Package leaflet: Information for the user

Lecicarbon, 500 mg + 680 mg, suppositories
Sodium hydrogen carbonate + Sodium dihydrogen phosphate
For use in adults
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed
by a doctor or pharmacist.
Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse effects, including any possible adverse effects not listed
in this leaflet, inform your doctor or pharmacist.
See section 4.
If there is no improvement after 3 days, or if you feel worse, consult your doctor.

Contents of the leaflet

What Lecicarbon is and what it is used for
Important information before using Lecicarbon
How to use Lecicarbon
Possible side effects
How to store Lecicarbon
Further information

1. What Lecicarbon is and what it is used for

Lecicarbon is used in various forms of constipation, for example, caused by consuming
foods low in dietary fibre, lack of physical activity, or in diseases requiring easy passage of stool.
Lecicarbon is also used for bowel evacuation prior to surgery or diagnostic procedures
involving the rectum.

2. Important information before using Lecicarbon

When not to use Lecicarbon
if the patient is allergic (hypersensitive) to sodium bicarbonate, sodium dihydrogen phosphate, or
any of the other ingredients of this medicine (listed in section 6).
in case of intestinal obstruction.

Warnings and precautions
In the case of toxic colonic dilatation (pathological dilation of the end of the large intestine due to various causes), the medicine should be used only after obtaining clear consent from the treating physician.

Lecicarbon with other medicines
Lecicarbon can be used while taking other medicines.
You should tell your doctor or pharmacist about all medicines currently taken or recently taken by the patient, as well as any medicines the patient plans to take, including those available without a prescription.

Lecicarbon with food and drink
No special precautions required.

Pregnancy, breastfeeding and effects on fertility
Pregnancy:
Lecicarbon may be used during pregnancy after consultation with the treating physician.

Breastfeeding:
Lecicarbon may be used during breastfeeding.

Fertility:
There are no data regarding the effect of Lecicarbon on human fertility. Effects on male and female fertility have not been evaluated in animal studies.

Before using any medicine, consult a doctor or pharmacist.

Driving and operating machinery
Lecicarbon has no influence on the ability to drive or operate machinery.
Please note that bowel movement (defecation) is expected 15–30 minutes after administration.

Lecicarbon contains (3-sn-phosphatidyl)choline (from soybean oil, lecithin)
Do not use if hypersensitivity to peanuts or soybeans has been diagnosed.

3. How to use Lecicarbon

Children over 12 years of age and adults
This medicine should always be used exactly as described in this patient information leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Unless otherwise prescribed, insert one suppository rectally as needed. If necessary, the dose may be repeated after 30–60 minutes.
Before using Lecicarbon, remove the suppository from its packaging by separating one suppository from the strip at the perforation. Hold the plastic ends with both hands and pull in opposite directions. Insert the suppository into the rectum. Briefly soaking it in water beforehand may facilitate insertion.
Onset of action occurs within 15–30 minutes.
Do not use oil or vaseline as a lubricant.
Lecicarbon may be used in adults and children over 12 years of age. Lecicarbon is not suitable for use in children under 12 years of age.
Lecicarbon is safe for long-term use and does not lead to habituation. However, in cases of chronic constipation, medical advice should always be sought.
Use of a higher than recommended dose of Lecicarbon
The usual dose is one suppository. If necessary, the dose may be repeated after 30–60 minutes. There is no danger in exceeding this dose, but there is no benefit in administering more than two suppositories.
Missed use of Lecicarbon
Lecicarbon is used only as needed.
Stopping use of Lecicarbon
Lecicarbon is used only as needed.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Lecicarbon usually does not cause any problems (side effects).
Insertion of the suppository may occasionally, in rare cases, cause a mild burning sensation,
which quickly subsides.
If any of the side effects worsen or if any side effects not listed in this leaflet occur,
inform your doctor or pharmacist.
Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, inform your doctor or pharmacist.
Side effects 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.: +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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lecicarbon

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

6. Contents of the pack and other information

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

What Lecicarbon looks like and contents of the pack
Lecicarbon is a cream-colored, homogeneous torpedo-shaped suppository, packed in PVC/PE blisters of five units, with the batch number and expiry date embossed.
It is available in packs containing 10, 30 or 100 suppositories, and in hospital packs containing 50x10 or 500 suppositories.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 authorised in the European Economic Area countries under the following names:
Germany: Lecicarbon E/K CO -Laxans zwei/drei
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