KOHLE

KOHLE Compretten Tablets

Important notes (mandatory information)

KOHLE Compretten, tablets. Active ingredient: medical charcoal. Areas of application: for acute diarrhoea, to prevent absorption in the event of oral poisoning and to accelerate excretion in the event of poisoning with substances that are subject to an enterohepatic circulation (e.g. carbamazepine, phenobarbital, phenylbutazone, theophylline).

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

KOHLE Compretten, tablets for oral administration for children and adults
Active ingredient: 250 mg medical charcoal

Dear patient! Please read the entire package leaflet carefully, as it contains important information for you. This medicine is also available without a prescription. However, in order to achieve the best possible treatment success, KOHLE Compretten must be used as directed.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or if there is no improvement in the treatment of diarrhoea after 3 days, you must consult a doctor in any case.
• If any of the side effects listed occur to a significant extent or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.

This package leaflet contains

1. WHAT ARE KOHLE COMPRETTEN AND WHAT ARE THEY USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING KOHLE COMPRETTEN?
3. HOW SHOULD KOHLE COMPRETTEN BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD KOHLE COMPRETTEN BE STORED?
6. FURTHER INFORMATION

1. WHAT ARE KOHLE COMPRETTEN AND WHAT ARE THEY USED FOR?

KOHLE Compretten is a medicine for use in acute diarrhoea, to prevent absorption in the event of oral poisoning and to accelerate excretion in the event of poisoning with substances that are subject to an enterohepatic circulation (e.g. carbamazepine, phenobarbital, phenylbutazone, theophylline).

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING KOHLE COMPRETTEN?

KOHLE Compretten must not be taken:

• if you are hypersensitive (allergic) to medical charcoal or any of the other ingredients of KOHLE Compretten,
• in the case of feverish diarrhoea,
• in the case of poisoning with corrosive substances (strong acids and alkalis), as this makes diagnostic measures such as oesophageal endoscopy (oesophagoscopy) or gastric endoscopy (gastroscopy) more difficult.

Special care should be taken when taking KOHLE Compretten if poisoning is suspected. In this case, contact a doctor or poison information centre immediately (contact details see below)! Different or additional measures are required for various poisons and medicines. Medical charcoal is not effective in cases of poisoning with organic and inorganic salts and solvents, e.g. lithium, thallium, cyanide (prussic acid), iron salts, methanol, ethanol and ethylene glycol (e.g. antifreeze). Other measures for eliminating poisons (e.g. gastric lavage) are indicated here.

Important poisons for which medical charcoal is ineffective and for which a suitable oral therapy is known are listed below:

• Cyanide - Specific antidote 4-dimethylaminophenol
• Iron compounds - Specific antidote deferoxamine (desferrioxamine)
• Lithium - Specific antidote calcium polystyrenesulfonate
• Methanol - Specific antidote ethanol
• Ethylene glycol - Specific antidote ethanol

In many cases of poisoning, a specific antidote must also be administered in addition to medical charcoal (e.g. acetylcysteine in the case of paracetamol poisoning).

When taking KOHLE Compretten with other medicines

KOHLE Compretten should not be taken at the same time as other medicines, as their effectiveness may be reduced. Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even if they are non-prescription medicines.

When taken together with food and drink

Not required.

Pregnancy and breast-feeding

There are no restrictions on the use of KOHLE Compretten during pregnancy and breast-feeding.

Driving and operating machinery

No special precautions are required.

Important information about certain other ingredients of KOHLE Compretten

Not applicable.

3. HOW SHOULD KOHLE COMPRETTEN BE TAKEN?

Always take KOHLE Compretten exactly as described in this leaflet. Please ask your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the usual dose is:

• in the case of diarrhoea: adults and adolescents aged 14 and over 2-4 KOHLE Compretten 3 - 4 times a day, children under 14 years of age 1 - 2 KOHLE Compretten 3 - 4 times a day.
• in the case of poisoning: adults 2-4 KOHLE Compretten per kilogram of body weight, children 3-4 KOHLE Compretten per kilogram of body weight (equivalent to 0.5 - 1 g medical charcoal/kilogram of body weight). This corresponds to the following scheme:

Adults and adolescents or from 60 kg body weight: 120 - 240 KOHLE Compretten,
Children 10 - 14 years or from 30 kg body weight: 90 - 120 KOHLE Compretten,
Children 6-9 years or from 20 kg body weight: 60 - 80 KOHLE Compretten,
Children 3-5 years or from 15 kg body weight: 45 - 60 KOHLE Compretten,
Children 1 - 2 years or from 10 kg body weight: 30 - 40 KOHLE Compretten.

