Carboliq 200 mg/ml oral suspension
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
CARBOLIQ 200 mg/ml 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 questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet.
Contents of this leaflet
- What CARBOLIQ is and what it is used for
- What you need to know before taking CARBOLIQ
- How to take CARBOLIQ
- Possible side effects
- How to store CARBOLIQ
- Contents of the pack and other information
1. What CARBOLIQ is and what it is used for
CARBOLIQ is a medicine containing activated charcoal, a substance that adsorbs (attracts and retains) toxic substances from the digestive tract and prevents them from entering the bloodstream.
CARBOLIQ is indicated for the treatment of acute intoxications due to drug overdose or ingestion of toxic substances.
2. What you need to know before starting to take CARBOLIQ
Do not take CARBOLIQ
- If you are allergic to activated charcoal, or to any of the other ingredients of this medicine (listed in section 6).
- If you are about to undergo an endoscopy (an examination method in which a tube with an optical system is inserted to view the inside of the digestive tract).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking CARBOLIQ.
If the patient is unconscious or having seizures, the medicine should be administered via a nasogastric tube (a flexible plastic tube inserted through the nose or mouth into the stomach) using the provided adapter. Activated charcoal should be administered with caution, especially in patients with impaired consciousness, in order to avoid aspiration of the product into the respiratory tract (see section 4).
CARBOLIQ is not recommended after ingestion of corrosive agents such as strong acids or bases, as it is ineffective and may interfere with immediate endoscopy. Its use in these types of poisoning should be limited to cases where adsorption of another concurrently ingested toxin is required.
Activated charcoal should not be used concomitantly with oral emetics or antidotes such as methionine, as these compounds will be adsorbed by the activated charcoal, thereby preventing their absorption.
If you are in any of the following situations, inform your doctor immediately before using this medicine:
- if you have decreased intestinal motility;
- in case of risk of gastrointestinal obstruction, perforation, or hemorrhage;
- if you have recently undergone abdominal surgery;
- in case of electrolyte imbalance (abnormal levels of salts in the body) and/or loss of body fluid.
CARBOLIQ is not effective in the treatment of poisonings caused by cyanide, alcohol, iron salts, malathion, or DDT.
CARBOLIQ is a medicine used in the emergency management of poisonings. Before its use, basic measures such as gastric emptying should be performed if necessary.
CARBOLIQ should be used with caution in patients exposed to toxins that may interfere with intestinal motility (e.g., anticholinergics, opioids). Intestinal peristalsis should be regularly assessed, particularly in patients receiving multiple doses of activated charcoal.
Taking CARBOLIQ with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
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Do not administer emetics (medicines used to induce vomiting) before or after activated charcoal administration, to prevent the risk of aspirating (inhaling) activated charcoal into the lungs.
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In paracetamol poisoning, activated charcoal may reduce or nullify the effect of oral antidotes such as methionine. However, parenteral (injectable) antidotes such as N-acetylcysteine or cysteamine may still be used.
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It may interfere with the absorption of a wide variety of drugs; therefore, the route of administration of concomitant medications should be carefully evaluated when administered together with activated charcoal.
As a general rule, if any other medicine is administered during treatment with activated charcoal, it should be given at least 2 hours apart from the administration of activated charcoal.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Current clinical experience has not shown any contraindication for its use in pregnant women or in nursing infants. Activated charcoal is not absorbed through the intestinal tract, so adverse effects during pregnancy or breastfeeding are not expected.
Driving and use of machines
This medicine contains propylene glycol. It may produce symptoms similar to those of alcohol and may therefore impair your ability to drive or operate machinery.
CARBOLIQ contains sucrose, propylene glycol, and glycerol
- This medicine contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him or her before taking this medicine.
Patients with diabetes mellitus should be aware that this medicine contains 600 milligrams of sucrose per ml.
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This medicine contains propylene glycol. It may produce symptoms similar to those of alcohol, and may therefore impair your ability to drive or operate machinery.
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This medicine may cause headache, stomach discomfort, and diarrhea due to its glycerol content.
3. How to take CARBOLIQ
Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
This medicine is administered orally. If the patient is unconscious or having seizures, administer via gastric tube (a flexible plastic tube from the nose or mouth to the stomach), using the adapter.
Shake vigorously for one minute before taking.
Administer as soon as possible after ingestion of the toxic substance, separately or before and/or after emptying the gastrointestinal tract. Treatment is most effective if given within the first hour after ingestion of the toxin, although it may be indicated within the first 4–6 hours.
The dose may be repeated every 4–6 hours in cases of ingestion of large amounts of the toxin, until blood levels return to normal.
- Adults:
The recommended dose is 50 g of activated charcoal in suspension (1 bottle of 250 ml).
- Children and adolescents:
Gastric capacity of the patient should be taken into account.
The recommended dose is 1 g/kg (approximately 5 ml of suspension/kg).
In significant poisonings, repeated administration of activated charcoal every 4 to 6 hours is recommended (seek advice from the Toxicology Information Service, telephone: 91 562 04 20).
If you take more CARBOLIQ than you should
No adverse effects related to overdose have been reported except for vomiting and constipation.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the quantity used.
4. Possible adverse effects
Like all medicines, CARBOLIQ may cause adverse effects, although not everyone experiences them.
The following adverse reactions have been reported during treatment with activated charcoal; their frequency cannot be estimated from the available data:
- Nausea and vomiting (particularly in case of very rapid administration or large amounts of activated charcoal), constipation, and black discoloration of stools. Isolated cases of gastrointestinal obstruction associated with the use of multiple doses of activated charcoal have also been reported.
- Isolated cases of airway obstruction due to inhalation of activated charcoal have been reported; therefore, it should be administered with caution in patients with impaired consciousness (see section "Warnings and precautions").
- Dizziness may occur due to its propylene glycol content (see sections "CARBOLIQ contains sucrose, propylene glycol and glycerol" and "Driving and use of machines").
If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet.
5. Storage of CARBOLIQ
No special storage conditions are required.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Do not dispose of medicines via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the package and other information
Composition of CARBOLIQ
The active substance is activated charcoal. Each ml of suspension contains 200 milligrams of activated charcoal.
The other components (excipients) are: propylene glycol, glycerol (E-422), sucrose and purified water.
Appearance of the medicinal product and contents of the package
CARBOLIQ is available in polyethylene bottles with polyethylene screw cap and adapter, containing 125 ml (25 g of activated charcoal) or 250 ml (50 g of activated charcoal) of oral suspension.
Package sizes: cartons (1 bottle of 125 ml or 250 ml) and clinical packs (10 bottles of 125 ml or 250 ml).
Marketing Authorization Holder and Manufacturer
LAINCO, S.A.
Avda. Bizet, 8-12
08191 Rubí (BARCELONA)
SPAIN
Date of the most recent revision of this leaflet: January 2012
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.