DULCOLAX TWELVE PLUS

Adults and children over 12 years: one 10 mg suppository daily for immediate effect. Should not be used in children and adolescents under the age of 12 years. 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.

Instructions for use:

Suppositories are usually effective in about 20 minutes (usual range 10 to 30 minutes). Rarely the laxative effect has been reported 45 minutes after administration. They should be unwrapped and inserted into the rectum pointed end first.

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.

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).

Immune system disorders Rare: anaphylactic reactions, angioedema, hypersensitivity. Metabolism and nutrition disorders Rare: dehydration. Nervous system disorders Uncommon: dizziness.

Rare:

Syncope. g. to abdominal spasm, defaecation). Gastrointestinal disorders Uncommon: haematochezia (blood in stool), vomiting, abdominal discomfort, anorectal discomfort. Common: abdominal cramps, abdominal pain, diarrhoea and nausea. 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Should not be used in children and adolescents under the age of 12 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. 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. 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 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 diarrhoea occurring after taking bisacodyl. Some cases have been shown to be associated with colonic mucosal ischaemia. The use of suppositories may lead to painful sensations and local irritation, especially in patients with anal fissures and ulcerative proctitis.

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 phosphorus 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: Front of Pack • Does not help with weight loss • Overuse can be harmful

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. DULCOLAX Suppositories should not be used when anal fissures or ulcerative proctitis with mucosal damage are present.