Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Cabosorb X. It does not contain all the available information. It does not take the place of talking to your doctor.

All medicines have risks and benefits. Your doctor has weighed the risks of you being given Carbosorb X against the benefits this medicine is expected to have for you.

If you have any concerns about being given this medicine, ask your doctor.

Keep this leaflet in a safe place. You may need to read it again.

What Carbosorb X is used for

Carbosorb X is used to treat poisoning or drug overdose where the substance has been taken by mouth.

The activated charcoal in this medicine physically adsorbs certain drugs and toxic agents onto its surface. Not all drugs and poisons will be adsorbed by activated charcoal.

This medicine works best when it is given within 1 hour of the poison or drug being swallowed.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

Before you are given Carbosorb X

You must not be given Carbosorb X if you have an allergy to:

• any medicine containing activated charcoal
• any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

• shortness of breath
• wheezing or difficulty breathing
• swelling of the face, lips, tongue or other parts of the body
• rash, itching or hives on the skin.

Carbosorb X should not be used if you have been poisoned with any of the following:

• strong acids and alkalis
• ferrous sulphate and other iron salts
• cyanides
• medicines used in the treatment of diabetes known as sulphonylureas such as tolbutamide
• alcohols or hydrocarbons
• malathion, a type of pesticide
• lithium
• dicophane, a type of insecticide.

You must not be given this medicine if you have any problems with your digestive system that may have caused a hole or perforation e.g. a perforated ulcer or recent surgery.

You must not be given this medicine if due to a medical condition or surgery you have trouble swallowing. The doctor or nurse will check to ensure the medicine is not past its expiry date and has not been tampered with.

If you are not sure whether you should be given this medicine talk to your doctor.

Before you are given it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

• any problems with your gag reflex, the normal retching action when an object touches the back of your throat
• blockage of the bowel or any other problems with digestion
• recent surgery on the stomach and intestines, blockage of the intestine
• diabetes
• feeling drowsy.

Tell your doctor if you are pregnant or plan to become pregnant or are breast- feeding. Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell him/her before you are given Carbosorb X.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket, health food shop, naturopath or herbalist.

Some medicines and Carbosorb X may interfere with each other. These include:

• atropine, a medicine used to treat a number of conditions
• medicines used to relieve pain such as morphine or codeine
• verapamil, a medicine used to treat heart disease.

These drugs may increase the risk of a blockage of the bowel.

Tell your doctor if you have taken or been given any medicines that induce vomiting. Vomiting of activated charcoal may increase the risk of breathing the charcoal into your lungs.

Activated charcoal adsorbs many drugs in the stomach so drugs that need to be given while being treated with Carbosorb X will need to be given by injection. Your doctor has more information on what drugs may be affected by this medicine.

How Carbosorb X is given

Carbosorb X must only be given by a doctor or nurse.

The bottle will be shaken well for a minimum of 30 seconds. Carbosorb X may be given by mouth or through a tube through the nose or mouth into the stomach.

Carbosorb X may be diluted before it is used.

Your doctor will decide what dose of Carbosorb X you will receive and how many doses you will receive. This depends on your medical condition and other factors, such as your age and weight. Usually only a single dose of Carbosorb X is required.

If you are given too much (overdose)

Carbosorb X must only be given by a doctor or nurse so an overdose is not likely to occur.

Symptoms of an overdose may include:

• stomach cramps, bloating
• vomiting, loss of appetite
• blood in the stools
• fever.

If you notice any symptoms of an overdose immediately contact your doctor or go to the Emergency Department at the nearest hospital.

Contact the Poisons Information Centre on (AU) 13 11 26 or (NZ) 0800 764 766 for further advice on overdose management.

Side effects

Tell your doctor or nurse as soon as possible if you do not feel well while you are being given Carbosorb X. This medicine may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Do not be alarmed by the following list of side effects. You may not experience any of them.

Ask your doctor to answer any questions you may have.

Tell your doctor or nurse if you notice any of the following and they worry you:

• black coloured bowel motions
• vomiting.

