This information is intended for use by health professionals
Docusate sodium 100 mg.
For excipients, see Section 6.1.
A two colour (opaque white and opaque yellow) soft, oval, gelatin capsule with a clear, colourless liquid fill.
a) To prevent and treat chronic constipation.
(i) to soften hard, dry stools in order to ease defaecation and reduce straining at stool; and
(ii) in the presence of haemorrhoids and anal fissure, to prevent hard, dry stools and reduce straining.
b) As an adjunct in abdominal radiological procedures.
Route of administration: OralAdults and elderly
Up to 500 mg should be taken daily in divided doses. Treatment should be commenced with large doses, which should be decreased as the condition of the patient improves. For use with barium meals
400 mg to be taken with the meal.Children under 12 years
These capsules should not be administered when abdominal pain, nausea, vomiting or intestinal obstruction is present.
This product should not be given to patients with a known hypersensitivity to Dioctyl capsules or any of the components.
Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Organic disorders should be excluded prior to the administration of any laxative.
The treatment of constipation with any medicinal product is only adjuvant to a healthy lifestyle and diet, for example:
• Increased intake of fluids and dietary fibre.
• Advice on appropriate physical activity
If laxatives are needed every day, or if there is persistent abdominal pain, consult your doctor.
Contains sorbitol: do not use this medicine if you are intolerant to small quantities of sugar (sorbitol, fructose).
Contains colouring E110 which may cause allergic reactions.
These capsules should not be taken concurrently with mineral oil.
There are no adequate data from the use of the drug in pregnant women. Animal studies are insufficient with respect to effects on pregnancy and embryonic foetal development. The potential risk for humans is unknown. During wide use, no adverse consequences have been reported.
Use in pregnancy only if the benefits outweigh the risks.
Docusate sodium is excreted in breast milk and should therefore, be used with caution in lactating mothers.
Rarely, these capsules can cause diarrhoea, nausea, abdominal cramps or skin rash.
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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed below.
The Yellow Card Scheme
By reporting side effects, you can help provide more information on the safety of this medicine.
In rare cases of overdose, excessive loss of water and electrolytes should be treated by encouraging the patient to drink plenty of fluid. Electrolyte loss should be replenished where appropriate.
ATC code: A06A02 Laxatives, softeners, emollients
Docusate sodium is an anionic wetting agent, which acts as a faecal softener by lowering the surface tension and allowing penetration of accumulated hard dry faeces by water and salts.
Docusate Sodium also possesses stimulant activity.
Docusate sodium exerts its clinical effect in the gastrointestinal tract. There is some evidence that docusate sodium is absorbed and is excreted in the bile. There is also evidence that docusate sodium is capable of enhancing absorption of certain compounds administered concomitantly.
Gelatin 175 bloom
Titanium dioxide E171
Quinoline yellow E104
Sunset yellow E110
PVC/PVdC blister packs with aluminium foil: 18 months
Polyethylene / polypropylene containers: 24 months
Do not store above 25°C. Store in the original package in order to protect from moisture.
PVC/PVdC blister packs with aluminium foil containing 10, 20, 30, 40 or 50 capsules.
Polyethylene / polypropylene containers, e.g.: securitainers / tampertainers containing 30, 100 and 250 capsules.
Not all pack sizes may be marketed.
UCB Pharma Limited
208 Bath Road