Carbocisteine 250mg /5ml Syrup – patient leaflet, side effects, dosage

1. WHAT CARBOCISTEINE SYRUP IS AND WHAT IT IS USED FOR

Carbocisteine Syrup 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 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 SYRUP

Do not take this medicine and tell your doctor if:

• You are allergic (hypersensitive) to

  carbocisteine or any of the other ingredients of Carbocisteine 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.

• You have an ulcer in your stomach or

  gut (small intestine).

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Carbocisteine Syrup.

Do not give this medicine to a child under 2 years of age.

Warnings and precautions

Talk to your doctor before taking this medicine 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.

Other medicines and Carbocisteine syrup

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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.

Driving and using machines

Carbocisteine syrup will have little or no influence on your ability to drive or use machinery.

Carbocisteine Syrup contains

• Sucrose: This medicine contains 6g of sucrose per 15ml or 2g of sucrose per 5ml. This may be harmful to the teeth and should be taken into account in patients with diabetes mellitus. If you have been told by the doctor that you cannot tolerate some sugars, talk to your doctor before taking this medicine.

• Methyl parahydroxybenzoate:

  This medicine contains methyl parahydroxybenzoate which may cause allergic reactions (possibly delayed). Signs of an allergic reaction include: a rash or breathing problem, swelling of the lips, face, throat or tongue.

• Ethanol: This medicine contains up to

  44mg of alcohol (ethanol) per 15ml or up to 15mg of alcohol (ethanol) per 5ml which is equivalent to 0.30% w/v. The amount in 15ml or 5ml of this medicine (contained within the aromatic elixir flavouring as an ingredient necessary for the medicine to work properly) is equivalent to less than 1ml of beer or 1ml of wine. The small amount of alcohol in this medicine will not have any noticeable effects.

• Sodium: This medicine contains 100mg of sodium per 15ml. This is equivalent to 5% of the recommended maximum daily dietary intake of sodium for an adult. 5ml contains 33mg of sodium, this is equivalent to 2.75% of the recommended maximum daily intake of 1.2 g sodium for a child ≥4 years and 4.13% of the recommended maximum daily intake of 800 mg sodium for a child ≥2 years.

3. HOW TO TAKE CARBOCISTEINE SYRUP

Always take Carbocisteine Syrup exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Taking this medicine

• Take this medicine by mouth.
• Carbocisteine Syrup supplied with a 5 ml graduated oral syringe with intermediate graduations of 0.25 ml and a “Press-In” Bottle Adapter (PIBA). Open the bottle and at first use insert the “Press-In” Bottle Adapter (PIBA). Insert the syringe into the PIBA and draw out the required volume from the inverted bottle. Remove the filled syringe from the bottle in the upright position. Discharge the syringe contents into the mouth. Repeat steps as needed to achieve the required dose. Rinse the LEAFLET

Carbocisteine 250mg / 5ml syrup

Cutting Area Print Area

165.00 mm

Back

syringe and replace the cap on the bottle (PIBA remains in place).

• 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

• Give this medicine to your child by mouth.
• The amount of medicine will depend on the age of the child.
• This medicine is not indicated in children aged less than 2 years. - Children aged 2 – 5 years: 1.25ml – 2.5ml four times a day.
• Children aged 5 – 12 years: Usual dose is 5ml three times a day.

If you take more Carbocisteine Syrup than you should

If you take more Carbocisteine 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 Syrup, it is likely that you will get an upset stomach (gastrointestinal disturbance).

If you forget to take Carbocisteine 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, Carbocisteine Syrup can cause side effects, although not everybody gets them.

Stop taking Carbocisteine 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

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 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.

5. HOW TO STORE CARBOCISTEINE SYRUP

Keep out of the sight and reach of

children.

• Store below 25°C. Do not freeze. Store in the original package in order to protect from light.

Once opened use within 3 months. - Use as directed by your doctor. - For oral use.

• Do not take Carbocisteine Syrup after the expiry date which is stated on the bottle label or carton. The expiry date refers to the last day of the month. - If your doctor tells you to stop taking this medicine, return any unused syrup to your pharmacist (chemist) for safe disposal, Only keep this medicine if your doctor tells you to.
• If the syrup becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do. - Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Carbocisteine Syrup contains

• Each 5ml of syrup contains 250mg of the active substance, carbocisteine. - The other ingredients are methyl parahydroxybenzoate (E218), sucrose, caramel (E150), aromatic elixir flavour (contains ethanol), cinnamon flavour, sodium hydroxide and water.

What Carbocisteine Syrup looks like and contents of the pack

Carbocisteine Syrup is a clear to light yellow syrupy liquid supplied in a 125ml & 300ml amber glass bottle, with a child resistant screw-cap, along with a dosing syringe with an adaptor. Not all pack sizes may be marketed.

Bottle: Ph. Eur Type III Amber glass bottle.

Closure: Child-resistant, tamper-evident screw cap made of polyethylene.

Dosing Device: 5ml dosing syringe with adapter. Oral dosing syringe assembly consists of an outer polypropylene and inner low density polyethylene with 0.25ml graduation mark. Adapter made of polypropylene.

Marketing Authorisation Holder

Lyrus Life Sciences Limited

C/O Thakur-Chabert 7a Vine Street Uxbridge

United Kingdom

UB8 1QE

Manufacturer

Copea Pharma Limited

25 Compass West,

Spindus road,

Liverpool,

L24 1YA,

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.

Other formats

To request a copy of this leaflet in braille, large print or audio please call +44 7446 834691.

This leaflet was last revised in June 2026. POM

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