Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United Kingdom
Hypersensitivity to the active substance or to any of the excipients.
Not to be used the same time as other laxative agents.
Cases of intestinal obstructions and stenosis, atony, appendicitis, inflammatory colon diseases (e.g Crohn’s disease, ulcerative colits), abdominal pain of unknown origin, severe dehydration state with water and electrolyte depletion.
Children under 2 years of age.
If there is no bowel movement after three days, a doctor should be consulted.
If laxatives are needed every day or abdominal pain persists, a doctor should be consulted.
If laxatives are needed every day the cause of the constipation should be investigated. Long-term use of laxatives should be avoided.
Contains maltitol liquid. Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Each 5 ml of syrup can provide up to 3.2 kcal and this should be taken into account in patients with diabetes mellitus.
Methyl and propyl parahydroxybenzoate may cause allergic reactions (possibly delayed)
This medicinal product contains small amounts of ethanol (alcohol), less than 100mg per dose.
Do not exceed the stated dose.
Patients taking cardiac glycosides, antiarrhythmic medicinal products, medicinal products inducing QT-prolongation, diuretics, adrenocorticosteroids or liquorice root, have to consult a doctor before taking this product concomitantly.
Like all laxatives, this product should not be taken by patients suffering from faecal impaction and undiagnosed, acute or persistent gastro-intestinal complaints, e.g. abdominal pain, nausea and vomiting, unless advised by a doctor, because these symptoms can be signs of potential or existing intestinal blockage (ileus).
If stimulant laxatives are taken for longer than a brief period of treatment, this may lead to impaired function of the intestine and dependence on laxatives. This product should only be used if a therapeutic effect cannot be achieved by a change of diet or the administration of bulk forming agents.
Prolonged use may precipitate the onset of an atonic, non-functioning colon.
Prolonged and excessive use may lead to fluid and electrolyte imbalance and hypokalaemia.
Intestinal loss of fluids may promote dehydration. Symptoms may include thirst and oliguria.
Patients with kidney disorders should be aware of possible electrolyte imbalance.
When administering this product to incontinent adults, pads should be changed more frequently to prevent extended skin contact with faeces.
Laxatives do not help in long-term weight loss.
Hypokalaemia (resulting from long-term laxative abuse) potentiates the action of cardiac glycosides and interacts with antiarrhythmic medicinal products with medicinal products which induce reversion to sinus rhythm (e.g. quinidine) and with medicinal products inducing QT-prolongation. Concomitant use with other medicinal products inducing hypokalaemia (e.g. diuretics, adrenocorticosteroids and liquorice root) may enhance electrolyte imbalance.
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 the product 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.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
None known.
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