Senokot 7.5mg tablets 12 Years Plus

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

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Active ingredient:
Sennosides
Available from:
Reckitt Benckiser Healthcare (UK) Ltd
ATC code:
A06AB06
INN (International Name):
Sennosides
Dosage:
7.5mg
Pharmaceutical form:
Tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 01060200; GTIN: 5011417579008
Authorization number:
PL 00063/0768

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Senokot

Stimulant Laxative

Senna

Regular Tablet

100Tablets

RB439753

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RBH Contact:

Alexander Titmus

Connaught House, Connaught Road,

Kingswood Business Park, Hull, HU7 3AP, England.

T: +44 (0) 1482 828100

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Senokot 7.5mg Tablets 12 Years Plus

Senna Fruit (pods)

Read this leaflet carefully because it contains important information for you.

Keep this leaflet. You may need to read it again.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.

Ask your pharmacist if you need more information or advice.

If any of the side effects get serious or if you notice any side effect not listed in this leaflet, please tell

your doctor or pharmacist.

In this leaflet:

1. What Senokot 7.5mg Tablets 12 Years Plus is and what it is used for

2. What you need to know before you take Senokot 7.5mg Tablets 12 Years Plus

3. How to take Senokot 7.5mg Tablets 12 Years Plus

4. Possible side effects

5. How to store Senokot 7.5mg Tablets 12 Years Plus

6. Further information

1. What Senokot 7.5mg Tablets 12 Years Plus is and what it is used for

Senokot 7.5mg Tablets 12 Years Plus contains Senna/Sennosides which work as a stimulant laxative for the

short-term relief of occasional constipation. Senokot 7.5mg Tablets 12 Years Plus contains calcium sennosides.

Constipation is a fairly common and uncomfortable complaint. It usually involves difficult or irregular

bowel movements, accompanied by hard, dry motions which can be painful to pass. Laxatives do not

help with weight loss.

What is constipation?

Normal and regular bowel movement is important for most people. However, what is“normal and regular”

varies from person to person. Some may have a bowel movement every day, others less often. Whatever it is

like for you, it is best that your bowel movement has a regular pattern. Constipation is an occasional problem

for some people. For others, it may happen more often It happens when the normal muscle actions in the

bowel (large intestine) slow down. This can mean that material is not easily eliminated from the body.

The cause of constipation is often not known. It can be associated with:

Sudden change of diet

A diet with not enough fibre

Not drinking enough fluids

Loss of ‘tone’ of the bowel muscles in older people

Pregnancy

Medicines such as morphine or codeine

Having to stay in bed for a long time

Lack of exercise

Whatever the cause, constipation can be uncomfortable. It may

make you feel bloated and heavy or generally “off colour”.

Sometimes it causes headaches. It is recommended to use changes in diet and bulk forming medicines to

control constipation before using this medicine.

These healthy tips are recommended to try to prevent constipation happening:

Eat a balanced diet including fresh fruit and vegetables

Drink enough water so that you do not become dehydrated

Keep up your exercise and stay fit

Make time to empty your bowels when your body tells you

2. What you need to know before you take Senokot 7.5mg Tablets 12 Years Plus

Do not take if you:

are allergic to any of the ingredients (for a full list of ingredients, see section 6)

have blockage or narrowing of the gastro-intestinal tract or bowel (ileus, intestinal obstruction or

stenosis).

have paralysis or a lack of muscle tone in the bowel (atony).

have appendicitis, inflammatory bowel disease such as Crohn's disease or ulcerative colitis.

have severe dehydration.

have persistent or undiagnosed abdominal complaints e.g pain, nausea, or vomiting.

have faecal impaction or rectal bleeding for which you don't know the cause, or blood in your stools.

have already taken a laxative and are still constipated.

have had a sudden change in bowel habit that has lasted for more than 2 weeks.

are pregnant or breast-feeding.

have kidney or heart failure.

are under 12 years of age.

Does this help with weight loss?

Stimulant laxatives (including Senokot 7.5mg Tablets 12 Years Plus) do not help with weight loss.

They do not reduce the absorption of calories or nutrients. They can cause watery stools (diarrhoea),

abdominal cramps and dehydration. Dehydration can seem like weight loss.Overuse of laxatives may

damage your health by:

Causing disturbances of electrolyte and mineral balances. Sodium, potassium, magnesium, and

phosphorus are electrolytes and minerals that are present in very specific amounts necessary for

proper functioning of the nerves and muscles, including those of the colon and heart. Upsetting this

delicate balance can cause incorrect functioning of these vital organs.

Severe dehydration may cause tremors, weakness, blurry vision, fainting, kidney damage, and,

in extreme cases, death. Dehydration often requires medical treatment.

Overuse of laxatives can cause the colon to stop reacting to usual doses of laxatives so that larger and

larger amounts of laxatives may be needed to produce bowel movements.

Laxative dependency occurs from overuse.

