Senokot Max Strength

1. Name Of The Medicinal Product

Senokot Max Strength.

2. Qualitative And Quantitative Composition

The tablets contain standardised senna pods equivalent to a total sennoside content (calculated as sennoside B) of 15mg.

For excipients see 6.1.

3. Pharmaceutical Form

Tablets.

4. Clinical Particulars

4.1 Therapeutic Indications

For the relief of occasional or non-persistent constipation.

4.2 Posology And Method Of Administration

Route of administration

Oral.

Dosage

Adults, including elderly and children over 12: 1 tablet taken at night.

Children 12 and under: Consult your doctor.

4.3 Contraindications

Senokot Max Strength 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.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated.

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, the product 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 stated.

4.8 Undesirable Effects

Temporary mild griping may occur.

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

Lactose monohydrate (DC)

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.

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

United Kingdom

8. Marketing Authorisation Number(S)

PL 00063/0118

9. Date Of First Authorisation/Renewal Of The Authorisation

19/06/2007

10. Date Of Revision Of The Text

19/06/2007