Special Warning : אזהרת שימוש

4.4    Special warnings and precautions for use
Should not be used in children under the age of 6 years.
As with all laxatives, bisacodyl should not be taken on a continuous daily basis for more than five days without investigating the cause of constipation.
Frequent or prolonged use may cause dependence on laxatives.
Long term everyday use of stimulant laxatives may harm the intestinal function and should be avoided. If laxatives are needed every day the cause of the constipation should be investigated. This product should only be used if a therapeutic effect cannot be achieved by a change in diet or the administration of bulk forming agents, 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) bisacodyl should be discontinued and only be restarted under medical supervision.
Stimulant laxatives including bisacodyl 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.
If the symptoms worsen during the use of the medicinal product, a doctor or pharmacist should be consulted.
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 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 diarrhea occurring after taking bisacodyl. Some cases have been shown to be associated with colonic mucosal ischemia.
Patients should be advised to drink liberally when using laxatives to aid stool softening.
Laxadin Tablets contain a small amount of lactose (40 mg) in each tablet. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Effects on Driving

4.7    Effects on ability to drive and use machines
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.