Package leaflet: Information for the patient

Medicinal Charcoal (Norit), 200 mg, hard capsules
Carbo activatus
Please read all of this leaflet carefully before taking the medicine, as it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your 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 not listed in this leaflet, you should inform your doctor or pharmacist. See section 4.

Table of contents

What Medicinal Charcoal (Norit) is and what it is used for
Important information before taking Medicinal Charcoal (Norit)
How to take Medicinal Charcoal (Norit)
Possible side effects
How to store Medicinal Charcoal (Norit)
Contents of the pack and other information

1. What Medicinal Charcoal (Norit) is and what it is used for

Medicinal Charcoal (Norit) is derived from plant material and exhibits strong adsorptive properties.
In the gastrointestinal tract, it binds irritant and toxic substances, preventing their absorption. This medicine may also be used in children.

Indications:
Intestinal disorders, diarrhoea, flatulence, excessive intestinal fermentation, e.g. due to climate or dietary changes.
As an adjunctive treatment in poisoning with toxic substances, except cyanide, strong acids and alkalis – used only under medical advice.

2. Important information before using the medicinal product Węgiel leczniczy (Norit)

When not to use Węgiel leczniczy (Norit)

if the patient is allergic to the active substance or to any of the other components of this medicinal product (listed in section 6);
if the patient has gastrointestinal upset, suspected intestinal obstruction, acute abdominal pain, or ulcerative colitis (affecting the large intestine);
in unconscious patients whose airways have not been secured.

Warnings and precautions
Do not use Węgiel leczniczy (Norit) together with other medicinal products, as it may reduce their effectiveness.
During treatment, stools may become dark or black in colour.
If diarrhoea persists after 3 days of treatment, additional medical and laboratory tests should be performed to determine the underlying cause of the illness.
In the treatment of acute poisoning, any other necessary medicinal products should be administered by non-oral routes. If vomiting needs to be induced, it should be done before administering the medicinal product. Activated charcoal should be given 30 to 60 minutes after vomiting has ceased. Do not use activated charcoal if another specific antidote must be administered orally, e.g. methionine.
Use Węgiel leczniczy (Norit) with caution in cases of poisoning with substances affecting intestinal peristalsis (e.g. opioids). Due to the risk of developing disturbances in water and electrolyte balance, laxatives should be used cautiously and only occasionally during treatment.
Węgiel leczniczy (Norit) has low efficacy in poisoning with, among others, boric acid, ferrous sulfate, and other metal compounds, DDT, cyanides, lithium, methanol, ethanol, ethylene glycol, petroleum derivatives, and mineral acids and bases.
Patients taking the medicinal product for 7 days due to bloating or for 2 days due to diarrhoea, who continue to experience symptoms despite treatment, should contact a physician. If patients being treated for diarrhoea develop fever or blood in the stool, they should contact a physician.

Węgiel leczniczy (Norit) and other medicinal products
Węgiel leczniczy (Norit) may reduce, to some extent, the gastrointestinal absorption of other medicinal products.

Pregnancy and breastfeeding
Currently, there are no known contraindications for the use of this medicinal product during pregnancy and breastfeeding.

Driving and operating machinery
The medicinal product is considered safe and does not impair psycho-physical performance, ability to drive or operate machinery.

3. How to use Węgiel leczniczy (Norit)
Diarrhoea:
3 or 4 hard capsules at a time, taken orally with a small amount of water.
The dose may be repeated 3 or more times daily, if necessary. In cases of prolonged or recurrent diarrhoea, consult a physician.
Poisoning:
Immediately take 10 hard capsules (one after another, with a small amount of water).
Repeat the dose several times at short intervals.
Contact a physician immediately.
Activated charcoal suspension may be administered via a gastric tube, e.g. during gastric lavage.
In cases of poisoning, if immediate contact with a physician is not possible, the medicinal product should be taken as soon as possible. The earlier it is administered, the better the outcome.
During treatment with Węgiel leczniczy (Norit), stools may become dark or black in colour.
The medicinal product should only be used for the above-mentioned indications, and treatment should be discontinued once the therapeutic effect has been achieved.

Use of a higher than recommended dose of Węgiel leczniczy (Norit)
After ingestion of large doses, intestinal obstruction may occur. This can be prevented by administering agents that stimulate intestinal peristalsis (e.g. sodium sulfate).

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
In rare cases, constipation may occur. This can be prevented by administering drugs that stimulate intestinal peristalsis.
Additionally, the medicine may cause gastrointestinal disturbances and vomiting, especially in children.
Cases of inhalation of the medicine into the lungs have also been reported. Medicinal charcoal (Norit) turns stools black.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safe use of this medicine.

5. How to store Węgiel leczniczy (Norit)

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

6. Contents of the packaging and other information

What Węgiel leczniczy (Norit) contains

The active substance is activated charcoal (Carbo activatus).
The other components are: gelatin, titanium dioxide (E 171), black iron oxide (E 172).

What Węgiel leczniczy (Norit) looks like and contents of the pack
The medicine is in the form of hard capsules, packed in blisters made of Aluminium-PVC/PVDC foil and cardboard boxes.
The pack contains 15 or 30 capsules.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Norit Nederland B.V.
Astronaut 34
3824 MJ Amersfoort
The Netherlands

Manufacturer
Norit Nederland B.V.
Mr. Ovingkanaal-O.Z.3
7891 EV Klazienaveen
The Netherlands