SUMMARY CMI

Carbosorb^® X Suspension

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about being given this medicine, speak to your doctor or pharmacist.

1. Why is Carbosorb X being used?

Carbosorb X contains the active ingredient activated charcoal. Carbosorb X is used to treat poisoning or drug overdose where the substance has been taken by mouth.

For more information, see Section 1. Why is Carbosorb X being used? in the full CMI.

2. What should I know before Carbosorb X is used?

Do not use if you have ever had an allergic reaction to activated charcoal or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before Carbosorb X is used? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Carbosorb X and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How is Carbosorb X used?

• Carbosorb X must only be given by a doctor or nurse. 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 age and weight. Usually only a single dose of Carbosorb X is required.

More instructions can be found in Section 4. How is Carbosorb X used? in the full CMI.

5. What should I know while Carbosorb X is used?

For more information, see Section 5. What should I know while Carbosorb X is used? in the full CMI.

6. Are there any side effects?

Common side effects include black coloured bowel motions and vomiting. Very Serious side effects include chest pain, constipation, stomach pain and/or bloating and difficulty breathing (pneumonia).

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

Carbosorb^® X Suspension

Active ingredient: activated charcoal

Consumer Medicine Information (CMI)

This leaflet provides important information about using Carbosorb X. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about being given Carbosorb X.

Where to find information in this leaflet:

1. Why is Carbosorb X being used?
2. What should I know before Carbosorb X is used?
3. What if I am taking other medicines?
4. How is Carbosorb X used?
5. What should I know while Carbosorb X is used?
6. Are there any side effects?
7. Product details

1. Why is Carbosorb X being used?

Carbosorb X contains the active ingredient activated charcoal. The activated charcoal in this medicine adsorbs certain drugs and toxic agents onto its surface. Not all drug 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.

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

Ask your doctor if you have any questions about why this medicine is being given to you. Your doctor may have given it to you for another reason.

2. What should I know before Carbosorb X is used?

Warnings

You must not be given Carbosorb X if:

• you are allergic 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.

You must not be given Carbosorb X 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
• due to medical condition or surgery, you have trouble swallowing.

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

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

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.

Check with your doctor if you:

• have allergies to any other medicines, foods, preservatives, or dyes.
• have or have had 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 intestine, blockage of the intestine
  - diabetes
  - feeling drowsy.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

If you have not told your doctor about any of the above, tell them before you are given Carbosorb X. Your doctor can discuss with you the risk and benefits involved.

3. What if I am taking other medicines?

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

Some medicines may interfere with Carbosorb X and affect how it works. 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.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Carbosorb X.

4. How is Carbosorb X used?

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

How it is used

• The bottle should 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.

How much to use

• Your doctor will decide what dose of Carbosorb X you will receive and how long you will receive it for. 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.
• Carbosorb X may be diluted before it is used.

If too much Carbosorb X is used

Overdose is unlikely to occur as Carbosorb X is always given to you under the supervision of a doctor or nurse.

Symptoms of an overdose may include:

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

If you notice any symptoms of overdose you should immediately:

• phone the Poisons Information Centre
  by calling 13 11 26 AU, or 0800 764 766 NZ
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while Carbosorb X is used?

Things you should do

Tell your doctor if or nurse as soon as possible if you do not feel well while you are being given Carbosorb X.

Looking after your medicine

Carbosorb X must:

• be stored in the surgery, pharmacy, or ward of a hospital at a temperature below 25°C.
• not be refrigerated.
• be opened only at the time of use. It is intended for single use only, and any Carbosorb X remaining in the bottle will be discarded. It should never be stored once opened, nor used for more than one person.

Keep it where young children cannot reach it.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about 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.

Common/Less serious side effects

The above list includes the more common side effects.

Serious side effects

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

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you should then report these side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

What Carbosorb X contains

Carbosorb X contains sugars (as sucrose).

Do not take this medicine if you are allergic to any of these ingredients.

Carbosorb X does not contain gluten, lactose, tartrazine alcohol, dyes or preservatives.

What Carbosorb X looks like

Carbosorb X is contained in a plastic bottle with a tamper proof lid. Each bottle contains 250 mL of a black liquid. (AUST R 106470).

Phebra product code: SOL052.

Who distributes Carbosorb X

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 supplied in New Zealand by:

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

This leaflet was prepared in Dec 2021.

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

Published by MIMS March 2022

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