Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Carbocisteine may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
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Carbocisteine 250 mg/5 ml Sugar Free Syrup (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.
e Carbocisteine Sugar Free Syrup
Do not take Carbocisteine Sugar Free Syrup : 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. 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: • You are elderly.
• • •
You have had an ulcer in your stomach or gut. You are taking other medicines known to cause bleeding in the stomach. 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: • 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. • 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. Important information about some of the ingredients of Carbocisteine Sugar Free Syrup Carbocisteine Sugar Free Syrup contains: 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 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 35.6ml of beer or 14.8ml of wine (i.e. 1/10 glass of wine) per dose. This can be harmful for those suffering from alcoholism. It should also be taken into account in pregnant or breast-feeding women and high risk groups such as patients with liver disease or fits (epilepsy). Sodium: This medicine contains 33 mg sodium (main component of cooking/table salt) in each 5 ml. This is equivalent to 1.65 % of the recommended maximum daily dietary intake of sodium for an adult. 3.
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 Take this medicine by mouth Carbocisteine Sugar Free Syrup comes with a measuring beaker 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) Usual dose is 15ml three times each day If your symptoms improve, your dose may be lowered to 10ml, three times, each day 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. 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: 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 be something called 'Stevens-Johnson syndrome' 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: Feeling sick (nausea) or being sick (Vomiting) Diarrhoea 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
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.
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. 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 measuring beaker to take this medicine, make sure the beaker is clean and dry before you use it. Do not store above 25 °C.
Store in the original container and keep the bottle 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.
What Carbocisteine Sugar Free Syrup contains Each 5ml of syrup contains 250mg of the active substance, carbocisteine The other ingredients are Xanthan gum, sodium saccharin, liquid maltitol, 96% ethanol, sodium hydroxide, caramel flavouring agent*, purified water.
Carbocisteine 250 mg/5 ml Sugar Free Adult Syrup comes as oral solution containing 250mg / 5ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Carbocisteine 250 mg/5 ml Sugar Free Adult Syrup is carbocisteine.
Medicines with the same active substance, strength and form include: Carbocisteine 250 mg/ 5 ml syrup, Carbocisteine 250 mg/5 ml oral solution, Carbocisteine 250mg/5ml sugar-free oral solution. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Carbocisteine 250 mg/5 ml Sugar Free Adult Syrup, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Carbocisteine is a mucolytic agent for the adjunctive therapy of respiratory tract disorders characterised by excessive, viscous mucus, including chronic obstructive airways disease.
This medicine is not recommended for use in children and adolescents under the age of 18 years due to the alcohol content.
Posology
Adults including the elderly:
Dosage is based upon an initial daily dosage of 2250 mg Carbocisteine in divided doses, reducing to 1500 mg daily in divided doses when a satisfactory response is obtained e.g. for normal syrup 15ml tds reducing to 10ml tds.
Paediatric population:
This medicine is not recommended for use in children and adolescents under the age of 18 years due to alcohol content.
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
Use in patients with active peptic ulceration.
Caution is recommended in the elderly, in those with a history of gastroduodenal ulcers, or those taking concomitant medications known to cause gastrointestinal bleeding. If gastrointestinal bleeding occurs, patients should discontinue medication.
Patients with rare hereditary problems of fructose intolerance, the lapp lactase deficiency or glucose-galactase malabsorption should not take this medicine.
Carbocisteine Sugar Free syrup is contraindicated for use in children less than 2 years of age.
Carbocisteine Sugar Free Syrup contains approximately 11.9 % ethanol (alcohol). A 15 ml dose of this medicine contains upto 1.5 g of ethanol; this is about the same amount of alcohol as 35.6 ml of beer or 14.8 ml of wine (i.e. 1/10 glass of wine) per dose. This can be harmful for those suffering from alcoholism. It should be taken into account in pregnant or breast feeding women and high risk groups such as patients with liver disease or fits (epilepsy).
This medicinal product contains 33 mg sodium per 5 ml, equivalent to 1.65 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Precautions for use
This medicine contains maltitol liquid, may have a mild laxative effect
None stated.
Pregnancy:
There are no available data on carbocisteine use in pregnant women. No conclusions can be drawn regarding whether or not carbocisteine is safe for use during pregnancy. The use of carbocisteine in pregnant women is not recommended, especially during the first trimester.
Breast-feeding:
There are no available data on the presence of carbocisteine in human milk, milk production, or the effects on the breastfed infant. No conclusions can be drawn regarding whether or not carbocisteine is safe for use during breastfeeding. The use of carbocisteine in breastfeeding women is not recommended.
Fertility:
There is no known data available on the effects of this product on fertility in males or females.
Carbocisteine Sugar Free Syrup has no or negligible influence on the ability to drive and use machines.
The following CIOMS frequency rating is used, when applicable: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to ≤ 1/100); rare (≥ 1/10,000 to ≤ 1/1,000); very rare (≤ 1/10,000); not known (cannot be estimated from the available data).
Immune System Disorders
There have been reports of anaphylactic reactions, allergic skin eruption and fixed drug eruption.
Gastrointestinal Disorders
There have been reports of diarrhoea, nausea, epigastric discomfort and gastrointestinal bleeding occurring during treatment with Carbocisteine Sugar Free Syrup.
Frequency not know: vomiting, gastrointestinal bleeding
Skin and Subcutaneous Tissue Disorders
There have been reports of skin rashes and allergic skin eruptions. Isolated cases of dermatitis bullous such as Stevens–Johnson syndrome and erythema multiforme have also been reported.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
Gastric lavage may be beneficial, followed by observation. Gastrointestinal disturbance is the most likely symptom of Carbocisteine Sugar Free Syrup overdosage.
Ask anything about Carbocisteine 250 mg/5 ml Sugar Free Adult Syrup. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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