BIOLAX

Posology:

Adults: 1 to 2 coated tablets (5-10 mg) daily before bedtime. PL 33414/0139 Should not be used in children or adolescents under the age of 18 years 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. It is recommended to take the coated tablets at night to have a bowel movement the following morning.

They should be swallowed whole with an adequate amount of fluid. 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. Method of administration For oral use.

The tablets should not be crushed or chewed but swallowed whole with water.

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 to < 1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).

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 including ischaemic 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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Should not be used in children or adolescents under the age of 18 years. 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 the 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. PL 33414/0139 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. g. renal insufficiency, elderly patients) Bisacodyl should be discontinued and only be restarted under medical supervision. 1). 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. Bisacodyl contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Bisacodyl contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. The leaflet will state: “Before you take this medicine” section Does this help with weight loss?

Stimulant laxatives (including bisacodyl) do not help with weight loss. They do not reduce the absorption of calories or nutrients. They can cause watery stools (diarrhoea), abdominal cramps and dehydration. Dehydration can seem like weight loss.

Overuse of laxatives may damage your health by: • Causing disturbances of electrolyte and mineral balances. Sodium, potassium, magnesium, and phosphorous are electrolytes and minerals that are present in very specific amounts necessary for proper functioning of the nerves and muscles, including those of the colon and heart.

Upsetting this delicate balance can cause incorrect functioning of these vital organs. • Severe dehydration may cause tremors, weakness, blurry vision, fainting, kidney damage, and, in extreme cases, death. Dehydration often requires medical treatment.

• Overuse of laxatives must be avoided as it may harm the intestinal function.

The label will state:

PL 33414/0139 Front of pack: • Does not help with weight loss. • Overuse can be harmful.

1. Patients with ileus, intestinal obstruction, acute abdominal conditions including appendicitis, acute inflammatory bowel diseases, severe abdominal pain associated with nausea and vomiting which may be indicative of the aforementioned severe conditions.

Severe dehydration.