Carbocisteine 250mg/5ml oral solution

Each 5ml of oral solution contains 250mg of carbocisteine.

Excipient with known effect

Each 5ml of oral solution contain 32.2mg (1.4mmol) of sodium.

Each 5ml of oral solution contain 7.5mg of sodium methyl parahydroxybenzoate.

For the full list of excipients, see section 6.1.

Oral solution.

Clear, amber-coloured liquid, with raspberry odour.

Carbocisteine 250mg/5ml oral solution, is a mucolytic agent indicated in adults and children 2 years and above for the adjunctive therapy of respiratory tract disorders characterised by excessive, viscous mucus, including chronic obstructive airways disease.

Mode of administration:

This medicine is for oral use

Posology

Adults including the elderly:

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.

A measuring cup covering a range of capacities is provided. A 15 ml dosing cup with a range of graduations from 2ml up to 15ml is included in the package.

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

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.

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

Active peptic ulceration.

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 4.5).

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

This medicine contains sodium methyl para-hydroxybenzoate (E219) and may cause allergic reactions (possible delayed).

This medicine contains 289.7 mg (12.6 mmol) sodium per 45ml, equivalent to 14.4% of the WHO recommended maximum daily intake of the 2 g sodium for an adult.

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.

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

Pregnancy

Although tests in mammalian species have revealed no teratogenic effects, Carbocisteine is not recommended during the first trimester of pregnancy.

Breast-feeding

It is unknown whether carbocisteine/metabolites are excreted in human milk.

Fertility

There are no fertility data available.

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

Adverse reactions listed by System Organ Class.

Frequencies are defined using the following convention:

very common (≥1/10);

common (≥1/100 to <1/10);

uncommon (≥1/1000 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)

Gastrointestinal disorders

Very common: stomach pains, nausea, diarrhoea.

Uncommon: vomiting

Very rare: There have been reports of gastrointestinal bleeding occurring during treatment with carbocisteine.

Immune system disorders

Rare: There have been reports of anaphylactic reactions and fixed drug eruption.

Not known: Allergic skin eruption.

Skin and subcutaneous tissue disorders

Rare: itching, rash, erythematous rash, or swelling in the face.

Not known: Isolated cases of bullous dermatitis such as Stevens-Johnson syndrome have 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.

The most likely symptoms associated with overdose are gastrointestinal (gastralgia, nausea and vomiting). Supportive therapy should be instituted, and gastric lavage could be considered.

Pharmacotherapeutic group: mucolytic, ATC code: R05CB03

Carbocisteine (S-carboxymethyl L-cysteine) is a mucolytic agent that modifies mucous secretions. It acts during the gel phase of the mucus, most likely by breaking up the disulfide bonds of the glycoproteins, and thus favouring expectoration.

Moreover, carbocisteine has effects on bronchial secretion by normalization of mucus hyperviscisity.

After oral administration, carbocisteine is rapidly absorbed; maximum plasma concentration is reached in two hours.

Its bioavailability is low, less than 10% of the administered dose, which is probably due to intraluminal metabolism and a marked liver first pass effect.

Elimination half-life is about 2 hours. Carbocisteine and its metabolites are mainly eliminated via the kidneys.

Tests in a wide range of animal species have revealed no significant toxicity. Serious adverse events associated with the use of carbocisteine have not been reported. Even symptomatic adverse events are very rare.

Glycerol (E 422)

Sodium Saccharin (E 954)

Hydroxyethylcellulose (E 1525)

Xanthan gum (E 415)

Caramel powder

Raspberry flavor

Sodium Methyl Parahydroxybenzoate (E 219)

Sodium Hydroxide (E 524)

Purified water

Not applicable.

24 months

Do not store above 25°C.

Carbocisteine 250mg/5ml oral solution is packed in 300ml glass bottle with child resistant (HDPE) screw cap and comes with a graduated,15 ml measuring cup, a syringe adaptor and an oral dosing syringe which is marked per 0.25ml.

No special requirements for disposal.

ROMA Pharmaceuticals Limited

Gibraltar House

Crown Square

Centrum 100

Burton on Trent

DE14 2WE

PL 49578/0001

19/12/2019

18/06/2021