BIOLAX

Route of administration: oral The tablets should not be crushed or chewed but swallowed whole with water.

Posology:

It is recommended to take the coated tablets at night to have a bowel movement the following morning. The coated tablets should not be taken together with products which reduce the acidity of the upper gastrointestinal tract, such as milk, antacids or proton pump inhibitors, in order not to prematurely dissolve the enteric coating.

No specific information on the use of this product in the elderly is available. Clinical trials have included patients over 65 years and no adverse reactions specific to this age group have been reported.

Short-term treatment of constipation:

Adults and children over 12 years: 1 to 2 coated tablets (5-10 mg) daily Children 4-10years: 1 coated tablet (5 mg) daily It is recommended to start with the lowest dose. The dose may be adjusted up to the maximum recommended dose to produce regular stools.

The maximum daily dose should not be exceeded. In the management of constipation, once regularity has been restarted dosage should be reduced and can usually be stopped.

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).

g. to abdominal spasm, defaecation).

Gastrointestinal disorders Common:

Abdominal pain, abdominal cramps, nausea and diarrhoea.

Uncommon:

Vomiting, haematochezia (blood in stool), abdominal discomfort, anorectal discomfort.

Rare:

Colitis 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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As with all laxatives, Bisacodyl should not be taken on a continuous daily basis for more than 5 days without investigating the cause of constipation. 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 constipation should be investigated. This product should only be used if a therapeutic effect cannot be achieved by a change of diet or the administration of bulk forming agents. Prolonged use can precipitate the onset of an atonic non-functioning colon.

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 should be discontinued and only be restarted under medical supervision.

Stimulant laxatives (including bisacodyl) do not help in long-term weight loss. 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 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.

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. Patients with rare hereditary problems of galactose intolerance, fructose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

1 • Patients with ileus, intestinal obstruction • Acute surgical abdominal conditions such as acute appendicitis • Acute inflammatory bowel diseases • Severe abdominal pain associated with nausea and vomiting Severe dehydration