What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: PL 04425/0204, PL 04425/0205.


Mucodyne 250mg/5ml Paediatric Syrup

PACKAGE LEAFLET: INFORMATION FOR THE USER

Mucodyne 250mg/5 ml Paediatric Syrup

Carbocisteine

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Read all of this leaflet carefully before you start taking this medicine

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • 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 Mucodyne Paediatric Syrup is and what it is used for
2. Before you take Mucodyne Paediatric Syrup
3. How to take Mucodyne Paediatric Syrup
4. Possible side effects
5. How to store Mucodyne Paediatric Syrup
6. Further information

1. What Mucodyne Paediatric Syrup is and what it is used for

Mucodyne 250 mg/5 ml Paediatric Syrup (called Mucodyne Paediatric Syrup in this leaflet) contains a medicine called carbocisteine. This belongs to a group of medicines called ‘mucolytics’.

It works by making mucus (phlegm) less sticky. This makes the mucus easier to cough up.

Mucodyne Paediatric Syrup is used for problems with the breathing passages (respiratory tract). These problems happen when too much mucus is made or the mucus is too sticky.

2. Before you take Mucodyne Paediatric Syrup

Do not take this medicine and tell your doctor if:

  • Your child is under 2 years of age.
  • You are allergic (hypersensitive) to carbocisteine or any of the other ingredients of Mucodyne Paediatric Syrup (listed in Section 6 below).
    Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of the lips, face, throat or tongue.
  • You have an ulcer in your stomach or gut (small intestine).

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Mucodyne Paediatric Syrup.

Warnings and Precautions

Talk to your doctor before taking this medicine if:

  • You are elderly.
  • Have had an ulcer in your stomach or gut.
  • You are taking other medicines known to cause bleeding in the stomach.

Important information about some of the ingredients of Mucodyne Paediatric Syrup

Mucodyne Paediatric Syrup contains:

Sucrose: This medicine contains 2g of sucrose in each 5 ml dose. May be harmful to teeth. If you have been told by your doctor or pharmacist that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

Ethanol: This medicine contains a small amount of ethanol (alcohol), less than 100mg per dose contained in the aromatic elixir flavouring as an ingredient necessary for the medicine to work properly.

Sodium: This medicine contains 32.33 mg of sodium in each 5ml dose.

Methyl parahydroxybenzoate: May cause allergic reactions (these may not happen straight away).

Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of the lips, face, throat or tongue.

3. How to take Mucodyne Paediatric Syrup

Always take Mucodyne Paediatric Syrup exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Taking this medicine

  • Take this medicine by mouth.
  • Mucodyne Paediatric Syrup (only for use in children) comes with a graduated oral dosing syringe for accurate dosing.
  • If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor.

How much to take Mucodyne Paediatric Syrup

For children

  • Give this medicine to your child by mouth.
  • The amount of medicine will depend on the age of the child.

Mucodyne Paediatric Syrup 125ml pack size comes with a graduated oral dosing syringe for measuring the correct dose. The syringe for oral administration is graduated per 0.25ml. One graduation, 0.25ml, corresponds to 12.5mg/ml of carbocisteine.

Children 2 – 5 years:
1.25–2.5ml four times a day.

Children 5 – 12 years:
5ml three times a day.

How to use the syringe – using the 5ml easy dosing syringe

Step 1: The syringe end should be placed into the neck of the bottle below the liquid fill line.

Step 2: To fill the syringe whilst holding the syringe in place, gently pull the plunger down drawing the medicine to the correct mark on the syringe. The dose for children is given above based on age.

Step 3: Remove the syringe from the bottle neck carefully.

Step 4: Place the end of the syringe into the child’s mouth against the cheek and carefully press the plunger down slowly to gently release the medicine. After use replace the bottle cap. Wash the syringe in warm water and allow to dry. Store out of the reach of children.

If you take more Mucodyne Paediatric Syrup than you should
If you take more Mucodyne Paediatric Syrup than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. If you take too much Mucodyne Paediatric Syrup it is likely that you will get an upset stomach (gastrointestinal disturbance).

If you forget to take Mucodyne Paediatric Syrup

If you forget a dose, do not worry. Just wait until the next dose is due. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist

4. Possible side effects

Like all medicines, Mucodyne Paediatric Syrup can cause side effects, although not everybody gets them.

Stop taking Mucodyne Paediatric Syrup and see a doctor or go to a hospital straight away if:

  • You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of the lips, face, throat or tongue.
  • You have blistering or bleeding of the skin, including around your lips, eyes, mouth, nose and genitals. You may also have flu-like symptoms and fever. This may something called ‘Stevens-Johnson Syndrome’.

Tell a doctor straight away if you notice any of the following serious side effects:

  • Blood in your vomit or black tarry stools.

Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:

  • Vomiting

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 Mucodyne Paediatric Syrup

Keep this medicine in a safe place where children cannot see or reach it.

Do not use Mucodyne Paediatric Syrup after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.

After use, wipe the neck of the bottle with a clean, damp cloth. This will remove any medicine left on the bottle, so you can put the cap back on tight.

If you use the oral dosing measuring syringe for Mucodyne Paediatric Syrup to take this medicine, make sure the measuring device is clean and dry before use.

Store below 25°C.

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 Mucodyne Paediatric Syrup contains

  • Each 5ml of Syrup contains 250mg of the active substance, carbocisteine
  • The other ingredients are methyl parahydroxybenzoate (E218), sucrose, caramel (E150), aromatic elixir flavour (contains ethanol), cinnamon flavour, sodium hydroxide and purified water.

What Mucodyne Paediatric Syrup looks like and contents of the pack

Mucodyne Paediatric Syrup is a clear amber coloured syrupy liquid.

Mucodyne Paediatric Syrup for children is available in 125ml bottles and comes with a graduated dosing syringe.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sanofi
One Onslow Street
Guildford
Surrey
GU1 4YS
UK
Tel: 0845 372 7 101
Email: [email protected] .com

Manufacturer

Unither Liquid Manufacturing
1-3 Allée de la Neste
Z.I. d’en Sigal
31770, Colomiers
France

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

This leaflet was last revised in 07/2019

© Sanofi, 1972 - 2019

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