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DIOCTYL 100 MG CAPSULES

Active substance(s): DOCUSATE SODIUM

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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

PHARMACOLOGICAL PROPERTIES

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 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
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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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