Eucarbon Herbal Tablets

F.Trenka/Vienna
Tablets
Scientiﬁc Brochure

Natural intestinal regulators
with a unique twofold action:
• as a mild laxative and
• as an agent against mild forms of diarrhoea
and

Contents
Page
1. Introduction to Eucarbon®
and Eucarbon®
herbal Tablets...........................2
1.1 Characteristics............................................................................................2
1.2 Composition................................................................................................3
1.3 Uses............................................................................................................3
1.4 Dosage........................................................................................................3
1.5 Safety......................................................................................................... 4
1.6 Drug Interactions........................................................................................5
1.7 Contra-indications and special notes.........................................................5
1.8 Pack Details................................................................................................5
2. Active Ingredients............................................................................................6
3. Indications........................................................................................................8
3.1 Constipation................................................................................................8
3.2 Irritable Bowel Syndrome............................................................................9
3.3 Radiological Examinations........................................................................10
3.4 Further Indications....................................................................................10
4. Pharmacology................................................................................................11
4.1 Pharmacodynamics..................................................................................11
4.2 Pharmacokinetics, Bioavailability.............................................................12
4.3 Toxicity Data.............................................................................................12
5. Clinical Efficacy.............................................................................................13
5.1 Clinical Studies with Eucarbon®
and Eucarbon®
herbal...........................13
6. Safety..............................................................................................................18
7. Summary.........................................................................................................19
8. References.....................................................................................................20
1

1. Introduction to Eucarbon®
and
Eucarbon®
herbal Tablets
1.1 Characteristics
Eucarbon®
was developed in 1909 by the pharmacist Mag. F. Trenka and
by Prof. Dr. W. Pauli who composed a unique medicine out of natural
components known since centuries.
Eucarbon®
tablets contain only vegetable and natural active ingredients
and are produced with up-to-date production methods in accordance
with GMP-standards. Eucarbon®
stimulates the entire digestive system,
increases colonic motility, has a mild laxative and spasmolytic effect,
relieves gas pain and can also be regarded as a detoxifying agent (mild
adsorbent).
Today this herbal medicinal product is available in two variants: Eucarbon®
and Eucarbon® herbal.
Eucarbon®
is a combination of anthranoid drugs (senna and rhubarb), sulfur,
and the mild adsorbent vegetable charcoal (carbo ligni) - ingredients which
as single drugs/substances or in different combinations have been used
as remedies for centuries in patients with intestinal complaints, mainly
with constipation. In the unique combination of this preparation the proven
and generally accepted effects of the single ingredients have additional
beneficial effects – presented in a standardized dosage form.
Eucarbon® herbal is a charcoal-sennoside combination which also is
indicated for the relief of the symptoms of constipation and general
gastrointestinal disorders.
The product has been developed out of the classical version, Eucarbon®
Tablets, a very established and traditional formula, which also includes
sulfur.
In the formula of Eucarbon® herbal, sulfur was removed because of
medicinal reasons as some patients feel more comfortable with the sulfur-
free variant and because of regulatory reasons in some countries.
Both are herbal remedies with mainly laxative effects. They also regulate
digestion in a totally natural way and provide for regular functioning of the
digestive system.
The action of the preparations is due to the content of vegetable charcoal
and the stimulatory action of anthraquinones and sulfur [in Eucarbon®].
Furthermore both preparations have a double effect against abdominal pain:
• the essential mint and fennel oils have well-known spasmolytic and
carminative effects,
• the amount of gas and tension in the abdominal cavity is reduced
through absorption, thus bringing about pain relief (reduction of flatulence
and tension).
2

1.2 Composition
Active ingredients of Eucarbon®
tablets are:
Fol. sennae – Senna Leaf 105,00 mg
Extractum Rhei – Rhubarb Extract 25,00 mg
Carbo Ligni – Wood Charcoal 180,00 mg
(Vegetable charcoal)
Sulfur depuratum – Sublimed Sulfur 50,00 mg
Excip. per tablet:
Peppermint oil 0,50 mg and
Fennel oil 0,50 mg
Active ingredients in Eucarbon®
herbal tablets are:
Fol. sennae – Senna Leaf 105,00 mg
Extractum Rhei – Rhubarb Extract 25,00 mg
Carbo Ligni – Wood Charcoal 180,00 mg
(Vegetable charcoal)
Excip. per tablet:
Peppermint oil 0,50 mg and
Fennel oil 0,50 mg
ThereforethecompositionofthemainactiveingredientsFol.sennae,Extractum
Rhei, and Carbo Ligni of Eucarbon® and Eucarbon® herbal is identical in both
products, with the conclusion that the data regarding efficacy and safety are
transferable from Eucarbon® tablets to Eucarbon® herbal tablets.
1.3 Uses
• Mild laxative, indicated for the relief of all forms of constipation
• sluggishness of the bowels
• haemorrhoidal obstipation
• fermenting and putrefying processes in the intestines
• meteorism
• flatulence (elevated diaphragm)
• intestinal auto-intoxication
(The indications are partly different in various countries.)
1.4 Dosage
The recommended dosage for both products Eucarbon® and Eucarbon®
herbal is:
• Adults and adolescents from 12 years on: 1 – 2 tablets 3 times a day
(at or after meals) with some liquid. If a stronger effect is desired, the
evening dose should be raised to 3 or 4 tablets.
• Children from 2 years on: ½ – 1 tablet up to 3 times a day at meals with
some liquid
3

