DULCOLAX TABLET 5 MG [SIN02669P]

Product Info

DULCOLAX TABLET 5 MG

[SIN02669P]

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.

Dosage and Administration
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) daily for immediate effect.
Children 4 – 10 years: 1 coated tablet (5 mg) daily before bedtime, or 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 achieve complete 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.

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.