Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Aventis Pharma Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, United Kingdom Trading as: Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, United Kingdom
DULCOLAX 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.
DULCOLAX is also contraindicated in severe dehydration and in patients with Known hypersensitivity to bisacodyl or any other component of the product.
In case of hereditary conditions that may be incompatible with an excipient of the product (please refer to “Special warnings and special precautions for use” the use of the product is contraindicated.
As with all laxatives, DULCOLAX should not be taken on a continuous daily basis for more than five days without investigating the cause of constipation.
Prolonged excessive use may lead to fluid and electrolyte imbalance and hypokalaemia.
Intestinal loss of fluids can promote dehydration. Symptoms may include thirst and oliguria. In patients suffering from fluid loss where dehydration may be harmful (e.g. renal insufficiency, elderly patients) DULCOLAX should be discontinued and only be restarted under medical supervision.
Stimulant laxatives including DULCOLAX do not help with weight loss (see section 5.1 Pharmacodynamic properties).
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 DULCOLAX. 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.
DULCOLAX Tablets contain a small amount of lactose (33.2 mg) and sucrose (23.4 mg) in each tablet. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
The concomitant use of antacids and milk products may reduce the resistance of the coating of the tablets and result in dyspepsia and gastric irritation.
The concomitant use of diuretics or adreno-corticosteroids may increase the risk of electrolyte imbalance if excessive doses of DULCOLAX are taken.
Electrolyte imbalance may lead to increased sensitivity to cardiac glycosides.
The concomitant use of other laxatives may enhance the gastrointestinal side effects of DULCOLAX.
There are no adequate and well-controlled studies in pregnant women. Long experience has shown no evidence of undesirable or damaging effects during pregnancy.
Clinical data show that neither the active moiety of bisacodyl (BHPM or bis-(p-hydroxyphenyl)-pyridyl-2-methane) nor its glucuronides are excreted into the milk of healthy lactating females.
Nevertheless, as with all medicines, DULCOLAX should not be taken in pregnancy, especially the first trimester, and during breast feeding unless the expected benefit is thought to outweigh any possible risk and only on medical advice.
No studies on the effect on human fertility have been conducted.
No studies on the effects of DULCOLAX 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.
The most commonly reported adverse reactions during treatment are abdominal pain and diarrhoea.
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).
Rare: anaphylactic reactions, angioedema, hypersensitivity.
Rare: dehydration.
Uncommon: dizziness.
__Rare: Syncope. Dizziness and syncope occurring after taking bisacodyl appear to be consistent with a vasovagal response (e.g. to abdominal spasm, defaecation).
Uncommon: haematochezia (blood in stool), vomiting, abdominal discomfort, anorectal discomfort.
Common: abdominal cramps, abdominal pain, diarrhoea and nausea.
Rare: colitis including ischaemic colitis.
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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
None stated.
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