Tell your doctor, pharmacist or nurse if:

you suffer from kidney disorders.

you are taking medicines for a heart condition (e.g. cardiac glycosides, antiarrhythmic medicines

e.g quinidine) medicines inducing QT elongation, diuretics, adrenocorticosteroids or liquorice root

preparations.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If any of the

following or other side effects occur, stop taking this medicine and consult a doctor or pharmacist:

abdominal pain, spasms and diarrhoea, in particular these effects may be experienced by patients with

irritable colon. In these cases, a reduction in dose may be neccessary.

hypersensitivity (allergic) reactions, hives (skin bumps), skin itchiness or local or more widespread,

rash or asthma.

can make you more likely to catch infections.

chronic use may lead to albuminuria and haematuria which is albumin or red blood cells in the urine.

yellow or red-brown discoloration of urine may occur, which is harmless.

chronic use may cause pigmentation of the gastroinestinal tract which usually recedes when the product

is no longer taken.

low potassium levels in the blood leading to muscle weakness and/or cramps

severe weight loss

changes in the shape of the finger and fingernail, muscular spasms and inflammatation of bones and joints

The frequency is not known.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmasist or nurse. This includes any possible side effects not

listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or

search for MHRA Yellow Card in the Google Play or Apple App Store.

5. How to store Senokot 7.5mg Tablets 12 Years Plus

Keep this medicine out of the sight and reach of children.

Store below 25°C, but do not freeze.

Do not use after the expiry date shown on the pack (EXP month/year).

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Senokot 7.5mg Tablets 12 Years Plus contains

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.

Also contains: calcium phosphate, maize starch, magnesium stearate and lactose monohydrate.

What your tablets looks like and the contents of the pack

Senokot 7.5mg Tablets 12 Years Plus are available in pack size of 60 and 100 tablets

PL Holder and Manufacturer: Reckitt Benckiser Healthcare (UK) Limited, Hull, HU8 7DS

PL 00063/0768

Leaflet last revised July 2020

Senokot is a trademark.

you have been told you have an intolerance to some sugars because this medicine also contains

lactose monohydrate (15.82mg per tablet).

When administering this product to incontinent adults, pads should be changed more frequently to

prevent extended skin contact with faeces. It is recommended to use changes in diet and bulk forming

medicines to control constipation before using this medicine.

Taking other medicines

You should consult your doctor or pharmacist for advice if you are taking or have recently taken any

other medicines, including medicines obtained without a prescription.

3. How to take Senokot 7.5mg Tablets 12 Years Plus

New users should start with the lowest dose and increase it to the maximum if necessary.

Once regularity has been regained dosage should be reduced and stopped.

Adults, the elderly and children 12 years and over: swalllow one to two tablets at night

Do not exceed the stated dose

Duration of use

Normally it is su

icient to take this medicinal product up to two to three times a week.

Not to be used for more than one week.

Tell a doctor, pharmasist or nurse if:

the symptoms worsen, or persist during the use of medicinal product.

there is no bowel movement within 3 days of use.

you need to take laxatives every day if abdominal pain persists.

Do not take more than the leaflet tells you. Overuse can be harmful.

If you take too many tablets:

Consult your doctor take this leaflet with you.

It may be harmful to take too much of this medicine or take it for too long.

This is because it may lead to:

‘lazy bowel’ where the muscle in the bowel becomes too relaxed. This means that bowel emptying

happens less often. This can lead to long-term constipation.

imbalance of fluids and salts in the body. This can affect the tightness of muscle such as those in the

bowel. It can also affect the salts in the blood.

low levels of potassium in the blood (called hypo-kalaemia). This can make you tired, dizzy, make your

muscles weak and cause an uneven heart beat.

dehydration making you thirsty, feel faint and giving you headaches. It can also mean that you cannot

pass enough urine.

If you forget to take Senokot 7.5mg Tablets 12 Years Plus

If you miss a dose, take your next dose at the usual time. Do not take or give a double dose, just carry on

with the recommended dose.

If you have any further questions on the use of this product as your doctor or pharmacist.

0000000

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Reckitt Benckiser

0004 PL00063-0768 Addition of 100s

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eCTD - Senokot Tablets - Pharmacy

Page 1

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Page

Date

First Name

Last Name

Content

Approvals

Date

First Name

Last Name

Type

16-Sep-20 23:48:50

Alex

Titmus

Approved

Reckitt Benckiser

0004 PL00063-0768 Addition of 100s

1.3.1 Package Leaflet Clean

eCTD - Senokot Tablets - Pharmacy

Page 2

Read the complete document

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

Senokot 7.5 mg Tablets 12 Years Plus

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 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

3

PHARMACEUTICAL FORM

Tablets

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

For the short-term relief of occasional constipation

4.2

Posology and method of administration

For oral administration.

The correct individual dose is the smallest required to produce a comfortable

soft-formed motion.

