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Senokot Tablets


Each tablet contains powdered Alexandrian Senna fruit (pods) (Cassia senna
L. (C. acutifolia Delile)) and Tinnevelly Senna fruit (pods) (Cassia
angustifolia Vahl) equivalent to 7.5mg hydroxyanthracene glycosides,
calculated as sennoside B.
Each tablet also contains 15.82 mg lactose monohydrate
For full list of excipients, see section 6.1






Therapeutic indications
For the relief of short-term, occasional constipation


Posology and method of administration
For oral administration.
The correct individual dose is the smallest required to produce a comfortable
soft-formed motion.
500 or 1000 Tablets (Dispensing) Pack
For the relief of short term occasional constipation

Adults, the elderly and children over 12 years: Swallow one to two tablets at
A higher dose may be prescribed under medical guidance. The maximum daily
dose of hydroxyanthracene glycosides is 30 mg.
Children over 6 years: One to two tablets at night under the guidance of a
medical professional
Children 6 years and under: Not recommended

All Other Packs
For the relief of short term occasional constipation
Adults, the elderly and children over 12 years: Swallow one to two tablets at
Children over 6 years: Not recommended unless advised by a medical
Children 6 years and under: Not recommended
New users should start with the lowest dose and increase it to the maximum
dose if necessary. Once regularity has been regained dosage should be reduced
and can usually be stopped.
If no bowel action has occurred after three days of progressively increased
dosage, a medical examination should be considered.
Duration of use
Normally it is sufficient to take this medicinal product up to two to three times
a week.
Use for more than 1-2 weeks requires medical supervision.
If the symptoms persist or worsen during the use of the medicinal product, a
doctor should be consulted.

Hypersensitivity to the active substance or to any of the excipients.
Not to be used at the same time as other laxative agents.
Cases of intestinal obstructions and stenosis, atony, appendicitis, inflammatory
bowel diseases (e.g Crohn’s disease, ulcerative colitis), abdominal pain of
unknown origin, severe dehydration state with water and electrolyte depletion


Special warnings and precautions for use
If there is no bowel movement after three days, a doctor should be consulted.
If laxatives are needed every day, or abdominal pain persists, a doctor should
be consulted.
If laxatives are needed every day the cause of the constipation should be
investigated. Long-term use of laxatives should be avoided.
The product contains lactose monohydrate. One tablet contains 15.82mg
lactose monohydrate. Patients with rare hereditary problems of galactose
intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
should not take this medicine.
Do not exceed the stated dose.
Patients taking cardiac glycosides, antiarrhythmic medicinal products,
medicinal products inducing QT-prolongation, diuretics, adrenocorticosteroids
or liquorice root, have to consult a doctor before taking this product

Like all laxatives, this product should not be taken by patients suffering from
faecal impaction and undiagnosed, acute or persistent gastro-intestinal
complaints, e.g. abdominal pain, nausea and vomiting, unless advised by a
doctor, because these symptoms can be signs of potential or existing intestinal
blockage (ileus).
If stimulant laxatives are taken for longer than a brief period of treatment, this
may lead to impaired function of the intestine and dependence on laxatives.
This product should only be used if a therapeutic effect cannot be achieved by
a change of diet or the administration of bulk forming agents.
Prolonged use may precipitate the onset of an atonic, non-functioning colon.
Prolonged and excessive use may lead to fluid and electrolyte imbalance and
Intestinal loss of fluids may promote dehydration. Symptoms may include
thirst and oliguria.
Patients with kidney disorders should be aware of possible electrolyte
When administering this product to incontinent adults, pads should be changed
more frequently to prevent extended skin contact with faeces.
The use in children under 12 years of age is not recommended unless under the
guidance of a medical practitioner because data are not sufficient and medical advice
should be sought.

Laxatives do not help in long-term weight loss.

Interaction with other medicinal products and other forms of interaction
Hypokalaemia (resulting from long-term laxative abuse) potentiates the action of
cardiac glycosides and interacts with antiarrhythmic medicinal products, with
medicinal products, which induce reversion to sinus rhythm (e.g. quinidine) and with
medicinal products inducing QT-prolongation. Concomitant use with other medicinal
products inducing hypokalaemia (e.g. diuretics, adrenocorticosteroids and liquorice
root) may enhance electrolyte imbalance.


Fertility, pregnancy and lactation
There are no reports of undesirable or damaging effects during pregnancy and
on the foetus when used at the recommended dosage schedule.
However, as a consequence of experimental data concerning a genotoxic risk
of several anthranoids, e.g emodin and aloe-emodin, use is not recommended
during pregnancy.
Use during breastfeeding is not recommended as there are insufficient data on
the excretion of metabolites in breast milk.
Small amounts of active metabolites (rhein) are excreted in breast milk. A
laxative effect in breast fed babies has not been reported.

