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TIXYLIX INFANT COUGH SYRUP, TIXYLIX CHILDRENS COUGH SYRUP - patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - TIXYLIX INFANT COUGH SYRUP, TIXYLIX CHILDRENS COUGH SYRUP

STADA



Product Title:

Tixylix Children’s Cough Syrup

Pack Size: 100ml

Mat.No:92894912­102_100ML_PIL

Dimensions: 210 x148mm

Keyline Ref:

Barcode:

Pharmacode: 337 Verified

Datamatrix: Verified

SAP Code:

Reason for Change:

Re- design

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  • 2. Colour: m Keyline (Non-Printing)

  • 3. Colour: m Technical Info (Non-Printing)

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  • 12.Colour:

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Point Size Used: Min:7.4pt Max: 9pt

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Proof Number: 4 Date: 20.07.2021

Operator: Artwork Number: 1225547

CRN: 17724 _____________­_________Suffix: F

Local Authority submission required: Yes

Manufacturer Art No:

Approved by: Date:



CHILDREN’S COUGH SYRUP


GLYCEROL


E E o

Cd



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 Children's Cough 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:

  • I. What Tixylix Children's Cough Syrup is and what it is used for

  • 2. Before you give Tixylix Children's Cough Syrup

  • 3. How to give Tixylix Children's Cough Syrup

  • 4. Possible side effects

  • 5. How to store Tixylix Children's Cough Syrup

  • 6. Further information

1. what tixylix children’s cough syrup is and what it is used for

Tixylix Children's Cough Syrup is a soothing cough suppressant which relieves the symptoms of dry, tickly coughs. Each 5 ml dose of Tixylix Children's Cough 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 CHILDREN’S COUGH SYRUP

  • ♦ If your child is allergic (hypersensitive) to any of the ingredients of Tixylix Children's Cough Syrup (see Section 6).

Take special care with Tixylix Children's Cough Syrup

  • ♦ Tixylix Children's Cough 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 Children's Cough Syrup and other medicines.

Taking Tixylix Children's Cough Syrup with food and drink

Tixylix Children's Cough 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 Children's Cough Syrup during pregnancy.

Driving and using machines

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

Important information about some of the ingredients of Tixylix Children's Cough Syrup.

Tixylix Children's Cough Syrup contains:

  • Maltitol, may have a mild laxative effect. Calorific value 2.3Kcal/g 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. This medicine contains 34mg propylene glycol (E1520) in each 5ml dose.

  • ♦ Sodium benzoate (E21 1), 10mg per 5ml dose.

  • ♦ Less than 1 mmol sodium (23mg) per 5ml dose, that is to say essentially „sodium-free“

  • 3. HOW TO GIVE TIXYLIX CHILDREN'S COUGH SYRUP

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



4.2 mm


Verso




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 Children's Cough Syrup

3 to I 2 months

One 5 ml spoonful

I to 5 years

Two 5 ml spoonfuls

210 mm


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

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

If you give more Tixylix Children's Cough Syrup than you should

Giving your child too much Tixylix Children's Cough 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 Children's Cough 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 Children's Cough Syrup can cause side effects, although not everybody gets them. Tixylix Children's Cough 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:. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store tixylix children’s cough syrup

Keep out of the sight and reach of children.

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

Do not use Tixylix Children's Cough 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

  • – The active substance is glycerol [0.75 ml per 5ml dose).

  • – The other ingredients are liquid maltitol (Lycasin), hydroxyethylce­llulose, sodium benzoate (E21 1), citric acid monohydrate, sodium citrate, vanilla flavour (contains propylene glycol El520), blackcurrant flavour (contains propylene glycol E1520), purified water.

What Tixylix Children's Cough Syrup looks like and contents of the pack

Tixylix Children's Cough 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 1 50 ml. Measuring spoon provided.

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

Sources: Original (products.mhra.gov.uk)