Activated Charcoal Powder for liquid suspension.

Composition:
50 gm activated charcoal as active ingredient 
6 gm excipients - citric acid monohydrate, glycerol, and acacia gum

Properties and use:
Norit Carbomix is a product made of activated charcoal, which, due to its large internal surface, can adsorb harmful or undesirable substances in the gastrointestinal tract. Norit Carbomix can be beaten in water so that a suspension can efficiently be obtained, with the result that intake or administration of larger quantities of activated charcoal in case of poisoning becomes possible. Norit Carbomix is applied in cases of acute oral poisoning and overdosage of medication.
 
Not to be used:
Norit Carbomix should not be administered if the poisoning is certain to have been caused by irritating (such as strong acids or bases) substances. It can interfere with inspection of the gullet (oesophagoscopy) and of the stomach (gastroscopy). In those cases in which an oral therapy or an oral, specific antidote may be crucially important for the patient, the use of activated charcoal is advised against.

Warnings and precautions:
In case of poisoning, administer Norit Carbomix suspension first and send for a doctor immediately. The use of Norit Carbomix will cause the feces to become black.
Activated charcoal will not adsorb well organic and inorganic salts and solvents, e.g. salts of iron, lithium, thallium, cyanide, methanol, ethanol, ethylene glycol, and petroleum containing solvents. With these substances, other methods of poison elimination (e.g. gastric lavage) should be used.
The main poisons concerned are listed below, together with the treatment for these substances:
Specific antidote:
cyanide                         sodium nitrite/4-dimethylaminophenol
iron compounds            deferoxamine
lithium                           calcium polystyrene sulphate
methanol                        ethanol
ethylene glycol              ethanol

For many intoxications both Norit Carbomix and a specific antidote should be administered (for example, for paracetamol poisoning: N-acetylcysteine).
 
Use during pregnancy and breastfeeding:
This medicine can, as far as is known, be used as prescribed during pregnancy and breastfeeding without any danger for the fetus or the child.  

Interaction with other medicines:
The use of Norit Carbomix will generally reduce the effect of orally applied medicines.
The use of Norit Carbomix can reduce the efficacy of oral contraceptive steroids and an additional method of contraception should be used when Norit Carbomix has been used.

Posology and method of administration:
Children up to 12 years of age:
Recommended dosage: about 1 g activated charcoal per kg body weight.
In case of acute poisoning in children younger than 12 years 1/2 dosage (1/2 bottle) should be administered; in children younger than 4 years a first dosage of 1/4 bottle should be given, which should be repeated a number of times in consultation with a doctor.
    
Adults and adolescents from 12 years of age:
50-100 g activated charcoal (1-2 bottles), to be administered as soon as possible. In case of serious poisoning the treatment should, during a number of days, be followed by a 20 g dose every 4-6 hours (20 g activated charcoal equals approximately 160 ml of suspension). In unconscious patients a doctor, or nurse under medical supervision, should administer the suspension through a stomach tube.

Norit Carbomix can also be administered after vomiting or gastric lavage.

In order to prevent the poison from being absorbed in the body and to remove the poison already absorbed, Norit Carbomix should be administered quickly. A slow administration, however, may be beneficial too.

In case of serious poisoning a repeated administration of activated charcoal is recommended.  

Directions for Use:
If the powder has "caked" it should be beaten loose. Add water to the bottle up to the red line. Shake vigorously for 1 minute. The result is about 400 ml of suspension. Carefully open the bottle and use the suspension immediately. In case of a repeated administration shake the bottle again before use.
    
The bottle is fitted with a special top which can be used as adaptor for fast and direct attachment of a stomach tube. Ventilate the bottle and cut off the top of the nozzle  partly before attachment of a stomach tube.
 
Side effects:
Severe constipation may occur in those predisposed to constipation. 

Storage and shelf life:
The granulate for the preparation of the suspension has a shelf life as stated on the packaging, if stored dry and in the original package. It has a shelf life of 3 days maximum after preparation. The reconstituted product (suspension) should be stored at 2-8° C.

Packaging:
Bottle (450 ml) with turning top and nozzle (for use of stomach tube).

NORIT N.V., Amersfoort, The Netherlands