There are no data on the effects of the product on fertility.

Effects on ability to drive and use machines
None known


Undesirable effects
Adverse events which have been associated with senna at OTC doses in short-term
use are given below, tabulated by system organ class and frequency.
In the treatment of chronic condition, under long-term treatment, additional adverse
effects may occur.
Adverse events table
System Organ Class
Immune System
Metabolism and Nutrition

Not known

Adverse Events
Hypersensitivity, urticaria, asthma,

Not known

Hypokalaemia1, cachexia

Gastrointestinal Disorders

Not known

Abdominal pain, abdominal spasm,
diarrhoea2, gastrointestinal tract
mucosal pigmentation3

Skin and Subcutaneous
Tissue Disorders

Not known

Pruritus, local or generalised

Musculoskeletal and
Connective Tissue

Not known

Finger clubbing, tetany and
hypertrophic osteoarthropathy

Renal and Urinary
Not known
Description of Selected Adverse Reactions
Prolonged use of laxatives resulting in diarrhoea and subsequently hypokalaemia.
in particular in patients with irritable colon. Symptoms may also occur generally as
a consequence of individual overdosage. In such cases dose reduction is necessary.
Chronic use may cause pigmentation of the intestinal mucosa (pseudomelanosis
coli), which usually recedes when the patient stops taking the preparation.
Yellow or red-brown (pH dependent) discolouration of urine by metabolites, which
is not clinically significant, may occur during the treatment.
Chronic use may lead to disorders in water equilibrium and electrolyte metabolism
and may result in albuminuria and haematuria.’
The frequency is not known (cannot be estimated from the available data).
If other adverse reactions not mentioned above occur, a doctor or a qualified
healthcare practitioner should be consulted.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk of the medicinal product.

Healthcare professionals are asked to report any suspected adverse reactions via the
Yellow card Scheme at


Where diarrhoea is severe, conservative measures are usually sufficient;
generous amounts of fluid, especially fruit drinks, should be given.
The major symptoms of overdose/abuse are griping pain and severe diarrhoea
with consequent losses of fluid and electrolytes, which should be replaced.
Diarrhoea may especially cause potassium depletion, which may lead to
cardiac disorders and muscular asthenia, particularly where cardiac glycosides,
diuretics, adrenocorticosteroids or liquorice root are being taken at the same
Treatment should be supportive with generous amounts of fluid. Electrolytes,
especially potassium, should be monitored. This is especially important in the
elderly. Chronic ingested overdoses of anthranoid containing medicinal
products may lead to toxic hepatitis.




Pharmacodynamic properties
Pharmaco-therapeutic group: contact laxatives
ATC-code: A 06 AB
The sugar moiety of the sennosides is removed by bacteria in the large
intestine releasing the active anthrone fraction. This stimulates peristalsis via
the submucosal and myenteric nerve plexuses.
1,8-dihydroxyanthracene derivatives possess a laxative effect. The β-Ο-linked
glycosides (sennosides) are not absorbed in the upper gut; they are converted
by bacteria of the large intestine into the active metabolite (rhein anthrone).
There are two different mechanisms of action:
1. stimulation of the motility of the large intestine resulting in accelerated
colonic transit.
2. influence on secretion processes by two concomitant mechanisms viz.
inhibition of absorption of water and electrolytes (Na+, Cl-) into the colonic
epithelial cells (antiabsorptive effect) and increase of the leakiness of the tight
junctions and stimulation of secretion of water and electrolytes into the lumen
of the colon (secretagogue effect) resulting in enhanced concentrations of fluid
and electrolytes in the lumen of the colon.

Defaecation takes place after a delay of 8 - 12 hours due to the time taken for
transport to the colon and metabolisation into the active compound.

Pharmacokinetic properties
The action of the sennosides is colon specific and does not depend upon
systemic absorption.
The β-Ο-linked glycosides (sennosides) are neither absorbed in the upper gut
nor split by human digestive enzymes. They are converted by the bacteria of
the large intestine into the active metabolite (rhein anthrone). Aglyca are
absorbed in the upper gut. Animal experiments with radio-labeled rhein
anthrone administered directly into the caecum demonstrated absorption <
10%. In contact with oxygen, rhein anthrone is oxidised into rhein and
sennidins, which can be found in the blood, mainly in the form of glucuronides
and sulphates. After oral administration of sennosides, 3 - 6% of the
metabolites are excreted in urine; some are excreted in bile.
Most of the sennosides (ca. 90%) are excreted in faeces as polymers
(polyquinones) together with 2 - 6% of unchanged sennosides, sennidins, rhein
anthrone and rhein. In human pharmacokinetic studies with senna pods
powder (20 mg sennosides), administered orally for 7 days, a maximum
concentration of 100 ng rhein/ml was found in the blood. An accumulation of
rhein was not observed. Active metabolites, e.g. rhein, pass in small amounts
into breast milk. Animal experiments demonstrated that placental passage of
rhein is low.