At low doses (1-3 tablets daily), Eucarbon®
has an adsorbent effect, at
higher doses (4-6 tablets daily), Eucarbon®
has both, an adsorbent and
laxative effect.
For X-ray purposes (adults): 6 to 8 tablets as a single dose in order to
cleanse the digestive tracts and remove all gas, preferably on the eve of the
examination.
In order to achieve intestinal regularity in the treatment of Irritable Bowel
Syndrome (IBS), it will be necessary to observe two conditions:
• an average period of treatment of 4 to 6 weeks until regular transit is
achieved and
• a progressive reduction of dosage in conformity with the progress of
improvement of the intestinal functions
1.5 Safety
The efficacy and safety of Eucarbon®
tablets have been established and
highly acknowledged for more than 100 years. There are no preparation-
specific contra-indications known for Eucarbon®
/Eucarbon®
herbal neither
from the daily practice nor from studies or post-marketing surveillance
data.
The overall tolerability and safety of both preparations is worldwide
known in more than 60 countries and documented again and again. Using
Eucarbon®
/Eucarbon®
herbal as a drug of choice in constipation has
never been associated with life-threatening adverse reactions. In the usual
dosage regime, i.e. at the recommended doses, no preparation-related
side effects, neither in the daily practice nor in clinical studies have been
reported.
There are no findings on drug interactions for Eucarbon®
so far, nor any
restrictions on the ability to drive or to operate machinery.
One important point is that people very easily can modify and adapt their
individual dose and therefore prevent potential stronger side effects that
might be expected due to its content of anthraquinones.
Like all anthranoid-containing preparations, Eucarbon®
tablets may
produce abdominal pain and colicky gastrointestinal symptoms and
passage of liquid stools, in particular in patients with irritable colon.
However, these symptoms may also occur generally as a consequence
of individual overdosage. In such cases dose reduction is necessary. The
correct individual dose is the smallest required to produce a comfortable
soft-formed motion.
Chronic use may lead to disorders in water equilibrium and electrolyte
metabolism and may result in albuminuria and haematuria.
Furthermore, use over a long period may lead to pigmentation of the
intestinal mucosa (pseudomelanosis coli), which usually recedes when the
patient stops taking the preparation.
4

Yellow or red-brown (pH dependent) discolouration of urine by metabolites,
which is not clinically significant, may occur during the treatment.
1.6 Drug Interactions
Overdose of laxatives in general may upset the water and electrolyte
balance so that for instance the tolerance of digitalis compounds may be
lessened.
1.7 Contra-indications and special notes
• Hypersensitivity to one of the components
In case of
• Ileus or intestinal obstruction
• Enteritis, appendicitis or abdominal pain without known cause
• Serious disorder of water and electrolyte balance
• Pregnancy or lactation
• When gastric or intestinal ulcer is suspected
any kind of laxative should be avoided; patient is to consult a doctor
immediately.
In case of becoming pregnant the patient is to consult a doctor
immediately.
Eucarbon®
and Eucarbon®
herbal are not suited for weight reduction.
1.8 Pack Details
Presentation:
Original: 10, 30 and 100 tablets
Hospital: 1000 tablets
5

2. Active Ingredients
Sennae folium:
Senna leaf consists of the dried leaflets of Cassia senna L. (C. acutifolia De
Lile), known as Alexandrian or Khartoum senna, or Cassia angustifolia Vahl,
known as Tinnevelly senna, or a mixture of the two species. It contains
not less than 2,5 percent of hydroxyanthracene glycosides, calculated
as sennoside B (C42
H38
O20
; M, 863) with reference to the dried drug. The
main active ingredients are anthraquinone glycosides which have laxative
effects. Additionally water and electrolytes are secreted into the lumen
of the intestine by stimulation of active chloride secretion. Senna leaf is
used as a laxative due to its main effects: reduced absorption of liquids
and salts, increased peristaltic activity of the small and large intestine, and
stool softening.The material used in Eucarbon®
complies with the German
Monograph “Sennae folium” of the Commission E (22) as well as the EMEA
Monograph “Cassia Senna” (6).
Extractum Rhei:
Rhubarb consists of the whole or cut, dried underground parts of Rheum
palmatum L. or of Rheum officinale Baillon or of hybrids of these two
species or of a mixture. The underground parts are often divided; the stem
and most the bark with the rootlets are removed. It contains not less than
2.2 per cent of hydroxyanthracene derivatives, expressed as rhein (C15
H8
O6
,
Mr 284.2), calculated with reference to the dried herbal substance (7), and
in addition tannins and antioxidative agents.
The material used in Eucarbon®
complies with the German Monograph (21),
DAB 10, ÖAB 90, Helv. VII and Ph. Eur. as well as the EMEA Monograph
“Rhei Radix” (7).
Rhubarb is used as a laxative as well and has the main effects as for
senna. As a result the stool remains soft and the action of the bowels is
made easier.
Anthraquinone-content of Eucarbon®
:
Referring to the Chemical-, Pharmaceutical- and Biological Documentation
of Eucarbon®
, the total content of anthraquinone is 3,30 ± 0,65 mg/
tablet (2,65 – 3,95 mg/tablet) and thus when taking the recommended
dosage of 6-8 tablets/day in the recommended dosage range of the EMEA
monographies for Cassia Senna (6) and Rheum (7), where 15-30mg resp.
15-50mg hydroxyanthracen derivates/day are recommended. The WHO
monographies recommed 10-30mg sennosides/day (cited in 6, 7).
6

