1. Name Of The Medicinal Product
Boots Natural Senna Laxative Tablets
2. Qualitative And Quantitative Composition
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3. Pharmaceutical Form
Tablet
4. Clinical Particulars
4.1 Therapeutic Indications
For the relief of occasional constipation.
4.2 Posology And Method Of 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.
For oral administration.
4.3 Contraindications
Hypersensitivity to any of the ingredients. This product should not be used when abdominal pain, intestinal obstruction, nausea or vomiting is present.
4.4 Special Warnings And Precautions For Use
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.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
No clinically significant drug interactions known.
4.6 Pregnancy And Lactation
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.
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 losses.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Senna is an anthraquinone laxative. 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
There are no preclinical data of relevance to the prescriber which are additional to that already included.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Tricalcium phosphate 118
Magnesium stearate
Maize starch
Purified water
6.2 Incompatibilities
None known.
6.3 Shelf Life
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
6.4 Special Precautions For Storage
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
6.5 Nature And Contents Of Container
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
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
7. Marketing Authorisation Holder
The Boots Company PLC
1 Thane Road West
Nottingham NG2 3AA
Trading as: BCM
8. Marketing Authorisation Number(S)
PL 0014/5375R
9. Date Of First Authorisation/Renewal Of The Authorisation
Date of grant: 29 August 1984
Date of renewal: 25 September 1996
10. Date Of Revision Of The Text
August 2010
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