1. Name Of The Medicinal Product
Dioctyl 100 mg Capsules.
DulcoEase, 100 mg capsules
2. Qualitative And Quantitative Composition
Docusate sodium 100 mg.
For excipients, see Section 6.1.
3. Pharmaceutical Form
Capsules
A two colour (opaque white and opaque yellow) soft, oval, gelatin capsule with a clear, colourless liquid fill.
4. Clinical Particulars
4.1 Therapeutic Indications
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.
4.2 Posology And Method Of Administration
Route of administration: Oral
Adults 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:
Not recommended.
4.3 Contraindications
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.
4.4 Special Warnings And Precautions For Use
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.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
These capsules should not be taken concurrently with mineral oil.
4.6 Pregnancy And Lactation
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.
4.7 Effects On Ability To Drive And Use Machines
None known.
4.8 Undesirable Effects
Rarely, these capsules can cause diarrhoea, nausea, abdominal cramps or skin rash.
4.9 Overdose
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.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
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.
5.2 Pharmacokinetic Properties
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.
5.3 Preclinical Safety Data
None Stated
6. Pharmaceutical Particulars
6.1 List Of Excipients
Macrogol 400
Propylene glycol
Gelatin 195 bloom
Purified water
Sorbitol special
Glycerol
Titanium dioxide E171
Quinoline yellow E104
Sunset yellow E110
6.2 Incompatibilities
None.
6.3 Shelf Life
3 years.
6.4 Special Precautions For Storage
Do not store above 25ºC. Store in the original package in order to protect from moisture.
6.5 Nature And Contents Of Container
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.
6.6 Special Precautions For Disposal And Other Handling
None
7. Marketing Authorisation Holder
UCB Pharma Limited
208 Bath Road
Slough
Berkshire
SL1 3WE
United Kingdom
8. Marketing Authorisation Number(S)
PL 00039/0737
9. Date Of First Authorisation/Renewal Of The Authorisation
28 February 2008
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