3. AIM OF THE SURVEILLANCE

IBS: Post marketing surveillance Eucarbon®
1. SYNOPSIS
Sponsor
Investigational Product
Composition
Aim of the investigation
Design/Methology
Sample size
Diagnosis and criteria
for inclusion
Physicians
Product and dose
Mode of administration
Duration of treatment
Investigational period
F. TRENKA
F. TRENKA
CHEMISCH-PHARMAZEUTISCHE FABRIK GES. M. B. H.
A-1040 WIEN, GOLDEGGASSE, VIENNA, AUSTRIA
Eucarbon® tablets
1 tablet contains: 180 mg vegetable charcoal, 50 mg sublimed
sulphur, 105 mg senna leaf, 25 mg rhubarb extract,
(0,5 mg Aetherol (Menthae) and 0,5 mg Aetherol (Foeniculi))
The aim of this postmarketing surveillance is to examine
efficacy and tolerance of Eucarbon® tablets in a big number of
patients suffering from lrritable Bowel Syndrome (IBS).
According to the pharmaceutical law it is the duty of care of the
holder of a registration to gain further information on efficacy
and tolerance of their products in approved indications.
Open label, multi-centre post marketing surveillance with no
intervention in an approved indication.
A minimum of 150 patients in different countries
Patients suffering from lrritable Bowel Syndrome (IBS)
characterised by recurrent abdominal pain and altered bowel
function. Eucarbon® tablets are used in the approved indication.
Internists, General Practitioners
Eucarbon® tablets in the approved prescribed dose (1-2 tablets
up to 3 times a day).
Many years of experience show excellent effects by reducing
the dose from 6 to 4 tablets after the first 2 days for the next 5
days, to reduce the dose to 3 tablets after the first week, to 2
tablets after the second week, to 1 tablet after the third week for
7 days. From the 5 th week on 1 to 2 tablets when necessary.
Oral
According to the approved Summary of Product Characteristics
(approx. 12 weeks).
May 2005 to December 2005
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IBS: Post marketing surveillance Eucarbon®
2. INTRODUCTION
F. TRENKA
Irritable bowel syndrome (IBS) is a benign relapsing chronic disorder, characterised by
recurrent abdominal pain and altered bowel function. It is estimated that 9 to 22% of the
general population has clinical symptoms of IBS but only about 5% seek medical care.
IBS is the most common diagnosis made by gastroenterologists and accounts for
approximately 50% of all referrals. IBS contributes significantly to disability, days off work
or school and health care costs.
IBS is considered as a complex disease whereby clinical and therapeutical management is
particularly difficult. There is however no evidence that IBS predisposes to cancer or any
other disorder. Patients complain of general symptoms of abdominal pain (most frequently
located in the lower left quadrant), changes in bowel habits/ stools, (e.g., stools may be softformed
with pencil-size diameter), flatulence and / or abdominal distension with the onset of
symptoms usually weeks or months prior to seeking medical attention.
The management of irritable bowel syndrome is quite complex. Bile acid-binding agents such
as cholestyramine have been successfully used. The beneficial effect of this treatment may be
a result of the general constipation effect of the resin. Furthermore it has been proposed that
elevated levels of short-chain fatty acids in the stools may mediate the diarrhea in irritable
bowel syndrome, however symptoms have not correlated with fecal levels.
The active ingredients contained in Eucarbon® are exclusively of vegetable and mineral origin. The
effect of Eucarbon® is twofold: it regulates the bowel functions and acts as a mild laxative. The
vegetable charcoal adsorbs toxic substances originating from bacteria and from metabolic processes.
Eucarbon® is a combination of senna, rhubarb, carbo ligni and sulfur. It belongs by its
pharmacological and pharmacodynamical properties to the stimulant laxatives, but due to the mild
adsorptive activity of carbo ligni Eucarbon® also is a mild adsorbent and therefore a medicine
against general digestive disorders.
Laxatives such as Eucarbon® may increase intestinal motility via decreased absorption of salt
and water secondary to a decrease in transit time.
Eucarbon® was developed in 1909 by the pharmacist Mag. F. Trenka and by Prof. Dr. W.
Pauli. Eucarbon® tablets contain only vegetable and mineral active ingredients and are
produced with up-to-date production methods in accordance with GMP-Standards.
Eucarbon® is on the market for several years in different European and non-European
countries, such as Morocco, South Africa and Indonesia.
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IBS: Post marketing surveillance Eucarbon®
3. AIM OF THE SURVEILLANCE
F. TRENKA
The aim of this postmarketing surveillance is to examine efficacy and tolerability of
Eucarbon ® tablets in patients suffering from Irritable Bowel Syndrome (IBS).
Due to the character of a post marketing surveillance no defined investigations are proposed.
Eucarbon® is used according to the approved guidelines given in the SPC (summary of
product characteristics). There is no therapeutic measure proposed, which goes beyond the
usual routine of medical care.
4. TREATMENT AND MEDICATION
Eucarbon® is used according to the approved indication and dosage given in the SPC.
