Carbo Medicinalis Vp

Package Leaflet: Information for the User

Carbo medicinalis VP, 300 mg, tablets

Carbo activatus

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement (in the case of diarrhea after 2 days, and in the case of bloating after 7 days) or if the patient feels worse, they should contact their doctor.

Package Leaflet Contents

• 1. What is Carbo medicinalis VP and what is it used for
• 2. Important information before taking Carbo medicinalis VP
• 3. How to take Carbo medicinalis VP
• 4. Possible side effects
• 5. How to store Carbo medicinalis VP
• 6. Package contents and other information

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

Carbo medicinalis VP contains activated carbon as the active substance, which is powdered activated carbon. After oral administration, it binds to various substances in the gastrointestinal tract, including compounds that enhance intestinal peristalsis and increase water penetration into the intestine. The medicine also binds to bacterial toxins, bacteria, medicines, putrefaction products, intestinal gases, toxic substances, etc., and thus prevents their absorption from the gastrointestinal tract. It also prevents the reabsorption of substances excreted into the intestines, e.g., with bile.

Carbo medicinalis VP is used:

• to treat diarrhea, indigestion, and bloating;
• in cases of poisoning with medicines and other chemical compounds - after consulting a doctor.

2. Important information before taking Carbo medicinalis VP

When not to take Carbo medicinalis VP

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

Warnings and precautions

• If, despite treatment, bloating persists for 7 days or diarrhea for 2 days, or if fever or blood in the stool occurs, the patient should consult a doctor, as this may indicate that treatment with activated carbon alone is insufficient.
• If poisoning is caused by medicines that suppress the central nervous system or lead to seizures, as there is a risk of aspiration into the lungs (entry of liquids or solids into the lungs) in such cases, similar to unconscious patients. In such situations, before gastric lavage, the doctor should first perform intubation.
• If Carbo medicinalis VP is used in poisoning with substances that affect intestinal peristalsis.

Activated carbon should not be taken simultaneously with other medicines, as it may reduce their effectiveness.

Activated carbon is less effective in poisoning with, among others, boric acid, iron(II) sulfate, and other metal compounds, DDT, cyanides, lithium, ethanol, methanol, ethylene glycol, petroleum refining products, as well as inorganic acids and bases.

Laxatives should be used with caution and only occasionally during treatment with activated carbon, as severe and prolonged diarrhea can lead to water and electrolyte disorders.

Carbo medicinalis VP and other medicines

The patient should inform their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Orally administered activated carbon to some extent inhibits the absorption of numerous medicines taken simultaneously. If other medicines need to be taken orally, they should be administered at least 2 hours before or after taking activated carbon.

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 carbon.

Pregnancy and breastfeeding

Before taking any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

The medicine does not affect the ability to drive or operate machines.

Carbo medicinalis VP contains sucrose

The medicinal product contains 253.5 mg of sucrose in one tablet, which corresponds 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 the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking the medicine.

Carbo medicinalis VP contains sodium

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

3. How to take Carbo medicinalis VP

Recommended dose of Carbo medicinalis VP:

Indigestion and bloating:

Adults and children over 12 years:

Orally, on average 3 to 4 tablets several times a day, until symptoms subside. Tablets can be swallowed whole, but for faster action, it is recommended to chew them.

Diarrhea:

Adults and children over 12 years:

Orally, approximately 4.0 g (10 to 13 tablets) at a time, best in the form of a water paste prepared from crushed tablets. The dose can be repeated every few hours if necessary.

Poisoning with medicines and chemical compounds:

Adults and children over 1 year:

A single oral dose is usually about 12.5 g (41 to 42 tablets). If necessary, it can be administered several times a day.

Children under 1 year:

A single oral dose is usually 1 g/kg body weight. If necessary, it can be repeated every 4-6 hours.

Elderly patients, patients with renal and hepatic impairment:

No change in dosage.

In the treatment of poisoning with medicines and chemicals, the medicine is usually administered in a water suspension, e.g., for gastric lavage. It 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 in the recommended dose through a gastric tube and removed by suction or induced vomiting, recovering the entire amount of administered carbon.

Taking a higher dose of Carbo medicinalis VP than recommended

In case of taking too high a dose of Carbo medicinalis VP, constipation may occur.

However, the medicine is not absorbed from the gastrointestinal tract and does not cause systemic symptoms of poisoning.

Missing a 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 close to the time for the next dose, the missed dose should be skipped. A double dose should not be taken to make up for a missed dose.

Stopping treatment with Carbo medicinalis VP

If treatment with Carbo medicinalis VP is stopped, the symptoms for which it is being taken may worsen.

In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Carbo medicinalis VP can cause side effects, although not everybody gets them.

The frequency of the following side effects is unknown (cannot be determined from available data).

Gastrointestinal disorders: vomiting, especially in children, constipation.

Respiratory, thoracic, and mediastinal disorders: aspiration into the lungs (entry of liquids or solids into the lungs), especially during vomiting after administration of activated carbon.

Activated carbon turns the stool black.

Reporting side effects

If any side effects occur, including any side effects not listed in this package leaflet, the patient should inform their doctor or pharmacist.

Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,

Jerozolimskie Avenue 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309,

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Carbo medicinalis VP

Store in a temperature below 25°C. Store in the original package.

The medicine should be stored out of 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 month stated.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Carbo medicinalis VP contains

• The active substance of the medicine is activated carbon. One tablet contains 300 mg of activated carbon.
• The other ingredients are: sucrose, microcrystalline cellulose, gelatin, sodium carboxymethylcellulose, glycerol, magnesium stearate.

What Carbo medicinalis VP looks like and what the package contains

Carbo medicinalis VP tablets are round, flat on both sides, and smooth, black in color.

The medicine is available in a package containing 20 tablets (2 blisters of aluminum/PVC/PVDC foil containing 10 tablets each).

Marketing authorization holder

Bausch Health Ireland Limited

3013 Lake Drive

Citywest Business Campus

Dublin 24, D24PPT3

Ireland

Manufacturer

ICN Polfa Rzeszów S.A.

Przemysłowa Street 2

35-959 Rzeszów

Date of last revision of the package leaflet: