Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Carbosorb XS. 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 XS 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 XS is used for

Carbosorb XS is used for the treatment of poisoning and drug overdose where the substance has been taken by mouth.

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

The sorbitol in Carbosorb XS will cause the activated charcoal to pass through the intestines more rapidly.

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 Carbosorb XS has been prescribed for you. Your doctor may have prescribed it for another reason.

Before you are given Carbosorb XS

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

• any medicine containing activated charcoal or sorbitol
• 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 XS should not be used to treat poisoning with:

• 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 already been given a dose of Carbosorb XS. Only a single dose of Carbosorb XS should be given during treatment.

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.

You should not be given this medicine if you have significant fluid abnormalities such as oedema or body salt abnormalities.

This medicine should not be given to a child under the age of 1 year. This medicine may cause excessive diarrhoea in children under the age of 1 year.

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 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 intestines
• feeling drowsy
• dehydration or salt imbalance.

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 XS.

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

How Carbosorb XS is given

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

Carbosorb XS may be diluted before it is used.

Your doctor will decide what dose of Carbosorb XS you will receive. This depends on your medical condition and other factors, such as your age and weight.

Only one dose of Carbosorb XS will be given.

If you are given too much (overdose)

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

Symptoms of an overdose may include:

• feeling dizzy and light headed
• dry or sticky mouth
• producing less urine
• 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 13 11 26 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 XS. 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.

If you are over 65 years of age, you may have an increased risk of getting side effects. Children aged between 1 and 11 may also have an increased risk of getting 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 immediately or go to the Emergency Department at your local hospital:

• difficulty breathing (pneumonia)
• constipation
• stomach pain and/or bloating
• chest pain
• symptoms of dehydration including:
  - diarrhoea
  - feeling light headed
  - dry mouth
  - producing less urine than usual.

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 XS

Storage

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

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

Ingredients

Carbosorb XS contains activated charcoal 0.2 g/mL and sorbitol 0.283 g/mL as the active ingredients.

It also contains:

• 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 XS is supplied in Australia by:

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

Carbosorb XS is distributed in New Zealand by:

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

Carbosorb® XS activated charcoal
0.2 g/mL and sorbitol
0.283 g/mL suspension.
250 mL bottle

AUST R 307429

Phebra product code- SOL054

Date of most recent amendment: 09 July 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 September 2019

1 Name of Medicine

Activated charcoal.
Sorbitol.

2 Qualitative and Quantitative Composition

Carbosorb XS is a suspension containing activated charcoal 0.2 g/mL and sorbitol 0.283 g/mL.
Each bottle of Carbosorb XS contains 50 g of activated charcoal and 70.75 g sorbitol in 250 mL of suspension.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Carbosorb XS 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 XS 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 XS is more likely to produce benefit if administered within one hour of poison ingestion.
Carbosorb XS may be administered after the stomach contents have been emptied by emesis or gastric lavage.
Carbosorb XS may be administered orally or by nasal or orogastric tube. 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.
Dilution with water if required prior to use with nasogastric and orogastric tubes.
Due to the viscosity of Carbosorb XS, dilution with water prior to nasal or orogastric tube administration may be required. The dilution ratio is dependent on a number of variables including the gauge and length of the tube to be used, the size of the syringe used, patient cooperation and individual operator technique. As a guide, a minimum of 0.1 parts water to 1 part Carbosorb XS is recommended for administration via tubes of less than 12 French Gauge.

Adults and children 12 years and over.

Repeat doses.

Children 1 to 11 years.

4.3 Contraindications

Carbosorb XS is contraindicated in poisoning with strong acids and alkalis and for 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 XS is contraindicated in patients who have an unprotected airway or a gastrointestinal tract that is not anatomically intact. It is also contraindicated in patients who have significant fluid or electrolyte abnormalities.
Carbosorb XS is contraindicated in infants less than one year of age due to the possibility of excessive catharsis.
Repeat doses of Carbosorb XS are contraindicated.

4.4 Special Warnings and Precautions for Use

Carbosorb XS 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 XS. 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 and sorbitol 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 XS 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 XS 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 XS.
Activated charcoal preparations are known to adsorb minerals, vitamins, enzymes and amino acids from the gastrointestinal tract.
The cathartic effect of sorbitol may produce diarrhoea that may result in electrolyte disturbance or dehydration.
Only a single dose of Carbosorb XS should be given during repeat dose activated charcoal therapy in adults, with consideration of the patient's condition and monitoring of fluid and electrolyte status.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Carbosorb XS 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 single doses of Carbosorb XS have been reported. 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).
The presence of sorbitol in Carbosorb XS may produce diarrhoea, resulting in disturbance of fluid and electrolyte balance. There have been case reports of dehydration and electrolyte imbalance in adults. There have also been a few case reports of serious dehydration and electrolyte imbalance in infants and young children, resulting in permanent disability and fatality. These cases were attributed to excessive repeat doses of sorbitol cathartic (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

Excipients include sodium hydroxide, propylene glycol, glycerol, 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.
¹AUST R 307429.

6.4 Special Precautions for Storage

Store below 25°C. Do not refrigerate.

6.5 Nature and Contents of Container

Each bottle of Carbosorb XS contains 50 g of activated charcoal and 70.75 g sorbitol in 250 mL of suspension.
Carbosorb XS is contained in a high-density polyethylene (HDPE) bottle with a tamper evident screw cap. It is supplied in cartons containing 10 bottles.
Phebra product code - SOL054.

6.6 Special Precautions for Disposal

Single use only. Use only once and discard any unused suspension.
In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.

Sorbitol.

CAS number.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes