Source: Υπουργείο Υγείας (CY) Revision Year: 2022 Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus
Lax-Tab 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.
Lax-Tab is also contraindicated in severe dehydration and in patients with known hypersensitivity to bisacodyl or any other ingredient of the product.
In case of hereditary conditions that may be incompatible with an excipient of the product (please refer to “Special warnings and precautions for use”) the use of the product is contraindicated.
As with all laxatives, Lax-Tab should not be used 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) Lax-Tab should be discontinued and only be restarted under medical supervision.
Stimulant laxatives including Lax-Tab 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 bisacodyl. The details available for these cases suggest that the events would be consistent with defecation 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.
This product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
This product contains sucrose. 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 Lax-Tab 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 Lax-Tab.
There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of bisacodyl in pregnant women.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
As a precautionary measure, it is preferable to avoid the use of bisacodyl during pregnancy, especially in the first trimester.
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, bisacodyl should not be taken 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 Lax-Tab 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 authorization 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 national reporting system.
Cyprus, Pharmaceutical Services, Ministry of Health, CY-1475 Nicosia, Tel: +357 22608607, Fax: +357 22608669, Website: www.moh.gov.cy/phs.
None stated.
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