Composition:
Each tablet contains 7,5 , 15 or 25mg Sennoside (B).
Mechanism of action:
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.
Defaecation takes place after a delay of 8 - 12 hours due to the time taken for transport to the colon and metabolism into the active compound.
Pharmacokinetics:
The action of the sennosides is colon specific and does not depend upon systemic absorption.
After oral administration of sennosides, 3 - 6% of the metabolites are excreted in urine; some are excreted in bile.
Most of the sennosides (ca. 90%) are excreted in faeces as polymers (polyquinones) together with 2 - 6% of unchanged sennosides.
Indications:
- For short term relief of occasional constipation.
- For oral administration.
- Take preferably at bedtime or as directed by a doctor.
Dosage and method of administration:
The correct individual dose is the smallest required to produce a comfortable soft-formed motion.
For the short term relief of occasional constipation
- Adults, the elderly and children over 12 years: Swallow one to two tablets at night.
A higher dose may be prescribed under medical guidance. The maximum daily dose of hydroxyanthracene glycoside is 30mg.
- Children over 6 years: 1/2 to One tablets at night under the guidance of a medical professional.
- Children 6 years and under: Not Recommended.
The maximum daily dose must not exceed 15mg sennosides.
New users should start with the lowest dose and increase it to the maximum dose if necessary. Once regularity has been regained dosage should be reduced and can usually be stopped.
If no bowel action has occurred after three days of progressively increased dosage, a medical examination should be considered.
- Duration of use:
Normally it is sufficient to take this medicinal product up to two to three times a week.
Use for more than 1-2 weeks requires medical supervision.
If the symptoms persist or worsen during the use of the medicinal product, a doctor should be consulted.
Overdose:
Symptoms
Where diarrhoea is severe, conservative measures are usually sufficient; generous amounts of fluid, especially fruit drinks, should be given.
The major symptoms of overdose/abuse are griping pain and severe diarrhoea with consequent losses of fluid and electrolytes, which should be replaced.
Diarrhoea may especially cause potassium depletion, which may lead to cardiac disorders and muscular asthenia, particularly where cardiac glycosides, diuretics, adrenocorticosteroids or liquorice root are being taken at the same time.
Treatment
Treatment should be supportive with generous amounts of fluid. 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.
Undesirable effects:
Hypersensitivity reactions (pruritus, urticaria, local or generalized exanthema) may occur.
Abdominal pain and spasm and passage of liquid stools have been reported, in particular in patients with irritable colon. However, these symptoms may also occur generally as a consequence of individual overdose. In such cases, dose reduction is necessary.
Chronic use may lead to disorders in water equilibrium and electrolyte metabolism and may result in albuminuria and haematuria.
Furthermore, chronic use may cause pigmentation of the intestinal mucosa (pseudomelanosis coli) which usually recedes when the patient stops taking the preparation.
Yellow or red-brown (pH dependent) discolouration of urine by metabolites, which is not clinically significant, may occur during the treatment.
If other adverse reactions not mentioned above occur, a doctor or a qualified healthcare practitioner should be consulted.
Contraindications:
Hypersensitivity to the active substance or to any of the excipients .
Cases of intestinal obstructions and stenosis, atony, appendicitis, inflammatory bowel diseases (e.g Crohn's disease, ulcerative colitis), abdominal pain of unknown origin, severe dehydration state with water and electrolyte depletion.
Not to be used at the same time as other laxative agent.
Drug Interactions:
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.
warnings and precautions for use
- 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.
- Do not exceed the stated dose.
- laxative products for longer than 1 week unless directed by a doctor.
Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.
• 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.
• 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.
• 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.
• The use in children under 12 years of age is not recommended unless under the guidance of a medical practitioner because data are not sufficient and medical advice should be sought.
• Laxatives do not help in long-term weight loss.
Pregnancy:
There are no reports of undesirable or damaging effects during pregnancy and on the foetus when used at the recommended dosage schedule.
However, as a consequence of experimental data concerning a genotoxic risk of several anthranoids, e.g emodin and aloe-emodin, use is not recommended during pregnancy.
Lactation:
Use 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 breast fed babies has not been reported.