Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Carbocisteine 250mg/5ml sugar-free oral solution
⚠ This medicine appears to have been discontinued
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.
What it is and what it is used for
for Carbocisteine 250mg/5ml Sugar-Free Oral Solution (called Carbocisteine Oral Solution in this leaflet) contains a medicine called Carbocisteine. This belongs to a group of medicines called "mucolytics" used in the therapy of respiratory tract disorders that are characterised by excessive and viscous ("sticky") mucus. It works by making the mucus (catarrh) less sticky. This makes the mucus easier to exit when coughing.
2 W hat you need to know before you take Carbocisteine Oral Solution Do not take Carbocisteine Oral Solution:
- If you have a gastroduodenal (stomach or gut) ulcer;
- If you are allergic to Carbocisteine or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor or pharmacist before taking Carbocisteine Oral Solution:
- A sthmatic patients and with a history of bronchial spasm (tightening of the airways muscles),
- S evere respiratory insufficiency,
- D ebilitated patients. Due to the decrease of the cough reflex, there is risk of obstruction of the airway as a consequence of the increase of the quantity of secretions. Children This medicine is not indicated in children aged less than 2 years.
Other medicines and Carbocisteine Oral Solution Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. You should not take cough calming or secretion-drying medicines, because these have an effect contrary to that of Carbocisteine. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Pregnancy: It is not recommended for use in pregnant women, especially during the first trimester of pregnancy because the effects are not known. Breast-feeding: It is not recommended to use during breast-feeding because the effects are not known. Driving and using machines No effects were seen on the ability to drive and use machines. Carbocisteine Oral Solution contains Sodium methyl parahydroxybenzoate (E219). May cause allergic reactions (possibly delayed). Carbocisteine Oral Solution contains sodium This medicine contains 12.7mg sodium per ml. It should be taken into account for those patients who are under a sodium-controlled diet.
3 How to take Carbocisteine Oral Solution Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Using the measuring device (oral measuring cup), measure the quantity that you will need whether you are an adult or a child, according to the general posology.
- For oral use only. Take this medicine by mouth.
- T o give the correct dose use either a 15ml measuring cup or dosing syringe (marked per 0.25ml).
- Shake the bottle before use. Use in adults including the elderly and adolescents over 12 years The usual dose for adults is 15ml (one measuring cup) three times a day. If your symptoms improve, your dose may be lowered to 10ml three times a day. Wash the measuring cup after use. Use in children and adolescents This medicine is not indicated in children aged less than 2 years. From 2 to 5 years old: 1.25 – 2.5ml four times a day. From 6 to 12 years old: 5ml three times a day in evenly spaced intervals. After using the oral solution, close the bottle well.
How to take it
the dosing syringe
- P lace the syringe into the neck of the bottle below the fill line.
- T o 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 of the syringe.
- T urn the bottle the right way up, removing the syringe from the bottle.
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 the 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.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Uncommon: Digestive changes: nausea, vomiting and diarrhoea. Rare: Hypersensitivity reactions, such as hives and bronchospasm (tightening of the airways muscles). Special attention in asthmatic patients due to the risk of occurring bronchoconstriction (contraction of a muscle of the bronchial wall that leads to a reduction in the air passage). In these cases, the treatment should be stopped. Headache, muscle pain, dizziness, involuntary urination (uncontrolled leakage of urine), palpitations and breathlessness. Not known Allergic reactions, such as skin rash. Special attention in patients with compromised thyroid function due to the risk of occurring hypothyroidism (underactive thyroid). Gastric discomfort (stomach pains), bronchorrhea (increased bronchial secretion).
Do not store above 25°C. 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 carton and bottle after "EXP." The expiry date refers to the last day of that month. Once the bottle is opened, Carbocisteine must be used within 6 months. If your oral solution appears to be discoloured or shown any other signs of deterioration, take it back to your pharmacist who will advise you. 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.
How to store it
Carbocisteine Oral Solution
- P lace the end of the syringe into the mouth against the
cheek and gently press the plunger down to slowly and gently release the medicine.
- A fter 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 Carbocisteine Oral Solution than you should If upset stomach, nausea and vomiting occur, you should stop taking Carbocisteine and see the doctor. If you forget to take Carbocisteine Oral Solution If you forget to take a dose, do not worry, wait until the next dose is due. Do not take a double dose to make up for a forgotten dose. If you stop taking Carbocisteine Oral Solution Not applicable. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Contents of the pack and other information
What Carbocisteine Oral Solution contains
- T he active substance is Carbocisteine. Each 5ml of Carbocisteine contains 250mg of Carbocisteine.
- T he other ingredients are glycerol, Sodium methyl parahydroxybenzoate (E219), Saccharin sodium, Sodium hydroxide, Hydrochloric acid, Hydroxyethylcellulose, Strawberry Flavour, Caramel colourant and Purified water. What Carbocisteine Oral Solution looks like and contents of the pack Carbocisteine is presented as an amber liquid with strawberry flavour and a sweet taste. It is in 300ml bottles, of type Ill amber glass with a child resistant screw cap, with a 15ml measuring device (oral measuring cup graduated to 2.5ml) and dosing syringe. The dosing syringe is marked per 0.25ml. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Aspire Pharma Limited, Unit 4, Rotherbrook Court Bedford Road, Petersfield, Hampshire GU32 3QG, United Kingdom Manufacturer Labialfarma – Laboratório de Produtos Farmacêuticos e Nutracêuticos, S.A., Edifício Labialfarma no 1, Felgueira 3450-336, Sobral, Mortágua, Portugal This leaflet was last revised in September 2021 1010529-P1.9
Frequently asked questions about Carbocisteine 250mg/5ml sugar-free oral solution
How do I take Carbocisteine 250mg/5ml sugar-free oral solution?
Carbocisteine 250mg/5ml sugar-free 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.
What is the active substance in Carbocisteine 250mg/5ml sugar-free oral solution?
The active substance in Carbocisteine 250mg/5ml sugar-free oral solution is carbocisteine.
Are there equivalent medicines to Carbocisteine 250mg/5ml sugar-free oral solution?
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 250 mg/5 ml oral solution. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Carbocisteine 250mg/5ml sugar-free 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.
Can I get Carbocisteine 250mg/5ml sugar-free oral solution without a prescription?
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.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: carbocisteine
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Carbocisteine is a mucolytic agent for the adjunctive therapy of respiratory tract disorders characterised by excessive, viscous mucus, including chronic obstructive airways disease.
4.2. Posology and method of administration
Posology
Adults including the elderly and adolescents over 12 years: 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 oral solution 15 ml three times a day reducing to 10 ml three times a day.
Children 2-5 years: The usual dose is 1.25 - 2.5 ml four times a day.
Children 5-12 years: The usual dose is 5ml three times a day.
Method of administration
This medicine is for oral use.
This medicine, due to its composition (does not contain sugar), is suitable for administration to diabetics.
An oral dosing syringe is provided for use for dosing.
How to use the oral dosing syringe
The syringe end should be placed into the neck of the bottle below the liquid fill line.
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. Remove the syringe from the bottle neck carefully. Place the end of the syringe into the mouth against the cheek and gently 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.
4.3. Contraindications
Hypersensitivity to the active substance (Carbocisteine) or to any of the excipients referred to in section 6.1.
Active peptic ulcer.
Children less than 2 years of age.
4.4. Special warnings and precautions for use
- Asthmatic patients with a history of bronchospasm;
- Severe respiratory failure;
- Debilitated patients. By decreasing the cough reflex there is a risk of obstruction of the airways as a consequence of the secretions amount increase.
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 section 4.5).
Caution is recommended in the elderly and in patients with a history of gastroduodenal ulcers, or those who are receiving concomitant medications that are known to cause gastrointestinal bleeding. If gastrointestinal bleeding occurs, patients should discontinue medication immediately.
This medicine contains sodium methyl parahydroxybenzoate (E219), which can cause allergic reactions (possibly delayed).
This medicine contains 12.7 mg sodium per ml. It should be taken into account by patients in controlled sodium diet.
4.5. Interaction with other medicinal products and other forms of interaction
No drug interactions have been identified
4.6. Fertility, pregnancy and lactation
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 consistent evidence on the effects of carbocisteine on fertility.
4.7. Effects on ability to drive and use machines
Carbocisteine has no or negligible influence on the ability to drive or use machines.
4.8. Undesirable effects
Adverse reactions are listed by System Organ Class. Frequencies are defined using the following convention: 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).
System Organ Class
Frequency
Adverse Reaction
Gastrointestinal Disorders
Uncommon
Nausea, vomiting, and diarrhoea
Very Rare
Gastrointestinal bleeding
Not known
Gastric discomfort
Immune System Disorders
Rare
Urticaria and bronchospasm **
Very Rare
Rash
Not known
Anaphylactic reactions, allergic skin eruption and fixed drug eruption
Cardiac Disorders
Rare
Palpitations
Musculoskeletal and connective tissue disorders
Rare
Muscle Pain
Nervous System Disorders
Rare
Headache, dizziness, urinary incontinence, palpitations
Respiratory, thoracic and mediastinal disorders
Rare
Shortness of Breath
Not known
Bronchorrhoea
Skin and subcutaneous tissue disorders
Not known
Skin rashes and allergic skin eruptions, Isolated cases of dermatitis bullous such as Stevens-Johnsons syndrome, erythema multiforme
Endocrine Disorders
Not known
Hypothyroidism *
* Special attention in patients with compromised thyroid function due to the risk of transient hypothyroidism occurrence.
** Special attention in asthmatic to the risk of bronchoconstriction occurrence (contraction of a muscle of the bronchial wall that leads to a reduction in airflow). In these cases, treatment discontinuation is recommended.
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, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Gastric lavage may be beneficial, followed by observation. Gastrointestinal disorders is the most likely symptom of overdosage. In such cases, it is advised to reduce the dosage.
💬 Ask about this leaflet
Ask anything about Carbocisteine 250mg/5ml sugar-free 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.
Medicines containing Carbocisteine
- Carbocisteine 250 mg/ 5 ml syrup
- Carbocisteine 250 mg/5 ml oral solution
- Carbocisteine 250 mg/5 ml Sugar Free Adult Syrup
- Carbocisteine 375 mg Capsules
- Carbocisteine 375 mg Capsules, Hard
- Carbocisteine 375 mg Capsules, hard Milpharm Limited
- Carbocisteine 750 mg Capsules, Hard
- Carbocisteine 750 mg hard capsules
- Carbocisteine 750mg/10ml sugar-free oral solution in sachet
- Carbocisteine 750mg/5ml sugar-free syrup