Consumer medicine information

Carbosorb XS

Charcoal, activated; Sorbitol

BRAND INFORMATION

Brand name

Carbosorb XS

Active ingredient

Charcoal, activated; Sorbitol

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Carbosorb XS.

SUMMARY CMI

Carbosorb® XS 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 XS being used?

Carbosorb XS contains the active ingredients activated charcoal and sorbitol. Carbosorb XS is used for the treatment of poisoning and drug overdose where the substance has been taken by mouth.

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

2. What should I know before Carbosorb XS 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 XS is used? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Carbosorb XS 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 XS used?

  • Carbosorb XS must only be given by a doctor or nurse. Carbosorb XS may be diluted before it is used.
  • Your doctor will decide what dose of Carbosorb XS 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 XS is required.

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

5. What should I know while Carbosorb XS 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 XS.
Looking after your medicine
  • Carbosorb XS is stored in the surgery, pharmacy, or ward of a hospital at a temperature below 25°C. Carbosorb XS is not refrigerated.
  • A Carbosorb XS bottle is opened at the time of use. It is intended for single use, in one patient only and unused portion if any, will be discarded and not stored.

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

6. Are there any side effects?

Common side effects include black coloured bowel motions and vomiting. Serious side effects include difficulty breathing (pneumonia), constipation, stomach pain and/or bloating, chest pain, and dehydration (symptoms of it includes diarrhoea, feeling light headed, dry mouth and producing less urine than usual).

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® XS Suspension

Active ingredients: activated charcoal and sorbitol


Consumer Medicine Information (CMI)

This leaflet provides important information about using Carbosorb XS. 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 XS.

Where to find information in this leaflet:

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

1. Why is Carbosorb XS being used?

Carbosorb XS contains the active ingredients activated charcoal and sorbitol. The activated charcoal in this medicine physically adsorbs certain drugs and toxic agents onto its surface. Not all drug and poisons will be adsorbed 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.

Carbosorb XS is used for the treatment of poisoning and 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 XS is used?

Warnings

You must not be given Carbosorb XS if:

  • you are allergic 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.

You must not be given Carbosorb XS if:

  • have already been given a dose of Carbosorb XS.
    Only a single dose of Carbosorb XS should be given during treatment.
  • 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.
  • have significant fluid abnormalities such as oedema or body salt abnormalities.

You should not be given Carbosorb XS 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
    - dehydration or salt imbalance.

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 XS. Your doctor can discuss with you the risk and benefits involved.

Use in children

Carbosorb XS should not be given to a child under the age of 1 year. Carbosorb XS may cause excessive diarrohea in children under the age of 1 year.

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 XS 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 XS will need to be given by injection. Your doctor has more information on what drugs may be affected by this medicine.

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 XS.

4. How is Carbosorb XS used?

Carbosorb XS 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 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.

How much is used

  • Your doctor will decide what dose of Carbosorb XS 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.
  • Only one dose of Carbosorb XS will be given.

If too much Carbosorb XS is used

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

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 overdose you should immediately:

  • phone the Poisons Information Centre
    by calling 13 11 26
  • 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 XS 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 XS.

Looking after your medicine

  • Carbosorb XS 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 XS 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

Common/Less serious side effectsWhat to do
  • black coloured bowel motions
  • vomiting
Speak to your doctor if you have any of these less serious side effects and they worry you.

The above list includes the more common side effects.

Serious side effects

Serious side effectsWhat to do
  • 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
Tell or call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these 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 XS contains

Active ingredient
(main ingredient)
activated charcoal 0.2 g/mL
sorbitol 0.283 g/mL
Other ingredients
(inactive ingredients)
propylene glycol
glycerol
citric acid
purified water
sodium hydroxide and citric acid (for pH adjustment)

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

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

What Carbosorb X looks like

Carbosorb XS is contained in a plastic bottle with a tamper proof lid. (AUST R 307429).

Each bottle contains 250 mL of a black liquid.

Phebra product code: SOL054.

Who distributes Carbosorb XS

Carbosorb XS is supplied in Australia by:

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

This leaflet was prepared in Sep 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 November 2021

BRAND INFORMATION

Brand name

Carbosorb XS

Active ingredient

Charcoal, activated; Sorbitol

Schedule

Unscheduled

 

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.

A single dose based on 1 g activated charcoal (equivalent to 5 mL Carbosorb XS suspension) per kg bodyweight (to a maximum dose of 50 g) is recommended. Carbosorb XS is formulated to be a single dose unit for an average adult.

Repeat doses.

Certain patients may require repeat doses of activated charcoal because of the pharmacokinetic properties of the ingested drug or poison. Patients poisoned with sustained or slow release formulations, drugs that undergo enterohepatic recirculation and drugs subject to gastrointestinal dialysis fall into this category. Based on experimental and clinical studies, repeat dose activated charcoal should be considered in patients who have ingested a life threatening amount of carbamazepine, dapsone, phenobarbitone, quinine or theophylline.
More than a single dose of Carbosorb XS is contraindicated during repeat dose activated charcoal therapy. Repeat doses of activated charcoal should be accompanied with monitoring of fluid and electrolyte balance.

Children 1 to 11 years.

A single dose based on 1 g activated charcoal (equivalent to 5 mL Carbosorb XS suspension) per kg bodyweight (to a maximum dose of 50 g). The presence of sorbitol may produce diarrhoea disturbing fluid and electrolyte balance.
Repeat doses of activated charcoal therapy are not recommended in children and should be administered only when necessary, accompanied by monitoring of fluid and essential electrolytes.
Carbosorb XS is contraindicated in infants less than 1 year of age.

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.

Elderly patients may be susceptible to fluid and electrolyte disturbances resulting from excessive catharsis due to sorbitol. Only a single dose of Carbosorb XS should only be given during repeat dose activated charcoal therapy, depending on the patient's clinical condition and with careful monitoring of fluid and electrolyte balance.
The clinical condition of the elderly should therefore be monitored closely during treatment with Carbosorb XS.

Paediatric use.

Carbosorb XS is contraindicated in infants less than one year of age due to the possibility of excessive catharsis. Although a single dose may be used in children from 1 to 11 years of age, careful monitoring of fluid and electrolyte balance is required.
See Section 4.2 Dose and Method of Administration.
The clinical condition of children should therefore be monitored closely during treatment with Carbosorb XS.

Effects on laboratory tests.

No data available.

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.

No data available.
There is little data on the use of Carbosorb XS during pregnancy.
Activated charcoal is not absorbed from the gastrointestinal tract and is not expected to pose a risk to the fetus during pregnancy. However, the cathartic effect of sorbitol may cause diarrhoea resulting in electrolyte disturbances or dehydration.
Carbosorb XS should be used during pregnancy only when necessary. The potential risk to the fetus of both the poisoning and the treatment need to be balanced against the risk of failing to detoxify the mother.
There is little data on the use of Carbosorb XS during lactation. Activated charcoal and sorbitol are not absorbed from the gastrointestinal tract so there is no excretion into the breast milk. The cathartic effect of sorbitol may cause fluid and electrolyte disturbances or dehydration in the breastfeeding mother.

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.

Reporting suspected adverse reactions after registration 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 at www.tga.gov.au/reporting-problems.

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.

Activated charcoal is an adsorbent used to remove drugs from the gastrointestinal tract as a treatment for poisoning. Its mechanism of action is by physical adsorption of drugs and toxic agents onto its surface. It is effective in the adsorption of many drugs including aspirin, barbiturates, tricyclic antidepressants, digoxin, amphetamines, morphine, cocaine, digitalis and the phenothiazines. The adsorptive capacity of activated charcoal is too low for treatment of poisoning with ferrous sulfate and other iron salts, cyanides, tolbutamide and other sulfonylureas, malathion, dicophane, lithium, ethanol, methanol, ethylene glycol and hydrocarbons.
Since sorbitol has a rapid cathartic action the combination of activated charcoal and sorbitol counteracts the constipation produced by charcoal alone, thereby hastening the elimination of the toxic drug. The decreased transit time does not appear to diminish the activity of the charcoal.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Activated charcoal and sorbitol are not absorbed from the gastrointestinal tract.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

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.

No chemical structure of activated charcoal is available.

Sorbitol.


CAS number.

Activated charcoal: 7440-44-0.
Sorbitol: 50-70-4.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes