ULTRACARBON

ULTRACARBON granules

Important notes (mandatory information)

Ultracarbon 50 g, granules. Active ingredient: activated charcoal. Areas of application: used for acute oral poisoning and overdose of medicines.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Ultracarbon 50 g, granules for oral suspension
Active ingredient: 50 g activated charcoal

Read the entire package leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, Ultracarbon must be used as directed in order to be effective.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• In case of acute poisoning or overdose of medication, you should contact a doctor or poison control centre immediately. Ultracarbon should be administered immediately as recommended.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

This package leaflet includes

1. WHAT IS ULTRACARBON AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO KNOW BEFORE TAKING ULTRACARBON?
3. HOW TO TAKE ULTRACARBON?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE ULTRACARBON?
6. FURTHER INFORMATION

1. WHAT IS ULTRACARBON AND WHAT IS IT USED FOR?

The active ingredient in Ultracarbon can bind (adsorb) harmful or unwanted substances in the gastrointestinal tract. Ultracarbon is used for acute oral poisoning and overdose of medicines.

2. WHAT DO YOU NEED TO KNOW BEFORE TAKING ULTRACARBON?

Ultracarbon must not be taken:

• if you are hypersensitive (allergic) to charcoal or any of the other ingredients
• if it is certain that the poisoning was caused by corrosive substances (strong acids, e.g. hydrochloric acid, or bases, e.g. drain cleaner). It can then interfere with diagnostic examinations such as oesophageal endoscopy (oesophagoscopy) or gastric endoscopy (gastroscopy).

Special care must be taken when taking Ultracarbon

Inform a doctor or poison control centre. Ultracarbon can be used for many types of poisoning. However, a number of organic and inorganic salts and solvents such as iron compounds, lithium, thallium, cyanide, methylated spirits (methanol), alcohol (ethanol), antifreeze (ethylene glycol) and petroleum-based substances cannot be sufficiently adsorbed by Ultracarbon. Other measures for removing the poison are required for these substances (e.g. gastric lavage). The most important poisons for which there are suitable antidotes are listed below. Specific antidote: Cyanide Sodium nitrite, 4-dimethylaminophenol, Iron compounds Deferoxamine (desferrioxamine), Lithium Calcium polystyrene sulfonate, Methanol/ Alcohol (ethanol), Methylated spirits, Ethylene glycol/ Alcohol (ethanol), Antifreeze. In many cases of poisoning, a specific antidote must also be given in addition to Ultracarbon (e.g. for paracetamol poisoning: N-acetylcysteine). Ultracarbon causes the stools to turn black.

Taking Ultracarbon with other medicines

The effect of medicines taken orally is generally reduced by the use of activated charcoal. Activated charcoal can affect the effect of oral contraceptives (the "pill"). Therefore, an additional method of contraception is necessary after taking Ultracarbon.

Pregnancy and breast-feeding

As far as is known, activated charcoal can be taken during pregnancy and breast-feeding as directed without endangering the foetus or child. Ask your doctor or pharmacist for advice before taking any medicine. Please inform your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even if they are non-prescription medicines.

Driving and using machines

The use of activated charcoal does not affect the ability to drive and use machines.

3. HOW TO TAKE ULTRACARBON?

Adults and adolescents aged 12 and over

In case of acute poisoning and overdose, take the contents of 1 to 2 bottles of Ultracarbon as soon as possible (equivalent to 50 - 100 g activated charcoal). In serious cases of poisoning, the treatment should be continued for several days by administering a dose of 20 g Ultracarbon every 4 to 6 hours (20 g activated charcoal corresponds to approximately 160 ml suspension). Shake the bottle vigorously again before repeated administration. The suspension is taken or administered orally (= by mouth). The product must not be administered orally to (unconscious) patients who cannot swallow the preparation safely. In patients with impaired consciousness, the suspension should be administered by a doctor or nursing staff under medical supervision using a stomach tube.

Children between 4 and 12 years of age

In acute cases of poisoning and overdose in children under 12 years of age, 1/2 bottle should be administered orally (corresponding to 200 ml of ready-to-use suspension).

Children under 4 years of age

As a first dose, 1/4 bottle (corresponding to 100 ml of ready-to-use suspension) should be administered and repeated several times after consulting a doctor.

Shake the bottle vigorously again before repeated administration. In order to prevent the absorption of toxic substances into the body as much as possible and to subsequently remove the toxins that have already been absorbed, Ultracarbon should be used early on. However, later use can also be beneficial. In serious cases of poisoning, repeated use of activated charcoal is recommended. Shake the bottle vigorously again before repeated administration. Ultracarbon can also be used after vomiting or after gastric lavage.

Preparing the suspension

Carefully loosen the granules, open the bottle and carefully add water to the granules up to the red line on the bottle. Close the bottle and shake vigorously for about 1 minute. Carefully open the bottle and take the suspension immediately. The bottle is equipped with a special attachment that serves as an adapter for quick, direct connection to a stomach tube. Vent the bottle and cut off the tip of the adapter before connecting the stomach tube. If you notice that Ultracarbon is too strong or too weak, contact your doctor or pharmacist.

If you have taken more Ultracarbon than you should, contact your doctor or pharmacist immediately. After using too high a dose of activated charcoal, stomach pain and a serious blockage of the gastrointestinal tract may occur.

If you forget to take Ultracarbon, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue with the normal dosing schedule. Do not take a double dose of Ultracarbon to make up for a missed dose. If you are not sure, please ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Ultracarbon can have side effects, although not everybody gets them.

Possible side effects

Constipation (obstipation) can occur frequently (in less than 1 in 10 but more than 1 in 100 patients). Please inform your doctor or pharmacist if any of the side effects gets serious, or if you notice any side effects not listed in this leaflet.

5. HOW TO STORE ULTRACARBON?

Keep out of the reach of children. Do not use the medicine after the expiry date which is stated on the label and carton. Store in the original container. No special storage temperature required. Store the prepared suspension at 2°C - 8°C (in the refrigerator). It can be stored for 3 days.

6. FURTHER INFORMATION

What Ultracarbon contains

The active ingredient in Ultracarbon is activated charcoal of plant origin. 1 bottle with 61.5 g granules contains 50 g activated charcoal. The other ingredients are: Citric acid monohydrate (E330), glycerol (E422) and gum arabic (E414).

What Ultracarbon looks like and contents of the pack

The dark grey to black granules are filled into a plastic bottle with a screw cap.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Norit N.V.
Nijverheidsweg-Noord 72
3812 PM Amersfoort
Netherlands

Manufacturer

Norit Nederland B.V.
Nijverheidsweg-Noord 72
3812 PM Amersfoort
Netherlands

Co-distributor

Merck Selbstmedikation GmbH
Rößlerstraße 96
64293 Darmstadt
Tel.: 0 61 51/8 56-22 60
Fax: 0 61 51/8 56-22 03

This package leaflet was last revised in April 2010.

Source: Package leaflet information
Version: 11/2016
Active ingredient: activated charcoal. Areas of application: used for acute oral poisoning and overdose of medicines.