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.
for Carbocisteine 250mg/5ml oral solution (called Carbocisteine oral solution in this leaflet) contains the active substance carbocisteine. This belongs to a group of medicines called "mucolytics". Mucolytics are used to treat mucus (phlegm) produced by infections of the breathing passages (respiratory tract) in adults and children 2 years and above. It works by making the mucus less sticky and easier to cough up.
e Carbocisteine oral solution Do not take Carbocisteine oral solution:
You can also report side effects directly via the Yellow Card Scheme at: 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.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Pregnancy and breastfeeding If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Carbocisteine oral solution is not recommended during pregnancy or breastfeeding. Fertility The effects on fertility are unknown. Driving and using machines This medicine is not known to affect the ability to drive or use machinery. Carbocisteine oral solution contains:
Carbocisteine oral solution Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Stop taking Carbocisteine oral solution immediately and see a doctor or go to hospital straightaway if:
Adults including the elderly
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Other side effects are: Very common (may affect up to 1 in 10 people)
Keep this medicine out of the sight and reach of children. Wash and dry the measuring cup and syringe after use.
Do not use this medicine after the expiry date which is stated on the carton after "EXP". The expiry date refers to the last day of that month. 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.
Carbocisteine oral solution
Do not store above 25oC.
If you take more Carbocisteine oral solution than you should
Once opened use within one month.
If you forget to take Carbocisteine oral solution If you forget a dose, take the next dose as soon as you remember. 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.
What Carbocisteine oral solution contains
For information in other formats contact [email protected]
Carbocisteine 250 mg/5 ml oral solution 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 oral solution is carbocisteine.
Medicines with the same active substance, strength and form include: Carbocisteine 250 mg/ 5 ml syrup, Carbocisteine 250 mg/5 ml Sugar Free Adult Syrup, 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 oral solution, 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 250mg/5ml oral solution, is a mucolytic agent indicated in adults and children 2 years and above for the adjunctive therapy of respiratory tract disorders characterised by excessive, viscous mucus, including chronic obstructive airways disease.
Mode of administration:
This medicine is for oral use
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.
A measuring cup covering a range of capacities is provided. A 15 ml dosing cup with a range of graduations from 2ml up to 15ml is included in the package.
Children:
Children 2 – 5 years: The usual dose is 1.25 – 2.5 ml four times daily
Children 5 – 12 years: The usual dose is 5 ml three times daily
Using the dosing syringe
• When you use the medicine for the first time, place the adaptor in the neck of the bottle.
• Push the syringe firmly into the adaptor in the neck of the bottle.
• To fill the syringe, turn the bottle upside down. Whilst holding the syringe in place, gently pull the plunger down drawing the medicine to the correct mark on the syringe. Your doctor will tell you the right dose for your child.
• Turn the bottle the right way up, remove the syringe from the adaptor by gently twisting the syringe.
• Place the end of the syringe into the child's mouth and gently press the plunger down to slowly and gently release the medicine.
• After use replace the bottle cap. Wash the syringe in warm water and allow to dry. Store out of reach of children.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Active peptic ulceration.
The use of Carbocisteine will result in less viscous mucus, requiring clearance via epithelial ciliary action and an intact cough reflex. The concomitant use of antitussives-is therefore not recommended (see 4.5).
The use of bronchial mucous modifiers with anti-cough medicines and/or substances that dry out secretions (atropinic) is not recommended.
This medicine contains sodium methyl para-hydroxybenzoate (E219) and may cause allergic reactions (possible delayed).
This medicine contains 289.7 mg (12.6 mmol) sodium per 45ml, equivalent to 14.4% of the WHO recommended maximum daily intake of the 2 g sodium for an adult.
Caution is recommended in the elderly, in those with a history of gastroduodenal ulcers, or those taking concomitant medications known to cause gastrointestinal bleeding. Since mucolytics may disrupt the gastric mucosal barrier, caution should be taken in patients with a history of peptic ulcers. If gastrointestinal bleeding occurs, patients should discontinue medication.
The combination of mucolytics with antitussives and/or substances that dry out secretions (atropinic) is not recommended.
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 are no fertility data available.
The medicinal product has negligible influence on the ability to drive and use machines.
Adverse reactions listed by System Organ Class.
Frequencies are defined using the following convention:
very common (≥1/10);
common (≥1/100 to <1/10);
uncommon (≥1/1000 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).
Gastrointestinal disorders
Very common: stomach pains, nausea, diarrhoea.
Uncommon: vomiting
Very rare: There have been reports of gastrointestinal bleeding occurring during treatment with carbocisteine.
Immune system disorders
Rare: There have been reports of anaphylactic reactions and fixed drug eruption.
Not known: Allergic skin eruption.
Skin and subcutaneous tissue disorders
Rare: itching, rash, erythematous rash, or swelling in the face.
Not known: Isolated cases of bullous dermatitis such as Stevens-Johnson syndrome and erythema multiforme have 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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
The most likely symptoms associated with overdose are gastrointestinal (gastralgia, nausea and vomiting). Supportive therapy should be instituted, and gastric lavage could be considered.
Ask anything about Carbocisteine 250 mg/5 ml oral solution. 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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