Composition:
1 tablet contains:
Carbo Ligni – Wood Charcoal 180,00mg
Sulfur depuratum – Sublimed Sulfur 50,00 mg
Fol. sennae – Senna Leaf 105,00 mg
Extractum Rhei – Rhubarb Extract 25,00 mg
(Aetherol Menthae 0,5 mg)
(Aetherol Foeniculi 0,5 mg)
Prescription: over the counter (OTC)
Presentation (Packaging): 30, 50, 100 and 500 tablets
Shelf life: 60 months
Dose: 1 to 2 tablets up to 3 times a day
Many years of experience show excellent effects by reducing the initial dose from 6 to 4
tablets after the first 2 days for the next 5 days. The reduction of 1 tablet per day should
maintain from the second week on. After the 4 th week, from the 5 th week on 1 to 2 tablets are
prescribed when necessary.
5. DESIGN OF THE SURVEILLANCE
The total duration of the PMS will be 7 months. The investigation starts in May 2005 and will
end in December 2005.
Patients will be treated with Eucarbon® according to the approved SPC for approximately 12
weeks. Approximately 6 weeks after the baseline visit the first control visit will be performed.
After additional 6 weeks (a total of 12 weeks) a second control visit will be conducted.
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IBS: Post marketing surveillance Eucarbon®
F. TRENKA
The results of each visit of the patient will be reported in the provided case report forms
(CRFs).
6. SUBJECTS
The investigation will be conducted with patients with Irritable Bowel Syndrome (IBS).
Patients with well known hypersensitivities or allergic reactions against components of
Eucarbon® tablets must be excluded from the post marketing surveillance. There are no
restrictions to the physicians choice of therapy.
At any time the investigator can withdraw by his discretion the patient from the surveillance.
7. EFFICACY AND TOLERANCE
7.1. Efficacy
The main parameter for evaluating the efficacy of Eucarbon® is the change in symptoms
from baseline to the end of the PMS.
Furthermore the change in the severity of the illness and an overall assessment of the
effectiveness will be evaluated.
7.2. Tolerance
Parameters for evaluating the tolerance of Eucarbon® tablets are clinical findings and a
global evaluation of tolerance by the physician and the patient. All AEs will be listed and all
reasons for discontinuation of the treatment will be documented.
If an Adverse Event (AE) occurs, the AE Reporting Page must be completed. All new
indispositions occurring between baseline visit and end of visit (intercurrent illnesses) are
handled as adverse events and have to be reported on the adverse event reporting page.
A serious adverse event (SAE) is defined as an adverse event, which is observed during any
phase of the intake of Eucarbon®, independently of its dosage and fulfils one of the following
criteria:
• results in death
• is immediately life-threatening
• requires or prolongs patient hospitalisation
• results in permanent diability/incapacity of the patient
• development of a new tumour
• congenital anomaly/birth defect
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IBS: Post marketing surveillance Eucarbon®
F. TRENKA
Reporting of SUSARS
Suspected Unexpected Serious Adverse Reactions are SAEs where a causal relationship with
the administration of Eucarbon® cannot be excluded. SUSARs have to be reported within one
working day per telephone or fax to the responsible person of TRENKA GmbH:
To: Herr Dr. E.H Moser
Fa. TRENKA GmbH
Goldeggasse 5
A-1040 Wien
Telephone: +43-1-505 30 53-0
Fax: +43-1-505 30 53-31
E – mail: office@eucarbon.at
8. INFORMATION AND PATIENTS INFORMED CONSENT
Because all patients are treated within the limitations of the SPC information of the patient
going beyond the medical obligation of the physician is not necessary during the PMS.
9. ETHICAL ASPECTS
For the conduction of this post marketing surveillance no approval of the local Ethic
committees or other authorities are needed.
To maintain confidentiality of the patient data the name/data of the patients will only be
transmitted anonymized by their physician. The coding is done in a way, which makes a
reconstruction of the patients name impossible.
10. MONITORING AND HANDLING OF THE DATA
For assuring the quality of the data an in-house monitoring after receipt of the CRFs will be
conducted. For removing possible ambiguities enquiries will be sent to the investigating
physician.
The original Case Report forms will be numbered consecutively. The number of the report
form will be handed as document/patients number.
All investigational results as well as all deviations of the protocol will be summarised in a
final report.
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IBS: Post marketing surveillance Eucarbon®
F. TRENKA
Please send the electronically finalized CRF of each patient, either per e-mail or by fax to:
11. STATISTICS
Dr. Robert Heinz und Partner GmbH
c/o Dr. Brigitte Monsberger
Kaiserstrasse 84/9
1070 Wien
E-mail: monsberger@heinz-consulting.com
Fax: +43-1-524 61 78-22
Descriptive measures will be used to report the results of this open label post marketing
surveillance. If necessary, confirmatory analyses will be performed (Wilcoxon-Mann-
Whitney test, two sided, alpha = 0.05).
12. CONFIDENTIALITY AND PUBLICATIONS OF THE RESULTS
All data and information provided have to be treated confidentially. The information
contained in the CRF and protocol is the property of F. TRENKA and is therefore provided to
the investigator in confidence. It is understood that the information will not be disclosed to
others and publications will not be done without prior written approval from F. TRENKA.
3 months after tzhe end of the post marketing surveillance a final report with statistical
analysis and clinical interpretation will be performed.
13. STORAGE
The CRFs will be stored for later use and evaluations 10 years after the surveillance.
14. APPENDICES
Case Report Form (CRF)
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