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BOOTS MAX STRENGTH SENNA LAXATIVE 15 MG TABLETS

Active substance(s): ALEXANDRIAN SENNA FRUIT POWDERED / ALEXANDRIAN SENNA FRUIT POWDERED / ALEXANDRIAN SENNA FRUIT POWDERED

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Boots Max Strength Senna Laxative 15 mg Tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Alexandrian Senna fruit (Cassia senna L. (C. acutifolia
Delile) fruit) corresponding to 15 mg hydroxyanthracene glycosides,
calculated as sennoside B

3

PHARMACEUTICAL FORM
Tablet
A plain greenish-brown round tablet

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For short term relief of occasional constipation.

4.2

Posology and method of administration
For oral use only.
The maximum daily dose of hydroxyanthracene glycosides is 15 mg. This is
equivalent to 1 tablet.
The correct individual dose is the smallest required to produce a comfortable
soft-formed motion.
Adults, the elderly and children 12 years and over: 1 tablet
Children under 12 years: Not recommended
The tablets should be taken at bedtime and the dose should be decreased as the
bowel habit becomes regular.
Normally it is sufficient to take this product for up to two to three times a
week.
Duration of use
Use for more than 1 week requires medical supervision.
If there is no bowel movement after three days a doctor should be consulted.
If symptoms persist during the use of the medicinal product, a doctor or a
qualified healthcare practitioner should be consulted.

4.3

Contraindications
Hypersensitivity to any of the ingredients.

Cases of intestinal obstructions and stenosis, atony, appendicitis, inflammatory
colon diseases (e.g. Crohn’s disease, ulcerative colitis) 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
Do not exceed the stated dose
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.
Laxatives do not help in long-term weight loss.
Patients taking cardiac glycosides, antiarrhythmic medicinal products,
medicinal products inducing QT-prolongation, diuretics, adrenocorticosteroids
or liquorice root, have to consult a doctor before taking senna pods
concomitantly.
Like all laxatives, senna pods 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 laxatives are needed every day the cause of the constipation should be
investigated. Long-term use of laxatives should be avoided.
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.
Senna pod preparations should only be used if a therapeutic effect cannot be
achieved by a change of diet or the administration of bulk forming agents.
When administering this product to incontinent adults, pads should be changed
more frequently to prevent extended skin contact with faeces.
Patients with kidney disorders should be aware of possible electrolyte
imbalance.
If the symptoms persist during the use of the medicinal product, a doctor or a
pharmacist should be consulted.

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,
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 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.
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.
4.7

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

4.8

Undesirable effects
Hypersensitivity reactions (pruritis, urticaria, local or generalized exanthema)
may occur.
This product may produce abdominal pain and spasm and passage of liquid
stools, in particular in patients with irritable colon. However, these symptoms
may also occur generally as a consequence of individual overdose. In such
cases dose reduction is necessary.
Chronic use may lead to disorders in water equilibrium and electrolyte
metabolism and may result in albuminuria and haematuria. Furthermore,
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. The
frequency is not known.
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 balance
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
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 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
1,8-dihydroxyanthracene derivatives possess a laxative effect. The β-O-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 β-O-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 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 of 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 noobservable-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 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.
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

Magnesium stearate
Maize starch
6.2

Incompatibilities
None known.

6.3

Shelf life
24 months

6.4

Special precautions for storage
Do not store above 25°C. Store in original package.

6.5

Nature and contents of container
250 PVC/40PVdC Clear and 20 microns hard temper aluminium foil with heat seal
lacquer

Pack sizes: 12, 24, 36, 48
Not all pack sizes may be marketed.
6.6

Special precautions for disposal
Not applicable.

7

MARKETING AUTHORISATION HOLDER
The Boots Company PLC
D90 Support Office
Thane Road
NG90 1BS

8

MARKETING AUTHORISATION NUMBER(S)
PL 00014/0863

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
23/11/2015

10

DATE OF REVISION OF THE TEXT
23/11/2015

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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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