There are no reports of undesirable or damaging effects during pregnancy and on the foetus when used at the recommended dosage. However, as a consequence of experimental data concerning a genotoxic risk of several anthranoids, e.g emodin and aloe-emodin, use is not recommended in pregnancy.
Use during breastfeeding is not recommended as there are insufficient data on the excretion of metabolites in breast milk. Small amounts of active metabolites, such as rhein, are excreted in breast milk in small amounts. A laxative effect in breast fed babies has not been reported.
There are no data on the effects of senno glycosides on fertility.
No studies on the effect on the ability to drive and use machines have been performed.
Adverse events which have been associated with sennosides at OTC doses in short-term use are given below, tabulated by system organ class and frequency.
In the treatment of chronic condition, under long-term treatment, additional adverse effects may occur.
Not known: Hypersensitivity, urticaria, asthma, hypogammaglobulinaemia
Not known: Hypokalaemia1, cachexia
Not known: Abdominal pain, abdominal spasm, diarrhoea2, gastrointestinal tract mucosal pigmentation3
Not known: Pruritus, local or generalised exanthema
Not known: Finger clubbing, tetany and hypertrophic osteoarthropathy
Not known: Chromaturia4
1 Prolonged use of laxatives resulting in diarrhoea and subsequently hypokalaemia.
2 In particular in patients with irritable colon. Symptoms may also occur generally as a consequence of individual overdosage. In such cases dose reduction is necessary.
3 Chronic use may cause pigmentation of the intestinal mucosa (pseudomelanosis coli), which usually recedes when the patient stops taking the preparation.
4 Yellow or red-brown (pH dependent) discolouration of urine by metabolites, which is not clinically significant, may occur during the treatment.
Chronic use may lead to disorders in water equilibrium and electrolyte metabolism and may result in albuminuria and haematuria.'
The frequency is not known (cannot be estimated from the available data).
If other adverse reactions not mentioned above occur, a doctor or a qualified healthcare practitioner should be consulted.
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