Vemgiel lehnihi (norit)

Leaflet attached to the packaging: patient information

Medicinal charcoal (Norit), 200 mg, hard capsules
Carbo activatus

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

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Medicinal charcoal (Norit) and what is it used for
• 2. Important information before taking Medicinal charcoal (Norit)
• 3. How to take Medicinal charcoal (Norit)
• 4. Possible side effects
• 5. How to store Medicinal charcoal (Norit)
• 6. Package contents and other information

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

Medicinal charcoal (Norit), produced from plant raw materials, has strong adsorptive properties.
In the gastrointestinal tract, it binds irritating and toxic substances, preventing their absorption. The medicine
can also be used in children.
Indications for use:
Intestinal inflammation, diarrhea, bloating, excessive intestinal fermentation, e.g., with climate or diet changes.
As a supplementary medicine in the treatment of toxic substance poisoning, except for cyanide, strong acid, and base poisoning - used in consultation with a doctor.

2. Important information before taking Medicinal charcoal (Norit)

When not to take Medicinal charcoal (Norit)

• in unconscious patients who have not had their airways secured.

Warnings and precautions

Medicinal charcoal (Norit) should not be taken with other medicines, as it may weaken their effect.
During treatment, stools may have a dark or black color.
If diarrhea persists after 3 days of treatment, additional medical laboratory tests should be performed to determine the cause of the disease.
In the treatment of acute poisoning, other necessary medicines should be administered parenterally. If vomiting needs to be induced, it should be done before taking the medicine. Charcoal should be taken 30 to 60 minutes after vomiting has stopped. Charcoal should not be taken if it is necessary to administer another specific antidote orally, e.g., methionine.
The medicine should be used with caution in cases of poisoning with substances that affect intestinal peristalsis (e.g., opioids). Due to the risk of water and electrolyte balance disorders, laxatives should be used with caution and only occasionally during treatment.
Medicinal charcoal (Norit) is less effective in poisoning with, among others, boric acid, iron(II) sulfate, and other metal compounds, DDT, cyanides, lithium, methanol, ethanol, ethylene glycol, petroleum refining products, and mineral acids and bases.
Patients taking the medicine for 7 days due to bloating or 2 days due to diarrhea, who still experience symptoms despite treatment, should consult a doctor. If patients being treated for diarrhea develop a fever or blood in their stool, they should consult a doctor.

Medicinal charcoal (Norit) and other medicines

Medicinal charcoal may partially weaken the absorption of other medicines from the gastrointestinal tract.

Pregnancy and breastfeeding

So far, there are no known contraindications to using the medicine during pregnancy and breastfeeding.

Driving and operating machinery

The medicine is considered safe and does not impair psychophysical fitness, the ability to drive vehicles, and operate machinery.

3. How to take Medicinal charcoal (Norit)

Diarrhea:
3 or 4 hard capsules at a time orally, with a small amount of water.
If necessary, the dose can be repeated 3 or more times a day. In case of prolonged or recurrent diarrhea, a doctor's advice should be sought.
Poisoning:
Take 10 hard capsules (one after another, with a small amount of water) immediately.
The dose should be repeated several times, with short intervals.
A doctor should be notified immediately.
A suspension of activated charcoal can be administered through a gastric tube, e.g., during stomach lavage.
In case of poisoning, if immediate contact with a doctor is not possible, the medicine should be taken as soon as possible. The sooner it is taken, the better the effect.
During treatment with the medicine, stools may have a dark or black color.
The use of the medicine should be limited to the above indications, and after achieving the therapeutic effect, its use should be discontinued.

Using a higher dose of Medicinal charcoal (Norit) than recommended

After taking large doses, intestinal obstruction may occur. This can be prevented by administering medicines that stimulate intestinal peristalsis (e.g., sodium sulfate).

4. Possible side effects

Like any medicine, this medicine can cause side effects, although not everyone will experience them.
In rare cases, constipation may occur. This can be prevented by administering medicines that stimulate intestinal peristalsis. Additionally, the medicine may cause gastrointestinal disorders and vomiting, especially in children. Cases of inhalation of the medicine into the lungs have also been reported. Medicinal charcoal (Norit) stains the stool black.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist, or nurse.
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.: 22 49-21-301, fax: 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 gather more information on the safety of the medicine.

5. How to store Medicinal charcoal (Norit)

Store at a temperature below 25°C.
Store in the original packaging to protect from moisture.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.

6. Package contents and other information

What Medicinal charcoal (Norit) contains

• The active substance of the medicine is activated charcoal (Carbo activatus).
• Other ingredients are: gelatin, titanium dioxide (E 171), black iron oxide (E 172)

What Medicinal charcoal (Norit) looks like and what the package contains

The medicine is in the form of hard capsules, packaged in aluminum-PVC/PVDC film blisters and cardboard boxes.
The package contains 15 or 30 capsules.

Marketing authorization holder and manufacturer

Marketing authorization holder
Norit Nederland B.V.
Astronaut 34
3824 MJ Amersfoort
Netherlands
Manufacturer
Norit Nederland B.V.
Mr. Ovingkanaal-O.Z.3
7891 EV Klazienaveen
Netherlands

Date of last update of the leaflet: 03/2022