Regulatory Information
OPELLA HEALTHCARE SINGAPORE PTE. LTD.
OPELLA HEALTHCARE SINGAPORE PTE. LTD.
Therapeutic
General Sale List
Formulation Information
ENTERIC COATED TABLET
**Dosage and Administration** 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. **Short-term treatment for constipation** Adults and children over 10 years: 1 to 2 coated tablets (5 – 10 mg) daily before bedtime, or 1 suppository (10 mg) for immediate effect. Children 4 – 10 years: 1 coated tablet (5 mg) daily before bedtime, or 1 suppository (5 mg) for immediate effect. **For preparation of diagnostic procedures and preoperatively** Should only be used under medical supervision. 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. When using DULCOLAX to prepare the patient for radiographic examination of the abdomen or employing it preoperatively, tablets should be combined with suppositories in order to achieve complete evacuation of the intestine. 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. 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.
ORAL
Medical Information
**Indications** For use in patients suffering from constipation. For preparation of diagnostic procedures, in pre- and postoperative treatment and in conditions, which require defecation to be facilitated.
**Contraindications** 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 severe conditions. DULCOLAX is also contraindicated in severe dehydration and in patients with known hypersensitivity to bisacodyl or any other component of the product. In case of rare hereditary conditions that may be incompatible with an excipient of the product (please refer to "Special Precautions" – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) the use of the product is contraindicated.
A06AB02
bisacodyl
Manufacturer Information
OPELLA HEALTHCARE SINGAPORE PTE. LTD.
Delpharm Reims
Active Ingredients
Documents
Package Inserts
Dulcolax Tab PI.pdf
Approved: February 7, 2022