Senna Laxative Tablets (Boots Company plc)

1. Name Of The Medicinal Product

Senna Laxative Tablets or Senna Tablets BP or Senna Laxative Tablets BP

2. Qualitative And Quantitative Composition

Active ingredient	mg/tablet
Sennosides, obtained from de-seeded senna fruit; Alexandrian	7.5

3. Pharmaceutical Form

Tablet.

4. Clinical Particulars

4.1 Therapeutic Indications

For the relief of occasional constipation.

4.2 Posology And Method Of Administration

For oral administration

Adults and children over 12 years: 2 tablets.

Children 6-12 years: 1 tablet.

Children under 6 years: Not recommended

Elderly: The normal adult dose is suitable in the elderly.

The tablets should preferably be taken at bedtime and the dose should be decreased as the bowel habit becomes regular.

4.3 Contraindications

Hypersensitivity to any of the ingredients. Senna Laxative Tablets should not be used when abdominal pain, intestinal obstruction, nausea or vomiting is present.

4.4 Special Warnings And Precautions For Use

Senna Laxative Tablets should not be used for prolonged periods since they may decrease the sensitivity of the intestinal mucous membranes, so larger doses have to be taken and the bowel fails to respond to normal stimuli.

Laxatives should not be taken where there is severe abdominal pain or used regularly for prolonged periods except on medical advice.

Keep all medicines out of reach of children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically significant drug interactions are known.

4.6 Pregnancy And Lactation

The safety of Senna Laxative Tablets during pregnancy and lactation has not been established, but use during these periods is not considered to constitute a hazard.

4.7 Effects On Ability To Drive And Use Machines

No adverse effects known.

4.8 Undesirable Effects

Prolonged use may produce watery diarrhoea with excessive loss of fluid and electrolytes, particularly potassium, muscular weakness and weight loss.

Changes in the intestinal musculature associated with malabsorption and dilation of the bowel similar to ulcerative colitis and to megacolon may also occur. Cardiac and renal symptoms have been reported. Melanosis coli and a red or yellow discolouration of the urine and faeces may also occur.

4.9 Overdose

Overdosage may produce watery diarrhoea with excessive loss of water and electrolytes, particularly potassium. Treatment consists of emptying the stomach by emesis or aspiration and lavage. Otherwise treatment should include symptomatic and supportive measures, particularly replacement of fluid and electrolyte loss.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Senna is an anthraquinone purgative. The stimulant effect of senna occurs in the colon, whilst the stomach and small intestine are not normally affected.

5.2 Pharmacokinetic Properties

There is some absorption of anthraquinone laxatives following administration by mouth.

Senna glycosides are hydrolysed by colonic bacteria in the intestinal tract and the active anthraquinones liberated into the colon.

Excretion occurs in the urine and the faeces and also in other secretions including breast milk.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Tricalcium phosphate

Maize starch

Magnesium stearate

6.2 Incompatibilities

None known.

6.3 Shelf Life

Amber glass bottle/PPR Cap: 18 months.

Amber glass bottle/IHS liner/Cap: 24 months.

HDPE bottle: 24 months.

Blister: 36 months.

6.4 Special Precautions For Storage

Glass: Store below 25°C in a dry place.

HDPE: None.

Blister: Store below 25°C in a dry place.

6.5 Nature And Contents Of Container

Amber glass bottle having an unlined polypropylene cap, in a cardboard carton.

Pack sizes: 50, 100, 200, 1000.

Amber glass bottle with polypropylene cap with IHS liner faced with surlyn/aluminium or polyethylene/aluminium.

Pack sizes: 50, 100, 200, 1000.

HDPE bottle with polypropylene cap with waxed aluminium faced liner.

Pack sizes: 50, 100, 200, 1000.

PVC/PVDC/aluminium foil blister.

Pack sizes: 10, 20, 30, 40, 50, 60, 70, 80, 90, 100.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

BCM Ltd

1 Thane Road West

Nottingham NG2 3AA

8. Marketing Authorisation Number(S)

PL 12557/0033

9. Date Of First Authorisation/Renewal Of The Authorisation

First authorisation: 17 March 1995

Renewal of the authorisation: 22 January 2002

10. Date Of Revision Of The Text

February 2006