Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
CHARCOAL, ACTIVATED
Beacon Pharmaceuticals Ltd
A07BA01
CHARCOAL, ACTIVATED
81.3 %w/w
Granules for Oral Suspension
Product not subject to medical prescription
Charcoal preparations
Authorised
2006-04-28
PATIENT INFORMATION LEAFLET _50G GRANULES FOR ORAL SUSPENSION _ _(ACTIVATED CHARCOAL) _ _ _ Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Keep this leaflet. You may need to read it again If you have any further questions, ask your doctor or pharmacist This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet It is possible that you may have been treated with Carbomix before you were able to read this leaflet. If you would like any more information, or are not sure about anything, you should ask your doctor or pharmacist. WHAT IS IN THIS LEAFLET: 1. What Carbomix is and what it is used for 2. What you need to know before you take Carbomix 3. How to take Carbomix 4. Possible side effects 5. How to store Carbomix 6. Contents of the pack and other information 1. WHAT CARBOMIX IS AND WHAT IT IS USED FOR The active ingredient of Carbomix is activated charcoal in the form of very fine granules. Carbomix is used as an emergency treatment for acute oral poisoning or drug overdose. It works by adsorbing the drugs or toxic substances so reducing their absorption into the blood or helping to eliminate them from the body. Carbomix itself is not absorbed into the blood and passes through the gut unchanged. Carbomix is usually taken under medical supervision. For single use only. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARBOMIX You should not take Carbomix if you have taken a medicine to make you sick or an oral antidote such as methionine as they will be adsorbed by Carbomix. Tell your doctor or pharmacist if you are taking any other medication. Carbomix is of limited use in treating poisoning by the following: corrosive substances (such as acids or alkalis) cyanides, iron salts some solvents such as meth Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Carbomix 50 g Granules for Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Activated Charcoal Activated 50g in 61.5g of granules (81.3 % w/w). Also contains glycerol (5g/50g activated charcoal) as an excipient. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Granules for oral suspension. Odourless black granules. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Emergency treatment of acute oral poisoning or drug overdose. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posolgy _Adults:_ 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. _Neonates:_ Use not recommended Method of Administration Carbomix should be given as soon as possible after the ingestion of the potential poison. Carbomix granules should be mixed with water and swallowed as a suspension under medical supervision only.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 universal applicator provided. Carbomix may be administered after emesis or gastric lavage and may be used concurrently with parenteral antidotes such as acetyl cystine. 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. 4.3 CONTRAINDICATIONS Although Carbomix is not contraindicated in poisoning by strong acids and alkalis and other corrosive substances, its value as a detoxicant for these substances is limited. Carbomix is poor in binding cyanide, iron salts and some solvents including methanol, ethanol and ethylene glycol (see section 4.4). H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Lees het volledige document