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

Tablet.

For the relief of occasional constipation.

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.

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

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.

No clinically significant drug interactions are known.

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.

No adverse effects known.

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.

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.

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

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.

None stated.

Tricalcium phosphate

Maize starch

Magnesium stearate

None known.

Amber glass bottle/PPR Cap: 18 months.

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

HDPE bottle: 24 months.

Blister: 36 months.

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

HDPE: None.

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

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.

None.

BCM Ltd

1 Thane Road West

Nottingham NG2 3AA

PL 12557/0033

First authorisation: 17 March 1995

Renewal of the authorisation: 22 January 2002

February 2006