Adults, the elderly and children over 12 years: Swallow one to two tablets at

night

Should not be used in children or adolescents under the age of 12 years (see

section 4.3).

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

Not to be used for more than 1 week. Usually it is sufficient to take this

medicinal product up to two to three times during that week.

If the symptoms persist during the use of the medicinal product, a doctor or a

pharmacist should be consulted.

See also section 4.4 Special warnings and precautions for use.

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

bowel 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

If the symptoms worsen during the use of the medicinal product or there is no

bowel movement after three days, a doctor or pharmacist 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.

product

contains

lactose

monohydrate.

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 senna leaf preparations

concomitantly.

Like all laxatives, Senokot should not be taken by patients suffering from

faecal

impaction

undiagnosed,

acute

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).

Long-term use of stimulant laxatives should be avoided, as use for more than a

brief period of treatment may lead to impaired function of the intestine and

dependence on laxatives. If laxatives are needed every day the cause of the

constipation should be investigated. 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 excessive use may lead to fluid and electrolyte imbalance and

hypokalaemia. Patients with kidney disorders should be aware of possible

electrolyte imbalance.

Intestinal loss of fluids may promote dehydration. Symptoms may include

thirst and oliguria. In patients suffering from fluid loss where dehydration may

be harmful (e.g. renal insufficiency, elderly patients) Senokot should be

discontinued and only be restarted under medical supervision.

When products containing senna leaf preparations are administered to

incontinent adults, pads should be changed more frequently to prevent

extended skin contact with faeces.

Stimulant laxatives (including Senokot) do not help with weight loss.

The leaflet will state:

“Before you take this medicine” section

Does this help with weight loss?

Stimulant laxatives (including Senokot) do not help with weight loss. They do

not reduce the absorption of calories or nutrients. They can cause watery stools

(diarrhoea), abdominal cramps and dehydration. Dehydration can seem like

weight loss.

Overuse of laxatives may damage your health by:

Causing disturbances of electrolyte and mineral balances. Sodium,

potassium, magnesium, and phosphorus are electrolytes and minerals

that are present in very specific amounts necessary for proper

functioning of the nerves and muscles, including those of the colon and

heart. Upsetting this delicate balance can cause incorrect functioning of

these vital organs.

Severe dehydration may cause tremors, weakness, blurry vision,

fainting, kidney damage, and, in extreme cases, death. Dehydration

often requires medical treatment.

Overuse of laxatives can cause the colon to stop reacting to usual doses

of laxatives so that larger and larger amounts of laxatives may be

needed to produce bowel movements.

Laxative dependency occurs from overuse.

The label will state:

Front of pack:

Does not help with weight loss.

Overuse can be harmful.

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

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 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.

Fertility

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

4.7

Effects on ability to drive and use machines

None known

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

Frequency

Adverse Events

Immune System

Disorders

Not known

Hypersensitivity, urticaria, asthma,

hypogammaglobulinaemia

Metabolism and Nutrition

Disorders

Not known

Hypokalaemia

, cachexia

Gastrointestinal Disorders

Not known

Abdominal pain, abdominal spasm,

diarrhoea

, gastrointestinal tract

mucosal pigmentation

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

Disorders

Not known

Chromaturia

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

lead

disorders

water

equilibrium

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 or search for MHRA Yellow Card in the

Google Play or Apple App Store.

4.9

Overdose

Symptoms

Where

diarrhoea

severe,

conservative

measures

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

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

-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.

-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

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

sulphates.

After

oral

administration

sennosides,

metabolites are excreted in urine; some are excreted in bile.

Most

sennosides

(ca.

90%)

excreted

faeces

polymers

(polyquinones) together with 2 - 6% of unchanged sennosides, sennidins, rhein

anthrone

rhein.

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

extracts

senna

pods

containing

3.5%

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

mg/kg.

addition

specified

senna

extract

given

orally

years

carcinogenic

male

female

rats.

extract

investigated

contained

approximately

40.8%

anthranoids

from

which

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.

Chronic

laxative

risk

factor

colorectal

cancer

(CRC)

investigated in some clinical trials. Some studies revealed a risk for CRC

associated with the use of anthraquinone-containing laxatives, some studies

not.

However,

risk

also

revealed

constipation

itself

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

Tablets packed in uPVC/PVdC/foil blisters: three years

6.4

Special precautions for storage

For tablets packed in uPVC/PVdC/foil blisters: store below 25

Store in the original package

6.5

Nature and contents of container

60 or 100 tablets packed in uPVC/PVdC/foil blisters, contained in a carton.

6.6

Special precautions for disposal

Not applicable

7

MARKETING AUTHORISATION HOLDER

Reckitt Benckiser Healthcare (UK) Limited

Dansom Lane

Hull

HU8 7DS

8

MARKETING AUTHORISATION NUMBER(S)

PL 00063/0768

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

07/02/2020

10

DATE OF REVISION OF THE TEXT

07/12/2020

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