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THE BOOTS COMPANY PLC

1 Thane Road West, Beeston, Nottingham, NG2 3AA
Telephone: +44 (0)1159 595 165
Fax: +44 (0)1159 592 565

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Summary of Product Characteristics last updated on the eMC: 04/05/2011
SPC Boots Syrup of Figs Laxative


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1. NAME OF THE MEDICINAL PRODUCT

Boots Syrup of Figs Laxative


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredient

ml/5ml

Senna fruit extract for figine

0.40

Fig liquid extract for figine

0.50


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3. PHARMACEUTICAL FORM

Oral solution


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

For the relief of occasional constipation

For oral administration.


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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


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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.


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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.


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4.5 Interaction with other medicinal products and other forms of interaction

No clinically significant drug interactions are known.


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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.


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4.7 Effects on ability to drive and use machines

No adverse effects known.


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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.


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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.


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5. PHARMACOLOGICAL PROPERTIES

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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.


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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.


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5.3 Preclinical safety data

Not applicable.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Malt extract

Benzoic acid

Liquid sugar

Methyl salicylate

Coriander oil

Peppermint oil

Chloroform

Clove leaf oil


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6.2 Incompatibilities

None stated.


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6.3 Shelf life

36 months


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6.4 Special precautions for storage

None.


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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


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6.6 Special precautions for disposal and other handling

Not applicable.


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7. MARKETING AUTHORISATION HOLDER

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

England


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8. MARKETING AUTHORISATION NUMBER(S)

PL 00014/5150R


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

19 February 1986 / 14 January 2002


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10. DATE OF REVISION OF THE TEXT

February 2011



More information about this product

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/12022/SPC/


Active Ingredients/Generics

 
   senna fruit extract
   fig liquid extract