Dulcoease 100 mg capsules

Docusate sodium 100 mg.

For excipients, see Section 6.1.

Capsules

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: 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.

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 Dulcoease 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.

None known.

Rarely, these capsules can cause diarrhoea, nausea, abdominal cramps or skin rash.

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.

None stated.

Macrogol 400

Propylene glycol

Gelatin 195 bloom

Purified water

Sorbitol special

Glycerol

Titanium dioxide E171

Quinoline yellow E104

Sunset yellow E110

None.

PVC / PVdC blister packs with aluminium foil: 18 months.

Polyethylene / polypropylene containers: 24 months.

Do not store above 25ºC. 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.

None

UCB Pharma Limited

208 Bath Road

Slough

Berkshire

SL1 3WE

United Kingdom

PL 00039/0737

28 February 2008 / 17 June 2010

August 2010