Carbocisteine 250 mg/5 ml oral solution

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

• 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).

Talk to your doctor before taking this medicine if:

• You are elderly.
• Have had an ulcer in your stomach or gut.

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

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.

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.

The effects on fertility are unknown.

No effects were seen on the ability to drive and use machines.

This medicine contains:

• Sodium: 289.7mg (12.6mmol) of sodium per 45ml. 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 (possible delayed), and exceptionally, bronchospasm.
• Propylene glycol: This medicine contains 0.8 mg propylene glycol in each millilitre, which is equivalent to 0.81 mg/ml

The initial dose is 15ml (one measuring cup) three times a day; if 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 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.

Not recommended.

• 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 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 a dose, take the next dose as soon as you remember.

Do not take a double dose.

• 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 blood in your vomit or black tarry stools.
  Your doctor may reduce your dose.

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.

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/yellow card or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

• 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.

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 a dosing syringe. The syringe is marked per 0.25ml.

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