PregnancyThere are no reports of undesirable or damaging effects during pregnancy and on the foetus when used at the recommended dosage schedule. As a consequence of experimental data concerning a genotoxic risk of several anthranoids, e.g. emodin and aloe-emodin, the use is not recommended in pregnancy.
Breast-feedingUse during breastfeeding is not recommended as there are insufficient data on the excretion of metabolites in breast milk. Small amounts of active metabolites (rhein) are excreted in breast milk. A laxative effect in breastfed babies has not been reported.
FertilityPreclinical studies with sennosides do not indicate special hazard to fertility at therapeutically relevant doses. No data are available with Senna fruit preparations.
Tabulated list of adverse reactionsBased on available data the frequency of the following adverse reactions cannot be estimated.
|System Organ Class (SOC) Frequency
|Metabolism and nutrition disorders Not known
|Hyperaldosteronism Hypomagnesaemia Dehydration Hypokalaemia Blood electrolytes decreased
|Vascular disorders Not known
|Gastrointestinal disorders Not known
|Musculoskeletal and connective tissue disorders Not known
|Renal and urinary disorders Not known
|Renal disorders Chromaturia
|General disorders and administration site conditions Not known
|Fatigue Drug tolerance
Paediatric populationFrequency, type and severity of adverse reactions in children are expected to be the same as in adults.
Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme (www.mhra.gov.uk/yellowcard)
SymptomsThe major symptoms of overdose/overuse are griping pain and severe diarrhoea with consequent losses of fluid and electrolytes, which should be replaced. Diarrhoea may especially cause potassium depletion, particularly where cardiac glycosides, diuretics, adrenocorticosteroids or liquorice root are being taken at the same time
ManagementTreatment should be supportive with an increase in fluid intake to reverse the loss of fluid and electrolytes. Electrolytes, especially potassium, should be monitored. This is especially important in the elderly. Chronic ingested overdoses of anthranoid containing medicinal products may lead to toxic hepatitis.
Mechanism of action and pharmacodynamic effects1,8-dihydroxyanthracene derivatives possess a laxative effect. The β-O-linked glycosides (sennosides) are not absorbed in the upper gut; they are converted by bacteria of the large intestine into the active metabolite (rhein anthrone).There are two different mechanisms of action:1. stimulation of the motility of the large intestine resulting in accelerated colonic transit.2. influence on secretion processes by two concomitant mechanisms viz. inhibition of absorption of water and electrolytes (Na+, Cl-) into the colonic epithelial cells (antiabsorptive effect) and increase of the leakiness of the tight junctions and stimulation of secretion of water and electrolytes into the lumen of the colon (secretagogue effect) resulting in enhanced concentrations of fluid and electrolytes in the lumen of the colon.Sennoside laxatives generally produce bowel movement in 6 to 12 hours.