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

1. What Carbocisteine oral solution is and what it is used 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.

2. What you need to know before you take Carbocisteine oral solution

Do not take Carbocisteine oral solution:

• If you have an ulcer in your stomach or gut (small intestine).
• If you are allergic to carbocisteine or any of the other ingredients of this medicine (listed in Section 6). 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 oral solution. Warnings and precautions

Talk to your doctor before taking Carbocisteine oral solution 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.

Children and adolescents

Do not give Carbocisteine oral solution to children younger than 2 years of age.

Other medicines and Carbocisteine oral solution

Tell your doctor if you are taking a medicine to treat a

cough, as a productive cough is needed to remove mucus from your breathing passages.

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:

• Sodium: This medicine contains 289.7mg sodium (main component of cooking/table salt) in each 45ml dose. This is equivalent to 14.4% of the recommended maximum daily dietary intake of sodium for an adult.
• Sodium methyl parahydroxybenzoate: it may cause allergic reactions (possibly delayed).
• Propylene glycol: This medicine contains 0.8mg propylene glycol in each millilitre, which is equivalent to 0.81mg/ml.

3. How to take 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.

• For oral use only. Take this medicine by mouth.
• To give the correct dose use either a 15ml measuring cup or dosing syringe (marked in 0.25 ml quantities).
• If you feel that this medicine is too weak or too strong, do not change the dose yourself, but ask your doctor.
• Shake the bottle before use.

Adults including the elderly

• The initial dose is 15ml (one measuring cup) three times a day.
• If your symptoms improve, your doctor may lower your dose to 10ml, 3 times a day.
• The maximum daily dose is 45ml (3 measuring cups).
• Wash the measuring cup after use.

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.

Children under 2 years

Not recommended.

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.

If you take more Carbocisteine oral solution than you should

• If you take more Carbocisteine oral solution than the label states or your doctor has prescribed, or if you think a child has accidently swallowed any, contact the nearest hospital casualty department or a doctor for advice immediately.
• Take this leaflet with you.

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.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Carbocisteine oral solution immediately and see a doctor or go to hospital straightaway if:

• You have an allergic reaction. Signs of an allergic reaction include: a rash, itching, problems swallowing or breathing, 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 have flu-like symptoms and fever. This is called “Stevens-Johnson syndrome”.
• You have a skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge). This is called “erythema multiforme”.
• You have blood in your vomit or black tarry stools.

Other side effects are:

Very common

(may affect up to 1 in 10 people)

• Stomach pains, feeling sick and diarrhoea.

Uncommon

(may affect up to 1 in 100 people)

• Being sick

Rare (may affect up to 1 in 1,000 people)

• Itching or a rash or swelling of the face.

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 oral solution

Do not store above 25oC.

Keep this medicine out of the sight and reach of children.

Wash and dry the measuring cup and syringe after use.

Once opened use within one month.

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.

6. Contents of the pack and other information

What Carbocisteine oral solution contains

• Each 5ml of oral solution contains 250mg of the active substance, carbocisteine.
• The other ingredients are: glycerol, sodium saccharin, hydroxyethylcellulose, xanthan gum, caramel powder, raspberry flavour (contains propylene glycol E1520), sodium methyl parahydroxybenzoate (E219), sodium hydroxide, and purified water.

What Carbocisteine oral solution looks like and contents of the pack

Carbocisteine 250mg/5ml oral solution is a clear, amber-coloured liquid, with a raspberry odour.

Carbocisteine 250mg/5ml oral solution is packed in a 300ml glass bottle and comes with a 15ml measuring cup and an oral dosing syringe. The syringe is marked per 0.25ml.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

ROMA Pharmaceuticals Limited

Gibraltar House

Crown Square

Centrum 100

Burton-upon-Trent

DE14 2WE

email: medinfo@romapharma.co.uk

Manufacturer

LABOMED PHARMACEUTICAL COMPANY S.A. 84, Ioannou Metaxa Str.,

Koropi,

Attica, 19441,

Greece

This leaflet was last revised in May 2026.

For information in other formats contact medinfo@romapharma.co.uk

Product number Roma No.: Carbocisteine

250mg/5ml ROMA

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