The charcoal is more effective the sooner it is taken after the poison has been ingested. Start taking KOHLE Compretten immediately after becoming aware of the poisoning and follow the instructions of the poison information centre or emergency doctor.

How and when should you take KOHLE Compretten?
In the case of diarrhoea: Dissolve the KOHLE Compretten in water while stirring or take them whole with liquid. Milk or milk products are not suitable for stirring. It is advisable to administer KOHLE Compretten together with a glucose-electrolyte solution to replace the loss of water and salt.

In the case of poisoning: Suspend the KOHLE Compretten in water (approx. 50 ml water per 30 tablets) by stirring or shaking to form a paste and take in small sips or administer via a gastric tube (only under medical supervision). The doctor will decide whether to repeat the dose. Milk or milk products are not suitable for stirring.

Following the administration of KOHLE Compretten to prevent absorption, it is also advisable to take a saline laxative 30 - 60 minutes later. This ensures that the poison bound to the charcoal is removed from the intestinal tract before some of the bound toxins can be released again.

How long should you take KOHLE Compretten?
In the case of diarrhoea until the stool has returned to normal. If the treatment has been unsuccessful after 3 days, a doctor should be consulted.

If you have taken more KOHLE Compretten than you should

Continue taking the medicine as described in the dosage instructions.

If you forget to take KOHLE Compretten

Do not take a double dose to make up for a forgotten dose. Continue taking the medicine as described in the dosage instructions.

If you stop taking KOHLE Compretten

An interruption or premature termination of treatment is harmless.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, KOHLE Compretten can have side effects, although not everybody gets them. The following frequency categories are used to assess side effects

The following frequency categories are used to assess side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Since the following possible side effects are based on spontaneous reports from extensive use after market launch, a precise estimation of the frequency is not possible. Therefore, the frequency is classified as "not known". Significant side effects or signs to watch out for, and measures to take if affected: If you are affected by any of the following side effects, stop taking KOHLE Compretten and see your doctor as soon as possible. No side effects are known when KOHLE Compretten is taken for diarrhoea in the recommended dosages. In the case of very high doses, which may be taken in the event of poisoning, constipation and intestinal obstruction (mechanical ileus) may occur in individual cases, which can be prevented by administering saline laxatives (e.g. sodium sulphate). Since medical charcoal is excreted unchanged, the stool turns black after taking KOHLE Compretten, but this is harmless.

Other possible side effects

No other possible side effects are known.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information about the safety of this medicine.

5. HOW SHOULD KOHLE COMPRETTEN BE STORED?

Keep out of reach of children. The expiry date of this pack is printed on the folding box and blister strip. Do not use this pack after the stated date! Storage conditions: No special storage conditions are required for this medicine.

6. FURTHER INFORMATION

What KOHLE Compretten contains

The active ingredient is: 1 tablet contains 250 mg medical charcoal. The other ingredients are: bentonite, maize starch. One tablet contains approx. 0.006 BE.

What KOHLE Compretten looks like and contents of the pack

Packs of 30 or 60 tablets.

Pharmaceutical entrepreneur

Merck Selbstmedikation GmbH
Frankfurter Straße 250
64293 Darmstadt
Tel.: 0 61 51/8 56-22 60
Fax: 0 61 51/8 56-22 03
www.merckselbstmedikation.de

Manufacturer

Merck KGaA
Frankfurter Straße 250
64293 Darmstadt

This leaflet was last revised in May 2014.

Source: Information from the package leaflet
Status: 01/2018
Active ingredient: medical charcoal. Areas of application: for acute diarrhoea, to prevent absorption in the event of oral poisoning and to accelerate excretion in the event of poisoning with substances that are subject to an enterohepatic circulation (e.g. carbamazepine, phenobarbital, phenylbutazone, theophylline).