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SENOKOT MAX STRENGTH

Active substance(s): SENNA PODS POWDERED / SENNA PODS POWDERED / SENNA PODS POWDERED

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Senokot Max Strength.

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains powdered Alexandrian Senna fruit (pods) (Cassia senna
L. (C. acutifolia Delile)) and Tinnevelly Senna fruit (pods) (Cassia
angustifolia Vahl) equivalent to 15mg hydroxyanthracene glycosides,
calculated as sennoside B.
Each tablet also contains 15.82 mg lactose monohydrate.
For full list of excipients see Section 6.1.

3

PHARMACEUTICAL FORM
Tablets.

4

CLINICAL PARTICULARS

4.1

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

4.2

Posology and method of administration
For oral use only.
Dosage
Adults, the elderly and children over 12 years: 1 tablet taken at night.
Children 12 years and under: Not recommended
Duration of use
Usually 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 or a pharmacist should be consulted.

4.3

Contraindications
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
colon diseases (e.g Crohn’s disease, ulcerative colits), abdominal pain of
unknown origin, severe dehydration state with water and electrolyte depletion.
Children under 12 years of age.

4.4

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 concomitantly.
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
hypokalaemia.
Intestinal loss of fluids may promote dehydration. Symptoms may include thirst and
oliguria.
Patients with kidney disorders should be aware of possible electrolyte imbalance.
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 because data are not
sufficient and medical advice should be sought.

Laxatives do not help in long-term weight loss.

4.5

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

4.6

Fertility, pregnancy and lactation
Pregnancy
There are no reports of undesirable or damaging effects during pregnancy and on the
foetus when used at the recommended dosage.
However, as a consequence of experimental data concerning a genotoxic risk of
several anthranoids, e.g emodin and aloe-emodin, use is not recommended in
pregnancy.
Lactation
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.
Fertility
There are no data on the effects of the product on fertility.

4.7

Effects on ability to drive and use machines
No studies on the effect on the ability to drive and use machines have been performed

4.8

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
Disorders
Metabolism and Nutrition
Disorders

Frequency

Not known

Hypokalaemia1, cachexia

Gastrointestinal Disorders

Not known

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

Not known

Adverse Events
Hypersensitivity, urticaria, asthma,
hypogammaglobulinaemia

Skin and Subcutaneous
Tissue Disorders

Not known

Pruritus, local or generalised
exanthema

Musculoskeletal and
Connective Tissue
Disorders

Not known

Finger clubbing, tetany and
hypertrophic osteoarthropathy

Renal and Urinary
Not known
Chromaturia4
Disorders
Description of Selected Adverse Reactions
1
Prolonged use of laxatives resulting in diarrhoea and subsequently hypokalaemia.
2
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.
3
Chronic use may cause 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.
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 www.mhra.gov.uk/yellowcard.

4.9

Overdose
Symptoms
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
time.
Treatment
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.

5

PHARMACOLOGICAL PROPERTIES

5.1

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.

5.2

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.

5.3

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 aloeemodin 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 mg/kg.
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 aloe-emodin 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.
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.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Calcium phosphate
Maize starch
Lactose monohydrate
Magnesium stearate

6.2.

Incompatibilities
None known.

6.3.

Shelf life
Two years.

6.4.

Special precautions for storage
Do not store above 30°C. Store in the original package.

6.5

Nature and contents of container
12, 24 or 48 tablets packed in UPVC/PVDC/Foil blisters, contained in a
carton. Not all pack sizes may be marketed.

6.6.

Instruction for use and handling
Not applicable

7.

MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Limited
Dansom Lane
Hull
HU8 7DS
United Kingdom

8.

MARKETING AUTHORISATION NUMBER
PL 00063/0118

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
19/06/2007

10

DATE OF REVISION OF THE TEXT
28/08/2015

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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