Lecicarbon

Package Leaflet: Information for the User

Lecicarbon, 500 mg + 680 mg, Suppositories

Sodium Hydrogen Carbonate + Sodium Dihydrogen Phosphate
For use in adults

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

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.
Keep this package leaflet, you may need to read it again.
If you need advice or further information, consult a pharmacist.
If you experience any side effects, including any not listed in this package leaflet, tell your doctor or pharmacist.
See section 4.
If after 3 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Package Leaflet

• 1. What is Lecicarbon and what is it used for
• 2. Important information before using Lecicarbon
• 3. How to use Lecicarbon
• 4. Possible side effects
• 5. How to store Lecicarbon
• 6. Other information

1. What is Lecicarbon and what is it used for

Lecicarbon is used for various forms of constipation, e.g. caused by a diet low in fiber, lack of physical activity, or in diseases requiring easy bowel movements.
Lecicarbon is also used for bowel evacuation before surgery or diagnostic procedures in the rectal area.

2. Important information before using Lecicarbon

When not to use Lecicarbon

if you are allergic (hypersensitive) to sodium hydrogen carbonate, sodium dihydrogen phosphate, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

In cases of toxic megacolon (pathological dilation of the end of the large intestine for various reasons), the medicine should only be used after obtaining the explicit consent of the attending physician.

Lecicarbon and other medicines

Lecicarbon can be used while taking other medicines.
Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take, including those obtained without a prescription.

Lecicarbon with food and drink

No special precautions are necessary.

Pregnancy, breastfeeding, and fertility

Pregnancy:
Lecicarbon can be used during pregnancy after consulting a doctor.
Breastfeeding:
Lecicarbon can be used during breastfeeding.
Fertility:
There are no data on the effect of Lecicarbon on human fertility. The effect on male and female fertility has not been evaluated in animal studies.
Before using any medicine, consult a doctor or pharmacist.

Driving and using machines

Lecicarbon has no effect on the ability to drive vehicles and operate machines.
Note that the action (bowel movement) is expected 15-30 minutes after application.

Lecicarbon contains (3-sn-phosphatidyl)choline (from soybean oil, lecithin)

Do not use if you have a known hypersensitivity to peanuts or soy.

3. How to use Lecicarbon

Children over 12 years and adults
This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Unless otherwise directed, insert one suppository into the rectum as needed. If necessary, it can be repeated after 30-60 minutes.
Before using Lecicarbon, remove it from the packaging by separating one suppository from the blister pack at the perforation. Hold the plastic ends with both hands and pull in opposite directions. Insert the suppository into the rectum. Brief pre-soaking in water facilitates the insertion of the suppository.
The action starts after 15-30 minutes.
Do not use oil or petroleum jelly as a lubricant.
Lecicarbon can be used in adults and children over 12 years. Lecicarbon is not suitable for use in children under 12 years.
Lecicarbon is safe for long-term use and does not lead to habituation. However, in cases of chronic constipation, you should always consult a doctor.

Using more than the recommended dose of Lecicarbon

The usual dose is one suppository. If necessary, it can be repeated after 30-60 minutes. If this dose is exceeded, there is no danger, but it makes no sense to administer more than two suppositories.

Missing a dose of Lecicarbon

Lecicarbon is used only as needed.

Stopping the use of Lecicarbon

Lecicarbon is used only as needed.
If you have any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Lecicarbon usually does not cause any problems (side effects).
Insertion of the suppository may sometimes, in rare cases, cause a mild burning sensation, which quickly subsides.
If any of the side effects get serious, or if you notice any side effects not listed in this package leaflet, tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any not listed in this package leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department for 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.: +48 22 49 21 301, fax: +48 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 to gather more information on the safety of this medicine.

5. How to store Lecicarbon

Store and transport in a cool place (2°C – 8°C).
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after: "Expiry Date (EXP)". The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Lecicarbon contains

The active substances are sodium hydrogen carbonate and sodium dihydrogen phosphate.
The other ingredients are: (3-sn-phosphatidyl)choline (= soy lecithin, phosphatides), solid fat, and anhydrous colloidal silica.

What Lecicarbon looks like and contents of the pack

Lecicarbon is a cream-colored suppository, uniform, torpedo-shaped, packaged in PVC/PE blisters of 5, with the batch number and expiry date printed.
It is available in packs of 10, 30, or 100 suppositories and in hospital packs containing 50x10 or 500 suppositories.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

athenstaedt GmbH & Co KG
Am Beerberg 1
D-35088 Battenberg (Eder)
Germany
Tel. +49 6452 92 942-0
Fax. +49 6452 92 942-15

Manufacturer:

Haupt Pharma Livron S.A.S.
1 Rue Comte de Sinard,
F-26250 Livron-Sur-Drôme
France
Tel.: +33-4-75 61 02 00,
Fax: +33-4-75 61 02 10

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany:

Lecicarbon E/K CO -Laxans two/three
United Kingdom:Lecicarbon A/C Suppository

Hungary:

Lecicarbon Felnött végbélkúp/Lecicarbon Gyermek végbélkúp

Luxembourg:

Lecicarbon E/K

Slovenia:

Lecicarbon za odrasle 500 mg/680 mg svečke / Lecicarbon za otroke 250 mg/340 mg svečke

Date of last revision of the package leaflet: