Patient leaflet - Carbocisteine 750 mg/15 ml sugar-free Adult syrup in sachet
1. What Carbocisteine Sugar Free Syrup is and what it is used for
Carbocisteine 750 mg/15ml Sugar-Free Adult Syrup in Sachet (called Carbocisteine Sugar Free 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.
Carbocisteine Sugar Free 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. What you need to know before you take Carbocisteine Sugar Free Syrup
Do not take Carbocisteine Sugar Free Syrup : Ÿ If you are allergic (hypersensitive) to carbocisteine or any
of the other ingredients of Carbocisteine Sugar Free Syrup (listed in section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of the lips, face, throat or tongue.
Ÿ If you have an ulcer in your stomach or gut (small intestine). Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Carbocisteine Sugar Free Syrup.
Warnings and precautions
Talk to your doctor before taking Carbocisteine Sugar Free Syrup if:
Ÿ You are elderly.
Ÿ You have had an ulcer in your stomach or gut. Ÿ You are taking other medicines known to cause bleeding
in the stomach.
Ÿ This medicine is not recommended for use in children and
adolescents under the age of 18 years due to the alcohol content.
This medicine can cause a mild laxative effect due to the content of maltitol liquid.
Pregnancy and breast-feeding
Carbocisteine Sugar Free Syrup is not recommended during pregnancy or breast-feeding.
Talk to your doctor before taking this medicine if: Ÿ You are pregnant, might become pregnant or think you
may be pregnant. This medicine should not be taken during the first three months of your pregnancy. Ÿ You are breast-feeding or planning to breast-feed Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.
Driving and using machines
Carbocisteine Sugar Free Syrup will have little or no influence on your ability to drive or use machines.
Important information about some of the ingredients of Carbocisteine Sugar Free Syrup
Carbocisteine Sugar Free Syrup contains:
Ÿ Liquid Maltitol: If you have been told by the doctor that
you cannot tolerate some sugars, talk to your doctor before taking Carbocisteine Sugar Free Syrup Ÿ Ethanol: Carbocisteine Sugar Free Syrup contains
approximately 11.9 % ethanol (alcohol). A 15ml dose of this medicine contains up to 1.5 g of ethanol; this is about the same amount of alcohol as 36 ml of beer or 15 ml of wine (i.e. 1/10 glass of wine) per dose.
The amount of alcohol in this medicine is not likely to have an effect in adults and adolescents, and its effects in children are not likely to be noticeable. It may have some effects in younger children, for example feeling sleepy. The alcohol in this medicine may alter the effects of other medicines. Talk to your doctor or pharmacist if you are taking other medicines.
If you are pregnant or breast-feeding, talk to your doctor or pharmacist before taking this medicine.
If you are addicted to alcohol, talk to your doctor or pharmacist before taking this medicine.
Ÿ Sodium: This medicine contains 99 mg sodium (main
component of cooking/table salt) per 15 ml dose. This is equivalent to 4.95 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.
3. How to take Carbocisteine Sugar Free Syrup
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Taking this medicine
Ÿ Take this medicine by mouth (oral use)
Ÿ Carbocisteine Sugar Free Syrup comes in a sachet pack.
The sachet should be opened carefully and the entire contents of one sachet (15 ml) should be consumed for one dose.
Ÿ If you feel that this medicine is too weak or too strong, do
not change the dose yourself, but ask your doctor
How much to take
Adults (including the elderly)
Ÿ Usual dose is 15ml three times each day
Ÿ If your symptoms improve, your dose may be lowered to
15 ml, two times, each day
Size: 190(L) x 277(W) mm Front Side
| |||||||
| Code No. : | NA | Revision: 00 | |||||
| Reason for Change | NA | Date: 25-05-24 | |||||
| Reviewed by | Reviewed by | Reviewed by | Reviewed by | ||||
| Contract Giver/ PL holder | Regulatory Affairs | Head Production/ Packing (Site) | Head QA (Site) | ||||
Children
Carbocisteine Sugar Free Syrup is not recommended for children.
This medicine is not recommended for use in children and adolescents under the age of 18 years due to the alcohol content.
There are other formulations available which are indicated for paediatric patients.
If you take more Carbocisteine Sugar Free Syrup than you should
If you take more Carbocisteine Sugar Free 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 Carbocisteine Sugar Free Syrup, it is likely that you will get an upset stomach (gastrointestinal disturbance).
If you forget to take Carbocisteine Sugar Free 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, this medicine can cause side effects, although not everybody gets them.
Stop taking Carbocisteine Sugar Free Syrup and see a doctor or go to a hospital straight away if:
Ÿ You have an allergic reaction. The signs may include: a
rash, swallowing or breathing problems, swelling of the lips, face, throat or tongue
Ÿ 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 be something called 'Stevens-Johnson syndrome' Ÿ You have 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:
Ÿ Feeling sick (nausea) or being sick (Vomiting) Ÿ Diarrhoea
Ÿ Stomach pain
Talk to your doctor or a pharmacist if you notice any side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website www.mhra.gov.uk/yellowcard or
: search for 'MHRA Yellow Card' in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Carbocisteine Sugar Free Syrup
Keep this medicine out of the sight and reach of children.
Do not use this medicine 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.
Size: 190(L) x 277(W) mm Back Side
Do not store above 25 °C.
Store in the original container and keep the sachet in outer carton in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Carbocisteine Sugar Free Syrup contains
Ÿ Each 15ml of syrup contains 750mg of the active substance, carbocisteine
Ÿ The other ingredients are Xanthan gum, sodium saccharin, liquid maltitol, 96% ethanol, sodium hydroxide, caramel flavouring agent*, purified water.
* Composition of caramel flavouring agent IFF SC227828 : diacetyl, propylene glycol, butyric acid, methylcyclopentenolone, maltol, 4-hydroxy-2,5-dimethyl-3(2H)-furanone, piperonal and vanillin.
What Carbocisteine Sugar Free Syrup looks like and contents of the pack
Carbocisteine Sugar Free Syrup is clear pale yellow syrup with caramel odour sweetened with saccharin sodium and liquid maltitol.
Carbocisteine Sugar Free Syrup is available in sachet of 15 ml with 15's pack.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder & Manufacturer Brown & Burk UK Ltd
5 Marryat Close Hounslow West Middlesex
TW4 5DQ
United Kingdom
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.