The above list includes the more common side effects of your medicine.

If any of the following happen tell your doctor or nurse immediately or go to the Emergency Department at your local hospital:

• difficulty breathing (pneumonia)
• constipation
• stomach pain and/or bloating
• chest pain.

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.

Tell your doctor or nurse if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people.

After being given Carbosorb X

Storage

Carbosorb X will be stored in the surgery, pharmacy or ward of a hospital at a temperature below 25°C. Carbosorb X will not be refrigerated.

Carbosorb X will be opened for use on you. It will be used only once and then it will be discarded. It will never be stored after it is opened nor used for more than one person.

Product description

What it looks like

Carbosorb X is contained in a plastic bottle with a tamper proof lid. Each bottle contains 250mL of a black liquid.

Ingredients

Carbosorb X contains 0.2 g/mL of activated charcoal as the active ingredient.

It also contains:

• sucrose 0.33 g/mL
• propylene glycol
• glycerol
• anhydrous citric acid
• purified water.

The following may also be added for pH adjustment:

• sodium hydroxide
• anhydrous citric acid.

This medicine does not contain gluten, lactose, tartrazine alcohol, dyes or preservatives.

Supplier

Carbosorb X is supplied in Australia by:

Phebra Pty Ltd
19 Orion Road, Lane Cove West,
NSW 2066, Australia.
Telephone: 1800 720 020

Carbosorb X is distributed in New Zealand by:

AFT Pharmaceuticals Ltd
PO Box 33-203, Auckland.
Telephone: +64 9 4880232

Carbosorb® X 0.2 g/mL charcoal suspension 250 mL bottle

AUST R 106470

Phebra product code- SOL052

Date of most recent amendment: 02 March 2018

Carbosorb, Phebra and the Phi symbol are trademarks of Phebra Pty Ltd, 19 Orion Road, Lane Cove West, NSW 2066, Australia.

Published by MIMS November 2018

1 Name of Medicine

Activated charcoal.

2 Qualitative and Quantitative Composition

Carbosorb X suspension contains 0.2 g/mL activated charcoal.
Each bottle of Carbosorb X contains 50 g of activated charcoal in 250 mL of suspension.

Excipients with known effect.

3 Pharmaceutical Form

Carbosorb X is a black, viscous suspension.

4 Clinical Particulars

4.1 Therapeutic Indications

For the treatment of poisoning and drug overdosage by oral ingestion.

4.2 Dose and Method of Administration

To be fully effective, Carbosorb X should be administered as soon as possible after oral ingestion of the poison as activated charcoal can only adsorb that portion of the drug not absorbed from the gastrointestinal tract. Administration of Carbosorb X is more likely to produce benefit if administered within one hour of poison ingestion.
Carbosorb X may be administered after the stomach contents have been emptied by emesis or gastric lavage, although suspensions of activated charcoal may be used as a lavage fluid. Some situations may require the use of a cathartic in which case the use of Carbosorb XS, as a single dose only, may be appropriate.
Carbosorb X may be administered orally or by nasal or orogastric tube (dilute with water if required prior to nasal or orogastric tube administration). Prior to administration, the container should be shaken vigorously for a minimum of 30 seconds.
Recommendations as to absolute dosage regimens are difficult to make due to individual patient variations in type of poisoning and patient weight and age.

Adults and children 12 years and over.

Single dose.

Repeat doses.

Infants and children (1 month to 11 years).

4.3 Contraindications

Carbosorb X is contraindicated in poisoning with strong acids and alkalis and those poisons for which its adsorptive capacity is too low (ferrous sulfate and other iron salts, cyanides, tolbutamide and other sulfonylureas, malathion, dicophane, lithium, ethanol, methanol, ethylene glycol and hydrocarbons).
Carbosorb X is contraindicated in patients who have an unprotected airway or a gastrointestinal tract that is not anatomically intact.

