1. Name Of The Medicinal Product
Boots Syrup of Figs Laxative
2. Qualitative And Quantitative Composition
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3. Pharmaceutical Form
Oral solution
4. Clinical Particulars
4.1 Therapeutic Indications
For the relief of occasional constipation
For oral administration.
4.2 Posology And Method Of Administration
Adults and children over 12 years: 10ml (two teaspoonfuls)
Children 5 to 12 years: 5ml (one teaspoonful)
Children 1 to 5 years: 2.5ml (half a teaspoonful)
The dose should be taken at bedtime
Elderly: The normal adult dose is suitable in the elderly
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 it 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. Caution should be observed in patients with inflammatory bowel disease. 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 are known.
4.6 Pregnancy And Lactation
The safety of this product 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 dilatation 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.
Fig has mild laxative properties.
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
Not applicable.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Malt extract
Benzoic acid
Liquid sugar
Methyl salicylate
Coriander oil
Peppermint oil
Chloroform
Clove leaf oil
6.2 Incompatibilities
None stated.
6.3 Shelf Life
36 months
6.4 Special Precautions For Storage
None.
6.5 Nature And Contents Of Container
100ml Amber glass bottle with a tinplate cap with a pulpboard liner faced with steran BK
or a roll-on pilfer-proof cap with a flowed-in liner or a triseal (LDPE/EPE/LDPE) liner
or a wadless polypropylene tamper evident cap
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
England
8. Marketing Authorisation Number(S)
PL 00014/5150R
9. Date Of First Authorisation/Renewal Of The Authorisation
19 February 1986 / 14 January 2002
10. Date Of Revision Of The Text
February 2011
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