Herbal Charcoal:
Synonym: Carbo Ligni, vegetable charcoal
Charcoal is a fine odourless, tasteless, black powder, free from grittiness.
It is made from common charcoal by repeated nealing in closed containers
and has a particularly detoxicating effect.
Classical experiments showed that vegetable charcoal has the potential to
adsorb inorganic poisons as well as viruses, bacteria and their metabolites
(bacterial toxins). It can adsorb many drugs including digoxin, yellow
oleander, barbiturates, and tricyclic antidepressants. Charcoal neutralises
gases and toxins through adsorption and helps in cases of diarrhoea and
acute oral poisoning by a faster elimination of the charcoal-bound toxic
substances (30). Carbo Ligni in Eucarbon®
also binds air and other gases in
the intestinal tract which reduces flatulence and tension.
And in Eucarbon®
tablets additionally:
Sulfur depuratum:
Sulfur is an element of molecular weight 32 known since ancient times.
It is yellow, tasteless and odourless and is usually used in the form of
precipitated sulfur, which is an amorphous or microcrystalline powder.
It melts at around 118 - 120°C to form a yellow liquid, which becomes dark
and viscous at around 160°C. It is soluble only to a slight extent in water
and alcohol, but quite freely soluble in carbon disulfide, light petroleum and
turpentine (32). The element is present in all living tissues.
When taken orally, sulfur is converted in the gut into alkali sulfides with mild
disinfectant properties, stimulation of peristalsis and promotion of a mild
laxative effect.
The essential mint and fennel oils which are contained in both
preparations have well-known spasmolytic and carminative effects.
The essential oil of peppermint has mild disinfectant effects in the intestine,
promotes the production of gall-liquid and thus the digestion of fat.
All active and inactive substances are subject to Pharmacopoeial
specification with the exception of vegetable charcoal, which deviates from
European Pharmacopoeia specification.
7

Note: Eucarbon®
herbal has the same composition but
without sulfur.
3. Indications
3.1 Constipation
Chronic constipation is one of the most common complaints in clinical
medicine. It is a rising problem in modern society affecting approximately
one of five adults in industrialized countries.
Chronic constipation (Figure 2) is defined as the delayed evacuation of dry,
hard stools (23) or the passage of small hard faeces infrequently and with
difficulty (8).
8
Figure 2:
Definition and symptoms of constipation
Constipation Definition
• Infrequent hard stools
Associated symptoms
• Flatulence
• Bloating
• Abdominal pain
• Feeling of incomplete evacuation
Symptoms of complications
• Anorexia
• Overflow diarrhoea
• Confusion
• Nausea and vomiting
• Urinary dysfunction
Herbal
charcoal
Purified
sulfur
Senna
Leaves
Rhuburb
root
Name
Quantity 180 mg 50 mg 105 mg 25 mg
Eucarbon®
components
Figure 1: Eucarbon®
components and composition

Constipation has several possible causes (Figure 3). The most common
ones are associated with nutritional factors such as the consumption of
food with poor dietary fibre content, which results in insufficient filling of
the intestine. Furthermore, intake of readily absorbed food with a reduced
water-binding capacity or the lack of exercise may lead to constipation.
Other causes include factors related to organ dysfunction or organ damage
including gastro-intestinal disorders, changes in the intestinal wall (due to
a tumour or chronic inflammation e.g.), metabolic and endocrine disorders
(diabetes mellitus e.g.), functional and organic disturbances of the nervous
system, such as Parkinson’s disease, or may be caused by the side-effects
of drugs such as analgesics, antidepressants, antispasmodics or sedatives
(38).
Constipation per se is diagnosed if no bowel movements occur for three
days or more and if this irregularity persists for longer than six days.
Figure 3: Further causes of constipation
Many of the associated symptoms may mimic features of the underlying
disease. About half of the patients admitted to specialist palliative care
units report constipation, but about 80% of patients require laxatives (8).
3.2 Irritable Bowel Syndrome
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 (35) but only about 5% seek medical care. IBS is the most common
diagnosis made by gastroenterologists and accounts for approximately
50% of all referrals. lt contributes significantly to disability, days off work
9
Causes of constipation
Caused by diseases
• Abdominal tumours
• Hypercalcaemia
• Intra-abdominal or pelvic disease
• Spinal cord compression
• Cauda equina syndrome
• Depression
Caused by treatment
• Antidepressants
• Analgesics
• Opioids
• Antiemetics
• Anticholinergics
• Aluminium salts
• Non-steroidal anti-inflammatory drugs
Associated with debility
• Weakness
• Inactivity or bed rest
• Poor nutrition
• Poor fluid intake
• Confusion
• Inability to reach the toilet
Concurrent disorders
• Haemorrhoids
• Anal fissure
• Endocrine dysfunction

