Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland
1. Undiagnosed painful abdominal symptoms which may be due to acute appendicitis and or other acute surgical conditions such as intestinal obstruction or acute inflammatory bowel disease.
2. Ileus.
3. In severe dehydration states with water and electrolyte depletion.
4. Anal fissures, ulcerative proctitis with mucosal damage and ulcerated haemorrhoids.
5. Hypersensitivity to bisacodyl or to any of the excipients listed in section 6.1.
1. If laxatives are needed every day, the cause of the constipation should be investigated.
2. Excessive and prolonged use is dangerous and may result in diarrhoea leading to dehydration, electrolyte imbalance such as hypokalaemia, malabsorption and protein losing enteropathy.
3. Prolonged and daily use may precipitate the onset of rebound constipation.
4. In anal fissures and ulcerative proctitis, the use of micro enema suspension may lead to pain and perianal bleeding.
5. The development of laxative dependence, chronic constipation and loss of bowel function – “cathartic colon” with atony, dilatation, and resemblance of ulcerative colitis or proctitis – is also possible.
6. Dizziness and/or syncope has been reported during the use of bisacodyl. The event could be related to defecation syncope or to a vasovagal response to abdominal pain.
7. Haematochezia may be seen but is usually mild and self-limiting; more severe bloody diarrhoea may be associated with colonic mucosal ischaemia.
This medicinal product contains less than 1 mmol (23 mg) sodium per 5ml Rectal Suspension, that is to say essentially ‘sodiumfree’.
Concomitant use with diuretics, cardiac glycosides or adrenocorticosteroids may enhance the electrolyte imbalance.
Although no teratogenic effects have been detected in animals or human infants, bisacodyl should not be used during pregnancy, especially the first trimester, unless the expected benefits outweigh the possible risks to the foetus.
Breast feeding is not recommended as there is insufficient data on the excretion of Bisacodyl and/or its metabolites in breast milk.
No studies on the effects of bisacodyl on the ability to drive and use machines have been performed.
However, patients should be advised that due to a vasovagal response (e.g. to abdominal spasm) they may experience dizziness and/or syncope. If patients experience abdominal spasm they should avoid potentially hazardous tasks such as driving or operating machinery.
At recommended doses, adverse reactions are unlikely to occur. Abdominal pain and cramping and cases of nausea and vomiting have been reported. Haematochezia may be seen and also rare cases of colitis including ischaemic colitis have been reported. Rectal formulations can cause local irritation and mild proctitis. Mild, transient skin reactions have rarely been described in association with bisacodyl administration. Dizziness and syncope have been reported.
Frequency convention by MedDRA: Common (>1/100), uncommon (>1/1000 – <1/100), rare (<1/1000) or not known (cannot be estimated from the available data).
| Organ group | Common | Uncommon | Rare | Not known |
|---|---|---|---|---|
| Immune system disorders | Hypersensitivity including angioedema and anaphylactoid reactions | |||
| Nervous system disorders | Dizziness syncope | |||
| Gastrointestinal disorders | Abdominal pain and cramping, nausea | Local irritation, pain and bleeding, mild proctitis | Vomiting | Haematochezia, colitis including ischaemic colitis |
| Skin and subcutaneous tissue disorders | Mild, transient skin reactions |
Reporting 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 HPRA website: www.hpra.ie or email: medsafety@hpra.ie.
Not applicable.
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