Vemgiel lehnihi Vp

Package Leaflet: Information for the User

Medicinal Charcoal VP, 200 mg, Hard Capsules

Carbo activatus

Read the Leaflet Carefully Before Taking the Medication, as it Contains

Important Information for the Patient.
This medication should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist.

• This 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 those not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement (in the case of diarrhea after 2 days, or in the case of bloating after 7 days) or if the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

• 1. What is Medicinal Charcoal VP and What is it Used For
• 2. Important Information Before Taking Medicinal Charcoal VP
• 3. How to Take Medicinal Charcoal VP
• 4. Possible Side Effects
• 5. How to Store Medicinal Charcoal VP
• 6. Package Contents and Other Information

1. What is Medicinal Charcoal VP and What is it Used For

Medicinal Charcoal VP contains activated charcoal as the active substance, which is properly prepared charcoal with high adsorptive capacity. After oral administration, it binds various substances in the gastrointestinal tract, including compounds that enhance peristalsis and water penetration into the intestine, bacterial toxins, bacteria, medications, putrefaction products, intestinal gases, toxic substances, etc., and thus prevents their absorption from the gastrointestinal tract. It also prevents the secondary absorption of compounds excreted into the intestines, e.g., with bile. Large doses of charcoal are used because it adsorbs not only toxic substances in the intestine. Activated charcoal is the most effective of the adsorbing agents - 1 g can adsorb 1.8 g of sublimate, 400 mg of phenol, 800 mg of morphine, but only 300 mg of ethyl alcohol. It is estimated that in the treatment of poisoning, it is as effective as gastric lavage or vomiting, and in some cases even more effective, especially if a laxative is administered after it. Medicinal Charcoal VP is used:

• for diarrhea, indigestion, bloating;
• for poisoning with medications and other chemical compounds - after consulting a doctor.

2. Important Information Before Taking Medicinal Charcoal VP

When Not to Take Medicinal Charcoal VP

Warnings and Precautions

• when Medicinal Charcoal VP is administered to an unconscious patient or one whose poisoning is caused by medications that suppress the central nervous system or lead to seizures, as there is a risk of the medication or stomach contents entering the airways (before performing gastric lavage, it is necessary to secure the airways with intubation);
• when Medicinal Charcoal VP is used in the treatment of poisoning caused by an agent that affects intestinal peristalsis (e.g., an anticholinergic agent - such as oxybutynin - or an opioid - such as methadone);
• if other medications are taken simultaneously, as Medicinal Charcoal VP may reduce their effectiveness.

Laxatives should be used with caution and only occasionally during treatment with activated charcoal, as severe and prolonged diarrhea can lead to water and electrolyte disorders. In the treatment of acute poisonings, other necessary medications should be administered parenterally; if it is necessary to induce vomiting with an oral medication (e.g., ipecacuanha), it should be induced before administering charcoal. Charcoal should be given 30-60 minutes after vomiting has stopped. Charcoal should not be used when it is necessary to administer a specific antidote orally (e.g., methionine).

Medicinal Charcoal VP and Other Medications

The patient should inform their doctor about all medications they are currently taking or have recently taken, as well as any medications they plan to take. Activated charcoal, when taken orally, to a varying degree inhibits the absorption of numerous medications taken simultaneously, including salicylates, barbiturates, and glutethimide. If it is necessary to administer other medications orally, they should be taken at least 2 hours before or after taking activated charcoal.

Medicinal Charcoal VP with Food and Drink

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

Pregnancy, Breastfeeding, and Fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medication. There is currently a lack of data on the safety of using activated charcoal during pregnancy and lactation. Despite the lack of contraindications, the constipating effect of the medication should be considered.

Driving and Operating Machinery

The medication does not affect the ability to drive or operate machinery.

3. How to Take Medicinal Charcoal VP

This medication should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist. The recommended dose is:
Indigestion and Bloating
Adults and children over 12 years old: orally, on average 4 to 6 capsules several times a day, until symptoms subside. Capsules can be swallowed whole, but for faster action, it is recommended to use them in the form of a suspension created by pouring the contents of the capsules into a small amount of water.
Diarrhea
Adults and children over 12 years old: orally, approximately 4.0 g (20 capsules) at a time, best in the form of a suspension created by pouring the contents of the capsules into a small amount of water. The dose can be repeated every few hours if necessary.
Poisoning with Medications and Chemical Compounds
Adults and children over 1 year old: the usual single dose is approximately 12.5 g (about 62 capsules). If necessary, it can be administered several times a day.
Children under 1 year old: the usual single dose is approximately 1 g/kg body weight. If necessary, it can be repeated every 4-6 hours.
In the treatment of poisoning with medications and chemical substances, the medication is usually administered in the form of a suspension created by pouring the contents of the capsules into a small amount of water. The suspension is administered orally through a gastric tube in the recommended dose and removed by suction or vomiting, recovering the entire amount of administered charcoal.
If the patient feels that the medication's action is too strong or too weak, they should consult their doctor.

Taking a Higher Than Recommended Dose of Medicinal Charcoal VP

There are no known cases of poisoning with activated charcoal - it is not absorbed from the gastrointestinal tract, and even large doses are well tolerated. If taken in excess, it may cause constipation. In case of taking a higher dose than recommended, the patient should contact their doctor.

Missing a Dose of Medicinal Charcoal VP

In case of missing a dose, the patient should take it as soon as possible. However, if the time for the next dose is near, the missed dose should be skipped. A double dose should not be taken to make up for the missed dose.

Stopping Medicinal Charcoal VP

Stopping the use of Medicinal Charcoal VP may cause the worsening of symptoms (diarrhea, indigestion, bloating). If there are any further doubts about the use of this medication, the patient should consult their doctor or pharmacist.

4. Possible Side Effects

Like all medications, Medicinal Charcoal VP can cause side effects, although not everybody gets them. During treatment with the medication, gastrointestinal disorders may occur (rarely - in 1 to 10 people out of 10,000)

• vomiting, constipation, diarrhea, black discoloration of stool. Cases of aspiration of the medication (entry of the medication into the lungs with inhaled air) have been reported.

Reporting Side Effects

If any side effects occur, including those not listed in the 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, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: [email protected]. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medication.

5. How to Store Medicinal Charcoal VP

Store in a temperature below 25°C. Store in the original packaging to protect from moisture. The medication should be stored out of sight and reach of children. Do not use this medication after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month. Medications should not be disposed of in wastewater or household waste containers. The patient should ask their pharmacist how to dispose of unused medications. This will help protect the environment.

Package Contents and Other Information

What Medicinal Charcoal VP Contains

• The active substance of the medication is activated charcoal. One capsule contains 200 mg of activated charcoal.
• The other ingredients are: gelatin, black iron oxide (E 172).

What Medicinal Charcoal VP Looks Like and What the Package Contains

Medicinal Charcoal VP is produced in the form of capsules. It is packaged in blisters of 10 capsules each. A cardboard box contains 20 capsules (2 blisters of PVC/PVDC/Aluminum foil, each containing 10 capsules).

Marketing Authorization Holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer

ICN Polfa Rzeszów S.A.
ul. Przemysłowa 2
35-959 Rzeszów
Date of Last Revision of the Leaflet:February 2024