or school and health care costs; 69 to 85% of the patients report that they
experienced difficulties in carrying out their daily activities (3).
Patients complain of general symptoms of abdominal pain (most frequently
located in the lower left quadrant), abdominal cramping, changes in bowel
habits / stools (e.g., stools may be soft-formed with pencil-size diameter),
flatulence and / or abdominal distension with the onset of symptoms
usually weeks or months prior to seeking medical attention.
The cause of IBS is still unknown and abnormalities in gut motility fail to
explain the diverse features of IBS. Symptoms of IBS may be related to
stress, to depression, anxiety or other psychological manifestations, and
food intolerance (most commonly lactose and gluten) or enteric infections.
IBS is considered as a complex disease whereby clinical and therapeutical
management is particularly difficult and individually focussed on the
complaints of the specific patient.
3.3 Radiological Examinations
Intestinal gas in excess impairs the quality of abdominal ultrasonic and
X-ray investigations. Thus it is important to cleanse the bowel of its
contents thoroughly before sonographic or radiological procedures such as
barium enema or urography (4, 5).
Standard regimens for emptying of the bowel prior to radiographic or
sonographic examinations are laxatives and diet for 24 hours, occasionally
supplemented by oral ingestion of an electrolyte polyethylene glycol
solution or by an enema.
Especially for the elderly, the bowel preparation providing optimum
cleansing of the bowel with the least associated discomfort and
inconvenience for the patient must be found.
10
Figure 4:
Contrast radiograph of the colon (patient with
megacolon). Minimum of bloating and flatulence
after Eucarbon® intake.

3.4 Further Indications
In some countries Eucarbon®
and Eucarbon®
herbal are also used in
pregnant women (during the last trimenon) suffering from constipation, gas,
haemorrhoids and anal fissures, in post surgery situations for bedridden
patients, in cases of constipation under the prescription of neuroleptics as
well as bad breath caused by constipation.
4. Pharmacology
Eucarbon®
tablets contain only vegetable and natural active ingredients.
Eucarbon®
stimulates the entire digestive system, increases colonic
motility, has a mild laxative and spasmolytic effect, relieves gas pains and
can also be regarded as a detoxifying agent.
4.1 Pharmacodynamics of Eucarbon®
As a combination of senna, rhubarb and carbo ligni [as well as sulfur
in Eucarbon®
] Eucarbon®
and Eucarbon®
herbal belong, by their
pharmacological and pharmacodynamical properties, to the stimulant
laxatives. For the laxative effect these agents stimulate accumulation of
water and electrolytes in the colonic lumen, and enhance intestinal motility,
too. Due to the mild adsorptive activity of carbo ligni Eucarbon®
also
is a mild adsorbent and therefore a medicine against general digestive
disorders (29).
The effects of Eucarbon®
as a stimulant laxative on intestinal fluxes of
electrolytes and water are readily demonstrated in vitro or in situ under
conditions in which effects on motility are excluded (9). Concentrations
of these agents that reduce net absorption of electrolytes and water also
increase the permeability of the mucosa, possibly by making tight junctions
leaky. The stimulant laxatives may inhibit intestinal Na+
, K+
-ATPases. This
action could account for at least a part of their laxative effect. Many of
the stimulant laxatives also increase the synthesis of prostaglandins and
cyclic AMP, and this action may contribute to increased secretion of water
and electrolytes. Inhibition of prostaglandin synthesis with indomethacin
reduces the effects of many of these agents on net water flux (1). The mode
of action of Eucarbon®
and Eucarbon®
herbal is shown in Figure 5.
11

4.2 Pharmacokinetics, Bioavailability of Eucarbon®
None of the active substances senna, rhubarb, carbo ligni [and sulfur in
Eucarbon®
] are absorbed but act in situ, thus no pharmacokinetic studies
for Eucarbon®
were conducted.
Adequate bioavailability can be supposed because efficacy has been
shown for more than 100 years in daily practice and in several studies
with the single constituents as well as with the combination preparation
Eucarbon®
and Eucarbon®
herbal in the recent years.
4.3 Toxicity Data of Eucarbon®
Information on the toxicity of the different components of Eucarbon®
such as senna, rhubarb, carbo ligni (vegetable charcoal) as well as that of
Eucarbon®
tablets was collected, examined and evaluated in detail (9).
The results of the reviews and an acute toxicity study show that Eucarbon®
was well tolerated without specific toxic effects. Eucarbon®
caused no
death among rats (29).
In spite of the fact that Eucarbon®
was a well-tolerated drug, a purgative or
laxative effect of Eucarbon®
was noticed, which was dose dependent but
did not give cause for concern as regards of safety.
12
[A, B] Food is insalivated in the oral cavity, pre-digested [C]
and travels through the pylorus into the duodenum.
[D] In the duodenum, the pre-digested food pulp is mixed with
digestive enzymes from the gall-bladder and pancreas.
[E] The pulp continues on to the small intestine, where the
broken up food parts are absorbed into the bloodstream.
This is where Eucarbon®
reveals its main effect:
The laxative effect prevents faeces from drying out too
much. At the same time and in cases of minor indigestion,
charcoal binds those toxins and gases which could cause
diarrhoea.
[F] Large intestine: Due to Eucarbon®
, fluid retention from
faeces is prohibited and the faeces remain soft.
[G] Colon-rectum: Elimination via soft stool: Toxins which have
arisen from incomplete digestion remain bound to charcoal and
the laxative substances make sure that faeces are evacuated
rapidly.
A B
C
D
E
F
G
Figure 5: Mode of action of Eucarbon®