4.4 Special Warnings and Precautions for Use

Carbosorb X should not be administered concomitantly with systemically active emetics such as ipecacuanha, since it adsorbs the active components making them unavailable systemically. Emetics may be given to induce vomiting prior to administration of Carbosorb X. Induced emesis should not be used if the patient is drowsy, unconscious, fitting or if the patient is likely to become drowsy within 30 minutes of taking the emetic.
Aspiration of activated charcoal and gastric contents is a potentially serious complication. Patients who have an absent or impaired gag reflex, are comatose or drowsy, or have ingested large amounts of CNS depressant drugs or drugs that may cause seizures require airway protection, for example in the form of a cuffed endotracheal tube, to protect against aspiration. Vomiting of activated charcoal may contribute to the occurrence of aspiration. Care should, therefore, be taken in patients who have been administered systemically active emetics and when patients are extubated. Consideration should be given to withholding Carbosorb X for an adequate time interval prior to extubation.
In the event of an antidote to a specific poison being available this should be the first choice for treatment. Specific antidotes should not be used in conjunction with activated charcoal as they themselves may be adsorbed and inactivated by activated charcoal. Since activated charcoal adsorbs many drugs, any concurrent medication should be given parenterally.
Carbosorb X should be used with extreme caution in patients with ileus, decreased or absent bowel sounds, or who have ingested a large amount of drugs that may impair peristalsis. The concomitant use of supportive agents that decrease gut motility (e.g. atropine, morphine, verapamil) should be avoided if possible due to the increased risk of gastrointestinal obstruction with repeat doses of activated charcoal. Patients who are at risk of haemorrhage or gastrointestinal perforation due to recent surgery or pathology could be further compromised by administration of Carbosorb X.
Carbosorb X contains sucrose 0.33 g/mL. Clinical judgment should be used prior to administration of Carbosorb X to diabetic patients.
Activated charcoal preparations are known to adsorb minerals, vitamins, enzymes and amino acids from the gastrointestinal tract. In patients receiving repeat dose regimens, particularly children, monitoring of fluid and electrolyte changes is recommended.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Carbosorb X may adsorb other orally administered drugs and antidotes. Any concurrent medication required should be given parenterally.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Few serious adverse reactions or complications from the use of a single dose of activated charcoal have been reported in poisoned patients.
Faecal discolouration frequently occurs. Black stools may be utilised as a diagnostic sign of gastrointestinal transit.
Vomiting may occur. This could prove hazardous to a patient who has ingested a caustic or volatile substance (see Section 4.3 Contraindications).
Cases of aspiration pneumonia have been reported with the use of activated charcoal slurry for poisoning. Fatalities have been reported due to complications of aspiration. There has been one report of bronchiolitis obliterans and a few reports of progressive respiratory failure resulting in death, due to aspiration of activated charcoal. Care should be taken to ensure adequate airway protection (see Section 4.3 Contraindications; Section 4.4 Special Warnings and Precautions for Use).
There have been several documented case reports of serious gastrointestinal adverse effects with the use of repeat dose activated charcoal. These include intestinal obstructions and charcoal bezoar formation. Fatalities have occurred. Care should be taken in patients with ileus or diminished or absent bowel sounds (see Section 4.3 Contraindications; Section 4.4 Special Warnings and Precautions for Use).

Reporting suspected adverse effects.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

The excipients include sucrose, propylene glycol, glycerol, sodium hydroxide, purified water and citric acid.

6.2 Incompatibilities

See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG)¹. The expiry date can be found on the packaging.
¹ AUSTR 106740.

6.4 Special Precautions for Storage

Store below 25°C. Do not refrigerate.

6.5 Nature and Contents of Container

Each bottle of Carbosorb X contains 50 g of charcoal as the active ingredient in a 250 mL suspension.
Carbosorb X is contained in a high density polyethylene (HDPE) bottle with a tamper evident screw cap. It is supplied in cartons containing 10 bottles. Single use only.
Phebra product code - SOL052.

6.6 Special Precautions for Disposal

Single use only. Use only once and discard any unused suspension.

6.7 Physicochemical Properties

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes