CARBOMIX Granules Ref.[6651] Active ingredients: Charcoal activated

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: Beacon Pharmaceuticals Ltd, DCC Vital, Westminster Industrial Estate, Repton Road, Measham, DE12 7DT, England

Contraindications

There are no contraindications to the use of Carbomix but see under (4.4).

Special warnings and precautions for use

The value of Carbomix in the treatment of poisoning by strong acids, alkalis and other corrosive substances is limited. It should also be borne in mind that the presence of charcoal will render difficult any immediate endoscopy that may be required. Carbomix is poor at binding cyanide, iron salts and some solvents including methanol, ethanol and ethylene glycol. In cases where the toxicant has diuretic properties or has been ingested with alcohol, plenty of fluid should be given after the administration of Carbomix. Carbomix should not be used concurrently with systemically active oral emetics or oral antidotes such as methionine since such agents would be adsorbed by the charcoal.

Carbomix should only be administered to unconscious patients who have a cuffed endotracheal tube in place to protect the airway.

Carbomix contains glycerol as an excipient, which may cause headache, stomach upset and diarrhoea.

Interaction with other medicinal products and other forms of interaction

The purpose of the product is to interact with other medicaments and toxicants taken in overdosage. There are no systemic interactions because the product is not absorbed from the gut.

Pregnancy and lactation

There is no evidence to suggest that Carbomix should not be used during pregnancy or lactation. The product is not systemically absorbed.

Effects on ability to drive and use machines

None (the product is not systemically absorbed).

Undesirable effects

In general, Carbomix is well tolerated. Some patients may however experience constipation or diarrhoea.

Activated charcoal has been associated with bezoar formation, intestinal obstruction and, rarely, intestinal perforation following multiple dosing – although a direct causative association has not been demonstrated.

Faecal impaction has been reported in a patient treated for an overdose of a diuretic with alcohol.

Aspiration of activated charcoal has been reported to cause airway obstruction and appropriate precautions should be taken.

Activated charcoal will produce black stools which may be alarming to the patient but is medically insignificant.

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. Website: www.mhra.gov.uk/yellowcard.

Incompatibilities

Carbomix should not be used concurrently with systemically active oral emetics or oral antidotes such as methionine since such agents would be adsorbed by the charcoal.

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