BISACODYL

Posology Short-term relief of occasional constipation:

Adults and children over 12 years: 1 suppository (10 mg) for immediate effect.

Children and adolescents under 12 years:

Should not be used in children and adolescents under the age of 12 years. Method of Administration For Rectal Use Only Do not swallow

Use of the suppositories can occasionally cause rectal irritation, and repeated use may cause proctitis or sloughing of the epithelium. Prolonged use can result in diarrhoea with excessive loss of water and electrolytes, particularly potassium.

There is also the possibility of developing an atonic non-functioning colon. Adverse events have been ranked under headings of frequency using the following convention: Very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, <1/100); rare (≥ 1/10000, <1/1000); very rare (<1/10000).

Not known – incidence cannot be estimated from the available data. Immune system disorders Rare: hypersensitivity, anaphylactic reactions, angioedema. Metabolism and nutrition disorders Rare: dehydration. Gastrointestinal disorders Uncommon: vomiting, haematochezia (blood in stool), abdominal discomfort, anorectal discomfort.

Common: abdominal pain, abdominal cramps, nausea and diarrhoea. Rare: colitis. Nervous system disorders Uncommon: dizziness.

Rare:

Syncope. g. to abdominal spasm, defaecation). Reporting of suspected adverse 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.

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Prolonged use may precipitate the onset of an atonic, non-functioning colon. Laxatives do not help in long-term weight loss. As with all laxatives, Bisacodyl Suppositories should not be used on a continuous daily basis for more than five days without investigating the cause of constipation.

Prolonged and excessive use may lead to fluid and electrolyte imbalance and hypokalaemia. Intestinal loss of fluids can promote dehydration. Symptoms may include thirst and oliguria. g. renal insufficiency, elderly patients) Bisacodyl Suppositories should be discontinued and only be restarted under medical supervision.

Patients may experience haematochezia (blood in stool) that is generally mild and self-limiting. Dizziness and / or syncope have been reported in patients who have taken Bisacodyl Suppositories. The details available for these cases suggest that the events would be consistent with defaecation syncope (or syncope attributable to straining at stool), or with a vasovagal response to abdominal pain related to the constipation, and not necessarily to the administration of bisacodyl itself.

There have been isolated reports of abdominal pain and bloody diarrhoea occurring after taking bisacodyl. Some cases have been shown to be associated with colonic mucosal ischaemia. The use of suppositories may lead to painful sensations and local irritation, especially in patients with anal fissures and ulcerative proctitis.

Bisacodyl Suppositories should not be used by children under 10 years without medical advice.

3 Contra-indications Bisacodyl is contraindicated in patients with ileus, intestinal obstruction, acute abdominal conditions including appendicitis, acute inflammatory bowel diseases, and severe abdominal pain associated with nausea and vomiting which may be indicative of the aforementioned severe conditions.

Bisacodyl is also contraindicated in severe dehydration and in patients with known hypersensitivity to bisacodyl or any other component of the product. Bisacodyl Suppositories should not be used when anal fissures or ulcerative proctitis with mucosal damage are present.