5. Clinical Efficacy of Eucarbon®
Eucarbon®
has been on the market for more than 100 years and meanwhile
in more than 60 countries. The safety and efficacy of the ingredients
per se are accepted by German Commission E monographs, European
Pharmacopoeias and their inclusion in the “General Sales List” in the UK.
5.1 Clinical Studies with Eucarbon®
and Eucarbon®
herbal
A number of clinical studies has been performed and clinical data have
been systematically collected for Eucarbon®
and Eucarbon®
herbal. Main
outcome variables from clinical studies were Likert scales for severity of
complaints, symptomatology, well-being as well as global assessment
for efficacy and safety/tolerance, modified Clinical Global Impressions
Score (CGI) (25) and modified Francis IBS-Score (11), which summarises
the actual complaints, incorporating pain, distension, bowel dysfunction,
classified as mild, moderate or severe.
Table 1: Tabular Overview of the Clinical Trials with Eucarbon®
and Eucarbon®
herbal
Study
Number
Author
(Ref.-No)
Year Title No. of
Patients
treated with
Eucarbon®
1 Breier (2) 1980 Clinical Results after the Application
of Eucarbon®
in Patients with
Constipation
102
2 Feruglio (10) 1981 Clinical Report on the Tolerance and
Efficacy of Eucarbon®
31
3 Schmidbauer
and Schuster
(33)
1985 Intestinal Cleaning before
Uroradiology and Urosonographie
28
4 Yoman (39) 1993 The Use of Eucarbon®
in Preparing
Radiology (Abdominal X-ray,
Echography)
5
5 El Mrini et
al. (5)
1995 Evaluation of the Clinical Efficacy
of Eucarbon®
in the Preparation of
Urography and Urologic Surgery
44
6 Irnius and
Juodagalvyte
(17)
2002 Eucarbon®
for the treatment of IBS 21
7 Krejs (18) 2002 Efficacy of Eucarbon®
in Patients
suffering from IBS
262
8 Irnius and
Juodagalvyte
(16)
2002 Preparation of the bowel for X-ray
examinations with Eucarbon®
herbal
19
13

14
9 Hübner and
Moser (13)
2002 Treatment of Patients Suffering from
IBS with Eucarbon®
herbal
284
10 Machavariani
et al. (19)
2003 Use of Eucarbon®
for the Treatment of
Patients Suffering from IBS and from
Constipation
35
11 Dumitrascu
et al. (4)
2003 A Combination of Charcoal and
Senna Improves the Accuracy of
Abdominal US Investigation
14
12 Hübner and
Alken (14)
2004 Treatment of Patients Suffering from
Constipation with Eucarbon®
61
13 Nicolava et
al. (27)
2005 Preparation and radiological
Investigations
35
14 Narzharov
(24)
2005 Eucarbon®
administration in patients
with pathology of hepatoduodenal
area
40
15 Heinz (12) 2009 Evaluation of the Post Marketing
Surveillance of Eucarbon®
in 3
countries
802
16 Okasha (28) 2012 Eucarbon®
in Abdominal Ultrasound
Examinations in Egyptian Patients
450
In all indications investigated Eucarbon®
and Eucarbon®
herbal could prove
their efficacy, namely in the relief of complaints in constipated patients
or in patients suffering from irritable bowel syndrome as well as for the
preparation of radiological or sonographic examinations (15).
In a drug-monitoring study (14), efficacy and safety of Eucarbon®
tablets
were investigated in patients suffering from constipation, especially those
with spasmodic complaints. After the 12-week treatment period, 61
patients were available for analyses, whereby the following questionnaires
were used: global assessment for efficacy and safety/tolerance, modified
Clinical Global Impressions Score (CGI) (25) and modified Francis Score
(IBS-Score) (11). The majority of patients took 3x2 tablets daily. All major
symptoms and complaints like abdominal pain, altered frequency of stool,
flatulence, hyperperistalsis, tenderness on pressure, tympanitic resonance,
decreased during treatment. The global assessment of efficacy after 12
weeks treatment with Eucarbon®
by physician and patient was consistent
(Figure 6): the physicians rated the efficacy of the treatment at 93.5 % as
“very good” and “good”, the patients at 93.4%.
The medication was very well tolerated and efficacy and safety of the
natural drug Eucarbon®
in the indication constipation could be confirmed.

Figure 6:
Global assessment of efficacy after 12 weeks treatment with Eucarbon®
by physician and patient (14).
A post marketing surveillance study was performed in 3 different countries
– Hungary, Morocco and Albania – to evaluate the efficacy and tolerability
of Eucarbon®
tablets in treatment of patients suffering from IBS (12).
Patients of each country were statistically evaluated separately as a
subgroup. In a second step the data of all patients of all subgroups were
pooled and calculated as total collective. A total of 399 Hungarian, 349
Moroccan and 54 Albanian patients (mean age 42 years, mean body weight
76 kg, 68.2% women) were included and interviewed by a physician using
a structured interview. The dosage varied during the observation period.
After a first baseline examination two follow-up visits after 6 and 12 weeks
followed.
More than 95% of the patients had IBS as diagnosis and many of them for
months. In IBS patients 60% were constipated, 12% had diarrhoea, 20%
suffered frequently from alternated constipation and diarrhoea. The average
dosage was 3.7 Eucarbon®
tablets per day. Severity of illness significantly
improved from 50% moderate or severe illness to less than 16% over 12
weeks of treatment with Eucarbon®
tablets. Symptoms, like constipation,
flatulence, abdominal distension and hard stool were in more than 50%
of patients moderate or severe at baseline examination. After 12 weeks
of treatment all these symptoms were reported only by less than 10%.
Efficacy was rated more than 75%, tolerability in more than 85% of all
cases as very good or good as well as by physicians as patients. In 21 of
802 patients mild side effects were observed.
15
Global Assessment of Efficacy
after 12 Weeks Treatment with Eucarbon®
70
60
50
40
30
20
10
0
[%]
very good good moderate ineffective
Physician
Patient

