CARBOMIX 81.3 %w/w Granules for Oral Suspension

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
CHARCOAL, ACTIVATED
Available from:
Beacon Pharmaceuticals Ltd
ATC code:
A07BA01
INN (International Name):
CHARCOAL, ACTIVATED
Dosage:
81.3 %w/w
Pharmaceutical form:
Granules for Oral Suspension
Prescription type:
Product not subject to medical prescription
Therapeutic area:
Charcoal preparations
Authorization status:
Authorised
Authorization number:
PA1312/002/001
Authorization date:
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:

What Carbomix is and what it is used for

What you need to know before you take Carbomix

How to take Carbomix

Possible side effects

How to store Carbomix

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 methanol, ethanol (the alcohol in alcoholic drinks) and ethylene

glycol

The presence of Carbomix may make any immediate endoscopy that may be required,

difficult. Carbomix may stain if spilt.

A laxative is often administered with Carbomix to hasten the removal of the poison and

charcoal. This may result in diarrhoea.

Other medicines and Carbomix

Tell your doctor or hospital staff if you are taking or have recently taken any other

medicines. The purpose of this medicine is to interact with other medicines and toxins.

However this product is not absorbed from the gut and so there is no systemic interactions.

If a specific antidote is to be administered the likelihood of its adsorption by activated

charcoal should be borne in mind, and a parenteral route of administration used if possible.

Pregnancy and breast-feeding

Tell your doctor or pharmacist if you are pregnant or breastfeeding.

Carbomix contains Glycerol

Carbomix contains glycerol which may cause headache, stomach upset and diarrhoea.

3. HOW TO TAKE CARBOMIX

Always take this medication exactly as your doctor has told you. Check with your doctor or

pharmacist if you are not sure.

The usual adult dose is 50g. Children under 12 years should be given 25g (half the

contents of the 50g bottle after it has been made up with water) unless there is a risk to life,

in which case a dose of 50g is recommended. The dose may be repeated if necessary,

usually under medical supervision.

Carbomix granules should be mixed with water and swallowed as a suspension (about

400ml). The contents of the bottle should be made up to the red band with water and

shaken thoroughly. Carbomix should be taken as soon as possible after the potential

poison has been swallowed. It is important to take the whole dose.

If the poison has diuretic properties (i.e. increases urine output) or has been taken with

alcohol, plenty of fluid should be drunk after taking Carbomix.

Carbomix can be taken after vomiting or after having a stomach pump. It may be given by

tube into the stomach, under medical supervision only. A universal applicator is provided

for this purpose.

DO NOT EXCEED THE RECOMMENDED DOSE

Remember to tell any doctor or pharmacist who is giving you advice about other medical

conditions that you have taken Carbomix. If you have any further questions on the use of

this medicine ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Carbomix can cause side effects, although not everybody gets them.

The following side effects occur with an unknown frequency in the general population

Some patients may experience stomach upset such as vomiting, constipation or

diarrhoea.

Blockage or perforation of the intestine have been associated with multiple

dosing’s with activated charcoal.

Activated charcoal can produce black stools.

Blockage to the airways, preventing air from getting to your lungs

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible

side effects not listed in this leaflet. You can also report side effects directly (see details

below). By reporting side effects you can help provide more information on the safety of

this medicine.

UK: Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2 Tel: +353 1 6764971,

Fax: +353 1 6762517 Website: www.hpra.ie e-mail: medsafety@hpra.ie

5. HOW TO STORE CARBOMIX

Keep this medicine out of the sight and reach of children.

Do not use Carbomix after the expiry date which is shown on the label and the carton of

each pack after "Use by". This refers to the last day of the month.

Store below 25˚C. Keep container tightly closed.

Dispose of any unused suspension after 24 hours.

Do not throw away medicines via wastewater or household waste. Ask your pharmacist

how to dispose of medicines you no longer use. These measures will help protect the

environment.

6. CONTENTS OF THE PACK AND FURTHER INFORMATION

What Carbomix contains: The active ingredient is 81.3% activated charcoal 50g in 61.5g

granules. The other ingredients are citric acid, acacia and glycerol.

What Carbomix looks like and the contents of the pack: Carbomix is black granules in

plastic bottles which contain 50g activated charcoal.

Marketing Authorisation Holder: Beacon Pharmaceuticals Ltd, DCC Vital, Westminster

Industrial Estate, Repton Road, Measham, DE12 7DT, England

Manufacturer: Cabot Norit Nederland B.V., 7891 EV Klazienaveen, The Netherlands.

