Medicinal charcoal vp

Package leaflet: Information for the user

Medicinal Charcoal VP, 200 mg, hard capsules
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
a doctor 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 (diarrhea lasting more than 2 days, or bloating lasting more than 7 days), or if you feel worse, you should contact your doctor.

Table of contents of the leaflet

1. What Medicinal Charcoal VP is and what it is 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. Contents of the pack and other information

1. What Medicinal Charcoal VP is and what it is used for

Medicinal Charcoal VP contains activated charcoal as the active substance, which is a specially
prepared form of carbon with high adsorptive (absorbing) capacity. After oral administration, it binds
various substances present in the gastrointestinal tract, including compounds that enhance peristalsis
and water secretion into the intestinal lumen, 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 compounds excreted into the intestine, for example via bile.
High doses of charcoal are used because it adsorbs not only toxic substances in the intestine.
Activated charcoal is the most effective among adsorbent 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 considered equally effective
as gastric lavage or induced vomiting in the treatment of poisoning, and in some cases even more effective,
especially if a laxative is administered some time after charcoal administration.
Medicinal Charcoal VP is used:

• in diarrhea, indigestion, and bloating;
• in poisoning with drugs and other chemical compounds—after consultation with a doctor.

2. Important information before using the medicinal product Węgiel leczniczy VP

When not to use Węgiel leczniczy 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 adequately protected.

Warnings and precautions

• if bloating persists for 7 days or diarrhoea for 2 days despite treatment, or if fever or blood in the stool occurs along with diarrhoea, consult a doctor, as this may indicate that treatment with activated charcoal is insufficient;
• if poisoning is caused by substances such as boric acid, ferrous sulphate and other metal compounds, DDT, cyanides, lithium, ethanol, methanol, ethylene glycol, petroleum distillates, or inorganic acids and bases, because activated charcoal is poorly effective in such poisonings (another medicinal product may need to be used);
• when Węgiel leczniczy VP is administered to an unconscious patient or to a patient whose poisoning is caused by drugs that depress the central nervous system or cause seizures, because there is a risk of the medicinal product or gastric contents entering the airways (in such cases, airway protection via intubation is required before gastric lavage is performed);
• when Węgiel leczniczy VP is used in poisoning caused by agents affecting intestinal peristalsis (e.g. anticholinergic agents – including oxybutynin – or opioids such as methadone);
• if other medicinal products are being used concurrently, because Węgiel leczniczy VP may reduce their effectiveness.

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.
In the treatment of acute poisonings, other essential medicinal products should be administered parenterally; if induction of vomiting by an oral medicinal product is necessary (e.g. ipecac), vomiting should be induced before administering charcoal.
Charcoal should be administered 30–60 minutes after vomiting has ceased. Do not administer charcoal when oral administration of a specific antidote (e.g. methionine) is required.

Węgiel leczniczy VP and other medicinal products
Inform the doctor about all medicinal products currently used or recently used, as well as any medicinal products the patient plans to use.
Orally administered activated charcoal may to varying degrees inhibit the absorption of numerous concurrently administered medicinal products, including salicylates, barbiturates, and glutethimide. When it is necessary to administer other medicinal products orally, they should be given at least 2 hours before or after activated charcoal.

Węgiel leczniczy VP with food and drink
Do not take Węgiel leczniczy VP 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, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicinal product.
There are currently no data available on the safety of using activated charcoal during pregnancy and lactation.
Despite the lack of contraindications, the constipating effect of the medicinal product should be taken into account.

Driving and operating machinery
This medicinal product does not affect the ability to drive or operate machinery.

3. How to use Węgiel leczniczy VP

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Recommended dosage

Indigestion and bloating
Adults and children over 12 years
Orally, an average of 4 to 6 capsules several times a day, until symptoms subside. The capsules may be swallowed whole, but for faster action it is recommended to use a suspension prepared by pouring the capsule contents into a small amount of water.

Diarrhoea
Adults and children over 12 years
Single oral dose of approximately 4.0 g (20 capsules), preferably as a suspension prepared by pouring the capsule contents into a small amount of water. The dose may be repeated every few hours, if necessary.

Poisoning with drugs and chemical substances
Adults and children over 1 year
Single oral dose is usually about 12.5 g (approximately 62 capsules). If necessary, it may be administered several times a day.
Children under 1 year
Single oral dose is usually 1 g/kg body weight. If necessary, it may be repeated every 4–6 hours.

In the treatment of poisoning with drugs and chemical substances, the medicine is most commonly administered as a suspension prepared by pouring the capsule contents into a small amount of water. The suspension is administered orally via a nasogastric tube in the recommended dose and then removed by aspiration or by inducing vomiting, recovering the entire amount of administered charcoal.

If you feel that the effect of the medicine is too strong or too weak, consult your doctor.

Use of a higher than recommended dose of Węgiel leczniczy 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. However, excessive doses may cause constipation.

If a higher than recommended dose has been taken, contact your doctor.

Missed dose of Węgiel leczniczy VP

If you forget to take a dose at the scheduled time, take it as soon as possible. However, if the time for the next dose is approaching, skip the missed dose. Do not take a double dose to make up for a missed one.

Stopping treatment with Węgiel leczniczy VP

Discontinuing treatment with Węgiel leczniczy VP may result in worsening of symptoms (diarrhoea, indigestion, bloating).

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody gets them.
Gastrointestinal disorders may occur during treatment (rarely - in 1 to 10 people per 10,000):

• vomiting, constipation, diarrhoea, black discolouration of faeces. Cases of drug aspiration (entry of the drug into the lungs together with inhaled air) have been reported.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, please inform your doctor or pharmacist. Adverse effects 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, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, e-mail: [email protected]
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Węgiel leczniczy VP

Store below 25°C.
Keep in the original packaging to protect from moisture.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. 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. Doing so helps protect the environment.

6. Contents of the pack and other information

What Węgiel leczniczy VP contains

• The active substance is activated charcoal. Each capsule contains 200 mg of activated charcoal.
• Other ingredients: gelatin, iron oxide black (E 172).

What Węgiel leczniczy VP looks like and contents of the pack
Węgiel leczniczy VP is manufactured in the form of capsules. Packaged in blisters of 10 capsules.
Each cardboard box contains 20 capsules (2 blisters made of PVC/PVDC/Aluminium, each containing 10 capsules).

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