16
Eucarbon®
herbal tablets are modified by taking out sulfur. The remaining
composition is unchanged and thus may give strong evidence for the same
efficacy and safety profile as the original Eucarbon®
tablets.
This could be shown in a double blind, controlled, randomised, multi-
centre, prospective clinical trial in comparison to carbo ligni (C.l.) containing
tablets (13). 284 patients between 19-70 years suffering from IBS started
treatment (Eucarbon®
herbal group 145, C.l. group 139). After the 12-weeks
treatment period 262 patients were available for ITT analysis, whereby
changes of the disease and improvement in overall well-being have been
evaluated with a visual analogue scale (VAS) as the primary endpoint.
Symptoms decreased in the ITT population under Eucarbon®
herbal
treatment in the global assessment by about 60%, but surprisingly the
relative gain in terms of efficacy over the control group was only about 9%
(Fig. 7). On the other hand a number of clinical observations and subgroup
analyses showed that “Eucarbon” has been much more effective, e.g.
in the subgroup of patients suffering from constipation. Both treatments
were well tolerated, adverse events occurred with similar frequency in both
groups (22% of patients treated with Eucarbon®
herbal vs. 17% treated
with C.l.). In most cases it was not possible to distinguish the event from
symptoms of IBS.
The results of this trial are regarded as supportive data, as the test
preparation Eucarbon®
herbal had a modified composition compared
to the original commercially available Eucarbon®
containing no sulfur.
Nevertheless regarding drug safety the data from this trial support the
traditionally well-known good tolerance of Eucarbon®
tablets.

17
Figure 7: Improvement in overall well-being evaluated with a visual analogue scale (VAS) as the primary
endpoint. Symptoms decreased in the ITT population under “Eucarbon herbal” treatment by about 60%
(13). Visit 1: Pre-treatment; V-2: Start of treatment; V-3: after 4 weeks; V-4: after 8 weeks: V-5: after 12
weeks treatment
In a Phase IV, 3 arms interventional study the tolerability and efficacy of
Eucarbon® in abdominal ultrasound examinations in 450 Egyptian patients
was to assessed by OKASHA (28). The study was performed at the Faculty
of Medicine, Cairo University Hospital, as a single blinded (with respect to
the evaluator of the quality of the ultrasound graphs), randomized study
in parallel groups. The patients were allocated to two groups, group I
receiving Eucarbon® the day before the ultrasound examination and group
II fasting overnight only. Group I was again divided in patients receiving
6 tablets Eucarbon® (Ia) and 10 tablets (Ib), respectively. In addition,
BMI (body mass index) was recorded as a measure of obesity. Study
groups were compared in terms of quality of ultrasound investigation and
abdominal conditions (presence of gases, stools, flatulence and diarrhoea).
Tolerability of the medication was also recorded. Results: 148 patients were
included in group Ia, 150 in group Ib and 152 in group II. All patients were
eligible for analysis of the results. 270 patients had a BMI ≤ 30 and180
showed a BMI > 30. 42% of patients were male and 58% female. Average
age was 52,1 years. Eucarbon® proved to be effective in increasing the
Primary endpoint
Means of overall well-being VAS over visits (ITT population, n=262)
60
50
40
30
20
10
0
VASScore
0 1 2 3 4 5 6
Visit
B: Carbo ligniA: Eucarbon

18
quality of ultrasound examinations especially regarding the target organs
liver, pancreas, intestine, urinary tract and spine. No difference between
groups Ia and Ib was detected suggesting that the lower dose might
be sufficient. Eucarbon® was also effective in reducing the amount of
gases and stools and flatulence. BMI > 30 in itself decreases the quality
of abdominal ultrasound examinations regarding all organs studied.
Eucarbon® was still able to improve the quality of ultrasound investigations
even in patients with a BMI >30 especially regarding pancreas, kidney,
intestine, urinary tract and spine. The tolerability was rated as good and
very good by 97% of patients receiving Eucarbon®. No adverse event was
reported. Conclusion: Eucarbon® is an effective preparatory medication
improving the quality of abdominal ultrasound examination in non-obese
and also in obese (BMI >30) patients while showing a favorable safety
profile.
6. Safety
The overall tolerability and safety of Eucarbon®
is worldwide known
and traditionally documented. Using Eucarbon®
as a drug of choice in
constipation has never been associated with life-threatening adverse
reactions. In the usual dosage regime, i.e. at the recommended doses,
Eucarbon®
does not even show preparation-related side effects, neither in
the daily practice nor in the studies mentioned (15).
There are neither findings on drug interactions so far nor any restrictions on
the ability to drive or to operate machinery.
No side effects are to be expected, if the doses are properly adhered to.
The MCA report “Safety of Herbal Medicinal Products” published in
July 2002 (20) mentioned for rhubarb and senna as potential adverse
events only “purgative, irritant to GI tract” – thus known effects - but
recommended to avoid non-standardised preparations during pregnancy.
Thus the excellent safety of the drugs could be confirmed.
Long-time experience and clinical studies have demonstrated that patients
taking Eucarbon®
for one or two weeks get relief of abdominal swelling and
of dyspeptical troubles.
In case of suspected stomach or intestinal ulcers, appendicitis or intestinal
obstruction, any kind of laxative should be avoided; patient is to consult a
doctor immediately.
In general, some undesirable effects have been reported under the intake
of anthrachinone-laxatives:
Rarely abdominal pain and diarrhoea occur, uncommon are slight red
chromaturia on its alcalic reaction. Rare are nausea and vomiting with
anthrachinone-laxatives on central condition.
Long-time administration in high doses of laxatives may induce electrolyte
losses, especially potassium losses, which can aggravate constipation
(intestinal atony and constipation).

