Package leaflet: Information for the user

Carbo Medicinalis VP, 300 mg, tablets
Carbo activatus
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
the physician or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement (in case of diarrhoea after 2 days, or in case of bloating after 7 days), or if you feel worse, you should contact your doctor.

Contents of the leaflet

What Carbo Medicinalis VP is and what it is used for
Important information before using Carbo Medicinalis VP
How to take Carbo Medicinalis VP
Possible side effects
How to store Carbo Medicinalis VP
Contents of the pack and other information

1. What Carbo Medicinalis VP is and what it is used for

Carbo Medicinalis VP contains activated charcoal as the active substance, which is powdered
activated carbon. After oral administration, it binds various substances present in the gastrointestinal
tract, including compounds that enhance intestinal peristalsis (intestinal motility) and increase
water passage into the intestinal lumen. The medicine also binds bacterial toxins, bacteria, drugs,
putrefactive products, intestinal gases, toxic substances, etc., thereby preventing their absorption
from the gastrointestinal tract. It also prevents the reabsorption of substances excreted into the intestines, e.g.
via bile.

Carbo Medicinalis VP is used:

in the treatment of diarrhoea, indigestion, and bloating;
in poisoning with drugs and other chemical compounds – after consultation with a doctor.

2. Important information before using Carbo Medicinalis VP

When not to use Carbo Medicinalis VP

if the patient is allergic to activated charcoal or any of the other ingredients of this medicine (listed in section 6);
if the patient is unconscious and the airways are not properly secured.

Warnings and precautions

If bloating persists for 7 days or diarrhoea for 2 days, or if fever or blood in the stool occurs, consult a doctor, as this may indicate that treatment with activated charcoal alone is insufficient.
In cases of poisoning caused by drugs that depress the central nervous system or cause seizures, because in such cases – as with unconscious patients – there is a risk of pulmonary aspiration (entry of liquid or solid substances into the lungs). In such situations, the doctor should perform intubation before gastric lavage.
If Carbo Medicinalis VP is used in poisoning by agents affecting intestinal peristalsis.

Activated charcoal should not be taken simultaneously with other medicinal products, as it may reduce their effectiveness.

Activated charcoal is poorly effective in poisoning by, among others: boric acid, iron(II) sulfate and other metal compounds, DDT, cyanides, lithium, ethanol, methanol, ethylene glycol, petroleum distillates, as well as inorganic acids and bases.

Laxatives should be used cautiously and only occasionally during treatment with activated charcoal, because severe and prolonged diarrhoea may lead to water and electrolyte imbalances.

Carbo Medicinalis VP and other medicines

Inform the doctor about all medicines currently or recently taken, as well as any medicines the patient intends to take.

Orally administered activated charcoal may to various degrees inhibit the absorption of numerous medicinal products taken simultaneously. If it is necessary to administer other medicines orally, they should be taken at least 2 hours before or after taking activated charcoal.

Carbo Medicinalis VP with food and drink

Carbo Medicinalis VP should not be taken during or immediately after meals, as food reduces the adsorptive capacity of activated charcoal.

Pregnancy and breastfeeding

Before taking any medicine, consult a doctor or pharmacist.

Driving and operating machinery

Carbo Medicinalis VP has no influence on the ability to drive or operate machinery.

Carbo Medicinalis VP contains sucrose

The medicinal product contains 253.5 mg of sucrose per tablet, equivalent to 3.3 g of sucrose in 13 tablets and 10.6 g of sucrose in 42 tablets. This should be taken into account in patients with diabetes.

If a patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Carbo Medicinalis VP contains sodium

The medicinal product contains 1.029 mg of sodium (main component of table salt) per tablet, equivalent to 13.4 mg of sodium in 13 tablets (representing 0.67% of the maximum recommended daily dietary intake of sodium for adults) and 43.2 mg of sodium in 42 tablets (representing 2.16% of the maximum recommended daily dietary intake of sodium for adults).

3. How to use Carbo Medicinalis VP

Recommended dosage of Carbo Medicinalis VP:
Indigestion and flatulence:
Adults and children over 12 years of age:
Orally, 3 to 4 tablets several times daily, up to the disappearance of symptoms. Tablets may be
swallowed whole, but for faster action, chewing them is recommended.
Diarrhea:
Adults and children over 12 years of age:
Single oral dose of approximately 4.0 g (10 to 13 tablets), preferably administered as a water-based paste prepared from crushed tablets. The dose may be repeated every few hours, if necessary.
Poisoning with drugs and chemical substances:
Adults and children over 1 year of age:
The usual single oral dose is approximately 12.5 g (41 to 42 tablets). If necessary, it may be administered several times within 24 hours.
Children under 1 year of age:
The usual single oral dose is 1 g/kg body weight. If necessary, it may be repeated every 4–6 hours.
Elderly patients, patients with renal or hepatic impairment:
No dosage adjustment required.
In the treatment of poisoning with drugs and chemical substances, the medicine is usually administered as an aqueous suspension, e.g., for gastric lavage. The suspension is prepared by mixing crushed tablets with 400 ml of distilled water. The suspension should have the consistency of thick cream. It is administered orally via a nasogastric tube and removed by aspiration or by inducing vomiting, recovering the entire amount of administered charcoal.

Use of a higher than recommended dose of Carbo Medicinalis VP
Ingestion of an excessive dose of Carbo Medicinalis VP may lead to constipation.
However, the medicine is not absorbed from the gastrointestinal tract and does not cause systemic symptoms of poisoning.

Missed dose of Carbo Medicinalis VP
If a dose of Carbo Medicinalis VP is missed, it should be taken as soon as possible. However, if it is almost time for the next dose, the missed dose should be skipped. Do not take a double dose to make up for a missed dose.

Discontinuation of Carbo Medicinalis VP
Discontinuation of Carbo Medicinalis VP may result in worsening of symptoms for which the medicine is being used.

If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The frequency of the adverse reactions listed below is unknown (cannot be estimated from the available data).
Gastrointestinal disorders: vomiting, especially in children, constipation.
Respiratory, thoracic and mediastinal disorders: pulmonary aspiration (entry of liquid or solid substances into the lungs), especially during vomiting after administration of charcoal.
Charcoal may turn stools black.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw, Phone: +48 22 49 21 301, Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions allows the collection of further information on the safety of medicine use.

5. How to store Carbo Medicinalis VP

Store below 25°C. Keep in the original packaging.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Carbo Medicinalis VP contains

The active substance is activated charcoal. One tablet contains 300 mg of activated charcoal.
The other ingredients are: sucrose, microcrystalline cellulose, gelatin, sodium carboxymethyl starch, glycerol, magnesium stearate.

What Carbo Medicinalis VP looks like and contents of the pack
Carbo Medicinalis VP tablets are round, biconvex, smooth and black in colour.
The medicine is available in a pack containing 20 tablets (2 blisters made of Aluminium/PVC/PVDC foil, each containing 10 tablets).
Marketing Authorisation Holder
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Manufacturer
ICN Polfa Rzeszów S.A.
Przemysłowa 2 Street
35-105 Rzeszów
Poland