The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.Source: electronic medicines compendium (emc), DatapharmActive substance: carbocisteineOfficial document: view the original leaflet on emc →Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

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Carbocisteine 750mg/10ml sugar-free oral solution in sachet

⚠ 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.

Active substance: Carbocisteine

Source: electronic medicines compendium (emc)

Official leaflet: Read the PIL on emc

What it is and what it is used for

for 2. What you need to know before you take Carbocisteine oral solution in sachet 3. How to take Carbocisteine oral solution in sachet 4. Possible side effects 5. How to store Carbocisteine oral solution in sachet 6. Contents of the pack and other information

1. What Carbocisteine oral solution in sachet is and what it is used for This medicine belongs to a group of medicines called "mucolytics". It works by making mucus (phlegm) less sticky. This makes the mucus easier to cough up. This medicine is used for problems with the breathing passages (respiratory tract). This medicine is indicated in adults and children over 15 years.

What you need to know before you take it

e Carbocisteine oral solution in sachet Do not take Carbocisteine oral solution in sachet:

if you are allergic to carbocisteine or any of the other ingredients contained in Carbocisteine oral solution in sachet,
if you have an ulcer in your stomach or gut (small intestine). When in doubt, you should always consult a doctor or pharmacist. Please take special care with Carbocisteine oral solution in sachet: Consult your doctor immediately:
if you have thick, purulent sputum or fever,
if you suffer from chronic illness (long-term) of the bronchi or lungs,
if you are elderly,
if you have had an ulcer in your stomach or gut,
if you are taking other medicines known to cause bleeding in the gut.

Precautions for use This medicine should always be accompanied by voluntary efforts to cough, which help expectoration. Do not take cough medicine (to stop coughing) or medicine that dries out bronchial secretions during the treatment period with carbocisteine. CONSULT A DOCTOR IF NO IMPROVEMENT IS SEEN. Other medicines and Carbocisteine oral solution in sachet Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, even if it is medication obtained without a prescription. This medicine contains carbocisteine. Other medications also contain carbocisteine. Please do not take them at the same time in order to avoid exceeding the maximum doses advised (see 3. HOW TO TAKE Carbocisteine oral solution in sachet ) Pregnancy and breast-feeding Carbocisteine 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.
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 in Carbocisteine oral solution in sachet: This medicine contains the following excipients with known effects:
Sodium
Sodium methyl para-hydroxybenzoate (E 219)
Maltitol
Sorbitol
Ethanol (alcohol, present in caramel/vanilla flavouring) This medicine contains sodium. This medicine contains 97.5 mg (4.24 mmol) of sodium per sachet. This should be taken into account in patients following strict low sodium diets. This medicine contains sodium methyl para-hydroxybenzoate and can cause allergic reactions. This medicine contains maltitol and sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

ULM packaging code

+ Quiet area for datamatrix

Carbocisteine

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20 datamatrix control code = plant packaging code

Package leaflet: Information for the user

When in doubt, please ask your doctor or pharmacist.

How to take it

Carbocisteine oral solution in sachet Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Mode of administration Oral route. FOR ADULTS AND CHILDREN OVER 15 YEARS ONLY Do not use this medicine in children under 15 years. Posology The standard dose is 750 mg of carbocisteine 3 times a day, or one 10 ml sachet 3 times a day. If your symptoms improve, your dose may be lowered to 2 sachets per day (taken separately). This medicine is appropriate for patients following a low sugar or low calorie diet. If you feel that the effects of Carbocisteine oral solution in sachet are too strong or not strong enough, please talk to your doctor or pharmacist. If symptoms (cough) persist, consult your doctor. If you take more Carbocisteine oral solution in sachet than you should: Contact your 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, it is likely that you will get an upset stomach (gastrointestinal disturbance). If you forget to take Carbocisteine oral solution in sachet: 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, Carbocisteine oral solution in sachet can cause side effects, although not everybody gets them. Stop taking Carbocisteine oral solution 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

Reporting of side effects If you get 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

Possible 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.

Quiet area in backing of

By reporting side effects you can help provide more information on the safety of this medicine.

How to store it

Carbocisteine oral solution in sachet 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. The expiry date refers to the last day of that month. Do not store above 25°C. 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.

Contents of the pack and other information

What Carbocisteine oral solution in sachet contains The active substance is carbocisteine. Each 10 ml oral solution contains 750 mg of carbocisteine. The other ingredients are: Saccharin sodium, sodium methyl para-hydroxybenzoate (E 219), hydroxyethylcellulose, caramel/vanilla flavouring (contains alcohol), sorbitol liquid (non-crystallising), maltitol liquid, sodium hydroxide*, purified water.

sodium hydroxide pellets or sodium hydroxide 30 % solution What Carbocisteine oral solution in sachet looks like and contents of the sachet This medicine is available in 10 ml sachets and comes in boxes of 10, 12 or 15 sachets. It is a limpid, viscous, light brown solution. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Esteve Pharmaceuticals Ltd, The Courtyard Barns, Choke Lane, Cookham Dean, Maidenhead, Berks. SL6 6PT, United Kingdom Manufacturer UNITHER LIQUID MANUFACTURING 1-3 allée de la Neste ZI d'En Sigal 31770 COLOMIERS This leaflet was last revised in September 2022. Detailed information on this medicine is available on the web site of UK Medicines and Healthcare products Regulatory Agency (www.mhra.gov.uk/).

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This medicine contains small quantities of ethanol (alcohol), less than 100 mg per sachet.

Frequently asked questions about Carbocisteine 750mg/10ml sugar-free oral solution in sachet

How do I take Carbocisteine 750mg/10ml sugar-free oral solution in sachet?

Carbocisteine 750mg/10ml sugar-free oral solution in sachet comes as oral solution containing 750mg / 10ml. 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 750mg/10ml sugar-free oral solution in sachet?

The active substance in Carbocisteine 750mg/10ml sugar-free oral solution in sachet is carbocisteine.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Carbocisteine 750mg/10ml sugar-free oral solution in sachet, 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 750mg/10ml sugar-free oral solution in sachet 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 →

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Carbocisteine (12 medicines)

See every medicine containing this substance, or browse the full A–Z of active substances.

⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+

Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

This medicine is indicated in adults and children over 15 years 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

FOR ADULTS AND CHILDREN OVER 15 YEARS ONLY

Oral route.

One 10 ml sachet contains 750 mg of carbocisteine.

The standard dose is 750 mg, 3 times a day (i.e. 2250mg), or 1 sachet, 3 times a day. The dose should be reduced to 1500mg daily in divided doses when a satisfactory response is obtained i.e. dose reduction from 3 sachets per day to 2 sachets per day (taken separately).

This medicine is appropriate for patients following a low sugar or low calorie diet.

4.3. Contraindications

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.

Active peptic ulceration

4.4. Special warnings and precautions for use

Special warning

Productive coughs that represent a fundamental element in bronchial-pulmonary defences should be respected.

The association of bronchial mucous modifiers with anti-cough medicines and/or substances that dry out secretions (atropinic) is not rational.

This medicine contains sodium methyl para-hydroxybenzoate (E219) and can cause allergic reactions (sometimes late onset).

This medicine contains maltitol and sorbitol. It is not recommended for fructose-intolerant patients (rare hereditary disease).

This medicine contains small amounts of ethanol (alcohol), less than 100 mg per sachet.

This medicine contains sodium. This medicine contains 97.5 mg (4.24 mmol) of sodium per dose.

This should be taken into account in patients following strict low sodium diets.

Precautions for use

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.

4.5. Interaction with other medicinal products and other forms of interaction

The combination of mucolytics with antitussives and/or substances that dry out secretions (atropinic) is not rational.

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.

4.7. Effects on ability to drive and use machines

The medicinal product has negligible influence on the ability to drive and use machines.

4.8. Undesirable effects

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.

Frequency not known: 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 the Yellow Card Scheme at: 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.

🇷🇴 Known in Romania as

Medicines sold in Romania with the same active substance: Cunoscut în România ca

FLUIDOL 100 mg/5 ml prescriptionCARBOCISTEINUM · taken by mouth
FLUIDOL 250 mg/5 ml over the counterCARBOCISTEINUM · taken by mouth
RHINATHIOL 100 mg/5 ml PENTRU COPII prescriptionCARBOCISTEINUM · taken by mouth

Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →

🇵🇱 Known in Poland as

Medicines sold in Poland with the same active substance: W Polsce znany jako

MukolinaCarbocisteinum · taken by mouth
Pecto DrillCarbocisteinum · taken by mouth
FlegamaxCarbocisteinum · taken by mouth
PulnozinCarbocisteinum · taken by mouth
MucopectCarbocisteinum · taken by mouth
Mucopect KidsCarbocisteinum · taken by mouth

Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →

💬 Ask about this leaflet

Ask anything about Carbocisteine 750mg/10ml sugar-free oral solution in sachet. 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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