Preclinical safety data
Most data refer to extracts of senna pods containing 1.4 to 3.5% of
anthranoids, corresponding to 0.9 to 2.3% of potential rhein, 0.05 to 0.15% of
potential aloe-emodin and 0.001 to 0.006% of potential emodin or isolated
active constituents, e.g. rhein or sennosides A and B. The acute toxicity of
senna pods, specified extracts thereof, as well as of sennosides in rats and mice
was low after oral treatment.
As a result of investigations with parenteral application in mice, extracts are
supposed to possess a higher toxicity than purified glycosides, possibly due to
the content of aglyca.
In a 90-day rat study, senna pods were administered at dose levels from 100
mg/kg up to 1,500 mg/kg. The tested drug contained 1.83 % sennosides A-D,
1.6 % potential rhein, 0.11 % potential aloe-emodin and 0.014 % potential
emodin. In all groups epithelial hyperplasia of the large intestine of minor
degree was found and was reversible within the 8-week recovery period. The
hyperplastic lesions of the forestomach epithelium were reversible as well.
Dose-dependent tubular basophilia and epithelial hypertrophy of the kidneys
were seen at a dose of, or greater than 300 mg/kg per day without functional
affection. These changes were also reversible. Storage of a brown tubular
pigment led to a dark discoloration of the renal surface and still remained to a
lesser degree after the recovery period. No alterations were seen in the colonic

nervous plexus. A no-observable-effect-level (NOEL) could not be obtained in
this study.
A 104-week study on rats of both genders did not reveal any carcinogenic
effects with the same senna pods preparation at oral dosages of up to 300
In addition a specified senna extract given orally for 2 years was not
carcinogenic in male or female rats. The extract investigated contained
approximately 40.8% of anthranoids from which 35% were sennosides,
corresponding to about 25.2% of potential rhein, 2.3% of potential aloeemodin and 0.007% of potential emodin and 142 ppm free aloe-emodin and 9
ppm free emodin.
Further 2-year studies on male and female rats and mice with emodin gave no
evidence of carcinogenic activity for male rats and female mice, and equivocal
evidence for female rats and male mice.
Sennosides displayed no specific toxicity when tested at doses up to 500
mg/kg in dogs for 4 weeks and up to 100 mg/kg in rats for 6 months.
There was no evidence of any embryolethal, teratogenic or foetotoxic actions
in rats or rabbits after oral treatment with sennosides. Furthermore, there was
no effect on the postnatal development of young rats, on rearing behaviour of
dams or on male and female fertility in rats. Data for herbal preparations are
not available.
An extract and aloe-emodin were mutagenic in in vitro tests, sennoside A, B
and rhein gave negative results. Comprehensive in vivo examinations of a
defined extract of senna pods were negative.
Chronic laxative use as a risk factor in colorectal cancer (CRC) was
investigated in some clinical trials. Some studies revealed a risk for CRC
associated with the use of anthraquinone-containing laxatives, some studies
did not. However, a risk was also revealed for constipation itself and
underlying dietary habits. Further investigations are needed to assess the
carcinogenic risk definitely.




List of excipients
Calcium phosphate
Maize starch
Lactose monohydrate
Magnesium stearate


None known


Shelf life

Tablets in a polypropylene container: five years
Tablets packed in uPVC/PVdC/foil blisters: three years

Special precautions for storage
For tablets in a polypropylene container: store below 30oC
For tablets packed in uPVC/PVdC/foil blisters: store below 25oC
Store in the original package
Also for polypropylene container: replace cap firmly after use


Nature and contents of container
50, 100, 200, 500 or 1000 tablets in a polypropylene container with a snap-fit
6, 8, 10, 12, 20, 40, 60, 80 or 100 tablets packed in uPVC/PVdC/foil blisters,
contained in a carton.
Not all pack sizes may be marketed


Special precautions for disposal
Not applicable


Reckitt Benckiser Healthcare (UK) Limited
Dansom Lane


PL 00063/5000R


13/03/1987 / 15/07/2005



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Source: Medicines and Healthcare Products Regulatory Agency

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