Summary of Product Characteristics (SmPC) - Dioctyl 100 mg capsules
1 NAME OF THE MEDICINAL PRODUCT
Dioctyl 100 mg capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Docusate sodium 100 mg.
Excipients with known effect: sorbitol and sunset yellow (E110)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, soft.
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
Posology
Adults:
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.
Elderly:
As for adults.
Paediatric population:
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.
4.3 Contraindications
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.
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.
Excipients
Fructose intolerance:
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.
4.5 Interaction with other medicinal products and other forms of interaction
Dioctyl should not be taken concurrently with mineral oil.
4.6 Fertility, pregnancy and lactation
Pregnancy
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.
Breast-feeding
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
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).
Gastrointestinal disorders:
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.
4.9 Overdose
Management
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
Pharmacotherapeutic group: softeners, emollients, ATC code: A06AA02
Mechanism of action
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
Distribution
Docusate sodium exerts its clinical effect in the gastrointestinal tract.
Elimination
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 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: 2 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, holding 30 or 100 capsules.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements for disposal.
7 MARKETING AUTHORISATION HOLDER
Teofarma S.r.l.
Via Fratelli Cervi 8
Valle Salimbene
PV
27010
Italy
8 MARKETING AUTHORISATION NUMBER(S)
PL 16250/0014
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
17/06/2010
10 DATE OF REVISION OF THE TEXT
21/08/2023