Carbomix 50g Granules for Oral Suspension

Charcoal Activated 81.3% w/w

Also contains glycerol (5g/50g activated charcoal) as an excipient.

For a full list of excipients, see section 6.1.

Granules for oral suspension

Odourless black granules.

Emergency treatment of acute oral poisoning or drug overdose. Carbomix adsorbs toxic substances and reduces or prevents systematic absorption. The shorter the time interval between ingestion of the toxicant and the administration of Carbomix, the greater is the benefit for the patient. However, as the absorption of massive drug overdoses is often retarded in acute conditions of intoxication, even the delayed administration of Carbomix may be beneficial. In severe intoxication, repeated administration of Carbomix is recommended to prevent absorbed drug being released (in an unbound state) in the lower intestinal tract or to expedite the elimination and prevent the re-absorption of any drug undergoing enterohepatic circulation.

Carbomix granules should be mixed with water and swallowed as a suspension under medical supervision.

Adults (including the Elderly)

50g activated charcoal (one standard treatment pack), repeated if necessary.

Children under 12 years

25g activated charcoal (half the contents of the standard pack, repeated if necessary.

If a large quantity of toxicant has been ingested, and where there is a risk to life, a dose of 50g is recommended.

Carbomix should be given as soon as possible after the ingestion of the potential poison.

The contents of the bottle are made up to the red band with water and shaken thoroughly.

The suspension is then taken orally or given by intragastric tube using the applicator provided. Carbomix may be administered after emesis or gastric lavage and may be used concurrently with parenteral antidotes such as acetylcystine.

When ipecac syrup is used to induce emesis, it is recommended that Carbomix be administered only after vomiting has been induced and completed, since ipecac syrup is adsorbed by the charcoal thus preventing emesis.

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

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.

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.

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

None (the product is not systemically absorbed).

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.

Not applicable. In theory severe constipation would result from excessive use and this could be treated with laxatives.

Activated charcoal has well documented adsorptive properties and is effective in reducing the absorption of a wide range of toxicants, including drugs taken in overdose. From the gut, in addition, there is evidence that the administration of activated charcoal can enhance the elimination of some compounds by creating an effective concentration gradient from the circulation to the gut.

Activated charcoal is not systemically absorbed.

No findings have been reported which add to the prescribing information given in other sections.

Citric Acid

Acacia

Glycerol

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.

Unopened: 5 years.

After reconstitution: 24 hours.

Store below 25° C

Keep container tightly closed

HDPE bottle and cap containing 50g of activated charcoal (in 61.5g of granules).

For instructions on reconstitution and use, see section 4.2.

Product description after reconstitution: black suspension.

Any unused product or waste material should be disposed of in accordance with local requirements.

Beacon Pharmaceuticals Ltd

85 High Street

Tunbridge Wells

Kent TN1 1YG

PL 18157/0020

13/10/2009

18/01/2010