DULCOLAX

Short-term treatment for constipation:

Adults and children over 10 years: 1 suppository (10 mg) daily for immediate effect. Children 4 – 10 years: 1 suppository (5 mg) daily for immediate effect. 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. Children aged 10 years or younger with chronic or persistent constipation should only be treated under the guidance of a physician.

Bisacodyl should not be used in children aged 4 years or younger. For preparation of diagnostic procedures and preoperatively For preparation of diagnostic procedures, in pre- and postoperative treatment when defaecation needs to be facilitated, Dulcolax should be used under medical supervision.

The tablets should be combined with suppositories in order to achievecomplete evacuation of the intestine. Adults and children over 10 years: 2 coated tablets (10 mg) in the morning and 2 coated tablets (10 mg) in the evening and 1 suppository (10 mg) on the following morning is recommended.

Children aged 4 -10 years of age: 1 coated tablet (5 mg) in the evening and 1 suppository (5 mg) on the following morning is recommended.

Instructions for use:

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.

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.

As with all laxatives, Dulcolax should not be used 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) Dulcolax 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 Dulcolax.

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.

Dulcolax is contraindicated in patients with ileus, intestinalobstruction, 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.