19
7. Summary
Eucarbon®
is a combination of anthranoid drugs (senna and rhubarb), sulfur,
and the mild adsorbent vegetable charcoal (carbo ligni) - ingredients which
as single drugs/substances or in different combinations have been used
as remedies for centuries in patients with intestinal complaints, mainly with
constipation. In the unique combination of this preparation the proven and
generally accepted effects of the single ingredients have additional beneficial
effects – presented in a standardized dosage form.
Eucarbon®
herbal has the identical composition – but without sulfur.
They are medicinal products with mainly laxative effects. The action of the
preparations is due to the content of vegetable charcoal and the stimulatory
action of anthraquinones [and sulfur with Eucarbon®
]. The use of vegetable
charcoal, rather than activated charcoal, avoids the significant drug binding
of anthranoids as well as potential interactions. The adsorption properties
of carbo ligni are regarded for the effect to cure complaints due to intestinal
gases and to support the anti-putrefactive action of sulfur. This adsorbent
activity of carbo ligni, although definitely lower compared to activated
charcoal, has been extensively studied during the last 20 years. It could be
demonstrated that carbo ligni adsorbs many chemical entities, but does
not inhibit the release and efficacy of the anthrachinone glycosides from
Eucarbon®
/ Eucarbon®
herbal. The detoxifying effect has also been studied
and shown in in-vivo studies by various study groups (34).
At low dosage of 1 to 3 tablets per day, Eucarbon®
exhibits its adsorption
power, at higher dosages of 4 to 6 tablets per day Eucarbon®
acts as a mild
laxative.
The efficacy and safety of Eucarbon®
have been established and highly
acknowledged for more than 100 years. There are no preparation-specific
contra-indications known for Eucarbon®
. Long-time experience and clinical
studies have demonstrated that patients taking Eucarbon®
for one or two
weeks get relief of abdominal swelling and of dyspeptical troubles. The
action of Eucarbon®
is gradual, mild and prolonged. This determines its
value. Eucarbon®
is a well-tolerated product. Nevertheless patients have to
take care – as for every drug treatment - and must not abuse it.
In case of constipation the herbal laxative ingredients in Eucarbon®
/
Eucarbon®
herbal have the effect, within six to eight hours, of softening the
faeces, thereby facilitating defecation.
In the event of slight diarrhoea, the mild adsorbent carbo vegetabilis is
capable of binding toxic substances in the intestine. Mild laxatives are
capable of eliminating toxins, which may cause diarrhoea.
Eucarbon®
possesses unique properties and is a valuable tool in the therapy
of general digestive disorders with special regard to the indications (chronic)
constipation, irritable bowel syndrome and in the preparation for improvement of
X-ray and/or ultrasonic abdominal investigations. Because of its good tolerance
and lack of drug-drug interactions Eucarbon®
and Eucarbon®
herbal tablets
seem to be especially appropriate for the elderly and for long-term treatment.

20
8. References
1. BEUBLER, E., KOLLAR, G.: Prostaglandin-mediated action of sennosides.
Pharmacology 36 (1): 85-91 (1988)
2. BREIER, H.: An Open Study in general practice of 102 patients: Klinische
Untersuchungsergebnisse nach Verabreichung von Eucarbon. Biomed 5/81: 1-4 (1981)
3. CHASSANY, O., MARQUIS, P., SCHERRER, B. et al.: Validation of a specific quality of
life questionnaire for functional digestive disorders. Gut 44: 527-533 (1999)
4. DUMITRASCU, D.L., SIMON, B., DUMITRASCU, D.I.: A combination of Charcoal and
Senna Improves the Accuracy of Abdominal Ultrasonographic Investigation. Modern
Medicine 11/2003 (2003)
5. El MRINI, M., ABOU TAIEB, R., BENJELLOUN, S.: Evaluation of the clinical efficacy of
EUCARBON in the preparation of the intestine for urography and for enterocystoplastic
surgery. Central Hospital, Casablanca, Morocco
Data on file (F. Trenka) (1994)
6. EMEA - HMPC Assessment Report on Cassia Senna, April 2007 (2007)
7. EMEA - HMPC Assessment Report on Rhei Radix, June 2008 (2008)
8. FALLON, M., O’NEILL, B.: ABC of palliative care: Constipation and diarrhoea. BMJ
315: 1293-1296 (1997)
9. FARR, C., MAHY, P.: Expert Report on the Toxicological and Pharmacological
Documentation of Eucarbon. Data on file (F. Trenka) (1999)
10. FERUGLIO, F.S.: Treatment of hospital in-patients with EUCARBON®. An open
evaluation. A report on 31 hospital in-patients from the Clinica Medica Generale,
University of Trieste. Data on file (1981)
11. FRANCIS, C.Y., MORRIS, J., WHORWELL, P.J.: The irritable bowel severity scoring
system: a simple method of monitoring irritable bowel syndrome and its progress.
Aliment Pharmacol Ther 11: 395-402 (1997)
12. HEINZ, R.: Evaluation of the Post Marketing Surveillance of Eucarbon®
in 3 countries.
Scientific report, Data on file (F. Trenka) (2009)
13. HÜBNER, W.D., MOSER, E.H.: Charcoal Tablets in the Treatment of Patients With
Irritable Bowel Syndrome. Advances in Therapy 19(5): 245-252 (2002)
14. HÜBNER, W.D., ALKEN, R.G.: Treatment of Patients Suffering from Constipation with
Eucarbon®
. Modern Medicine 21: 36-40 (2004)
15. HÜBNER, W.D.: Clinical Expert Report on Eucarbon®
Tablets 2011. Data on file (F.
Trenka) (2011)
16. IRNIUS, A.: Herbal Intestinal Regulator for radiological examinations by contrast
media, Press release Fa. Trenka I; Z f Phytother 2: 58 (2002)
17. IRNIUS, A.: Herbal intestinal regulator for the treatment of IBS, the Irritable Bowel
Syndrome, Summary 14-08-2002; Press release Fa. Trenka II (2002)
18. KREJS, G.J.: Efficacy of Eucarbon in Patients suffering from IBS, Data on file (2002)
19. MACHAVARIANI, A., Maisaia, B.K., Kekelidze, N., Shashiashvili, T., Mamulashvili, M.:
Use of „Eucarbon“ for the treatment of patients suffering from irritable bowel syndrome
and from constipation. Modern Medicine 20: 53-59 (2003)
20. MEDICINES CONTROL AGENCY (MCA) London: Report on Safety of Herbal Medicinal
Products, July 2002 (2002)

