Senokot Tablets

1. Name Of The Medicinal Product

Senokot Tablets

2. Qualitative And Quantitative Composition

Each tablet contains 154mg of senna fruit, equivalent to 7.5mg hydroxyanthracene glycosides, calculated as sennoside B.

Also contains lactose monohydrate (15.82mg per tablet)

For full list of excipients, see section 6.1

3. Pharmaceutical Form

Tablets

4. Clinical Particulars

4.1 Therapeutic Indications

500 or 1000 Tablet (Dispensing) Pack

For the management of constipation

All Other Packs

For the relief of occasional or non-persistent constipation

4.2 Posology And Method Of Administration

Senokot Tablets are for oral administration

500 or 1000 Tablets (Dispensing) Pack

For the management of constipation

Adults, including elderly and children over 12: Two to four tablets

Children over 6: One to two tablets

Children 6 and under: Not recommended

Senokot should be taken as a single dose at bedtime by adults and in the morning by children.

New users should start with the lowest dose and increase it, if necessary, by one half of the initial dose each day. Once regularity has been regained dosage should be reduced and can usually be stopped.

All Other Packs

For the relief of occasional and non-persistent constipation

Adults, including elderly and children over 12: Two tablets taken at night

Children over 6: Consult your doctor

Children under 6: Not recommended

4.3 Contraindications

Senokot Tablets should not be given when any undiagnosed acute or persistent abdominal symptoms are present.

4.4 Special Warnings And Precautions For Use

If there is no bowel movement after three days, consult your doctor.

If laxatives are needed every day, or abdominal pain persists, consult your doctor.

The product contains lactose. One tablet contains 15.82mg lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known

4.6 Pregnancy And Lactation

There is some evidence for the safety of senna in human pregnancy and it has been in use for many years without apparent ill-consequence. If laxative treatment is required during pregnancy, Senokot Tablets may be used. Clinical studies have shown that breast-fed infants of mothers taking Senokot did not show any side-effects to the drug.

4.7 Effects On Ability To Drive And Use Machines

None known

4.8 Undesirable Effects

Temporary mild griping may occur during adjustment of the dosage.

4.9 Overdose

Where diarrhoea is severe, conservative measures are usually sufficient; generous amounts of fluid, especially fruit drinks, should be given.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

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. Senna acts in 8-12 hours.

5.2 Pharmacokinetic Properties

The action of the sennosides is colon specific and does not depend upon systemic absorption.

5.3 Preclinical Safety Data

No preclinical findings of relevance to the prescriber have been reported.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Calcium phosphate, maize starch, DC lactose and magnesium stearate

6.2 Incompatibilities

None known

6.3 Shelf Life

Tablets in a polypropylene container: five years

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

6.4 Special Precautions For Storage

For tablets in a polypropylene container: store below 30^oC

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

Store in the original package

Also for polypropylene container: replace cap firmly after use

6.5 Nature And Contents Of Container

50, 100, 200, 500 or 1000 tablets in a polypropylene container with a snap-fit lid

6, 8, 10, 12, 20, 40, 60, 80 or 100 tablets packed in uPVC/PVdC/foil blisters, contained in a carton.

6.6 Special Precautions For Disposal And Other Handling

Not applicable

7. Marketing Authorisation Holder

Reckitt Benckiser Healthcare (UK) Limited

Dansom Lane

Hull

HU8 7DS

8. Marketing Authorisation Number(S)

PL 00063/5000R

9. Date Of First Authorisation/Renewal Of The Authorisation

13/03/1987 / 15/07/2005

10. Date Of Revision Of The Text

02/07/2009