Dioctyl 100 mg capsules
Docusate sodium 100 mg.
Excipients with known effect: sorbitol and sunset yellow (E110)
For the full list of 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.
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.
As for adults.
The safety and efficacy of Dioctyl in children aged 0 to 11 years have not yet been established. No data are available.
Method of administration
For oral use.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Dioctyl should not be administered when abdominal pain, nausea, vomiting or intestinal obstruction is present.
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.
This product contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Excipients which may cause allergic reactions:
This product contains sunset yellow (E110) which may cause allergic reactions.
Dioctyl 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.
Frequencies are defined as follows: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Rare: diarrhoea, nausea, abdominal cramps
Skin and subcutaneous tissue disorders:
Not known: skin rash and pruritus.
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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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.
Pharmacotherapeutic group: softeners, emollients, ATC code: A06AA02
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: 2 years
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, holding 30 or 100 capsules.
Not all pack sizes may be marketed.
No special requirements for disposal.
Via Fratelli Cervi 8
17 June 2010