SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Dioctyl 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 500mg 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:

400mg to be taken with the meal.

Children under 12 yers:

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.

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

Website: www.mhra.gov.uk/yellowcard

By reporting side effects, you can help provide more information on the safety of this medicine.

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.

5.1 Pharmacodynamic properties

ATC code: A06A02 Laxatives, Softeners, emollients Docusate sodium is an anionic wetting agent, which is 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.

6.1 List of Excipients

Macrogol 400 Propylene glycol Gelatin 175 bloom Purified water Sorbitol special Glycerol

Titanium dioxide E171 Quinoline yellow E104 Sunset yellow E110 Lecithin

Isopropyl alcohol Medium-chain triglycerides

6.2 Incompatibilities

None

6.3 Shelf life

PVC/PVdC blister packs with aluminium foil: 18 months Polyethylene / polypropylene containers: 24 months

6.4 Special precautions for storage

Do not store above 25°C. 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

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

17/06/2010

10    DATE OF REVISION OF THE TEXT

29/07/2016