SUMMARY OF PRODUCT CHARACTERISTICS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Transcription

1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Charcodote 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Activated charcoal 200mg/ml 3. PHARMACEUTICAL FORM Oral suspension 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Charcodote is indicated for oral use as an emergency antidote in the treatment of poisoning or drug overdosage by most drugs and chemicals. It can be used either before or after gastric lavage where this is indicated. Charcodote adsorbs toxic substances and reduces or prevents systemic absorption. 4.2 Posology and method of administration Adult: Single dose:- 250ml (equivalent to 50g of activated charcoal) as soon as possible after ingestion or suspected ingestion of the potential poison. Charcodote may also be administered after emesis or gastric lavage via intragastric intubation. Dosage may be repeated as recommended by a physician. Children: Children aged under 12 years should be given half of the contents of one bottle (125ml; 25g of activated charcoal) unless a large quantity of intoxicant has been ingested, and where there is a risk to life. In these circumstances, the administration of the full 50g dose is indicated. Repeated dosing at intervals of four hours should be considered in the case of poisoning with phenobarbitone, carbamazepine, theophylline, quinine, dapsone or salicylate, but should only be undertaken where appropriate patient monitoring is available.

2 4.3 Contraindications None 4.4 Special warnings and precautions for use Appropriate precautions should be taken to prevent aspiration. Charcodote should only be administered to unconscious patients who have a cuffed endotracheal tube in place in order to protect the airway. Although not contraindicated in poisoning by caustic or corrosive substances, Charcodote has limited value as a detoxicant for these substances and the presence of activated charcoal may hinder the visualisation of oesophageal erosions or burns. Activated charcoal does not adsorb cyanide and is relatively ineffective in adsorbing lithium salts, caustic or corrosive alkalis and acids, ethanol, methanol, ethylene glycol, iron salts, sodium chloride, lead, boric acid, other mineral acids and petroleum distillates. If other oral antidotes are to be used (eg methionine for paracetamol poisoning) care must be taken as activated charcoal will reduce the effectiveness of such compounds. 4.5 Interactions with other medicinal products and other forms of interaction Ice-cream or other foods should not be used as a vehicle for the administration of activated charcoal as they reduce the adsorptive capacity of the activated charcoal. When used as an antidote for oral poisoning, simultaneous administration of ipecac syrup with activated charcoal is not recommended since the ipecac syrup is adsorbed by the charcoal thus preventing emesis. If both ipecac syrup and activated charcoal are to be used, it is recommended that the charcoal be administered only after vomiting has been induced and completed. 4.6 Pregnancy and lactation There is no evidence to suggest that Charcodote should not be used in pregnant or breast-feeding women. 4.7 Effects on ability to drive and use machines Activated charcoal should not affect the ability of patients to drive or operate machinery.

3 4.8 Undesirable effects 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. Charcodote will colour stools black which may be alarming to the patient but is medically insignificant. Cases of activated charcoal aspiration have been reported in the literature including fatalities due to associated complications. 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: Overdose Not applicable. 5. PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties Activated charcoal can adsorb a wide range of plant and inorganic poisons and many drugs. Thus, when administered by mouth it reduces their systemic absorption from the gastrointestinal tract and is used in the treatment of acute oral poisoning. However, activated charcoal does not adsorb cyanide and is relatively ineffective in adsorbing lithium salts, caustic or corrosive alkalis and acids, ethanol, methanol, ethylene glycol, iron salts, sodium chloride, lead, boric acid, other mineral acids and petroleum distillates. 5.2 Pharmacokinetic properties Following oral administration, activated charcoal does not get absorbed from the gastrointestinal tract and does not undergo metabolism. It is excreted in the faeces.

4 5.3 Preclinical safety data None 6. PHARMACEUTICAL PARTICULARS 6.1 List of excipients Purified water 6.2 Incompatibilities None known 6.3 Shelf life 2 years. Use immediately upon opening. Any remaining unused suspension should be discarded after first use. 6.4 Special precautions for storage Do not store above 25 C. Do not freeze. 6.5 Nature and contents of container Low density polyethylene bottle with screw cap designed for administration either directly or via an intragastric tube. Each bottle contains 250ml (50g activated charcoal). 6.6 Instructions for use/handling

5 Shake well before use. Administrative Data 7. MARKETING AUTHORISATION HOLDER Teva UK Limited Brampton Road Hampden Park Eastbourne East Sussex BN22 9AG 8. MARKETING AUTHORISATION NUMBER PL 00289/ DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 24 th August DATE OF REVISION OF THE TEXT 16/07/2015.