21. MONOGRAPH Rhei radix, German Kommission E, BAnz Nr. 133: 21-07-1993 (1993)
22. MONOGRAPH Sennae folium, German Kommission E, BAnz Nr. 133: 21-07-1993
(1993)
23. MUTSCHLER, E.: Laxantien Arzneimittelwirkungen – Lehrbuch der Pharmakologie
und Toxikologie, 7. Auflage, Stuttgart: 483-489 (1991)
24. NARZHANOV, B.A., SAMRATOV, T.U.: Eucarbon®
administration in patients with
pathology of hepatoduodenal area. Scientific report, Data on file (F. Trenka) (2005)
25. NATIONAL INSTITUTE OF MENTAL HEALTH:12-CGI. Clinical Global Impressions. In
GUY, W. and BONATO, R.R. (Eds.): Manual for the ECDEU Assessment Battery. 2.
Rev. Ed. Chevy Chase, Maryland 12-1 – 12-6 (1970)
26. N’DRI YOMAN: The use of EUCARBON in preparing radiology (unprepared
abdominal X-ray, echography). Assessments on 15 patients from Prof. Yoman,
University Hospital Centre of Yopougon/Ivory Coast. Data on file (F. Trenka) (1993)
27. NICOLOVA, P., JOTOVA, N., PESHEV, P., BOEVA, N., STOIKOVA, E.: Preparation
with Eucarbon®
for ultrasonic diagnosis and X-ray investigations of abdominal
organs. Modern Medicine 2005; 22: 26 – 27 (2005)
28. OKASHA, H.: A Phase IV, 3 Arms Interventional Study to Assess the Tolerability of
Eucarbon in Abdominal Ultrasound Examination in Egyptian Patients. Alexandria
Journal, 2012 Vol. IIX (III.) 33-38 (2012)
29. PEPEU, G.: Experimental Report on the Pharmacological Actions of Eucarbon®
.
University of Florence. Data on file (F. Trenka) (1981)
30. PEZZOLI, A.: Treatment of hospital in-patients with EUCARBON. An open
evaluation. A report on 31 hospital in-patients from the Clinica Medica Generale,
University of Trieste. Data on file (F. Trenka) (1981)
31. REYNOLDS, J.E.F.: Charcoal
Martindale – The Extra Pharmacopoeia, 31st Edition, London: Royal Pharmaceutical
Society: 973-974 (1996)
32. REYNOLDS, J.E.F., PRASAD, A.B.: Sulphur
Martindale: The Extra Pharmacopoeia, 30th Edition, The Pharmaceutical Press,
London: 504-506 (1993)
33. SCHMIDBAUER, C.P., SCHUSTER, F.X.: Darmreinigung vor Uroradiologie und
Urosonographie. Eine klinische Prüfung mit Eucarbon. Data on file (F. Trenka) (1985)
34. STRUHSAKER, T.T., COONEY, D.O., SIEX, K.S.: Charcoal Consumption by
Zanzibar Red Colobus Monkeys: Its Function and Its Ecological and Demographic
Consequences. International Journal of Primatology 18 (1): 61-72 (1997)
37. THOMPSON, W.G., GICK, M.: Irritable bowel syndrome. Semin Gastrointest Dis.
7(4):217-229 (1996)
38. WALD, A.: Approach to the Patient With Constipation. Textbook of
Gastroenterology, 2nd Edition, edited by Tadataka Yamada, JB Lippinott Company,
Philadelphia: 864-880 (1995)
39. YOMAN, N: The use of EUCARBON in preparing radiology (unprepared abdominal
x-ray, echography). Assessments on 15 patients from Prof. Yoman, University
Hospital Centre of Yopougon/Ivory Coast. Data on file (F. Trenka) (1993)

F. TRENKA Chemisch-pharmazeutische Fabrik GmbH
A-1040 Vienna, Goldeggasse 5
Austria
Telephone: 0043 1 505 03 41-0
Telefax: 0043 1 505 03 41-31
E-mail: office@eucarbon.at
www.eucarbon.at
July 2014

Eucarbon Herbal Tablets

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