Boots Natural Senna Laxative Tablets

Tablet

For the relief of occasional constipation.

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.

For oral administration.

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

This product 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 the reach of children.

No clinically significant drug interactions known.

The safety of this product taken 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 losses.

Senna is an anthraquinone laxative. 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.

There are no preclinical data of relevance to the prescriber which are additional to that already included.

Tricalcium phosphate 118

Magnesium stearate

Maize starch

Purified water

None known.

Amber glass bottle with unlined polypropylene cap: 18 months

Amber glass bottle with polypropylene cap with IHS liner faced with surlyn/aluminium or polyethylene/aluminium: 24 months

HDPE bottle with polypropylene cap with IHS liner faced with either surlyn/aluminium or polyethylene/aluminium: 24 months

HDPE bottle with polypropylene cap with waxed aluminium faced liner: 24 months

PVC/PVDC/aluminium foil blister: 36 months

Glass bottle: Do not store above 25°C. Store in original package.

Blister: Do not store above 25°C. Store in original package.

PET: None

1. Amber glass bottle, unlined polypropylene cap

Pack size: 50, 100, 200

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

Pack size: 50, 100, 200

3. HDPE bottle with polypropylene cap with IHS liner faced with surlyn/aluminium or polyethylene/aluminium.

Pack size: 50, 100, 200

4. HDPE bottle with polypropylene cap with waxed aluminium faced liner.

Pack size: 50, 100, 200

5. PVC/PVDC aluminium foil blister.

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

Not applicable.

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

Trading as: BCM

PL 0014/5375R

Date of grant: 29 August 1984

Date of renewal: 25 September 1996

August 2010