MKT
Production site
Reference SITE
AWF 24339 – OTDC 397519
TIX TODDLER SYRUP 100 ML GB_316675_PIL
148 x 210 mm – Ref. code not available – Recto/Verso
XXX
Black – P Cool Grey 10 C
Futura Std
Text body: 7.4 pts
–
BCM LTD
XXX
Pre-press
Diadeis Suisse S.A. – DO-16-E0027 – 12.01.2016
Recto
14 mm
11.5 mm
9 mm
®
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.
210 mm
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
Tixylix Toddler 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 Toddler Syrup during
pregnancy.
11.5 mm
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.
Pharma code XXX
(101010011)
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.
4.2 mm
148 mm
Draft Z
Order – AWF
Reference
Format
Pharma code
Colour
Font
Font min. size
Reference MKT
Production site
Reference SITE
AWF 24339 – OTDC 397519
TIX TODDLER SYRUP 100 ML GB_316675_PIL
148 x 210 mm – Ref. code not available – Recto/Verso
XXX
Black – P Cool Grey 10 C
Futura Std
Text body: 7.4 pts
–
BCM LTD
XXX
Pre-press
Diadeis Suisse S.A. – DO-16-E0027 – 12.01.2016
Verso
11.5 mm
9 mm
14 mm
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.
Age
Dose
Under 3 months
Do not give Tixylix Toddler Syrup
3 to 12 months
One 5 ml spoonful
1 to 5 years
Two 5 ml spoonfuls
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 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.
210 mm
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 TODDLER SYRUP
Keep out of the reach and sight of children.
Do not store above 25 ºC. 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
GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, Brentford, TW8 9GS, U.K.
Manufacturer:
BCM Limited, Beeston, Nottinghamshire, NG90 2PR.
11.5 mm
For any information about this medicinal product, please contact the Marketing Authorisation Holder.
This leaflet was last revised in January 2016
GB 316675 – XXX
148 mm
Order – AWF
Reference
Format
Pharma code
Colour
Font
Font min. size
Reference MKT
Production site
Reference SITE
AWF 24339 – OTDC 397519
TIX TODDLER SYRUP 100 ML GB_316675_PIL
148 x 210 mm – Ref. code not available – Recto/Verso
XXX
Black – P Cool Grey 10 C
Futura Std
Text body: 7.4 pts
–
BCM LTD
XXX
Pre-press
Diadeis Suisse S.A. – DO-16-E0027 – 12.01.2016
Recto
14 mm
11.5 mm
9 mm
®
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.
210 mm
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
Tixylix Toddler 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 Toddler Syrup during
pregnancy.
11.5 mm
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.
Pharma code XXX
(101010011)
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.
4.2 mm
148 mm
Draft Z
Order – AWF
Reference
Format
Pharma code
Colour
Font
Font min. size
Reference MKT
Production site
Reference SITE
AWF 24339 – OTDC 397519
TIX TODDLER SYRUP 100 ML GB_316675_PIL
148 x 210 mm – Ref. code not available – Recto/Verso
XXX
Black – P Cool Grey 10 C
Futura Std
Text body: 7.4 pts
–
BCM LTD
XXX
Pre-press
Diadeis Suisse S.A. – DO-16-E0027 – 12.01.2016
Verso
11.5 mm
9 mm
14 mm
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.
Age
Dose
Under 3 months
Do not give Tixylix Toddler Syrup
3 to 12 months
One 5 ml spoonful
1 to 5 years
Two 5 ml spoonfuls
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 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.
210 mm
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 TODDLER SYRUP
Keep out of the reach and sight of children.
Do not store above 25 ºC. 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
GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, Brentford, TW8 9GS, U.K.
Manufacturer:
BCM Limited, Beeston, Nottinghamshire, NG90 2PR.
11.5 mm
For any information about this medicinal product, please contact the Marketing Authorisation Holder.
This leaflet was last revised in January 2016
GB 316675 – XXX
148 mm
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
