CARBOMIX Granules (2017)
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Περιεχόμενα
Name of the medicinal product
Carbomix 50g Granules for Oral Suspension.
Qualitative and quantitative composition
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.
Pharmaceutical form
Granules for oral suspension. Odourless black granules.
Therapeutic indications
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 ...
Posology and method of administration
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. ...
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 ...
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, ...
Overdose
Not applicable. In theory severe constipation would result from excessive use and this could be treated with laxatives.
Pharmacodynamic properties
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 ...
Pharmacokinetic properties
Activated charcoal is not systemically absorbed.
Preclinical safety data
No findings have been reported which add to the prescribing information given in other sections.
List of excipients
Citric acid Acacia Glycerol
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.
Shelf life
Unopened: 5 years. After reconstitution: 24 hours.
Special precautions for storage
Store below 25°C. Keep container tightly closed.
Nature and contents of container
HDPE bottle and cap containing 50g of activated charcoal (in 61.5g of granules).
Special precautions for disposal and other handling
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 ...
Marketing authorization holder
Beacon Pharmaceuticals Ltd, DCC Vital, Westminster Industrial Estate, Repton Road, Measham, DE12 7DT, England
Marketing authorization number(s)
PL 18157/0020
Date of first authorization / renewal of the authorization
13/10/2009
Date of revision of the text
10 Aug 2017
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