United Kingdom Product Licence number: PL 18157/0020

Republic of Ireland Product Authorisation number: PA 1312/2/1

This leaflet was last revised in January 2017.

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).

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4.4 Special warnings and precautions for use

In cases of poisoning with corrosive substances, such as strong acids or alkalis the presence of charcoal will render

difficult any immediate endoscopy that may be required as it may obscure endoscopic visualization of oesphageal and

gastric lesions producted by the toxin.

Carbomix is of little or no value in the treatment of poisoning with cyanides, alcohols, iron salts, and malathion.

Carbomix is an adjunct in the management of poisoning emergencies. Prior to its use, proper basic life support

measures must be implemented where required as well as the appropriate gastric emptying technique if indicated.

Carbomix should be used with caution in patients who have been exposed to toxins which interfere with

gastrointestinal motility (e.g. anticholingerics, opiods). Bowel sounds should be monitored frequently to assess

peristaltic action, especially in patients undergoing multiple dose activated charcoal therapy (see section 4.8)

Both the patient and health care professionals should be aware that carbomix can produce black stools (see section 4.8).

A laxative may be given concurrently to accelerate the removal of the activated charcoal-toxin complex, but should be

used with caution and only intermittently during multiple dose activated charcoal therapy since profuse and protracted

diarrhoea may lead to fluid and electrolyte imbalance.

Aspiration of activated charcoal has been reported to produce airways obstruction and appropriate precautions should

be taken (see section 4.8).

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.

4.5 Interaction with other medicinal products and other forms of interaction

Not to be taken with ipecacuanha or other centrally acting emetics; since these would be adsorbed by the Carbomix.

The purpose of the product is to interact (by adsorption) with other medicaments and toxicants taken in overdose.

There are no systemic interactions because the product is not absorbed from the gut.

4.6 Fertility, pregnancy and lactation

The safety of this medicinal product for use in human pregnancy has not been established. Experimental animal studies

are insufficient to assess the safety with respect to the development of the embryo or foetus, the course of gestation and

peri- and postnatal development.

However activated charcoal is essentially inert pharmacologically and is not systematically absorbed from the

gastrointestinal tract there is no evidence to suggest that Carbomix should not be used during pregnancy or lactation.

4.7 Effects on ability to drive and use machines

Not applicable – used in acute poisoning situations.

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4.8 Undesirable effects

Undesirable effects are listed by MedDRA System Organ Classes.

The following CIOMS frequency rating is used, when applicable:

Very common (

1/10); common (

1/100 to <1/10); uncommon (

1/1000 to <1/100 ); rare (

1/10,000 to <1/1000);

very rare (<1/10,000), not known (cannot still be estimated from the available data).

Aspiration of activated charcoal has been reported to product airways obstruction (see section 4.4)

Associated with the use of multiple dose activated charcoal therapy

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.

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: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2. Tel: +353 1 6764971;

Fax: +353 1 6762517. Website: www.hpra.ie; e-mail: medsafety@hpra.ie.

4.9 Overdose

Not applicable – excessive use may result in constipation which could be treated with laxatives.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Not applicable

5.2 Pharmacokinetic properties

Not applicable – the product is not systematically absorbed.

5.3 Preclinical safety data

Not applicable.

Respiratory, thoracic and mediastinal

disorders

Not known:

Airways obstruction

Gastrointestinal disorders

Not known:

Black stools (see section 4.4)

Gastrointestinal obstruction

Gastrointestinal disturbances including vomiting,

constipation and diarrhoea

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6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Citric acid

Acacia

Glycerol

6.2 Incompatibilities

Carbomix should not be used concurrently with systematically active oral emetics or oral antidotes since such agents

would be adsorbed by the charcoal.

6.3 Shelf life

Unopened: 3 years

After reconstitution: 24 hours

6.4 Special precautions for storage

Store below 25°C.

Keep container tightly closed.

6.5 Nature and contents of container

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

Not all pack sizes may be marketed.

6.6 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 requirements.

7 MARKETING AUTHORISATION HOLDER

Beacon Pharmaceuticals Ltd

DCC Vial

Westminster Industrial Estate

Repton Road

Measham

DE12 7DT

England

8 MARKETING AUTHORISATION NUMBER

PA1312/002/001

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9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of First Authorisation:

3rd December 1992

Date of Last Renewal:

3rd December 2007

10 DATE OF REVISION OF THE TEXT

December 2017

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